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Affidavit #1 K. Warner
Made November 4, 2021

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No.
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VANCOUVER REGISTRY

IN THE SUPREME COURT OF BRITISH COLUMBIA

IN THE MATTER CONCERNING THE JUDICIAL REVIEW PROCEDURE ACT,

RSBC 1996, C. 241; AND THE PUBLIC HEALTH ACT, SBC 2008, c 28.

BETWEEN:

CANADIAN SOCIETY FOR THE ADVANCEMENT

OF SCIENCE IN PUBLIC POLICY and
KIPLING CONRAD SINGH WARNER
PETITIONERS
AND:

DR. BONNIE HENRY IN HER CAPACITY AS PROVINCIAL HEALTH

OFFICER FOR THE PROVINCE OF BRITISH COLUMBIA

RESPONDENT
AFFIDAVIT

I, Kipling Conrad Singh Warner, with an address for service in these proceedings at 1400
- 1125 Howe Street, in the City of Vancouver, in the Province of British Columbia, MAKE OATH
AND SAY THAT:

1. I am the Executive Director of the Petitioner, Canadian Society for the Advancement of
Science in Public Policy (the “Society”), and as such have personal knowledge of the facts
hereinafier deposed to save and except where stated to be upon information and belief, and where
so stated, I verily believe them to be true.

2. The Society is a non-profit society incorporated on or about January 14, 2021. Now
produced and shown to me and marked as Exhibit “A” to this my affidavit is a copy of the
Statement of Directors and Registered office.

3. On October 20, 2021 I emailed and faxed a request for reconsideration to the respondent,
Dr. Bonnie Henry along with supporting materials.

4. Now produced and shown to me and marked as Exhibit “B” to this my affidavit are true
copies of the email dated October 20, 2021 and the following attachments, which I sent to Dr.
Henry on October 20, 2021:
 Letter dated October 20, 2021;
21-10-20 Request for Reconsideration - Vaccine Passport;
21-10-20 Dr Kettner Report;
COVID l9 Certificates in Europe and a Selection of European Countries - September
29, 2021;
JCVI issues updated advice on COVID-19 vaccination of children aged 12 to 15 -
GOV.UK;
Reopening Ontario (A Flexible Response to Covid-l 0) Act Regulation;
Quebec-- decret-l 173-2021-anglais;
WHO-2019-nCoV-Sci-Brief-Natural-immunity-Z021 .l-eng;
SARS-CoV-Z re-infection risk in Austria;

*o—a“r'P‘qa 9' Lasting immunity found after recovery from COVID-19 - US National Institutes of
t-b 9

Health;
9

Op-Ed Quit Ignoring Natural COVID Immunity MedPage Today;

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario_
December 13, 2020 to October 10, 2021;
Lancet - Vaccine Side-effect Study - April 27 2021;
9 .8 Self-Reported Real-World Safety and Reactogenicity - life-11-00249-v2.

(collectively the “Reconsideration Request”)

5. Now produced and shown to me and marked as Exhibit “C” to this my affidavit is a true
copy of the Virtual Fax confirmation I received confinning the Reconsideration Request materials
were successfully sent to the respondent via facsimile to 1—250-952-1570.
6. Now produced and shown to me and marked as Exhibit “D” to this my affidavit is a true
copy of the automatic reply email dated October 20, 2021 I received from the respondent.
7. To date, I have not received any other response from the respondent or her staff.

SWORN BEFORE ME at Vancouver,

British Columbia, this 4th day of

7001. 1 /
November,

A Commiss1 Taking Affidavits

for British C ll], '

Citadel Law Co oration

1400 - 1125 Howe Street
Vancouver, BC V6Z 2K8
(778) 945-9990
 001

BRITISH
COLUMBIA

CERTIFIED COPY NAME OF SOCIETY: CANADIAN SOCIETY FOR THE ADVANCEMENT OF SCIENCE
$13.22;”.Téill’i‘cm‘m IN PUBLIC POLICY

m
Registrar oI Companies

Incorporation Number: 80074303

Business Number: 78811 4460 800001
CAROL PREST
Filed Date and Time: April 23, 2021 05:52 PM Pacific Time

REGISTERED OFFICE ADDRESS INFORMATION

Delivery Address: Mailing Address:

108 - 2115 CYPRESS ST 108 — 2115 CYPRESS ST
VANCOUVER BC V6J 3M3 VANCOUVER BC V6.1 3M3

EMELEFQBMATIQE ,

Last Name, First Name Middle Name:

GANDHI. DEEPANKAR
Delivery Address:

' 1381 18TH ST E

NORTH VANCOUVER BC V7J 1M2

Last Name, First Name Middle Name:

PARIHAR. ZUBIN SINGH
Delivery Address:
1806 - 1155 HARWOOD ST
VANCOUVER BC V6E 181

Last Name, First Name Middle Name:

WARNER, KIPLING CONRAD SINGH
Delivery Address:

;
—
108 2115 CYPRESS sr
VANCOUVER BC V6J 3M3
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From: Kip Warner <[email protected]>

Sent: October 20, 2021 5:28 PM
To: Dr. Bonnie Henry <[email protected]>
Cc: Polina Furtula <[email protected]>; Phil Dougan <[email protected]>
Subject: Request for Reconsideration about Proof of Vaccination

Dear Dr. Henry,

Please find enclosed pursuant to s 43 of the Public Health Act, SBC 2008, c 28, my request
and the request of the Canadian Society for the Advancement of Science in Public Policy (the
“Society”) for reconsideration of your Food and Liqueur Serving Premises and Gatherings
and Events orders of 10 September, 2021, on my own behalf and on behalf of the Society.
Attached are the following:

a. Our letter dated October 20, 2021;

b. 21-10-20 Request for Reconsideration - Vaccine Passport;
In addition, as supporting materials for the request are the following:
1. 21-10-20 Dr Kettner Report;
2. COVID 19 Certificates in Europe and a Selection of European Countries September -
29, 2021;
3. JCVI issues updated advice on COVID-19 vaccination of children aged 12 to 15 -
w;
Reopening Ontario (A Flexible Response to Covid-IO) Act Regulation;
Quebec-- decret-l 173-202 1-anglais;
WHO-20 19-nCoV-Sci-Brief-Natural-immunity-2021.1-eng;
SARS—CoV-2 re-infection risk in Austria;
Lasting immunity found after recovery from COVID-19 - US National Institutes of
Health;
9. Op-Ed'_ Quit Ignoring Natural COVID Immunity _ MedPage Today;
10. Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario_ December
13, 2020 to October 10,2021;
P°>'.U‘I
 003

-
11. Lancet Vaccine Side-effect Study - April 27 2021;
-
12. Self-Reported Real-World Safety and Reactogenicity life-11-00249-v2.
We look forward to your response,

Kip Warner and the Canadian Societyfor the Advancement of Science in Public Policy
Canadian Societyfor the Advancement of Science in Public Policy
108 - 2115 Cypress Street
Vancouver, BC V61 3M3
Canadian Society for the Advancement of Science in Public Policy
108 - 2115 Cypress Street
Vancouver, BC V6] 3M3

Attn: Dr. Bonnie Henry, PHO

4th Floor, 1515 Blanshard Street
PO Box 9648 Stn Prov Govt
Victoria, BC V8W 9P4

BY EMAIL: [email protected]
BY FAX: (250) 952-1570

20 October 2021

Re: Request for Reconsideration - Vaccine Passport

Dear Dr. Henry,

Please find enclosed pursuant to 5 £13 of the Public Health Act, SBC 2008, c 28, my request
and the request of the Canadian Society for the Advancement of Science in Public Policy (the
"Society") for reconsideration of your Food and Liquour Serving Premises and Gatherings and
Events orders of 10 September, 2021, on my own behalf and on behalf of the Society.

Yours truly,

Kip Warner, Executive Director

Canadian Society for the Advancement of Science in Public Policy (CSASPP)

KCSW/kcsw

cc: — Polina Furtula, by email to pfurtula@citadellawyersca;

- Phil Dougan, by email to [email protected].
 005

encl:
Request for reconsideration, 10 October, 2021;
Dr. Kettner Report, 20 October, 2021;
COVID-19 Certificates in Europe and a Selection of European Countries, 29, September,
2021;
JCVI issues updated advice on COVID-19 vaccination of children aged 12 to 15 - GOV.UK;
Reopening Ontario (A Flexible Response to Covid-10) Act Regulation;
Quebec — decret—1173-2021-anglais;
WHO-2019-nCoV-Sci-Brief-Natural-immunity-2021.1-eng;
SARSCoVZ reinfection risk in Austria;
-
Lasting immunity found after recovery from COVID-19 US National Institutes of Health;
-
Op—Ed Quit Ignoring Natural COVID Immunity - MedPage Today;
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario - December 13,
2020 to October 10, 2021;
Lancet - Vaccine Side-effect Study, 27 April, 2021;
Self-Reported Real-World Safety and Reactogenicity - life-1 1-00249-1/2.
 006

Request for Reconsideration - Vaccine Passport

A. Introduction and Summary
Kip Warner and the Canadian Society for the Advancement of Science in Public Policy
(the “Society”) write to request your reconsideration pursuant to s. 43 of the Public Health
Act, SBC 2008, c. 28 of the following orders (the “Orders”):
1. GATHERINGS AND EVENTS SEPTEMBER 10, 2021. Note: this order applies
—
to events. Section D governs “Proof of Vaccination”, and refers to a “vaccine card”,
which appears to be functionally equivalent to a “proof of vaccination”.
2. FOOD AND LIQUOR SERVING PREMISES SEPTEMBER 10, 2021. Note: this
order applies to restaurants and bars. Section B governs “Proof of Vaccination”,
and also refers to a “vaccine car
We make this request on behalf of the following class of persons in British Columbia
pursuant to s.43(7)(a) of the Public Health Act“.
(a) persons who attend events; M
(b) patrons of restaurants with table service, cafes, food primary or liquor primary
establishments, including pubs, bars, lounges, and nightclubs, liquor
manufacturing facilities that have tasting rooms with seating or private clubs.
Section 43(1) of the Public Health Act sets out the following grounds, inter alia, for a
request for reconsideration:
'

(a) the requester has additional relevant information that was not reasonably available
to the health officer when the order was issued or varied, o_r
(b) the requester a proposal that was not presented to the health officer when the
order was issued or varied but, if implemented, would

(i) meet the objective of the order, E

(ii) be suitable as the basis of a written agreement under section 38 of
the Public Health Act.
You must provide written reasons for any decision to reject our requests for
reconsideration under s.43(3)(a) of the Public Health Act, or to confirm or vary the order
under subsection s.43(3)(c) of the Act. If you rely on any scientific or medical studies,
data, or other information in your reasons, please provide a reference to such documents
in your reasons and append copies.
Our submissions rely on the expert report of Dr. Joel Kettner, the former Chief Medical
Officer of Health of the Province of Manitoba (attached).
 007

B. General Principles
At paras. 12 to 21 of his expert report, Dr. Kettner sets out a series of general principles,
which should govern the Orders and provide the framework for our request for
reconsideration. We adopt this portion of Dr. Kettner’s report in its entirety. For the sake
of clarity, we set out in summary form some of these principles below:

. The Orders must expressly set out, explain and transparently justify the specific
objectives they seek to achieve.

. The Orders must expressly set out the effectiveness, efficiency, and equity of the
interventions they adopt.
o The Orders must expressly set out alternative interventions, and provide a
comparative analysis of their effectiveness, cost-effectiveness, and equity.
0 The Orders must set out the parameters they have chosen, why they have chosen
then, their best estimate for each parameter, the evidence used for making these
estimates, and the use of these estimates.
0 The Orders must set out procedures for estimating, measuring and monitoring the
beneficial effects and harms of interventions.
There are three interrelated reasons that the Orders must comply with these principles.
flat, 8. 43(1)(b) of the Public Health Act provides that the Chief Medical Officer of Health
consider “a proposal that was not presented to the health officer when the order was
issued or varied but, if implemented, would meet the objective of the order”. To
determine if an alternative would meet the objective(s) of the Orders, the Orders m_l_1_s_t set
out what those objectives are. As a legal matter, this is a condition precedent for the s.
43 reconsideration process to function properly. As we explain below, the Orders do not
set out their objectives, which is a fundamental legal defect that places into question the
legality of the Orders.
Second, the Orders must comply with the Canadian Charter of Rights and Freedoms
(“Charter”). As is apparent, these principles are based on the test set out in R. v. Oakes,
[1986] 1 SCR 103, which held that measures that limit Charter rights are only justified if
they pursue a legitimate objective, if the measure chosen to pursue that objective is
rationally connected to that objective, if the measure is minimally impairing, and if the
positive effects of the measure outweigh the harmful effects of the measure. The reason
is that the Order restrict several Charter rights, inter alia the rights to freedom of religion
(s. 2(a)), freedom of expression (3. 2(b)), freedom of assembly (3. 2(c)), and freedom of
association (3. 2(d)), and the right to not be deprived of liberty and security of the person
except in accordance with the principle of fundamental justice (s. 7). It is our position that
the Orders do not satisfy the requirements of the Oakes test.
 008

Third, the Orders must comply with these principles to enable the public, experts, those
most affected, the media, and politicians to engage in meaningful discussion and debate
over the interventions.
C. Application of Principles to the Orders
Dr. Kettner’s expert report applies the principles set out above (Section B) to the Orders
and concludes that the Orders do not comply with them. We adopt Dr. Kettner’s criticisms
in their entirety. For the sake of clarity, we set out in summary form some of his
conclusions below:
The Orders do not provide sufficient information to determine if they are necessary
or proportionate to achieve their state objectives, because the objectives of the
order are unexplained or unclear, some essential information is absent, and
measurable objectives, targets and endpoints have not been stated or explained.

The Orders should provide a transparent explanation of the objectives and a

comprehensive analysis of the outcomes, benefits, harms, and costs - and how
these will be monitored for ongoing reconsideration of the strategy. It is not clear
yet that much change in vaccination rates has occurred in response to various
efforts to encourage or incentivize the 20% of Canadians that have not been fully
vaccinated.

It is not evident in Orders, or in other information on the websites of the British

Columbia government or British Columbia Centres for Disease Control (“BCCDC”),
which data were used, how they were analyzed, how they have been used, and
how they will be monitored and used to demonstrably justify - or not justify - the
mandatory vaccination policies. Presumably, some data and other information
were already used to consider — and reconsider — the rationale used for previous
public health orders and these most recent ones.

The Orders do not provide anyjustification for mandatory vaccination, which would
require estimating quantitatively the effect size of the most important beneficial and
harmful outcomes and comparing the anticipated impacts of different options and
strategies. In other words, to justify mandatory vaccination and access to
vaccination status personal information, there should be a description of the
anticipated benefits, including the estimated increase in vaccination rates, the
estimated decrease of high-risk exposures to infectious persons, the estimated
reduction of infections in higher risk people, and the estimated reduction in the rate
of hospitalizations and deaths - especially premature and unexpected deaths.
Similarly, there should be a description of the anticipated harms, including medical,
—
psychological, social, and economic and how they decrease or increase health
inequities.

There are three conditions which must be met for infection transmission to occur
from one person to another. The first condition is that one person be infected. The
second condition is exposure to the virus by the non-infected person. The third
condition is transmission occurrence — i.e., the exposure to the virus results in
 009

infection. In order to estimate the absolute and relative risk for each of the settings
affected by the Orders, and hence the efficacy of the interventions, data is required
in relation to each condition. With respect to the third condition, in the absence of
information or analysis from case or contact-tracing data in British Columbia or any
other province, there is insufficient information for estimating these probabilities in
local or regional circumstances.
It would not be fair to expect Dr. Henry to be able to answer questions for which
there are not yet sufficiently valid answers. However, an inability to answer
important questions should be expressed transparently as part of the explanation
of the evidence and rationale for a public health order, including the relevant
uncertainties and controversies. Below is a list of other questions which could have
been answered and are now important to answer (or estimate) to demonstrably
justify public health orders, especially when they restrict rights and freedoms and
may cause unintentional harms to health and its determinants.
o What are the goals and specific objectives of the overall public health
responses? Are there endpoints?
o What is the estimated absolute and relative (compared with all other
diseases and injuries) of COVID-19 burden of illness and their impact on
the health system with the current public health interventions without
mandatory vaccine policies?
0 What is the explanation for the minimal change, if any, of the estimated
reproductive value (Re) (one) since January 2021, two months before the
beginning of the vaccination program and since the achievement of a 60%
and higher two-dose vaccination population proportion since August, 2021?
o What is the estimated reduction of the absolute and relative rate (compared
with all other diseases and injuries) of COVID-1 9 burden of illness expected
from mandatory vaccine policies?
0 What are the results of the analyses of the case/contact—tracing data,
including the association of settings, exposures, vaccination status,
previous infection status, and other attributable factors with outcomes of
transmissions, hospitalizations, and deaths?
0 What is the estimated benefit (effect size) of these measures regarding
infection rates, hospitalizations, intensive care admissions, deaths, and
potential years quality-adjusted life years lost associated with COVID-19?
o What is the estimated medical, social, psychological, and economic harm
of these measures?
0 What is the analysis regarding the net impact with consideration of the
alternative activities of (othenivise) restaurant patrons regarding close
contact and transmission in other settings?
0 What other strategies and interventions were considered and how did they
compare with respect to anticipated and estimated effectiveness (including
 010

benefits and harms), efficiency (including cost-effectiveness and cost-

benefit), and equity (i.e., fairness with respect to health inequities)?
o What are the estimated impacts of mandatory vaccination on health and
other care services staffing, and productivity and function of other settings
in which mandatory vaccination policies are applied?
D. Proposed Alternative to the Orders
The Orders do not state the goals you intend to achieve through the interventions you
mandate.
On August 23, 2021,1 the British Columbia government announced by way of a press
release that the government of British Columbia would launch proof of vaccination
scheme to increase the rate of vaccination in the province. The Honourable Adrian Dix,
stated:
“This important step will continue to increase the vaccination rate across the
province and provide confidence to fully vaccinated people that those around them
are also fully vaccinated. ”
As an account of the purposes underlying the Order, we think that Minister Dix’s statement
is problematic for two reasons:
1. Justifying vaccine mandates by reference to the goal of increasing
vaccination rate is circular, because it defines the means in terms of the objective it
is designed to pursue. To be legally defensible, vaCcination must be a means to an
'

end not defined in terms of vaccination itself.

2. Providing confidence to fully vaccinated people that those around them are
also vaccinated is not a public health goal that can serve as the legal basis for an
order under the Public Health Act and/or justify the limitation of Charter rights. The
feelings of fully vaccinated people have nothing to do with arresting the spread of
COVID-19.
In the same press release, you also stated:
“These new measures will help reduce transmission and keep our communities
safe and ensure we can continue to keep businesses open and safely enjoy much-
needed social events.”
If the goal behind the Orders is to slow and reduce transmission, there are a number of
interventions that have been adopted by otherjurisdictions that intrude less on rights and
freedoms of their citizens. Under both the Public Health Act, and the Charter. you have
a legal obligation to opt for minimally impairing alternatives to achieve public health goals,
meciallv when thev are readilv at hand. We must proceed on the assumption all

1 https:l/news.gov.bc.ca/releases/2021 HLTH0053-001659
 011

jurisdictions face comparable risks from COVID-19, and are pursuing the same goal of
reducing the spread of the disease.
We make the following proposal based on policies in otherjurisdictions:
1. Persons be considered “safe” or equivalent to being double vaccinated in the
situations below, so they may enjoy the same rights and freedoms as persons
who are double vaccinated in the Orders:
a. Natural immuniy through a positive RT-PCR or rapid antigen test result
demonstrating recovery from COVID-19 issued no less than 11 days and
no more than 6 months after the date on which a person first tested
positive (e.g., France; this documentation is referred to as a “certificate
of recovery” by the European Union).
b. A negative PCR or antigen test less than 48 hours prior to attendance at
an event (this document is referred to as a “test certificate” by the
European Union or as pr0posed in Alberta under its Restrictions
Exemption Program).
c. A single vaccination after contracting COVID-19 after an interval of at
least 21 days following the illness (e.g., Quebec).
d. Persons who provide a written document, completed and supplied by a
physician or registered nurse, that sets out a documented medical reason
for not being fully vaccinated against COVID-19, and the effective time-
period for the medical reason; (e.g., Ontario).
2. Children up to and including age of 18 be excluded from the Orders.
Alternatively children between the ages of 12 and 17 be excluded from the
Orders.
3. Procedures for estimating, measuring, monitoring and publicly reporting in a
fully transparent manner the beneficial effects and harms of interventions
As indicated, this proposal draws on the following policies and advisories from other
jurisdictions:

. European Union: Attached is a summary of European Union member states

legislation and exemptions titled “COVID 19 Certificates in Europe and a Selection
of European Countries - September 29, 2021”. If you require copies of the

-
legislation form each EU member state, please advise.
United Kingdom: In the United Kingdom, the Joint Committee on Vaccination and
Immunisation (“JCVI”) has stated that the margin of benefit is considered too small
to support universal vaccination for healthy 12 to 15 year old’s at this time. It did
 012

advise vaccinating children over 12 with specific underlying health conditions who
are at greater risk?-
0
Alberta: In Alberta businesses, entities and events must requiring proof of
vaccination or negative test result, plus mandatory masking, to continue operating
as usual see the following link for details of Alberta’s Restrictions Exemption
—
Program: httpszllwwwalberta.ca/covid-l9-public-heaIth-actions.aspx#REP. The
details of Alberta’s Restrictions Exemption Program are also set out below:
To enter spaces participating in the Restrictions Exemption Program, people
aged 12 and older can show proof of a negative test result.
The test result should be a written or printed copy that indicates the individual
has tested negative for COVID-19 on a Health Canada approved rapid antigen,
rapid PCR, or lab-based PCR test approved by Health Canada or the lab
accreditation body of jurisdiction.
Valid test results should be a written or printed copy that clearly outlines the
type of test, time of sample collection, clear indication of a negative result, and
laboratory that completed the test, if applicable.
Photos of a rapid test or result taken offsite is not sufficient.
A self-test completed offsite or self-produced documentation of a negative test
result is not valid.
Do not bring completed self-tests or rapid tests to businesses due to
communicable disease risk.
Tests must not be from the Alberta Health Services public COVID-19 testing
system.
Operators offering on-site rapid testing should seek expert medical oversight
prior to implementing a rapid testing program.

. Ontario: Ontario provides exemptions as follows pursuant to s.2.1(6)(c) of the

Reopening Ontario (A Flexible Response to COVID-19) Act, 2020, Regulation
364/20 (pdf attached):
(6) A business or an organization is exempt from the requirement under
subsection (1) in respect of patrons,

2htt s://www. ov.uk/ overnment/news/‘cvi-issues-u dated-advice-on-covid-19-vaccination-of-children-

aged-12-to-15. (pdf also attached) See also: https://www.bbc.com/news/health-58Alg31Q
 013

(c) who provide a written document, completed and supplied by a physician or

registered nurse in the extended class, that sets out, in accordance with
the Ministry’s guidance mentioned in subsection (4),
(i) a documented medical reason for not being fully vaccinated
against COVID-19, and
(ii) the effective time-period for the medical reason
0 Quebec: Quebec also exempts persons from the requirement of double
vaccination, where a single vaccination is administered after contracting COVID-
19 after an interval of at least 21 days following the illness and requires
vaccination of those 13years and older. Attached is the Quebec Order-in-Council
No. 1173-2021. (pdf attached)

0 In addition, we would like you to consider the studies listed in Appendix A to

this letter, and provide a formal response in your reasons on their implications
for the necessity of the Orders.
 014

Appendix A

The following studies suggest that persons who have recovered from COVID-19 have a
natural immunity that provides protection against re-infection:
May 10, 2021 — Covid-19 Natural Immunity — World Health Organization
httpszllappswho.int/iris/bitstream/handle/10665/341241/WHO-2019-nCoV-Sci-
Brief-Natural-immunitv-2021 .1-enq.pdf?sequence=3&isAllowed=v
(pdf also attached)

The World Health Organization released a scientific update stating that most
people who have recovered from COVID-19 develop a strong protective immune
response. Within 4 weeks of infection, 90% to 99% of people who recover from
COVID-19 develop detectable neutralizing antibodies. Furthermore, given the
limited amount of time to observe cases, the immune response remains strong for
at least 6 to 8 months after infection.

April 17, 2021 - SARS-CoV-2 infection rates of antibody-positive compared with

antibody-negative health-care workers in England: a large, multicentre,
prospective cohort study (SIREN) - Lancet -
httpszllpubmed.ncbi.nlm.nih.qov/33844963/

Scientists have found that there is a decreased risk of re-infection and extremely
low rates of hospitalization and death due to repeat infection. The range of
reduction of re-infection from COVID-19 was between 82% to 95% among six
studies that encompassed nearly 1 million people conducted in the US, the UK,
Denmark, Austria, Qatar, and among US. Marines.

Feb. 13, 2021 - SARS-CoV-2 re-infection risk in Austria —

https:l/onlinelibrarv.wilev.com/doi/epdf/10.1111/eci.13520
(pdf also attached)

The study in Austria also found that the frequency of re-infection from COVID-19
caused hospitalization in only five out of 14,840 (0.03%) people and death in one
out of 14,840 (0.01%).

January 26, 2021 - Lasting immunity found after recovery from COVID-19
Department of Health and Human Services:
— US

https:llwww.nih.qov/news-events/nih—research-matters/lastinq-immunitv-found-
after-recoverv-covid-19#main-content
(pdf also attached)

May 28, 2021 - Op-Ed: Quit Ignoring Natural COVID Immunity

 015

— Antibody testing and proof of prior infection can allow more people to return to
normal - Jeffrey Klausner, MD, MPH, and Noah Kojima, MD:
https://www.medpaqetodav.com/infectiousdisease/covid19/92836
(pdf also attached)

The following studies suggest greater risk of side-effects for certain age, sex, and
previous Covid-19 infection:
0 Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario_ December
13, 2020 to October 10, 2021.pdf

httpszllwww.publichealthontario.ca/—/media/documents/ncov/epi/covid-19-aefi-
report.pdf?la=en
(pdf also attached)

Based on 438 reports of myocarditis or pericarditis, the overall crude reporting rate
is 20.9 per million doses of mRNA vaccines administered. The highest reporting
rates were observed in younger age groups Adverse Events Following
Immunization (AEFIs) for COVID-19 in Ontario 10 (12-17 and 18-24 years) and
among males. The highest reporting rate was observed for males aged 18- 24
years of age following dose 2, at 173.3 events per million doses administered.

. “Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the

COVID Symptom Study app in the UK: a prospective observational study” - Lancet
Infect Dis 2021; 21: 939—49 Published Online April 27, 2021 (https://doi.orgl10.1016/);
S1473-3099(21)00224—3

htt s: www.thelancet.com ‘ournals laninf article PIISl473~3099 21 00224-3 fulltext

Adverse effects are more frequently reported in younger individuals, women, and
among those who previously had COVID-19.

. “Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A

Vaccine Recipient Survey" - Life 2021,11, 249.

https://doi.org/10.3390/life11030249

A prior COVID-19 infection was associated with an increased risk of severe side
effects leading to hospital care (1.56 (1 .14—2.12)).

10
 016

Report
Citadel Law Corporation
October 19, 2021
Joel Kettner

Credentials

1. I am an associate professor in the Department of Community Health Sciences at the College

of Medicine, University of Manitoba.

2. I hold Canadian Royal College fellowship certifications in Public Health and Preventive
Medicine and General Surgery. I have a Master of Science in Epidemiology from the London
School of Hygiene and Tropical Medicine, University of London, United Kingdom.

3. Prior to January 2012, my employment included: Chief Medical Officer of Health and Chief
Public Health Officer for the Province of Manitoba (1999-2012), regional medical officer of health
in urban, rural, and northern parts of Manitoba (1990-1999), and clinical work in general practice,
emergency urgent care medicine. Since 1990, have been a professor at the University of Manitoba
College of Medicine.

4. As part of my 12-year tenure as Manitoba’s chief medical officer of health, I led the
province’s public health responses to several outbreaks including the SARS Coronavirus-l and the
H1N1 pandemic influenza.

5. Following the SARS outbreak, I was part of the Canadian delegation to the World Health
Organization special meeting in Geneva, November 1-12, 2004 to develop the fourth edition
(2005) of the International Health Regulations, which introduced the concept, definition, and
expectations of countries during a Public Health Emergency of International Concern (PHEIC).

6. I played a leading role at the World Health Organization-Pan American Health Organization
special HlNl meeting, October 14-16, 2009, in Washington DC. In addition to a plenary
presentation describing Manitoba’s experience with the first wave, I led a working group to
develop guidance for the prevention and treatment of HINI in poorly resourced parts of the world.
At that same meeting, I collaborated as an author of the first comprehensive review article of H1N1
 017

influenza published in the New England Journal of Medicine.

7. Following my tenure as chief medical officer of health, I have held several relevant roles and
responsibilities including Scientific Director of the Public Health Agency of Canada’s National
Collaborating Centre for Infectious Diseases, Medical Director of the International Centre for
Infectious Diseases in Winnipeg, the Board of Directors of the Canadian Public Health
Association, and President of the Public Health Physicians of Canada.

8. My relevant roles at the University of Manitoba have included director of the Medical
College undergraduate program in Community Health Sciences and director of the Master’s in
Public Health program. I continue to teach public health and epidemiology at the undergraduate,
graduate, and post-graduate levels. During this COVID-l9 pandemic, I have been active in
organizing events and providing expert opinion and dialogue in a variety of academic and public
media platforms, including radio, television, and newspaper. I have created and led a national
physicians’ chat group for COVID-l9. I have provided expert witness for court proceedings in
New Brunswick, Ontario, Manitoba, Yukon, and British Columbia.

Area at Opinion

9. In preparing this letter, I have reviewed:

3. Order of the Provincial Health Officer COVID-l9 VACCINATION STATUS

INFORMATION AND PREVENTIVE MEASURES ORDER — SEPTEMBER 9,
202] , September 27, 2021, and October 6, 202] .

b. Order of the Provincial Health Officer FOOD AND LIQUOR SERVING PREMISES
— SEPTEMBER 10, 2021
0. Order of the Provincial Health Officer GATHERINGS AND EVENTS —

SEPTEMBER 10, 2021

10. Please find attached as Exhibit A to this affidavit a list of references used as indicated by
superscripted numbers in the relevant paragraph.
 018

The questions

II. I have been asked to provide my opinion on the following questions:

I. Has Dr. Henry in the Preambles of the above-referenced Orders, included adequate
information and rationales to demonstrate that the Orders are proportionate and necessary to
achieve their stated objectives?

2. What is the efficacy of the COVID-19 vaccines currently being offered in British
Columbia, namely those manufactured by Pfizer, Moderna, AstraZeneca (the “vaccines”
over time? That is, do the vaccines lose efficacy, and if so, at what rate?

3. What degree of immunity to COVID-l9 do persons previously infected with COVID-l9

possess, as compared to persons who have been single or double vaccinated? How long does
this natural immunity last?

4. What is the probability of transmission of COVID-19 from an infected person to a non-

infected person who has been previously infected or vaccinated? What is the probability of
transmission of COVID-19 from an infected person to a non-infected person who is
unvaccinated?

5. What proportion of the population is immune to COVID-19 either through vaccines,

known or unknown infections?

6. Can double vaccinated persons transmit COVID-I 9, including variants such as Delta and
others currently circulating in British Columbia, and if so, to what extent? How does the rate
at which double vaccinated persons transmit COVID-19 compare to the rates at which
unvaccinated persons and single vaccinated persons transmit COVID-19? In answering these
questions, please consider Israel’s experience with double and triple vaccination with the
Pfizer Vaccine and the current surge of COVID-l 9 infections

7. How much have we reduced probability of transmission of COVID-19 by insisting that

people are vaccinated?

8. Some jurisdictions have determined that other statuses are equivalent to having been
 019

vaccinated twice. Please consider the following alternatives set out below. From a public
health perspective, are these measures equivalent to proof of two dose vaccination in
reducing or eliminating the spread of COVID—19? And if not, how different? How do they
compare with the “proof of vaccination” requirements in GATHERINGS AND EVENTS —
SEPTEMBER 10, 2021 and FOOD AND LIQUOR SERVING PREMISES SEPTEMBER 10,
2021?

8a. A positive RT-PCR or rapid antigen test result demonstrating recovery from COVID-19
issued no less than 11 days and no more than 6 months after the date on which a person first
tested positive (e.g., France; this documentation is referred to as a “certificate of recovery”
by the European Union).

8b. A negative PCR or antigen test less than 48 hours prior to attendance at an event (this
document is referred to as a “test certificate” by the European Union).

8c. A single vaccination after contracting COVID-19 after an interval of at least 21 days
following the illness (e.g., Quebec).

9. Would COVID-19 vaccination exemptions

for persons for a documented medical reason,
as confirmed by a physician or registered nurse (as is the case in Ontario), pose a public
health threat in light of the rate of COVID-19 immunization in British Columbia? To what
degree would it pose a threat and what would be the impact on important outcomes? If
someone has a medical exemption and takes a rapid PCR or other test within 48 hours of
entry to an event, is there an additional risk in terms of transmission and if so, how much?

10. What is the probability of severe illness of COVID-19 in children aged 12 to 18? Are the
serious or long-term side effects at least or less than the serious or long-term adverse effects
of COVID-19 in children aged 12 to 18?

11. What other questions, in my opinion, should have been answered by Dr. Henry to explain
and to justify the three public health orders referred to above?
 020

Principles and Practice used to Respond to Public Health Threats; my context and basis for
addressing the questions that I have been asked.

12. In addition to the Canadian Charter of Rights and Freedoms, most public health acts and
emergencies acts refer to the requirement of governments and public health authorities to use the
least intrusive means necessary to respond to a public health threat. These decisions are matters of
judgment. The standards and ethics of public health practice require that they be reasonable, fair,
based on science and evidence, and be explained transparently. These principles are described in
the British Columbia Centre for Disease Control (BCCDC) Ethics Framework and Decision-
Making Guide.l

13. Decisions should consider several factors, including the burden and severity of the public
health threat, the goals and objectives of the strategy, and the pros and cons of intervention options.
In public health plans or strategies, goals are usually broad and unmeasured (e.g., reduce burden
of COVID-19 on hospitals), whereas objectives are specific and measurable (e.g., to prevent the
number of COVID-19 patients requiring hospitalization from exceeding 10% of all hospital beds
at any one time).

14. I have not been able to find in any of Dr. Henry’s orders or on a British Columbia government
website a description or explanation of specific objectives of the COVID-19 strategy in general,
or the mandating of vaccination. A Google word search for “British Columbia COVID strategies
goals objectives” failed to find a website with a description of a strategy with goals and measurable
objectives. The same word search on the most recent BCCDC COVID-19 Situation Report2 found
none of these search terms. There is a table of vaccination phases, describing targeted age groups,
but no measurable targets or objectives (e.g., a percentage target of eligible persons to be
vaccinated) were found.

15. The pros and cons of interventions should consider net effectiveness (benefit minus harm),
efficiency (e.g., cost-effectiveness), and equity (fairness of the different impacts the intervention

' http://www.bccdc.ca/resource-
aallerv/Documents/Guidelines%20and%20Forms/Guidelines%20and%20Manuals/BCCDC Ethics Framework De
cision Making Guidebdf
2http://www.bccdc.ca/Health-lnfo-Site/Documents/COV|D sitren/Week 38 2021 BC COVID-
l9 Situation Reportndf
 021

might have on people and communities, especially those that were already disadvantaged with
respect to the determinants of health). I have not been able to find a description of the method or
estimates used to consider effectiveness, cost-effectiveness, or equity of the Orders. Nor have I
been able to find a description or comparative analysis of effectiveness, cost-effectiveness, and
equity of other options.

16. Decisions and judgments should be made using available data and evidence, including
scientific principles and previous relevant empirical experience. Because of the complex and
changing nature of biology and human society, the available evidence is always incomplete.

17. This lack of complete data is often truer in a public health threat that has new and unforeseen
elements, especially when the reactions of governments, public health leaders, and members of the
public may be more difficult to predict than the biological interactions between the virus and its
human host organism.

18. The expected approach of decision-makers and communicators when data is incomplete is
to make the best estimates possible of the most relevant and consequential parameters. It is
incumbent on decision-makers to explain why they have chosen such parameters, what are their
best estimates of each parameter, what evidence has been used for making these estimates, and
how they have used these estimates in their decision-making. Other considerations, some of which
may be more qualitative than quantitative, should also be explained. These include values, ethics,
and culture. For further clarity, considerations and outcomes of various strategy options include
personal, psychological, spiritual, health and social care, social relationships, and networks,
educational, environmental, economic (including employment and income), and recreational
determinants of health.

19. For quantitative estimates, such as the effectiveness of certain interventions, it is not enough
to say that “something works” or that something “may happen”. In public health, like clinical
medicine, effect size (measurable benefits and harms) and probabilities should be estimated even
in the absence of strong evidence. Assertions such as masks “work” without an estimate of the
infection transmission reduction and other benefits and harms should be considered just as
unacceptable as asserting that a vaccine “works” without providing a numerical estimation of its
efficacy or effectiveness such as the reduction of infections, hospitalizations, and deaths as well as
 022

the rate and severity of side effects.

20. For public health strategies such as mandatory vaccination or restriction of activities for
people without full vaccination, the beneficial effects and harms of such an intervention should be
estimated, measured, and monitored. The choice of measurements should be determined by the
objectives of the strategy whether they are to incentivize and increase vaccination rates and/or to
reduce infection transmission.

21. Interventions in public health should be explained and justified transparently, including
admissions of uncertainty. Options should be described. Reasons for their acceptance or rejection
should be explained. Without these, the ability of the public, including experts, those most affected,
the media, and politicians to engage in meaningful discussion and debate is limited. Citizen
engagement based on these principles should be expected to improve government decision-making
and should be expected to gain the trust and willingness of the public who are asked or mandated
to make personal, family, and community sacrifices in the interest of the public good.

My opinions on the questions

22. My answers to the questions asked of me by counsel are as follows:

1. Has Dr. Henry in the Preambles of the Orders included adequate information or rationale
to determine if the orders are proportionate and necessary to achieve the stated objectives?

23. I could not find adequate information or rationale to determine if the orders are proportionate
and necessary to achieve stated objectives. This is because some essential information is absent,
the rationale is unexplained or unclear, and measurable objectives, targets, and endpoints have not
been stated or elucidated.

24. In section 0 of COVID—I9 VACCINATION STATUS INFORA/IATION AND PREVENTIVE

MEASURES ORDER -— SEPTEMBER 9, 2021, Dr. Henry states, reasonably, that:

“constitutionally protected interests include the rights and freedoms guaranteed by the
Canadian Charter of Rights and Freedoms, including the right to life, liberty, and security
of the person, along with freedom of religion and conscience, freedom of thought, belief,
 023

opinion and expression. These rights and freedoms, are not, however, absolute and are
subject to reasonable limits, prescribed by law as can be demonstrably justified in a free and
democratic society. These limits include proportionate, precautionary, and evidence-based
restrictions to prevent loss of life, serious illness and disruption of our health system and
society. When exercising my powers to protect the health of the public from the risks posed
by COVID-19, I am aware of my obligation to choose measures that limit the Charter rights
and fi'eedoms of British Columbians less intrusively, where doing so is consistent with public
health principles.”

25. Some of these public health ethical principles are described in the document BCCDC Ethics
Framework and Decision-Making Guide3 and are quoted here. The “harm principle is...
justification for intervention by the state and a warrant for infringements on personal autonomy in
the name of harm prevention or reduction”. This “justification” is governed by the requirement for
“distributive justice” which entails “the fair distribution of both benefits and harms and risks
among a population”. This, in turn, is governed by “proportionality, the notion that any public
health intervention should be proportionate to the threat faced, and that measures taken should not
exceed those necessary to address the actual risk”. These last two words — “actual risk” - are
significant because assessments of proportionalities depend on best estimates of the “actual risk”
of the disease threat, best estimates of the effectiveness of the intervention options, and best
estimates of the harmful effects of the intervention options. In epidemiology, the scientific
foundation of public health practice, “actual risk” is usually measured and described quantitatively.

26. —
Without addressing harm, distributive justice, and proportionality and without reasonable
estimates of the risk and size of the threat and of the effectiveness and harms of intervention
options — “public justification” cannot be meaningful. “This is related to transparency. When a
public health program threatens to infringe on the liberties of an individual or community, public
justification is the notion that the agency has a responsibility to explain and justify this

3 http://www.bccdc.ca/resource~
aallerv/Documents/Guidelines%20and%20Forms/Guidelines%20and%20Manuals/BCCDC Ethics Framework De
cision Making Guidepdf
 024

infiingement.”4

27. BCCDC’s 10th principle of ethical practice of public health is: “Any program must have
clearly defined objectives; furthermore, there should be evidence of programs’ and policies’
effectiveness in achieving these goals.”5

28. In public health, a field of medicine based on the scientific methods of epidemiology, the
demonstrable justification of public health measures must include estimates of quantified
effectiveness, including benefits and harms of interventions. It is not sufficient to state that one is
“aware” of one’s “obligation to choose measures that limit the Charter rights and freedoms of
British Columbians less intrusively, where doing so is consistent with public health principles”. It
is incumbent on public health officials to apply public health principles to measure and estimate
quantitatively the health threat, to compare the benefits and harms of optional strategies, and to
explain the rationale for their decisions.

29. In section N of COVID-I9 VACCINA TION STATUS INFORMATION AND PREVENTIVE

MEASURES ORDER — SEPTEMBER 9, 2021, Dr. Henry includes, appropriately, some of the
information and rationale that would be considered in determining whether orders are
proportionate and necessary to achieve stated objectives. These include “infection rates, sources
of transmission, the presence of clusters and outbreaks, particularly in facilities, the number of
people in hOSpital and in intensive care, deaths, the emergence of and risks posed by virus variants
of concern, vaccine availability, immunization rates, the vulnerability of particular populations and
reports from the rest of Canada and other jurisdictions”. Dr. Henry states that she has “engaged
and will continue to engage in a process of reconsideration of these measures, based on the
information and evidence available”, including those above.

30. It is not evident in the preambles to the orders or in other information sites of the British
Columbia government or BCCDC which of these data were used, how they were analyzed, how

4 http://www.bccdc.ca/resource—
gallery/Documents/Guidelines%20and%20Forms/Guidelines%20and%20Manuals/BCCDC Ethics Framework De
cision Making. Guide.bdfp.5
5 http://www.bccdc.ca/resource-
gallery/Documents/Guidelines%203nd%20Forms/Guidelines%20and%20Manuals/BCCDC Ethics Framework De
cision Making Guide.pdfp.9
 025
10

they have been used, and how they will be monitored and used to demonstrably justify - or not
justify — the mandatory vaccination policies. Presumably, some data and other information were
already used to consider — and reconsider - the rationale used for previous public health orders and
these most recent ones.

31. The justification for mandatory vaccination should be demonstrated by estimating

quantitatively the effect size of the most important beneficial and harmful outcomes, and by
comparing the anticipated impacts of different options and strategies. In other words, to justify
mandatory vaccination and access to vaccination status personal information, there should be a
description of the anticipated benefits, including the estimated increase in vaccination rates, the
estimated decrease of high-risk exposures to infectious persons, the estimated reduction of
infections in higher risk people, and the estimated reduction in the rate of hospitalizations and
deaths — especially premature and unexpected deaths. Similarly, there should be a description of
the anticipated harms, including medical, psychological, social, and economic — and how they
decrease or increase health inequities.

32. Without objectives, targets, or endpoints, it is not clear why or when these orders will be
rescinded. Is there a target vaccination rate (e.g., 85%, 90%)? Is there a target rate of cases,
hospitalizations, or deaths? Is there a target of in-hospital and in-ICU COVID-l9 cases as a
proportion of bed occupancy? Without targets — and the rationale for them — one cannot compare
alternative strategies that might achieve the same outcomes with less disruption and harm. Without
targets — and the rationale for them - the public is unable to anticipate why or when these orders
will be rescinded.

2. What is the efficacy of the COVID-19 vaccines currently being offered in British
Columbia, namely those manufactured by Pfizer, Moderna, AstraZeneca (the “vaccines”)
over time? That is, do the vaccines lose efficacy, and if so, at what rate?

33. At this time, there is limited evidence on the duration of protection and on the efficacy of
these vaccines in reducing transmission of SARS-CoV-2.

34. It has been less than one year since the start of vaccination programs. Clearly, the duration
of protection beyond this time has not been ascertained. Furthermore, to answer this question
 026
11

requires clarification of the difference between efficacy and effectiveness, and a recognition of the
many variables associated with vaccine protection.

35. Efficacy, in contradistinction to effectiveness, refers to the performance of an intervention

when tested under ideal conditions, usually by an experimental method. Efficacy of vaccines are
typically studied in randomized controlled trials using a sample of participants screened for strict
inclusion and exclusion criteria. These methods may limit the generalizability of the results to
people with characteristics that were excluded from the trials. Efficacy studies can only estimate
what is measured and for the duration of the observation. Effectiveness, in contradistinction to
efficacy, is the performance of an intervention “in the real world”. Effectiveness studies, like
efficacy, can only estimate what is measured. Extrapolations to apply the findings of any study to
other circumstances or to the future are matters for scientific consideration and debate.

36. The efficacy of vaccines is estimated by comparing outcomes of people randomized to

receive the vaccine (study group) with people randomized to receive a placebo (control group).
Outcomes may include antibody levels, incidence of infection, incidence of severe infection, and
incidence of transmission, all of which should be defined at the time of study design.

37. Perhaps too obvious to state, the duration of defined outcomes — whether measured by
efficacy or effectiveness — cannot be longer than the period of time from the intervention.
However, trends of efficacy and effectiveness — and comparisons with other vaccines that have
been observed for longer time periods — may provide some evidence for extrapolation of new
vaccines beyond their time of observation.

38. The National Advisory Committee on Immunization (NACI) maintains an updated Advisory
Committee Statement on Recommendations on the use of COVID-I 9
vaccines.6 NACI’s September
28, 2021 Recommendations on the use of COVID-19 vaccines states: “There is currently limited
evidence on the duration of protection and on the efficacy of these vaccines in reducing
transmission of SARS-CoV-Z, although studies are ongoing.”7 The vaccines referred to in this
statement are Pfizer BioNTech Comimaty COVID-19 vaccine, Moderna Spikevax COVID-19

6 Imps://www.canada.ca/content/dam/phac-aspc/documents/sewices/immunization/national-advisorv-committee-on-
1mmunization-naci/recommendations-use-covid- l 9-vaccines/recom mendations-use-covid- I 9-vaccines-en.pdf
7 Imps://www.canada.ca/content/dam/phac-aspc/documents/services/immunizationlnational-advisorv-committee-on-
immunization-naci/rccommendalions-use-covid- l 9—vaccines/recommendations-use-covid- I 9-vaccines-en.pdf p.8
 027
l2

vaccine, AstraZeneca Vaxzevria COVID-19 vaccine, and Janssen COVID-19 vaccine.

3. What degree of immunity to COVID-l9 do persons previously infected with COVID-l9

possess, as compared to persons who have been single or double vaccinated? How long does
this natural immunity last?

39. The answers to these questions cannot be generalized, especially amongst different types or
manufacturers of vaccines. In general, during the one year since the first use of COVID-19
vaccines, it has been estimated that previous infection confers significant protection against re-
infection, at least as high as the protection associated with double vaccination and therefore, would
be expected to be higher than that achieved by single vaccination. The duration of immunity for
vaccinated or infected persons is not yet known.

40. The National Advisory Committee on Immunization (NACI) maintains an updated Advisory
Committee Statement on Recommendations on the use of COVID-19 vaccines.8 The most recent
version used for reference is September 28, 2021, published by the Public Health Agency of
Canada.

41. Regarding the efficacy of vaccines, NACI provides the following summary of the efficacy
of mRNA and non-replicating viral vector vaccines:

“In clinical trials, all COVID-l9 vaccines are efficacious in the short—term against
symptomatic, confirmed COVID-19 disease; trials are ongoing. mRNA COVID-19
vaccines have demonstrated high efficacy (294%). The AstraZeneca COVID-19 vaccine
has demonstrated an average efficacy of approximately 62% in those 18-64 years of age.
In adults 65 years of age and older who received one dose of AstraZeneca, real-world
observational data of vaccine effectiveness have shown a reduction in the risk of
symptomatic disease and hospitalization. The Janssen COVID-19 vaccine has
demonstrated efficacy of 67% against confirmed symptomatic moderate to severe/critical
infection based on trials conducted in South Africa and Brazil while B] .351 (Beta) variant
of concern (VOC) and P2 (Zeta) variant of interest (VOI) were circulating, respectively.

8
https://www.canada.ca/content/dam/phac-aspc/documents/serviceslimmunization/national-advisory-committee-on-
immunization-naci/recommendations-use-covid-19-vaccines/recommendations—use-covid-19-vaccines-en.pdf
 023
13

There is currently limited evidence on the duration of protection and on the efficacy of
these vaccines in reducing transmission of SARS-CoV—Z, although studies are ongoing.
Evidence of protection against asymptomatic SARS-CoV-Z infection is emerging for the
mRNA and Janssen vaccines?”

42. Regarding protection against re-infection in people previously infected, NACI states:

“These observational studies suggest previous infection with SARS-CoV-2 induces good
protection against subsequent infection and that the protective effect may be comparable
to complete mRNA COVID-l9 vaccination in individuals without prior infection.
However, whether the duration of protection generated from previous infection is similar
to that elicited by mRNA COVID-19 vaccination remains unknown. The duration of
protection provided by vaccination also remains unclear at this time.1°”

43. It is reasonable to conclude that natural immunity would be at least — and probably more —
protective than a single dose vaccination.

4. What is the probability of transmission of COVID-19 from an infected person to a non-

infected person who has been previously infected or vaccinated? What is the probability of
transmission of COVID-19 from an infected person to a non-infected person who is
unvaccinated?

44. Given a 90% protection efficacy, it is reasonable to estimate that the probability of
transmission to a previously infected or vaccinated person is ten'times lower than the probability
of transmission to an unvaccinated person that has not been infected. Given that the overall
population average number of transmissions from one infected person (the Re) is currently one, it
would be reasonable to estimate that an infected person would have a 10% probability of
transmitting infection to another person if all of their contacts were either vaccinated or previously

9 https://www.canada.ca/content/dam/phac-aspc/documents/services/1mmunization/national-advisoyy-committee-on-
immunization-naci/recommendations-use-covid- I 9-vaccines/rccommendations-use-covid- l 9-vaccines-en.pdf pp. 7-
8
'0 https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-
on-i m m unization-naci/recom mendations-use-covid- l 9-vaccines/recommendations-use-covid- l 9-vaccines-en. df p.
39.
 029
14

infected.

45. Despite a 60% two-dose population vaccination proportion for the past three months11 the
average estimated R value is not different today than it was in January of this year”, two months
before the start of the vaccination program. This raises another question. If the purpose of the
vaccination program — voluntary or mandatory — is to reduce the rate of transmission in the
population, why are the average number of transmissions per infected person not different than
they were two months before the vaccination program began?

46. However, the relative risk factor of 10 does not answer the question of the absolute
probability of transmission during a specific encounter under specific conditions. What is the
absolute probability that transmission of infection would occur from an infected person to a
vaccinated person? To an unvaccinated person? How can we answer this question? I am not aware
of validated estimates of the absolute risk of transmission resulting from one or more encounters,
sub-analyzed by exposure or setting type. But if an infected person, on average, transmits infection
to one other person — during their one-week period of infectiousness — the risk of transmission per
exposure could be estimated by dividing one by the number of person-exposures in a one-week
period.

47. There are three conditions which must be met for infection transmission to occur from one
person to another. The first condition is that one person be infected. The second condition is
exposure to the virus by the non-infected person. The third condition is transmission occurrence -
i.e., the exposure to the virus results in infection. Transmission is not equivalent to exposure to the
virus, or the event of viruses being passed from one person to the other. Those are mechanisms
that are necessary for transmission but are not sufficient for and do not necessarily result in
transmission of infection. Transmission refers to an actual infection resulting from the exposure.

48. For COVID-19 infection to occur, sufficient virus must invade cells and pathologically
impact on the host, usually causing an immune response and inflammatory reaction. Like most
other infectious diseases, an infected source (case) and a resultant transmission to a contact may
occur when the infected source has no symptoms, mild symptoms, or severe symptoms. This range

11http://www.bccdc.ca/Health-lnfo-Site/Documents/COVID sitrep/2021-10-07 Data Summarypdf p.26

12 http://www.bccdc.ca/Health-lnfo-Site/Docgments/COVID sitrepL2021-10-07 Data Summarvpdf p.43
 030
l5

of symptoms depends on many factors including the degree of inflammation, tissue damage, and
other pathological phenomena.

49. —
The probability of transmission is the product of each of the three probabilities the presence
of infection in one person (the source), exposure of the non-infected person to an infected person’s
SARS-CoV-2 virus, and a resultant infection in the exposed person.

50. The probability of the first condition (point prevalence in epidemiological terms) can be
estimated using the current incidence rate of new infections as indicated by reported case rates.
Using an average infectious period of one week”, the estimated point prevalence (probability on
any one day) of a person being infectious can be calculated by the rate of new cases per day
(incidence) multiplied by seven (duration of infectiousness). This formula can be used for a
population as a whole or it can be adjusted/filtered by subsets such as age group, occupation,
vaccination status, previous infectious status, etc.

51. Using general population-based case rates as reported in BCCDC Data Summary, October
1, 2021, the rate of new cases in BC has averaged about 750 per day for the past month.'4 Using
the BC population of 5.1 million15 as the denominator, the estimated daily rate of new cases has
been 750/5,100,000 = 0.00015 = 0.015% = 1 in 7,000. Using 7 days as an average number of days
of infectiousness, the probability that any one person is infectious on a given day is one per 1000.
For example, in an event with 1000 people, it could be estimated that one person would be
infectious and 999 would not.

52. Of the 999 non-infectious persons, how many would be estimated to be “completely
susceptible” because of no previous infection or vaccination? A reasonable estimate is that less
than 25% would be susceptible. This is explained further in my answer to question 5.

53. Estimating the absolute probabilities of exposure and transmission during any one encounter
is more difficult. This is a complex estimate because of the many relevant variables. Factors which
are likely to increase exposure and transmission are the presence of symptoms (e.g. sneezing or

'3 https://www.uptodate.com/contents/covid-19-epidemiology-virology-and-
prevention?search=undefined&source=covid 19_landing&usage_type=main_section
'4 http://www.bccdc.ca/Health-Info-Site/Documents/COVID_sitrep/2021-10-01-Data_Summary.pdf
'5 https://bcstats.shinyapps.io/popApp/
 031
16

coughing), nature of exposure (kissing or talking), distance of exposure, duration of exposure,

presence of barriers (masks, shields), outdoors vs. indoors, or social environment of various
settings (family households, workplace, education, etc.). In the absence of information or analysis
from case or contact-tracing data in British Columbia or any other province, there is insufficient
information for estimating these probabilities in local or regional circumstances.

54. Using today’s estimate of an effective R value of approximately 1.016, one can estimate that,
on average, through the whole duration of their infection, one infected person will infect one other
person. To estimate the absolute rate of transmission per exposure during the estimated seven days
of infectiousness would require an estimate of the average number and types of exposures and
settings per infected person during their infectious period. This information would be relevant to
estimating absolute and relative risk for each of the settings affected by these orders. It would also
be required to estimate the effect size of mandatory vaccination on the rate of higher risk exposures
and transmission. Such data or estimates have not been provided in the orders, by the Ministry of
Health, or by BCCDC.

5. What proportion of the population is immune to COVID—19 either through vaccines,

known or unknown infections?

55. This varies by age group, region, and other factors. There are three conditions that
contribution to an estimate of the proportion of a population that would be considered to have at
least some protective immunity against an infection or re-infection with the SARS-CoV-2 virus.
These are 1) cases (usually diagnosed with a positive RT-PCR test result), 2) vaccinated persons,
and/or 3) people with a positive serology (antibody) test, indicating previous infection (“natural
immunity”) or vaccine-induced immunity.

56. To estimate the proportion of the population that is considered protected from re-infection
is dependent on the following factors: 1) the cumulative incidence of cases — or full period
prevalence - since the first case, 2) the accuracy of diagnostic methods, and 3) the estimated level
and duration of protection for each of the three conditions described above.

57. The BCCDC states “Based on the published literature, commercial laboratory-based assays

1“
mJ/wwwbccdcca/Health-Info-Site/Documents/COVID sitrep/2021-10-07 Data Summarypdf p.43
 032
17

are about 95% sensitive at ~30 days post symptom onset and the specificity is approximately
99.5%”17 This means that these tests are will be positive 0.5% of the time in people that do not
have antibodies (i.e. false positive result) and negative 5% of the time in people that do have
antibodies (i.e. false negative result). The probability that a positive or negative test result will
accurately predict the true status of the individual depends on prevalence or pre-test probability
of positive and negative status of the individual being tested. There are a number
epidemiological and clinical factors that can be considered to estimated pre-test likelihoods.

58. Based on available data provided by situation reports of BCCDC and other sources of
information, a reasonable estimate of the proportion of the population that is susceptible to a
COVID-19 infections at the time of writing this report is less than 30%.

59. As of October 8, for the whole British Columbia population, 79% have had at least one
dose and 73% have been double-vaccinated”. More than 90% of the vaccinations administered
have been Moderna or Pfizer. Using 90% as the estimated effectiveness for double-vaccinated
and 50% for single vaccinated, about 70% of the total population and about 75% of the
population > 12 years could be considered vaccine-protected at this time.

60. The number of reported COVID-19 cases in children under 10, as of September 25 is
12,187”. Because the demographic division for reported cases, is <10 and 10-19, an average
annual case count for 0-19 is applied to the ages 11 and 12, resulting in an estimated rounded
total case count for <12 y.o. = 16,000. This number represents 0.3% of the population and does
not contribute significantly to the estimate of the proportion of British Columbians that could be
considered to be protected at this time.

61. To estimate the proportion of the unvaccinated population that are immune is more
complex. The cumulative case count, as of October 8 was 192,491”. This constitutes
192,491/5.1 million = 3.8% of the population. To estimate what proportion of these cases might

17 http://www.bccdc.ca/health-professionals/clinical-resources/covid-19-care/covid-19-testing/antibody-testing-
(serology)
‘8 httpsz/lcovid l 9tracker.ca/provincevac.htm l?p=BC

'9 http://www.bccdc.ca/Health-Info-Site/Documents/COVID_sitrep/Week_3 8_2021_BC_COVID-

19_Situation_Report.pdf
2° https://experience.arcgis.com/experience/a6t23959a8b14bfa989e3cda29297ded
 033
18

have occurred to double-vaccinated persons, we can estimate that using the age-adjusted case
rate for double-vaccinated persons of 12.4 per 10,000 per month”. It is reasonable to estimate
the number of infections amongst vaccinated individuals over the past three months as
12.4/10,000 (per month) *3 (months) * .73/2 (average percentage prevalence of the vaccinated
population vaccinated per month) * 5.1 million = 7,600. To avoid double counting, it is
reasonable to estimate that 7,600 cases can be attributed to double vaccinated persons and
192,491 minus 7,600 ~ 185,000 cases can be attributed to non- or single-vaccinated persons,
most of which occurred before vaccinations were available. Using these estimates, one can
assume that the proportion of non- or single vaccinated persons that have been identified as cases
= 185,000/(5.1m*.27) = 5%. Estimating that 90% of natural infections are considered immune
(similar to the double-vaccinated), it is reasonable to estimate that 5%*.9 = 4% of the population
that are not double vaccinated would be immune. (The addition of immunity from the 6% of the
population with one vaccination does not significantly change this estimate of 4%.) An estimated
proportion of the total population that are immune from double vaccination = 0.73 * 0.9) = 66%.
In total, therefore, it can be estimated that at least 70% of the British Columbia population are
immune.

62. Seroprevalence surveys of non-double vaccinated people and non-cases could identify the
proportion of that sub-population that is also immune, which would be additional to the
estimated 70%. I have not been able to find seroprevalence data for British Columbia. The World
Health Organization has recommended that countries should undertake sero-prevalence and sero-
epidemiological studies.

63. The World Health Organization seroepidemiological investigation protocol22 states:

“There are two primary objectives for this sew-epidemiological investigation:

1. To measure the seroprevalence of antibodies to COVID-19 in the general population

by sex and age group, in order to ascertain the cumulative population immunigj
(emphasis added); and

2' http://www.bccdc.ca/Health-lnfo-Site/Documents/COVID sitrep/2021-IO-Ol-Data Summarvpdf p.28

22 file:///U sers/j dkettner/Downloads/WHO-20 l 9-nCoV-Seroepidemiology-2020.2-eng.pdf
 034
19

2. To estimate the fraction of asymptomatic, pre-symptomatic or subclinical infections in

the population and by sex and age group.”

6. Can double vaccinated persons transmit COVID-19, including variants such as Delta and
others currently circulating in British Columbia, and if so, to what extent? How does the rate
at which double vaccinated persons transmit COVID-l9 compare to the rates at which
unvaccinated persons and single vaccinated persons transmit COVID-19? In answering
these questions, please consider Israel’s experience with double and triple vaccination with
the Pfizer Vaccine and the current surge of COVID-l9 infections.

64. This is a complex question. To answer it with confident accuracy requires the same data and
probabilities described in question 5 above, plus adjustments for differences in transmissibility of
variants for each condition of vaccination status. These data and these analyses have not been made
available in the orders or, based on my own searching, on British Columbia websites. It requires
—
an estimate of the probabilities of the same three conditions previously described in question 5 -
which must be met for transmission to occur.

65. The first condition is for a person to become infected with the SARS-CoV-2 virus. The
second condition is for that infected person to expose their virus to another person. The third
condition is for the contact person to become infected.

66. The probabilities of these three conditions are dependent on the incidence and prevalence of
infected people, the prevalence of susceptible persons, and the likelihoods of physical and social
enabling factors for exposure and transmission. These probabilities need to be adjusted for
differences of transmissibility (e.g. exposure load of replication-competent virus) of variants,
differences in vaccine effectiveness against variant SARS-COV-2 transmission, and for differences
associated with zero, single, double, or triple vaccination.

67. These data, information, and analyses should be included with the explanation and rationale
for any policy - such as mandating vaccination -— to estimate the effect size of beneficial and
harmful outcomes.
 035
20

68. Reported observations from other countries should be interpreted with caution. I have found
it difficult enough to obtain, verify, and interpret information from within Canada.

7. How much have we reduced probability of transmission by insisting that people are
vaccinated?

69. This important question is about the effectiveness of public health strategies to mandate
vaccination. It is one of the most important questions that should or should have been considered
and explained to justify any mandatory vaccine policy. Without access to more British Columbia
data and information, it is not possible for me to answer this question.

70. In Canada, vaccines cannot be ethically or legally administered without informed consent.
Mandatory vaccination, therefore, is about limiting one’s rights to gain access to settings and/or
activities based on their immunization and/or test result record. The probability of transmission in
any setting where high risk exposure can occur between people is dependent on several factors.
The most important factors are the likelihood of infectiousness in one or more persons, the
presence of symptoms in infectious people, the closeness and duration of face-to-face contact
without effective barriers, the air environment, and the immune status of the non-infectious person.
Immunity may be from a previous infection or vaccination.

71. The main public health science purposes of mandatory vaccination, as I understand them,
are 1) to reduce exposure to or from non-vaccinated people, because of their increased probability
of being in an infectious state and 2) to incentivize people who would not otherwise get vaccinated.

72. It would be important, in my opinion, in advance of launching such a program, for there to
be a transparent explanation of the objectives and a comprehensive analysis of the outcomes,
benefits, harms, and costs — and how these will be monitored for ongoing reconsideration of the
strategy. It is not clear yet that much change in vaccination rates has occurred in response to various
efforts to encourage or incentivize the 20% of Canadians that have not been fully vaccinated.

8. Some jurisdictions have determined that other statuses are equivalent to having been
vaccinated twice. Please consider the following alternatives set out below. From a public
health perspective, are these measures equivalent to proof of two dose vaccination, (in
reducing or eliminating the spread of COVID-l9)? And if not, how different? How do they
 036
21

compare with the “proof of vaccination” requirements in GA THERINGS AND EVFNTS —

SEPTEMBER 10, 2021 and FOOD AND LIQUOR SERVING PREMISES SEPTEMBER 10,
2021?

73. To answer these questions, it is important to first consider the purpose of reducing or
eliminating the spread of the SARS-CoV-2 in the context of the goals and objectives of the overall
strategy.

74. The September 27, 2021 version of the “COVID-19 VACCINATION STATUS
INFORMATION AND PREVENTIVE MEASURES ORDER — SEPTEMBER 27, 2021”23 does
not contain the words “goal”. The word “objective” appears once. In section 43 (1) (b) (i) of the
Public Health Act excerpt contained in the Order, a person affected by the order can request the
health officer who issued the order to reconsider the order if one or more conditions are met
including additional information that was not reasonably available to the health officer or a
proposal that was not presented to the health officer when the order was issued, but if implemented
would “meet the objectives of the order”.

75. In the absence of any statement of the goals or objectives in the order, one can only look to
other publicly available documentation for a description of goals and objectives.

76. Regarding additional relevant information or proposals that were not presented to the health
officer when the order was issued or varied, these conditions or criteria could only be met if there
is a transparent description of the relevant information or proposals that were presented to the
health officer when the issue was ordered.

77. Regarding reducing spread, based on the most recent NACI report, their estimate of the
effectiveness against infection of mRNA 2-dose vaccination is 90%. I have not seen a valid
estimate of the impact of vaccination on transmission. According to NACI, the duration of that
protection has not yet been determined. An estimate has not been provided.24

23 https://www2.gov.be.ca/assets/gov/health/about-bc-s~health-care-systemloffice-of-the-provincial-health-

officer/covid- 19/archived-docs/covid-l 9-pho-order-vaccination-status-information-sep27.pdf

2‘ https://www.canada.ca/en/public—health/services/immunization/nationaI-advisory-committee-on-

immunization-naci.html
 037
22

8. a. A positive RT-PCR or rapid antigen test result demonstrating recovery from COVID-
19 issued no less than 11 days and no more than 6 months after the date on which a person
first tested positive (e.g. France; this documentation is referred to as a “certificate of
recovery” by the European Union).

79. A positive RT-PCR test — which tests the presence of SARS-CoV-2 genetic material- does
not necessarily indicate current infection or infectiousness. It is considered to be a highly
sensitive and specific indicator of previous, if not current, infection. Eight days afier a positive
PCR test is considered long enough to rule out active infectiousness. To my knowledge there is
no evidence which demonstrates a significant inferiority of protection between previous infection
and double vaccination. Given the high sensitivity and specificity of these tests, it may be
reasonable to consider these tests and their results as comparable indicators of protection from
previous infection. If there is not validity of this information or rationale, it should be incumbent
on public health officials to explain why not. This is a good example of the type of question
which should be addressed by a public health official to demonstrably justify the issuing of
orders for mandatory vaccination.

8. b. A negative PCR or antigen test less than 48 hours prior to attendance at an event (this
document is referred to as a “test certificate” by the European Union).

80. Based on current documents of official public health organizations, it is reasonable to

estimate that a negative PCR test result would reduce the probability of being infectious at the
time of the test by 95%”. If the (pre-test) prevalence of infection is estimated as one per 1000,
the post-test probability of infection in a person with a negative test within 48 hours can be
estimated as one-in-20,000.

8. c. A single vaccination after contracting COVID-l9 after an interval of at least 21 days

following the illness (e.g. Quebec).

25 https://pubmed.ncbi.nlm.nih.gov/32659413/
 033
23

81. As described in NACI’s most recent report on COVID-19 vaccination recommendations

“These observational studies suggest previous infection with SARS-CoV-2 induces good
protection against subsequent infection and that the protective effect may be comparable to
complete mRNA COVID-19 vaccination in individuals without prior infection. However,
whether the duration of protection generated from previous infection is similar to that elicited by
mRNA COVID-19 vaccination remains unknown. The duration of protection provided by
vaccination also remains unclear at this time.”26

82. It is reasonable to believe that a single dose of an effective vaccine could maintain or
increase immunity in the short term and long term. The quantity of that increase is unknown and
not likely to be very significant given that the rate of reinfection amongst people with natural
immunity has been observed to be very low and is similar if not lower than fully vaccinated
people. NACI states “In studies looking at the immune response of individuals previously
infected with SARS-CoV-Z, binding and neutralizing antibodies have been shown to persist for
at least 6 months post-infection, with only a small proportion of people becoming re-infected for
potentially as long as 10 months”27

9. Would COVID-19 vaccination exemptions for persons for a documented medical reason,
as confirmed by a physician or registered nurse (as is the case in Ontario), pose a public
health threat in light of the rate of COVID-19 immunization in British Columbia? To what
degree would it pose a threat and what would be the impact on important outcomes? If
someone has a medical exemption and takes a rapid PCR or other test within 48 hours of
entry to an event, is there an additional risk in terms of transmission and if so, how much?

83. The pr0portion of the population that would qualify for a medical exemption for medical
reasons has not, by my investigation, been published in official British Columbia documents. This
would depend on criteria for medical exemption, which have not, to my knowledge been

2" httns://www.canada.ca/content/dam/phac-asuc/documents/services/immunization/national-advisorv-committee-
on-immunization-naci/recommendations-use-covid- l 9-vaccines/recommendations—use-covid- I 9-vaccines-en.pdf pp.
39.
27 https://www.canada.ca/en/pubIic—health/services/immunization/national-advisory-committee-on-

immunization-naci/recommendations-use-covid-19-vaccines.html#a7.3
 039
24

announced or published. In Manitoba, there are three general criteria: a severe adverse event (e.g.
myocarditis) following a previous dose, a severe allergic reaction (e.g. anaphylaxis), or a person
that is receiving an immune-suppressing treatment (e.g. cancer treatment). The third group,
paradoxically, is the group at higher risk for severe illness for the very reason that they are less
likely to react immunologically and benefit from the vaccine. Preventive practices and focused
protection for that group and others at higher risk for severe outcomes could compensate for their
risk of being unvaccinated. Considerations for allowing medical exemptions in British Columbia
should be based on an estimation of the added rates and numbers of severe outcomes amongst
exempted individuals. Adding a screening test within 48 hours of entry to an event, would be
expected to reduce the probability of transmission and severe outcomes by the sensitivity of the
tests. 95% would be a reasonable estimate of that.28

10. What is the probability of severe illness of Covid-l9 in children aged 12 to 18? Are the
serious or long-term side effects at least or less than the serious or long-term adverse effects
of COVID-19 vaccination in children aged 12 to 18?

84. There are data to show the rates of severe illness in children as indicated by hospitalization
and deaths, but there has been insufficient information and insufficient time to estimate long-
term effects. Similarly, although there are some data on short term adverse effects of vaccination
in children, there has been insufficient information and insufficient time to estimate long-term
adverse effects. Given the low rates of COVID-19-associated hospitalizations, ICU admissions,
and deaths, the rates of severe vaccine-associate adverse events resulting in such outcomes
would have to be significantly less to justify a voluntary or mandatory vaccine program for
children, unless there is a willingness to accept more harm than benefit for an individual child to
protect the population. Assuming that vaccinations would be repeated annually (as for influenza),
that threshold could be estimated at less than one in 8,000 serious adverse events resulting in
hospitalization and 0 deaths. In the absence of British Columbia or other Canadian data for
hospitalization rates following immunization, one cannot estimate a comparison at this time.

2" https://pubmed.ncbi.nlm.nih.gov/32659413/
 040
25

85. Table 4 of the BCCDC COVID-19 Situation Report Week 3829 shows cumulative rates of
cases, hospitalizations, ICU, and deaths by IO-year age groups.

Table 4: Age distribution: COVID-19 eases, hospital-dons, In! admissions, deaths, and BC population by age map
Jan 15,2020 (week 3) -Sept 25, 2021 (week 38) (Na 185,938)‘
human use: s
ICU BC

‘10 126 13

30-39 201

50-59 459

70-79 504
”89

Total
34 62 61 83 41

Amongtlmewlthmflabh qehfntnuticnonly.

". 7 museums: heelttuuthorltymeltneMswawhmofwmwmnlsumhmmn(Mlhbfwmmmmudm.

PCMSrhtawei-uindndcducumsmn.Duetaffeta-tamehhnmofimlWMWdfimthuundtheMMm
mhdudedlnmuoupsO—de 1019mm.
c. Median age: calculatedmhueden healthauthorttymftnel‘anonly.

86. Using these data, the age-specific population-based rates of cases amongst 10-19 year-olds
has been 20,732/529,387/20 months. The cumulative incidence since the beginning of the
pandemic (approximately 20 months) is 20,732/529,387 = 4% - or 1 in 25 - children aged 10-19.
The average daily, monthly, and annual incidence rates can be calculated as 0.007% (one per
15,000), 0.2% (one in 500), 2.4% (1 in 42), respectively.

87. In this age group, the proportion of all cases that have been hospitalized is 96/20,732 =
0.5% (one in 200 cases). The proportion of all cases in this age group that have been admitted to
an ICU has been is l 8/20,732 = 0.09% (one in 1,150 cases). There have been no COVID-19 deaths
reported.

88. Using population denominators, the cumulative hospitalization rates and ICU admission
rates, amongst all 10—19-year—olds has been 96/529,387 = 0.02% (one in 5,500), and l8/529,387
= 0.003% (one in 29,000), respectively.

89. The average daily, monthly, and annual incidence rates for hospitalization can be
calculated as 0.00003% (one per 3 million), 0.001% (one in 100,000), .01% (one in 8,000),
respectively.

29http:/lwww.bccdc.ca/I-Iealth-Info-Site/Documents/COVID_sitrep/Week_38_2021_BC_COVID-
19__Situation_Report.pdf
 041
26

90. The average daily, monthly, and annual incidence rates ICU admission can be calculated
as 0.000006% (one per 15 million), 0.00019% (one in 500,000), 0.002% (one in 40,000).

91. Post-marketing safety surveillance of mRNA COVID vaccines has found an increased
frequency of myocarditis and pericarditis. According to NACI, these have been reported most
frequently in adolescents and younger adults aged 12-30, more frequently after the second dose.
“However, the majority of cases have been mild and have resolved.”30

92. The BC Centre for Disease Control provides weekly reports on Adverse Events Following
Immunization with COVID-19 Vaccines. In their report that covers December 13, 2020 to October
2, 20213' the only data that is disaggregated by age is myocarditis/pericarditis. 12 cases were
reported, in associated with the Pfizer mRNA vaccine, 6 after the first dose, 6 after the second
dose.32 Denominators (number vaccinated) or severity information were not provided.

Regarding the effectiveness and safety of vaccination for children, NACI recommends that more
research is needed. Included in its list of “new and emergency research priorities” is following:
“What is the efficacy, effectiveness, immunogenicity, and safety of COVID-19 vaccines across
diverse population groups, e.g., children/adolescents?”33

11. What other questions, in my opinion, should have been answered by Dr. Henry to explain
and to justify the three public health orders referred to in paragraph 9.

94. As is evident, I have been unable to answer many of the important and relevant questions asked
of me. In many cases, that is because of limitations of data and information, my inability to find
information on official websites, or because most questions about long term outcomes or

3° https:l/www.canada.ca/content/dam/bhac-aspc/documents/services/1mmunization/national-advisorv-committee-

on-immunization-naci/recommendationsvuse-covid- I 9-vaccines/recommendations-use-covid- l 9—vaccines-en.ndf

p.63.
3‘ http://www.bccdc.ca/Health-lnfo-Site/Documents/COVID-
19 vaccine/AEFI reports/COVIDI9 AEFI Fortnightly Report 10072021.pdf
32 httn://www.bccdc.ca/Health-lnfo-Site/Documents/COVID-
19 vaccine/AEFI reports/COVIDI9 AEFI Fortnightly Report 10072021.pdfp.9.
3’ https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisorv-committee-
on-immunization-naci/recommendations-use-covid- l 9-vaccines/recommendations-use-covid- l 9-vaccines-en.bdf
p.57.
 042
27

projections have a low level of confidence in accuracy. It would not be fair to expect Dr. Henry to
be able to answer questions for which there are not yet sufficiently valid answers. However, an
inability to answer important questions should be expressed transparently as part of the explanation
of the evidence and rationale for a public health order, including the relevant uncertainties and
controversies. Below is a list of other questions which I think could have been answered and are
now important to answer (or estimate) to demonstrably justify public health orders, especially
when they restrict rights and freedoms and may cause unintentional harms to health and its
determinants.

a. What are the goals and specific objectives of the overall public health responses? Are
there endpoints?

b. What is the estimated absolute and relative (compared with all other diseases and
injuries) of COVID-19 burden of illness and their impact on the health system with the
current public health interventions without mandatory vaccine policies?

c. What is the explanation for the minimal change, if any, of the estimated reproductive
value (Re) (one) since January, 2021, two months before the beginning of the
vaccination program and since the achievement of a 60% and higher two-dose
vaccination population proportion since August, 2021?

d. What is the estimated reduction of the absolute and relative rate (compared with all
other diseases and injuries) of COVID-19 burden of illness expected from mandatory
vaccine policies?

e. What are the results of the analyses of the case/contact-tracing data, including the
association of settings, exposures, vaccination status, previous infection status, and
other attributable factors with outcomes of transmissions, hospitalizations, and deaths?

f. What is the estimated benefit (effect size) of these measures regarding infection rates,
hospitalizations, intensive care admissions, deaths, and potential years quality-adjusted
life years lost associated with COVID-19?

g. What is the estimated medical, social, psychological, and economic harm of these
 043

28
measures?

b. What is the analysis regarding the net impact with consideration of the alternative
activities of (otherwise) restaurant patrons regarding close contact and transmission in
other settings?

i. What other strategies and interventions were considered and how did they compare
with respect to anticipated and estimated efi‘ectiveness (including benefits and harms),
efficiency (including cost-effectiveness and cost-benefit), and equity (i.e. fairness with
respect to health inequities)?

j. What are the estimated impacts of mandatory vaccination on health and other care
services staffing, and productivity and function of other settings in which mandatory
vaccination policies are applied?

Dated: October 20, 2021

Dr. lKettner, MD, MSC, FRCSC, FRCPC
 044
Research Memo: COVID 19 Certificates in European Countries

COVID 19 Certificates in Europe and a Selection of European Countries

September 29, 2021

EUROPE

EU Regulation 2021(953 of European Parliament and of the Council of 14 June 2021.

The European Union has implemented a digital COVID certificate wich entered into application in all EU
member states since July 1, 2021. A transition period was in place from July 1to August 15, 2021 for member
states that were not yet ready to provide the EU certificate. It is valid across the European Union and has to be
accepted by all member states for the free movement of persons.

The certificate has to be issued, according to art. 3(1) of EU Reg 2021/953 to anyone who:
- has been vaccinated against COVID-19, or
- has received a negative test results for COVID-19, or
- has recovered from COVID-19.

The EU leaves it up to member states to decide whether 'vaccination’ status is provided after one dosage or
requires a full vaccination cycle.

EU Commission has the power adopt an ’implementing act’ to accord interoperability to certificates of other
countries (art. 8). It has done so for several countries.

The Regulation Annex specifies the data to be provided. In data fields related to recovery, point 3.h. specifies
”certificate valid until (not more than 180 days after the date of the first positive NAAT test result).”

GERMANY

General approach on the basis of the ”Decision: Measures to Cope with the CORONA
Pandemic”, an agreement between the federal government and state governments of 10
August 20211

The German federal government and the German States agreed on 10 August 2021 to implement the ”36-
Rule” no later than August 23rd 2021, barring entry into certain indoor spaces and participation in certain
activities to people who fall into at least one of three categories:2

1 Videoschaltkonferenz der Bundeskanzlerin mit den Regierungschefinnen und Regierungschefs der Ltinder am 10. August 2021,
Beschluss, Malinahmen zur Bewiiltigung der Corona-Pandemic. <httpszl [www.bundesregierungdez breg-
delthemenlbuerokratieabbaulbund-laender-beratung-1949504>.
’- An infographic from the German federal government briefly explaining the 36 Rule in English may be found here:
<https://www.integrationsbeauftragte.de/resource/b|ob/1864222/1877300/6f9c620c5274ba25c7acb10f2301bc87/210511—flyer-ib-
en-data.pdf?download=1>. Agreement text:
htt s: www.bundesre ierun .de resource blob 974430 1949532 d3f1da493b643492b6313e8e6ac64966 2021-08-10-m k-
data.pdf?download=1
 045
1) Fully vaccinated people; ”geimpft”
2) People who have a negative COVID-19 test; ”getestet”
3) People infected with COVID-19 but fully recovered ”genesen”
Areas with low infection rates may completely or partially suspend the 36-Rule.
The government will also discontinue its free COVID-19 test programs, except for people unable to be
vaccinated or for those for whom vaccination isn't recommended.
Regulation and legal implementation of the 36-Rule falls to each State, to enact relevant law and enforce
that law. Each State agreed to do so.

Exam le of State Re ulation Verordnun :Bavaria

Bavarian State Infection Protection Measures Regulation

(lnfektionsschutzmaBnahmenverordnung) implementing the 36 Rule in the State pursuant to
the agreement with the German federal government”

Summary: 14th Bavarian Infection Protection Measures Regulation imposes counties to restrict
access to all public & private events in public spaces (including educational institutions,
libraries) and services requiring physical proximity (not medical), when infection rates within 7
days exceeds 35 per 100k inhabitants to:
- asymptomatic person w proof/certificate of vaccination
- asymptomatic person w proof/certificate of recovery
- asymptompatic person having negative test result (or < 6 years)

AUSTRIA

Summary

As with Germany, Austria has decided to implement the BG-Rule.4 In addition to place— or activity-specific
applications of the 36 Rule, the Austrian government has also included general gatherings of people. The size
of gatherings to which the 36 Rule applies, as well as how the 36 Rule is applied, varies depending on the
current number of ICU beds taken by COVID-19 patients:

In all cases, the 36 Rule applied to gatherings of 25 or more persons: Entry allowed only to...
- Vaccinated persons: with either first or second doses of a two-dose vaccine, 3 dose of a one-dose
vaccine, or a dose of a vaccine in conjunction with proof of recovery from COVID-19
- Recovered persons: with medical proof of infection and recovery from COVID-19 in the last 180 days
- Tested persons: self-administered or authorized Antigen Tests or molecular-biological Tests

3Vierzehnte Bayerische lnfektionssch utzmaBnahmenverordnung (14. BayIfSMV) (1. September 2021)I BayRS 2126-1-18-6
4 Bundesgesetzblatt fiir die Republik Osterreich, 278. Verordnung: 2. COVID-19-Offnungsverordnung (28 June 2021). The full German
text of the ”2"d COVID-19 Opening Decree":
<https://www.ris.bka.gv.at/Dokumente/nglAuth/BGBLA_2021_ll_278/BGBLA_2021_II_278.htmI>; and of the ”8‘" Amendment to
the 2"" COVID-19 Opening Decree”:
<https://www.ris.bka.gv.at/Dokumente/nglAuth/BGBLA_2021_ll_394/B6BLA_2021_II_394.html>.
 046
Of interest are the details about what counts as proof of ’low epidemiological risk’:
5.1(2): Proof of a low epidemiological risk, in the meaning of this Regulation, may be:
1. Proof of a negative self-administered Antigen Test in an acceptable databank, no more than 24hrs old
2. Proof of a negative Antigen Test from an authorized facility, no more than 48hrs old
3. Proof of a negative molecular-biological Test from an authorized facility, no more than 72hrs old
4. A medical certificate of COVID-19 infection in the last 180 days, confirmed by molecular biology
5. Proof of successful vaccination against COVID-19:
a) First dose, taken at least 22 days ago and no more than 90 days ago,
b) Second dose, taken no more than 270 days ago,
c) A dose, taken at least 22 days ago and no more than 270 days ago, where only one dose is needed for
immunization, or
cl) A dose, taken at least 21 days after a positive molecular-biological Test for COVID-19 or taken after
proof of COVID-19 antibodies, and taken no more than 270 days ago
6. A quarantine-order given to a person demonstrably infected with COVID-19 in the last 180 days
7. Proof of COVID-19 antibodies, no older than 90 days

Stage 1: 200+ ICU beds expected to be taken by COVID-19 patients

Mask mandates at work for unvaccinated or unrecovered persons
36 Rule applies to gatherings of 25+ (limited to 100)
Stage 2: 300+ ICU beds expected to be taken by COVID-19 patients
In bars/clubs, similar settings, and gatherings of over 500 persons with unassigned seating,
26 Rule applies: entry only for vaccinated or recovered persons
Self-administered Antigen Tests no longer qualify under the 36 Rule

Stage 3: 400+ ICU beds expected to be taken by COVID—19 patients

Restriction of 36 Rule to exclude person with negative Antigen Tests

France

Loi no. 2021-1040 of 5 August 2021 on the Management of the Sanitary Crisis5

Authorizes the Prime Minister to issue a decree between 2 June 2021 and 15 November
2021 obliging people to present evidence/certificate of:
- result of virology testing that shows lack of infection; or
- evidence of vaccination status re COVID-19; or
- certicate of recovery following COVID-19 infection
This can be imposed :
- on any person > 12 years for the purpose of travel to/from the ’territoire hexagonal’
[metropolitan territory]
- to any person for access to: 'free-time’ activities; restaurants; long distance travel;
health facilities6 (can also be submitted to additional measures if emergencyjustifies it);
and ’if government demonstrates that characteristics and the gravity of the risk of
5
https://www.legifrance.gouv.fr/jorf/id/JORFI'EXT000043909676
6Art. 1.Il.A.(2)(d)
 O47
infection justify it’ (so higher obligation of justification) also large shops and shopping
malls.
Provisions also include right for employers to suspend employment7 + various control
measures and penalties.

Constitutional Court approved Constitutionality of this law in decision no. 2021-824 of

August 5, 20218, emphasizing the choice provided (i.e. that it does not contain an
obligation to vaccinate).

Decision no. 2021-824 DC of 5 August 2021

Decision of the Conseil Constitutionnel declares that COVID 19 measures are constitutionel. Note the emphasis, in the
discussion on the alleged infringement of the rights of freedom of movement, the right to personal privacy and
the right of collective expression of ideas and opinions:

35. Fourthly, the disputed provisions provide that the obligations imposed on the public may be
fulfilled by the presentation of proof of vaccination status, the results of a viral screening test
that do not show infection or a certificate of recovery from infection. Thus, these provisions do
not, in any case, introduce either an obligation to provide care or an obligation to vaccinate. In
addition, the legislator provided for the determination by decree, issued after the opinion of the
French high authority for health (Haute Autorité de Santé), of the cases of medical
contraindication preventing vaccination and issuing a document to the persons concerned that
can be presented in places, services or establishments where the presentation of a "health pass"
is required

United Kingdom

The UK Government has not introduced a Vaccine Mandate or Mandatory COVID Certificate. But it has
encouraged vaccination and public health measures. A certification system has been introduced, built around
a National Health Services [NHS] COVID Pass system. The government has prepared ‘plan B’ in case of
unsustainable pressure on NHS. In that case, the voluntary COVID pass system of NHS will shift to ’vaccine
only’.

Currently (so not under plan B), NHS COVID Pass is provided to:
Persons who had:
0 a vaccine used in the UK - NHS COVID Pass lasts for 30 days, but the 30 day period refreshes every

time people log in

o a negative PCR test or rapid lateral flow test - NHS COVID Pass is valid for 48 hours after a negative
result
0
a positive PCR test —NHS COVID Pass lasts 30 days, but the 30 day period refreshes every time person
logs in (for up to 180 days after you took the test)

7 Art. 1.|I.C
3 https://www.conseil-constitutionnel.fr/decision/2021/2021824DC.htm
 048
Italy:
: www.reuters.com world euro e ital -all-workers—2021-09—16
10/20I21. 1:03 PM JCVI issues updated advice on COVID-19 vaccination of children aged 12 to 15 - GOV.UK
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Press release
JCVI issues updated advice on COVID-19
vaccination of children aged 12 to 15
The JCVI has reviewed the evidence on vaccinating children aged 12 to 15 who do not have
underlying health conditions that put them at increased risk from severe COVID-19.

From:
Public Health England (/government/organisations/public-health-england)
Published
3 September 2021
Last updated
3 September 2021—

hlips:l/www.gov.uk/govemmeni/news/jcvi-issues-updaied-advice-on-covid-19—vaccination-of-children-aged-12-lo-15 1/5
10l20l21. 1:03 PM JCVI issues updated advice on COVID-19 vaccination of children aged 12 to 15 - GOV.UK
The assessment by the Joint Committee on Vaccination and Immunisation (JCVI) is that theofigalth
benefits from vaccination are marginally greater than the potential known harms. However, the
margin of benefit is considered too small to support universal vaccination of healthy 12 to 15 year
olds at this time.

It is not within the ,JCyJ’s remit to consider the wider societal impacts of vaccination, including
educational benefits. The government may wish to seek further views on the wider societal and
educational impacts from the Chief Medical Officers of the UK 4 nations.

For the vast majority of children, SARS-CoV-2 infection is asymptomatic or mildly symptomatic and
will resolve without treatment. Of the very few children aged 12 to 15 years who require
hospitalisation, the majority have underlying health conditions. The committee has recommended
the expansion of the list of conditions to which the offer applies for at-risk 12 to 15 year olds.

There is evidence of an association between mRNA COVID-19 vaccines and myocarditis. This is an
extremely rare adverse event. The medium- to long-term effects are unknown and long-term follow-
up is being conducted.
Given the very low risk of serious COVID-19 disease in othenrvise healthy 12 to 15 year olds,
considerations on the potential harms and benefits of vaccination are very finely balanced and a
precautionary approach was agreed.

Professor Wei Shen Lim, Chair of COVID-19‘lmmunisation for the JCVI, said:
Children aged 12 to 15 years old with underlying health conditions that put them at
higher risk of severe COVID-19 should be offered COVID-19 vaccination. The range of
underlying health conditions that apply has recently been expanded.

For othenrvise healthy 12 to 15 year old children, their risk of severe COVID-19 disease
is small and therefore the potential for benefit from COVID-19 vaccination is also small.
The JCMl’s view is that overall, the health benefits from COVID-19 vaccination to healthy
children aged 12 to 15 years are marginally greater than the potential harms.

Taking a precautionary approach, this margin of benefit is considered too small to

support universal COVID-19 vaccination for this age group at this time. The committee
will continue to review safety data as they emerge.

When deciding on childhood immunisations, the JCVI has consistently maintained that the main
focus should be the benefits to children themselves, balanced against any potential harms to them
from vaccination.

As longer-term data on potential adverse reactions accumulates, greater certainty may allow for a
reconsideration of the benefits and harms. This data may not be available for several months.

Previously, the ,IQMI advised that children with severe neurodisabilities, Down’s syndrome,
immunosuppression, profound and multiple learning disabilities, and severe learning disabilities or
who are on the learning disability register, should be offered COVID-19 vaccination.

Following consideration of updated data on hospital admissions and deaths, the ,I_C,V,l advises that
this offer should be expanded to include children aged 12 to 15 with the following:

. sickle
haematological malignancy
. cell disease
https:l/www.gov.uklgovemmentlnewsljcvi-issues-updated-advice-on-covid-1 9-vaccination-of-children-aged-12-to-15 2/5
10I20I21. 1:03 PM JCVI issues updated advice on COVID-19 vaccination of children aged 12 to 15 - GOV.UK

. type 1 diabetes 051

. congenital heart disease

. other health conditions as described in Annex A
Children with poorly controlled asthma and less common conditions, often due to congenital or
metabolic defects where respiratory infections can result in severe illness, should also be offered
COVID—1 9 vaccination.

Annex A: COVID-19 clinical risk groups for children aged 12 to 15 years

Chronic respiratory disease

including those with poorly controlled asthma that requires continuous or repeated use of systemic
steroids or with previous exacerbations requiring hospital admission, cystic fibrosis, ciliary
dyskinesias and bronchopulmonary dysplasia.

Chronic heart conditions

Haemodynamically significant congenital and acquired heart disease, or milder heart disease with
other co-morbidity.

Chronic conditions of the kidney, liver or digestive system

Including those associated with congenital malformations of the organs, metabolic disorders and
neoplasms, and conditions such severe gastro¢oesophageal reflux that may predispose to
respiratory infection.

Chronic neurological disease

This includes those with:

- neuro-disability and/or neuromuscular disease including cerebral palsy, autism, epilepsy and
muscular dystrophy
. hereditary and degenerative disease of the nervous system or muscles. or other conditions
associated with hypoventilation
. severe or profound and multiple learning disabilities (PMLD), Down’s syndrome, those on the
learning disability register, neoplasm of the brain

Endocrine disorders

Including diabetes mellitus, Addison’s and hypopituitary syndrome.

lmmunosuppression

lmmunosuppression due to disease or treatment, including:

httpszllwwgov.uk/governmenUnewsfjcvi-issues-updated-advice-on-covid-1 9-vaccination-of-children-aged-12-to-15 3/5

10/20/21, 1:03 PM JCVI issues updated advice on COVID-19 vaccination of children aged 12 to 15 - GOV.UK

. marrow or stem
those undergoing chemotherapy or radiotherapy, solid organ transplant recipients, bone)52
cell transplant recipients
. genetic disorders affecting the immune system (for example deficiencies of IRAK-4 or NEMO,
complement disorder, SQID)
. those with haematological malignancy, including leukaemia and lymphoma
. those receiving immunosuppressive or immunomodulating biological therapy
. those treated with or likely to be treated with high or moderate dose corticosteroids
. those receiving any dose of non-biological oral immune modulating drugs, for example
methotrexate, azathioprine, 6—mercaptopurine or mycophenolate
. those with auto-immune diseases who may require long term immunosuppressive treatments

Asplenia or dysfunction of the spleen

Including hereditary spherocytosis, homozygous sickle cell disease and thalassemia major.

Serious genetic abnormalities that affect a number of systems

Including mitochondrial disease and chromosomal abnormalities.

Public Health England press office

Wellington House
133-155 Waterloo Road
London
SE1 8UG
Email phe—pressoffi[email protected]
Telephone 020 7654 8400

Out of hours 020 8200 4400

Published 3 September 2021
Last updated 3 September 2021 + show all updates

1. 3 September 2021
First published.

Related content

. JCVI statement, September 2021: COVID-19 booster vaccine programme for winter 2021 to
2022 (lgovernment/publications/jcvi-statement-september-2021-covid—19-booster—vaccine-programme-
for-winter—2021-to-2022)
. Universal vaccination of children and young people aged 12 to 15 years against COVID-19
(Igovernment/publications/universal-vaccination-of-chiIdren-and-young-people-aged-12-to-15-years-
aaainst-covid-1 9)

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. COVID-19 vaccmation: booster dose resources (lgovernment/publrcations/covrd—i9—vaccrnairon-

. . . . . . 53

booster—dose-resources)
. Third primary COVID-19 vaccine dose for people who are immunosuppressed: JCVI advice
(/government/publications/third—primary—covid—19—vaccine-dose—for—peoplewho-are-immunosuppressed—
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vaccination-programme—guidance»for—healthcare-practitioners)

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 054

Francais
Reopening Ontario (A Flexible Response to COVID—19) Act, 2020

ONTARIO REGULATION 364/20

formerly under Emergency Management and Civil Protection Act

RULES FOR AREAS AT STEP 3 AND AT THE ROADMAP EXIT STEP

Consolidation Period: From October 15. 202] to the e-Laws currency date.
Last amendment: 710/21.

Legislative History: 415/20, 428/20, 453/20, 456/20, 501/20, 519/20, 529/20, 530/20, 531/20, 546/20, 574/20, 579/20,
588/20, 642/20, 655/20, 687/20, 4/21, 98/21, 105/21, 115/21, 119/21, 147/21, 164/21, 218/21, 223/21, 315/21, 346/21,
520/21, 524/21, 541/21, 577/21, 630/21, 645/21, 659/21, 678/21, 698/21, 710/21.
This is the English version of a bilingual regulation.

CONTENTS
L Terms of Order
3; Application
a Step 3
fl Roadmap Exit Step
fl References to this Order
i Indoor vs. outdoor
STEP 3

Schedule I General rules at step 3

Schedule 2 Specific rules at step 3
Schedule 3 Organized public events and certain gatherings at step 3
W
Schedule 4 General rules at the roadmap exit step
Schedule 5 Specific rules at the roadmap exit step

Terms of Order
1. The terms of this Order are set out in Schedules 1 to 5. O. Reg. 541/21, s. 2.
2. REVOKED: O. Reg. 574/20, s. 1.
Application
3. (1) Subject to subsections (2) and (3), this Order applies to the areas listed in Schedule 3 to Ontario Regulation 363/20
made under the Act. 0. Reg. 541/21, s. 3.
(2) Schedules 1 to 3 apply throughout the areas at Step 3. O. Reg. 541/21, s. 3.
(3) Schedules 4 and 5 apply throughout the areas at the Roadmap Exit Step. 0. Reg. 541/21, s. 3.
Step 3
3.1 In this Order, a reference to areas at Step 3 is a reference to all areas listed as being at Step 3 in Schedule 3 to Ontario
Regulation 363/20 made under the Act. 0. Reg. 541/21, s. 3.
Roadmap Exit Step
3.2 In this Order, a reference to areas at the Roadmap Exit Step is a reference to all areas listed as being at the Roadmap
Exit Step in Schedule 4 to Ontario Regulation 363/20 made under the Act. 0. Reg. 541/21, s. 3.
References to this Order
3.3 (1) In Schedules l to 3, a reference to “this Order” is a reference to Schedules l to 3. O. Reg. 541/21, s. 3.
(2) In Schedule 4, a reference to “this Order” is a reference to Schedules 4 and 5. O. Reg. 541/21, s. 3.
Indoor vs. outdoor
 055

4. (1) The outdoor capacity limits set out in this Order apply to a business, place, event or gathering if the people
attending it are only permitted to access an indoor area,
(a) to use a washroom;
(b) to access an outdoor area that can only be accessed through an indoor route; or
(c) as may be necessary for the purposes of health and safety. 0. Reg. 364/20, s. 4 (l).
(2), (3) REVOKED: O. Reg. 520/21, s. 4.
5. REVOKED: O. Reg. 98/21, s. 2.
STEP 3
SCHEDULE 1
GENERAL RULES AT STEP 3
Closures
1. (1) Each person responsible for a business or place, or part of a business or place, that is required to be closed by
Schedule 2 shall ensure that the business or place, or part of the business or place, is closed in accordance with that Schedule.
(2) Each person responsible for a business or place, or part of a business or place, that Schedule 2 describes as being
permitted to open if certain conditions set out in that Schedule are met shall ensure that the business or place, or part of the
business or place, either meets those conditions or is closed.
(3) Each person responsible for a business or place, or part of a business or place, that does not comply with sections 1 to
7 of this Schedule shall ensure that it is closed.
(4) Despite subsections (1), (2) and (3), temporary access to a business or place, or part of a business or place, that is
required to be closed by Schedule 2 is authorized, unless otherwise prohibited by any applicable law, for the purposes of,
(a) performing work at the business or place in order to comply with any applicable law;
(b) preparing the business or place to be reopened;
(c) allowing for inspections, maintenance or repairs to be carried out at the business or place;
(d) allowing for security services to be provided at the business or place; and
(e) attending at the business or place temporarily,
(i) to deal with other critical matters relating to the closure of the business or place, if the critical matters cannot be
attended to remotely, or
(ii) to access materials, goods or supplies that may be necessary for the business or place to be operated remotely.
(5) Nothing in this Order precludes a business or organization from operating remotely for the purpose of,
(a) providing goods by mail or other forms of delivery, or making goods available for pick-up; and
(b) providing services online, by telephone or other remote means.
(6) Nothing in this Order precludes a business or place from providing access to an outdoor recreational amenity that is
permitted to open under section 18 of Schedule 2, including by opening such limited areas of the business or place as are
necessary to enable access.
(7) Nothing in this Order precludes operations or delivery of services by the following in Ontario:
1. Any government.
2. Any person or publicly-funded agency or organization that delivers or supports government operations and services,
including operations and services of the health care sector.
General compliance
2. (1) The person responsible for a business or organization that is open shall ensure that the business or organization
operates in accordance with all applicable laws, including the Occupational Health and Safety Act and the regulations made
under it.
(2) The person responsible for a business or organization that is open shall operate the business or organization in
compliance with the advice, recommendations and instructions of public health officials, including any advice,
recommendations or instructions on physical distancing, cleaning or disinfecting.
 056

(2.1) The person responsible for a business or organization that is open shall operate the business or organization in
compliance with any advice, recommendations and instructions issued by the Office of the Chief Medical Officer of Health,
or by a medical officer of health after consultation with the Office of the Chief Medical Officer of Health,
(a) requiring the business or organization to establish, implement and ensure compliance with a COVID-19 vaccination
policy; or
(b) setting out the precautions and procedures that the business or organization must include in its COVID-l9 vaccination
policy.
(2.2) In subsection (2.1),
“medical officer of health” means a medical officer of health as defined in subsection 1 (l) of the Health Protection and
Promotion Act.
(3) The person responsible for a business or organization that is open shall operate the business or organization in
compliance with any advice, recommendations and instructions issued by the Office of the Chief Medical Officer of Health,
or another public health official, on screening individuals by, among other things,
(a) posting signs at all entrances to the premises of the business or organization, in a conspicuous location visible to the
public, that inform individuals on how to screen themselves for COVID-19 prior to entering the premises; and
(b) actively screening every person who works at the business or organization before they enter the premises of the
business or organization.
(3.1) The person responsible for a business or organization that is open shall ensure that any person in the indoor area of
the premises of the business or organization, or in a vehicle that is operating as part of the business or organization, wears a
mask or face covering in a manner that covers their mouth, nose and chin during any period when they are in the indoor area
unless subsection (4) applies to the person in the indoor area.
(4) Where there is any requirement under this Order that a person wear a mask or face covering, the requirement does not
apply to a person who,
(a) is a child who is younger than two years of age;
(b) is attending a school or private school within the meaning of the Education Act that is operated in accordance with a
return to school direction issued by the Ministry of Education and approved by the Office of the Chief Medical Officer
of Health;
(c) is attending a child care program at a place that is in compliance with the child care re-opening guidance issued by the
Ministry of Education;
(c.1) is attending a day camp or overnight camp for children that is in compliance with section 19 of Schedule 2;
(d) is receiving residential services and supports in a residence listed in the definition of “residential services and
supports” in subsection 4 (2) of the Services and Supports to Promote the Social Inclusion of Persons with
Developmental Disabilities Act, 2008;
(e) is in a correctional institution or in a custody and detention program for young persons in conflict with the law;
(f) is performing or rehearsing in a film or television production or in a concert, artistic event, theatrical performance or
other performance;
(g) has a medical condition that inhibits their ability to wear a mask or face covering;
(h) is unable to put on or remove their mask or face covering without the assistance of another person;
(i) needs to temporarily remove their mask or face covering while in the indoor area,
(i) to receive services that require the removal of their mask or face covering,
(ii) to engage in an athletic or fitness activity,
(iii) to consume food or drink, or
(iv) as may be necessary for the purposes of health and safety;
(j) is being accommodated in accordance with the A ccessibilityfor Ontarians with Disabilities Act, 2005;
(k) is being reasonably accommodated in accordance with the Human Rights Code; or
(I) performs work for the business or organization, is in an area that is not accessible to members of the public and is able
to maintain a physical distance of at least two metres fiom every other person while in the indoor area.
(5) Subsection (.3 1) does not apply with respect to premises that are used as a dwelling if the person responsible for the
business or organization ensures that persons in the premises who are not entitled to an exception set out in subsection (4)

3
 057

wear a mask or face covering in a manner that covers their mouth, nose and chin in any common areas of the premises in
which persons are unable to maintain a physical distance of at least two metres fi'om other persons.
(5.1) The person responsible for a business or organization shall ensure that every person who performs work for the
business or organization and whose mask or face covering is temporarily removed to consume food or drink under subclause
(4) (i) (iii) is separated from every other person by,
(a) a distance of at least two metres; or
(b) plexiglass or some other impermeable barrier.
(6) For greater certainty, it is not necessary for a person to present evidence to the person responsible for a business or
place that they are entitled to any of the exceptions set out in subsection (4).
(7) A person shall wear appropriate personal protective equipment that provides protection of the person’s eyes, nose and
month if, in the course of providing services, the person,
(a) is required to come within 2 metres of another person who is not wearing a mask or face covering in a manner that
covers that person’s mouth, nose and chin during any period when that person is in an indoor area; and
(b) is not separated by plexiglass or some other impermeable barrier from a person described in clause (a).
(8) Where directives, policies or guidance that apply to a long-term care home within the meaning of the Long-Term Care
Homes Act, 2007 are issued by the Office of the Chief Medical Officer of Health, the Minister of Long-Term Care or the
Ministry of Long-Term Care, such directives, polices or guidance apply despite anything in this Order.
Proof of vaccination
2.1 (1) The person responsible for a business or an organization described in subsection (2) that is open shall require each
patron who enters an area of the premises of the business or organization that is described in that subsection to provide, at the
point of entry, proof of identification and of being fully vaccinated against COVID-19.
(2) Subsection (1) applies with respect to the following areas of the premises of the following businesses and
organizations:
1. The indoor areas of restaurants, bars and other food or drink establishments where dance facilities are not provided,
but not with respect to takeout and delivery service.
2. The indoor and outdoor areas of food or drink establishments where dance facilities are provided, including nightclubs,
'

restoclubs and other similar establishments, but not with respect to takeout and delivery service.
3. The indoor areas of meeting and event spaces, including conference centres or convention centres, but not including
places described in subsection 4 (2) of this Schedule.
4. The indoor areas of facilities used for sports and recreational fitness activities, including waterparks and personal
physical fitness trainers, including, for greater certainty, the indoor areas of facilities where spectators watch events,
but not including places described in subsection 16 (4) of Schedule 2.
The indoor areas of casinos, bingo halls and other gaming establishments.
The indoor areas of concert venues, theatres and cinemas.
The indoor areas of bathhouses, sex clubs and strip clubs.
The indoor areas of horse racing tracks, car racing tracks and other similar venues.
The indoor areas of places where commercial film and television production takes place, where there is a studio
audience. For the purposes of this paragraph, a member of the studio audience is considered to be a patron of the
production.
10. Any of the following outdoor areas that have a usual capacity of 20,000 or more persons:
pase»

i. Outdoor meeting and event spaces, including conference centres or convention centres, but not including places
described in subsection 4 (2) of this Schedule.
ii. Outdoor facilities used for sports and recreational fitness activities, including waterparks and personal physical
fitness trainers, including, for greater certainty, the outdoor areas of facilities where spectators watch events, but
not including places described in subsection 16 (4) of Schedule 2.
iii. Outdoor concert venues, theatres and cinemas.
iv. Outdoor horse racing tracks, car racing tracks and other similar venues.
(3) Subsection (1) does not apply where a patron is entering an indoor area solely,
(a) to use a washroom;
 058

(b) to access an outdoor area that can only be accessed through an indoor route;
(0) to make a retail purchase;
((1) while placing or picking up an order, including placing a bet or picking up winnings in the case of a horse racing track;
(e) while paying for an order;
(t) to purchase admission; or
(g) as may be necessary for the purposes of health and safety.
(3.1) Despite subsection (1), if a quick service restaurant or other establishment at which food or drink is sold requires all
dine-in patrons to order or select their food or drink at a counter, food bar or cafeteria line and pay before receiving their
order, the person responsible for the restaurant or establishment may require dine-in patrons to provide the information
described in that subsection at the counter, food bar or cafeteria line.
(3.2) Subsection (3.1) does not apply to bars, nightclubs, restoclubs or other similar establishments.
(4) The person responsible for a business or an organization to which this section applies shall comply with guidance
published by the Ministry of Health on its website specifying,
(a) what constitutes proof of,
(i) identification,
(ii) being fully vaccinated against COVID-l9, and
(iii) being entitled to an exemption under subsection (6); and
(b) the manner of confirming, for the purposes of this section, that a patron is fiilly vaccinated against COVID-19 or is
entitled to an exemption under subsection (6).
(5) For the purpose of this section, a person is fully vaccinated against COVID-19 if,
(a) they have received,
(1) the full series of a COVID-19 vaccine authorized by Health Canada, or any combination of such vaccines,
(ii) one or two doses of a COVID-l 9 vaccine not authorized by Health Canada, followed by one dose of a COVID-19
mRNA vaccine authorized by Health Canada, or
‘

(iii) three doses of a COVID-l9 vaccine not authorized by Health Canada; and
(b) they received their final dose of the COVID-19 vaccine at least 14 days before providing the proof of being fully
vaccinated.
(6) A business or an organization is exempt from the requirement under subsection (1) in respect of patrons,
(a) who are under 12 years of age;
(b) who are under 18 years of age, and who are entering the premises of a facility used for sports and recreational fitness
activities solely for the purpose of actively participating in an organized sport, in accordance with guidance published
by the Ministry of Health on its website for the purposes of this provision;
(b.l) who provide documentation that confirms, in accordance with the Ministry’s guidance mentioned in subsection (4),
that the patron is currently participating in a COVID-19 vaccine clinical trial that is authorized by Health Canada and
specified in that guidance;
(c) who provide documentation that, in accordance with the Ministry’s guidance mentioned in subsection (4),
(i) confirms that the patron has a medical reason for not being fiilly vaccinated against COVID-19, and
(ii) specifies the effective time-period for the medical reason;
(d) who are entering the premises of a meeting or event space, including a conference centre or convention centre, solely
for the purposes of attending a wedding service, rite or ceremony or a funeral service, rite or ceremony, but not an
associated social gathering;
(e) who are entering the premises of ameeting or event space that is located in a place of worship or in a funeral
establishment, cemetery, crematorium or similar establishment that provides funeral, cemetery or cremation services
and that is operated by a person licensed under the Funeral, Burial and Cremation Services Act, 2002, for the purposes
of attending a social gathering associated with a funeral service, rite or ceremony; or
(f) who are entering the premises of a meeting or event space other than a place described in clause (e), including a
conference centre or convention centre, for the purposes of attending a social gathering associated with a wedding
service, rite or ceremony or a social gathering associated with a funeral service, rite or ceremony, on or after

5
 059

September 22, 2021, but before October 13, 2021, as long as the patron produces the results of an antigen test
administered within the previous 48 hours establishing that the person is negative for COVID-19 to the person
responsible for the establishment.
(7) A person who is a patron shall not enter an area described in subsection (2) without providing the information required
by subsection (1) except,
(a) for a purpose specified in subsection (3); or
(b) in the circumstances described in subsection (6).
(8) A business or organization may use an electronic application to confirm, for the purposes of this section, that a patron
is fully vaccinated against COVID-l9 or is entitled to an exemption under subsection (6) only if the electronic application is
listed in the guidance published by the Ministry of Health on its website.
(9) A person who provides any information to a business or an organization to satisfy a requirement under this section
shall ensure that their information is complete and accurate.
(10) Subject to subsection (11), no person shall retain, record, copy, modify, use or disclose any information provided
pursuant to this section.
(11) A business or organization may use information provided pursuant to this section solely for the purpose of
confirming, for the purposes of this section, that a patron is fiilly vaccinated against COVID-l9 or is entitled to an exemption
under subsection (6).
Capacity limits for businesses or facilities open to the public
3. (1) Subject to any other requirements set out in this Order with respect to capacity limits, the person responsible for a
place of business or facility that is open to the public shall limit the number of members of the public in the place of business
or facility so that the members of the public are able to maintain a physical distance of at least two metres from every other
person in the business or facility.
(2) For the purposes of this Order, the maximum number of members of the public permitted in a business or facility that
is operating in an outdoor setting at 75 per cent capacity is determined by taking the total square metres of area accessible to
the public, dividing that number by 1.33, and rounding the result down to the nearest whole number.
(3) For the purposes of this Order, the maximum number of members of the public permitted in a business or facility, or
part of a business or facility, that is operating in an indoor setting at 50 per cent capacity is determined by taking 50 per cent
of the maximum occupant load of the business or facility, or part of a business or facility, as applicable, as calculated in
accordance with Ontario Regulation 213/07 (Fire Code), made under the Fire Protection and Prevention Act, 1997.
(4) For the purposes of this Order, the maximum number of members of the public permitted in a business or facility, or
part of a business or facility, that is operating in an indoor setting at 25 per cent capacity is determined by taking 25 per cent
of the maximum occupant load of the business or facility, or part of a business or facility, as applicable, as calculated in
accordance with Ontario Regulation 213/07 (Fire Code), made under the Fire Protection and Prevention Act, 1997.
(5) For greater certainty, subsection (1) does not require persons who are in compliance with public health guidance on
households to maintain a physical distance of at least two metres fi'om each other while in a place of business or facility.
(6) Subsection (1) does not apply to schools and private schools within the meaning of the Education Act that are,
(a) operating in accordance with a return to school direction issued by the Ministry of Education and approved by the
Office of the Chief Medical Officer of Health; or
(b) operated by,
(i) a band, a council of a band or the Crown in right of Canada,
(ii) an education authority that is authorized by a band, a council of a band or the Crown in right of Canada, or
(iii) an entity that participates in the Anishinabek Education System.
(7) Subsection (1) does not apply with respect to the following areas:
1. Meeting and event spaces, including conference centres and convention centres.
2. Areas for spectators in facilities used for sports and recreational fitness activities.
3. Concert venues, theatres and cinemas.
4. Horse racing tracks, car racing tracks and other similar venues.
5. Places where commercial film and television production takes place.
Requirements that apply to individuals
 060

3.1 (1) Every person on the premises of a business or organization that is open shall wear a mask or face covering in a
manner that covers their mouth, nose and chin during any period in which they are in an indoor area of the premises.
(2) Every person shall wear a mask or face covering in a manner that covers their mouth, nose and chin during any period
in which they are,
(a) in attendance at an indoor organized public event permitted by this Order; and
(b) within two metres of another individual who is not part of their household.
(3) Subsections (l) and (2) do not require a person to wear a mask or face covering if they are subject to an exception set
out in subsection 2 (4).
(4) Every member of the public in an indoor place of business or facility that is open to the public, and every person in
attendance at an indoor organized public event permitted by this Order, shall maintain a physical distance of at least two
metres fi‘om every other person, except from their caregiver or fiom members of the person’s household.
(5) The physical distancing described in subsection (4) is not required,
(a) where necessary to complete a transaction or to receive a service, if the member of the public wears a mask or face
covering in a manner that covers their mouth, nose and chin or is subject to an exception set out in subsection 2 (4);
(b) when attending a day camp or overnight camp for children that is in compliance with section 19 of Schedule 2;
(c) when passing one another in a confined location, such as in a hallway or aisle, if the member of the public wears a
mask or face covering in a manner that covers their mouth, nose and chin or is subject to an exception set out in
subsection 2 (4);
(d) in situations where another provision of this Order expressly authorizes persons to be closer than two metres from each
other;
(e) when in an indoor instructional space at a post-secondary institution as defined in subsection 13 (2) of Schedule 2,
other than an Indigenous Institute to which paragraph 2 of subsection 13 (1) of Schedule 2 applies; and
(f) when in,
(i) an outdoor meeting or event space,
(ii) an area for spectators in a facility used for sports and recreational fitness activities,
(iii) a concert venue, theatre or cinema,
(iv) a horse racing track, car racing track or other similar venue, or
(v) a place where commercial film and television production takes place.
(6) For greater certainty, nothing in subsection (5) affects the obligation of persons who provide services to comply with
subsection 2 (7).
Physical distancing and masks or face coverings in lines, etc.
3.2 (1) The person responsible for a business or place that is open must not permit patrons to line up or congregate outside
of the business or place, or at an outdoor attraction or feature within the business or place, unless they are maintaining a
physical distance of at least two metres from other groups of persons.
(2) The person responsible for a business or place that is open must not permit patrons to line up inside an indoor part of
the business or place unless they are,
(a) maintaining a physical distance of at least two metres from other groups of persons; and
(b) wearing a mask or face covering in a manner that covers their mouth, nose and chin, unless they are entitled to any of
the exceptions set out in subsection 2 (4).
(3) This section does not apply with respect to day camps or overnight camps for children that are in compliance with
section 19 of Schedule 2.
Safety plan
3.3 (1) The person responsible for a business that is open shall prepare and make available a safety plan in accordance
with this section, or ensure that one is prepared and made available, no later than seven days after the requirement first
applies to the person.
(2) The safety plan shall describe the measures and procedures which have been implemented or will be implemented in
the business to reduce the transmission risk of COVID-19.
 061

(3) Without limiting the generality of subsection (2), the safety plan shall describe how the requirements of this Order will
be implemented in the location including by screening, physical distancing, masks or face coverings, cleaning and
disinfecting of surfaces and objects, the wearing of personal protective equipment and preventing and controlling crowding.
(3.1) For a business, place or event referred to in sections 1, 2 ,9, 16, 22 to 28, 32 or 33 of Schedule 2, the safety plan shall
also include information as to how the business, place or event will,
(a) prevent gatherings and crowds in the business or place or at the event;
(b) ensure that section 3.2 of this Schedule is complied with in the business or place or at the event; and
(c) mitigate the risk of any interactive activities, exhibits or games that may be included in the business or place or at the
event.
(4) The safety plan shall be in writing and shall be made available to any person for review on request.
(5) The person responsible for the business shall ensure that a copy of the safety plan is posted in a conspicuous place
where it is most likely to come to the attention of individuals working in or attending the business.
Meeting or event space, conference centres, convention centres
4. (1) The person responsible for a business or place that is open, including a conference centre or convention centre, may
rent out indoor or outdoor meeting or event space if the business or place complies with the following conditions:
1. REVOKED: O. Reg. 698/21, s. l (3).
2. The number of members of the public permitted to be in a particular room in the indoor portion of the rentable meeting
or event space at any one time must be limited to the number that can maintain a physical distance of at least two
metres fi'om every other person in the room.
3. REVOKED: O. Reg. 698/21, s. 1 (5).
4. The person responsible for the establishment must post a sign in a conspicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
5. The rented space must be configured so that patrons seated at different tables are separated by,
i. a distance of at least two metres, or
ii. plexiglass or some other'impermeable barrier.
6. Rooms must be separated by a partition with a hard, non-porous surface that can be easily and routinely cleaned and
disinfected.
7. The person responsible for the business or place must actively screen individuals in accordance with the advice,
recommendations and instructions of the Office of the Chief Medical Officer of Health before they enter the indoor
premises of the business or place.
8. The person responsible for the business or place must,
i. record the name and contact information of every member of the public who attends a meeting or event,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
(2) Paragraphs 2, 5, 7 and 8 of subsection (1) do not apply if the business or place is rented out,
(a) for a day camp or overnight camp for children described in section 19 of Schedule 2;
(b) to a provider of child care within the meaning of the Child Care and Early Years Act, 2014;
(c) for the purpose of the provision of social services;
((1) for the purpose of delivering or supporting the delivery of court services;
(c) for operations by or on behalf of a government; or
(f) for the purpose of delivering or supporting the delivery of government services.
(3) Paragraph 2 of subsection (1) does not apply if the business or place is rented out to participants in an international
single sport event hosted by a national sport organization that is either funded by Sport Canada or recognized by the
Canadian Olympic Committee or the Canadian Paralympic Committee.
(4) Paragraph 2 of subsection (1) does not apply if the business or place is rented out to participants in a sport league or
association identified in Column 2 of the Tables to this subsection that is associated with the sport identified in Column 3 of
the Tables to this subsection:
 062

TABLE 1
PROFESSIONAL SPORT LEAGUES OR ASSOCIATIONS
Column 1 Column 2 Column 3
Professional Sport Leagues or Associations Sport
1. American Hockey League Hockey
2. Canadian Elite Basketball League Basketball
3. Canadian Football League Football
4. Canadian Premier League Soccer
5. Major League Baseball Baseball
6. Major League Soccer Soccer
7. NBA G League Basketball
8. National Basketball Association Basketball
9. National Hockey League Hockey
10. National Lacrosse League Lacrosse
l 1. National Women’s Hockey League Hockey
12. Professional Women’s Hockey Players Association Hockey
13. USL League 1 Soccer

TABLE 2
ELITE AMATEUR SPORT LEAGUES OR ASSOCIATIONS
Column 1 Column 2 Column 3
Elite Amateur Sport Leagues or Associations Sport
1. Canadian Hockey League Hockey
2. Elite Baseball League of Ontario U 18 Division Baseball
3. League 1 Ontario Soccer
4. Ontario Junior “A” Lacrosse League Lacrosse
5. Ontario Scholastic Basketball Association Basketball
6. Ontario Women’s Field Lacrosse U 19 “A” League Lacrosse
7. Provincial Women’s Hockey League Hockey

Tents, canopies, retractable roofs, etc.

5. (l) The person responsible for a business or place that is open shall ensure that,
(a) if an outdoor area of the business or place is covered by a roof, canopy, tent, awning or other element, at least two full
sides of the entire outdoor area are open to the outdoors and are not substantially blocked by any walls or other
impermeable physical barriers; and
(b) if an outdoor area at the business or place is equipped with a retractable roof and the roof is retracted, at least one full
side of the outdoor area is open to the outdoors and is not substantially blocked by any walls or other impermeable
physical barriers.
(2) In the case of an event referred to in section 28 of Schedule 2 that is held outdoors, the requirement set out in
subsection (1) applies to the person responsible for the business that hosts the event.
(3) Clause (1) (b) does not apply with respect to the Rogers Centre in Toronto.
Live entertainment: requirements
6. (1) The person responsible for a business or place that is open shall ensure that, if live entertainment is performed for
spectators at the business or place, the performers maintain a physical distance of at least two metres fi'om any spectators or
are separated from any spectators by plexiglass or some other impermeable barrier.
(2) In the case of an event referred to in section 28 of Schedule 2 that is held outdoors, the requirement set out in
subsection (1) applies to the person responsible for the business that hosts the event.
Cleaning requirements
7. (1) The person responsible for a business or place that is open shall ensure that,
(a) any washrooms, locker rooms, change rooms, showers or similar amenities made available to the public are cleaned
and disinfected as frequently as is necessa1y to maintain a sanitary condition; and
(b) any equipment that is rented to, provided to or provided for the use of members of the public must be cleaned and
disinfected as fiequently as is necessary to maintain a sanitary condition.
(2) For greater certainty, clause (1) (b) applies to computers, electronics and other machines or devices that members of
the public are permitted to operate.
 063

8. REVOKED: O. Reg. 520/21, s. 5 (12).

O. Reg. 364/20, Sched. l; O. Reg. 415/20, s. 2; O. Reg. 428/20, s. 2; O. Reg. 501/20, s. l; O. Reg. 530/20, s. 1; O. Reg.
531/20, s. l; O. Reg. 546/20, s. 2; O. Reg. 574/20, s. 2; O. Reg. 579/20, s. 1; O. Reg. 588/20, s. l; O. Reg. 642/20, s. 4-7; 0.
Reg. 655/20, s. 1; O. Reg. 687/20, s. 1; O. Reg. 4/21, s. 1, 2; O. Reg. 98/21, s. l, 3; O. Reg. 115/21, s. 1; O. Reg. 119/21, s. 1;
O. Reg. 147/21, 5. 1(1,2); O. Reg. 164/21, s.1;O. Reg. 218/21, s. l; O. Reg. 223/21, s. 1; O. Reg. 315/21, s. 1; O. Reg.
520/21, s. 5; O. Reg. 541/21, s. 5; O. Reg. 577/21, s. 1; O. Reg. 630/21, s. 1; O. Reg. 645/21, s. 1;O. Reg. 659/21, s. 1; O.
Reg. 678/21, s. 1; O. Reg. 698/21, s. 1; O. Reg. 710/21, s. 1.
SCHEDULE 2
SPECIFIC RULES AT STEP 3
Food and drink
Restaurants, bars, etc.
1. (1) Restaurants, bars, food trucks, concession stands and other food or drink establishments may open if they comply
with the following conditions:
1. The total number of patrons permitted to be seated at the establishment, whether indoors or outdoors, must be limited
to the number that can maintain a physical distance of at least two metres from every other person at the establishment.
2. The establishment must be configured so that patrons seated at different tables are separated by,
i. a distance of at least two metres, or
ii. plexiglass or some other impermeable barrier.
3. The person responsible for the establishment must post a sign in a conspicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
4. The person responsible for the establishment must actively screen any dine-in patrons in accordance with the advice,
recommendations and instructions of the Office of the Chief Medical Officer of Health before they enter the
establishment.
5. The person responsible for the establishment must,
i. record the name and contact information of every patron that enters an area of the establishment, unless the
patron temporarily enters the area to place, pick up or pay for a takeout order,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
6. No patron shall dance at the establishment.
(2) For greater certainty, the person responsible for the establishment must prepare a safety plan in accordance with
section 3.3 of Schedule 1.
(3) Paragraphs 4 and 5 of subsection (1) do not apply with respect to an establishment which requires all dine-in patrons to
order or select their food or drink at a counter, food bar or cafeteria line and pay before receiving their order.
(4) Paragraphs 1, 3 and 4 of subsection (1) do not apply,
(a) with respect to establishments on hospital premises or in an airport; or
(b) with respect to an establishment located within a business or place if the only patrons permitted at the establishment
are persons who perform work for the business or place in which the establishment is located.
(5) For greater certainty, any business, place, facility or establishment at which food or drink is sold or served, including
those referred to in section 4 of Schedule 1 and in sections 4 and 5, paragraph 1 of section 18, and sections 22, 23, 24, 25, 26,
27, 28, 31, 32 and 33 of this Schedule, is a food or drink establishment to which this section applies,
(a) at any time when food or drink is served or sold at the business, place, facility or establishment; and
(b) in any part of the business, place, facility or establishment where the food or drink is served or sold.
(5.1) Despite subsection (5), if the capacity limit provided for in this section conflicts with the capacity limit set out
elsewhere in this Order in respect of a business, place, facility or establishment at which food or drink is sold or served, the
capacity limit for the business, place, facility or establishment is whichever limit is lower.
(6) For greater certainty, a restaurant, bar, food truck, concession stand or other food or drink establishment that is in
compliance with the conditions set out in subsection (1) may open in any business or place that is otherwise permitted to
open under this Order.

10
 064

(7) For greater certainty, this section does not apply to food or drink establishments where dance facilities are provided,
during a time when patrons are permitted to make use of the dance facilities.
(8) The physical distancing described in subsections 3 (1) and 3.1 (4) of Schedule 1 is not required when patrons are
seated together at a table in a food or drink establishment.
Food or drink establishments with dance facilities
2. (1) Food or drink establishments where dance facilities are provided, including nightclubs, restoclubs and other similar
establishments, may open if they comply with the following conditions during any time when patrons are permitted to make
use of the dance facilities:
1. In the case of an indoor establishment, the total number of members of the public permitted to be in the establishment
at any one time must be limited to the number that can maintain a physical distance of at least two metres from every
other person in the establishment and in any event may not exceed 25 per cent capacity, as determined in accordance
with subsection 3 (4) of Schedule 1, or 250 persons, whichever is less.
2. In the case of an outdoor establishment, the total number of members of the public permitted to be at the establishment
at any one time may not exceed 75 per cent capacity, as determined in accordance with subsection 3 (2) of Schedule 1,
or 5,000 persons, whichever is less.
3. The establishment must be configured so that patrons seated at different tables are separated by,
i. a distance of at least two metres, or
ii. plexiglass or some other impermeable barrier.
4. Every patron in an outdoor establishment must wear a mask or face covering in a manner that covers their mouth, nose
and chin, unless they are entitled to any of the exceptions set out in subsection 2 (4) of Schedule 1, or are seated with
members of their own household only, and every member of the household is seated at least two metres from every
person outside their household.
5. The person responsible for the establishment must post a sign in a conspicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
6. The person responsible for the establishment must actively screen patrons in accordance with the advice,
recommendations and instructions of the Office of the Chief Medical Officer of Health before they enter the premises
of the establishment.
7. The person responsible for the establishment must,
i. record the name and contact information of every patron that enters an area of the establishment,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
(2) For the purposes of paragraph 4 of subsection (1), the references to “indoor area” in clauses 2 (4) (i) and (l) of
Schedule 1 shall be read as “outdoor area”, and for greater certainty patrons are permitted to remove a mask or face covering
temporarily to consume food or drink, or as may be necessary for the purposes of health and safety.
(3) For greater certainty, the person responsible for the establishment must prepare a safety plan in accordance with
section 3.3 of Schedule 1.
(4) Subsection 3.1 (4) of Schedule 1 continues to apply to patrons of the dance facility, except when physical distancing
cannot be maintained while participating in the activities for which patrons normally frequent such an establishment.
(5) The physical distancing described in subsections 3 (1) and 3.1 (4) of Schedule 1 is not required when patrons are
seated together at a table in an establishment to which this section applies.
(6) For greater certainty, any business, place, facility or establishment at which food or drink is sold or served while dance
facilities are provided, including any business, place, facility or establishment referred to in section 4 of Schedule 1 and in
sections 22, 24, 25, 27 and 28 of this Schedule, is a food or drink establishment to which this section applies,
(a) at any time when food or drink is served or sold at the business, place, facility or establishment while dance facilities
are provided; and
(b) in any part of the business, place, facility or establishment where the food or drink is served or sold and dance facilities
are provided.
(7) For greater certainty,

ll
 065

(a) the indoor capacity limits set out in paragraph 1 of subsection (1) apply to each particular room in a business, place,
facility or establishment referred to in subsection (6) where dance facilities are provided during the periods of time
when dancing is permitted; and
(b) the outdoor capacity limits set out in paragraph 2 of subsection (1) apply to each outdoor area at a business, place,
facility or establishment referred to in subsection (6) where dance facilities are provided during the periods of time
when dancing is permitted.
Services
Public libraries, exception to capacity rule
3. Subsection 3 (1) of Schedule 1 does not apply to any part of a public library that is used,
(a) for a day camp or overnight camp for children described in section 19;
(b) by a provider of child care within the meaning of the Child Care and Early Years Act, 2014; or
(c) for the purpose of the provision of social services.
Community centres and multi-purpose facilities
4. (1) Community centres and multi-purpose facilities may open to permit space to be used for any purpose if they
comply with the following conditions:
1. Any indoor or outdoor sports or recreational fitness activities must be in compliance with section 16.
(2) Subsection 3 (l) of Schedule 1 does not apply to any part of the community centre or multi-purpose facility that is
used,
(a) for a day camp or overnight camp for children described in section 19;
(b) by a provider of child care within the meaning of the Child Care and Early Years Act, 2014; or
(c) for the purpose of the provision of social services.
Short-term rentals
5. Businesses providing short-term rental accommodation may open if they comply with the following condition:
1. Any indoor fitness centres or other indoor recreational facilities that are part of the operation of these businesses must
be in compliance with section 16.
Hotels, motels, etc.
6. Hotels, motels, lodges, cabins, cottages, resorts and other shared rental accommodation, including student residences,
may open if they comply with the following condition:
1. Any indoor fitness centres or other indoor recreational facilities that are part of the operation of these businesses must
be in compliance with section 16.
Real estate agencies
7. For greater certainty, subsection 3 (l) of Schedule 1 applies to any open house events a real estate agency hosts,
provides or supports.
Personal care services
8. (1) Personal care services relating to the hair or body, including hair salons and barbershops, manicure and pedicure
salons, aesthetician services, piercing services, tanning salons, spas and tattoo studios, may open if they comply with the
following conditions:
1. Persons who provide personal care services in the business must wear appropriate personal protective equipment.
2. For greater certainty, subsection 3 (l) of Schedule 1 must be complied with.
3. The person responsible for the establishment must post a sign in a conspicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
4. Oxygen bars must be closed.
5. Individuals must be actively screened in accordance with the advice, recommendations and instructions of the Office
of the Chief Medical Officer of Health before they enter the establishment.
6. No member of the public may be permitted to enter the premises except by appointment.
(2) Subsection (1) does not apply to hair and makeup services described in section 20.
Personal physical fitness trainers

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9. (1) Personal physical fitness trainers may open if they comply with the following conditions:
1. The number of patrons permitted indoors,
i. must be limited to the number that can maintain a physical distance of at least two metres from every other
person in an indoor space, and
ii. in any event may not exceed 50 per cent of the capacity of the indoor space where the services are provided, as
determined in accordance with subsection 3 (3) of Schedule 1, if the services are provided in an indoor space
where a maximum occupant load applies under Ontario Regulation 213/07 (Fire Code), made under the Fire
Protection and Prevention Act, I 997.
2. The personal physical fitness trainer must,
1. record the name and contact information of every member of the public whom they are providing services to,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
3. The personal physical fitness trainer must actively screen individuals in accordance with the advice, recommendations
and instructions of the Office of the Chief Medical Officer of Health before they engage in personal physical fitness
training activities.
(2) For greater certainty, the personal physical fitness trainer must prepare a safety plan in accordance with section 3.3 of
Schedule 1.
(3) For greater certainty, any person who is engaged in physical fitness training activities indoors must maintain a physical
distance of at least two metres from every other person in the establishment except from their caregiver or from members of
the person’s household.
(4) For greater certainty, subsection 3.1 (1) of Schedule 1 applies to persons who are engaged in physical fitness training
activities indoors, unless they are subject to any of the exceptions set out in subsection 2 (4) of that Schedule, including the
one set out in subclause (i) (ii) of that subsection.
Shopping and retail
Retailers
‘

10. (l) Businesses that engage in retail sales to the public may open if they comply with the following conditions:
1. The person responsible for the establishment must post a sign in a conspicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
2. If the business permits members of the public to test drive any vehicles, boats or watercraft,
i. the members of the public must be actively screened in accordance with the advice, recommendations and
instructions of the Office of the Chief Medical Officer of Health before they participate in the test drive, and
ii. all participants in the test drive must wear a mask or face covering in a manner that covers their mouth, nose and
chin, unless they are entitled to any of the exceptions set out in subsection 2 (4) of Schedule 1.
(2) For greater certainty, the total number of patrons permitted indoors in the establishment must be limited to the number
that can maintain a physical distance of at least two metres from every other person in the establishment.
(3) Despite subsection 32 (2) of Ontario Regulation 268/18 (General) made under the Smoke—Free Ontario Act, 2017, a
person responsible for a specialty vape store as defined in that Regulation that is permitted to be open in accordance with the
conditions described in subsection (1) shall not permit an electronic cigarette to be used for the purpose of sampling a vapour
product in the specialty vape store.
(4) Cannabis retail stores operating under the authority of a retail store authorization issued under the Cannabis Licence
Act, 2018 may open if they comply with the conditions set out in subsection (1) and provide products to patrons through in-
person sales or through an alternative method of sale, such as curbside pick-up or delivery.
Shopping malls
11. Shopping malls may open if the person responsible for the shopping mall ensures that the following conditions are
complied with:
1. Members of the public who enter the shopping mall must not be permitted to loiter in any area of the shopping mall.
2. The number of members of the public in the shopping mall at any one time must not exceed the total capacity
determined by taking the sum of the capacities of every business in the mall, as permitted under subsection 10 (2).

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Education
Schools and private schools
12. (1) Schools and private schools within the meaning of the Education Act may open if they comply with the following
conditions:
1. They must be operated in accordance with a return to school direction issued by the Ministry of Education and
approved by the Office of the Chief Medical Officer of Health.
2. If a person who holds a study permit issued under the Immigration and Refitgee Protection Act (Canada) and who
entered Canada on or after November 17, 2020 attends the school, in-person teaching or instruction may only be
provided to that person if the school or private school,
i. has a plan respecting COVID-19 that has been approved by the Minister of Education, and
ii. operates in accordance with the approved plan.
(2) The condition set out in paragraph 1 of subsection (1) does not apply to a school operated by,
(a) a band, a council of a band or the Crown in right of Canada;
(b) an education authority that is authorized by a band, a council of a band or the Crown in right of Canada; or
(c) an entity that participates in the Anishinabek Education System.
Post-secondary institutions
13. (I) Post-secondary institutions may open to provide in-person teaching or instruction if they comply with the
following conditions:
1. 1f the instructional space is outdoors,
i. the instructional space must be operated to enable students to maintain a physical distance of at least two metres
from every other person in the instructional space, except where necessary for teaching and instruction that
cannot be effectively provided if physical distancing is maintained, and
ii. the total number of students permitted to be in each instructional space in the institution at any one time must be
limited to the number that can maintain a physical distance of at least two metres from every other person in the
space, and in any event cannot exceed the lesser of 15,000 persons and 75 per cent of the capacity of the
instructional space, as determined in accordance with subsection 3 (2) of Schedule 1.
2. If the instructional space is indoors and is at an Indigenous Institute prescribed for the purposes of section 6 of the
Indigenous Institutes Act, 2017,
i. the instructional space must be operated to enable students to maintain a physical distance of at least two metres
from every other person in the instructional space, except where necessary for teaching and instruction that
cannot be effectively provided if physical distancing is maintained, and
ii. the total number of students permitted to be in each instructional space in the institution at any one time must be
limited to the number that can maintain a physical distance of at least two metres from every other person in the
space, and in any event cannot exceed the lesser of 1,000 persons and 50 per cent of the capacity of the
instructional space, as determined in accordance with subsection 3 (3) of Schedule 1.
(1.1) Paragraph 2 of subsection (1) does not apply if the Indigenous Institute implements a COVID-19 vaccination policy
consistent with any advice, recommendations and instructions issued under subsection 2 (2.1) of Schedule 1 for post-
secondary institutions.
(2) In this section, “post-secondary institution” means,
(a) a university,
(b) a college of applied arts and technology,
(c) a private career college,
(d) an Indigenous Institute prescribed for the purposes of section 6 of the Indigenous Institutes Act, 201 7,
(e) an institution that is authorized to grant a degree by an Act of the Legislature,
(f) a person who is delivering in-person teaching or instruction in accordance with a consent given under section 4 of the
Post-secondary Education Choice andExcellence Act, 2000,
(g) a person approved to provide training for apprenticeship programs under paragraph 5 of section 64 of the Ontario
College of Trades and Apprenticeship Act, 2009, or

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(h) any other institution that is a designated learning institution within the meaning of section 211.1 of the Immigration
and Refugee Protection Regulations (Canada), other than a school or private school within the meaning of the
Education Act.
Businesses that provide teaching and instruction
l4. Businesses that provide in-person teaching and instruction may open if they comply with the following conditions:
1. The space for any in-person teaching or instruction must be operated to enable students to maintain a physical distance
of at least two metres fiom every other person in the space, except where necessary for teaching and instruction that
cannot be effectively provided if physical distancing is maintained.
2. The total number of students permitted to be in each instructional space at any one time must be limited to the number
that can maintain a physical distance of at least two metres fiom every other person in the space, and in any event,
i. if the space is indoors cannot exceed 50 per cent of the capacity of the instructional space as determined in
accordance with subsection 3 (3) of Schedule 1, or 1,000 persons, whichever is less, and
ii. if the space is outdoors cannot exceed 75 per cent of the capacity of the instructional space, as determined in
accordance with subsection 3 (2) of Schedule 1, or 15,000 persons, whichever is less.
3. Students must be actively screened in accordance with the advice, recommendations and instructions of the Office of
the Chief Medical Officer of Health before they enter the business.
4. The person responsible for the business shall,
i. record the name and contact information of every student who attends the in-person teaching and instruction,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
Driving instruction
15. (1) Businesses that provide driving instruction in a motor vehicle may open if they comply with the following
conditions:
1. Every student must be actively screened in accordance with the advice, recommendations and instructions of the
Office of the Chief Medical Officer of Health before they enter the vehicle.
2. Every student and instructor must wear a mask or face covering in a manner that covers their mouth, nose and chin
when in the vehicle.
(2) For greater certainty, driving instruction that is provided in an instructional space must comply with the conditions set
out in section 14.
(3) A person is not required to comply with subsection 3 (l) or 3.1 (4) of Schedule 1 when driving instruction is provided
in a motor vehicle.
Sports and fitness
Facilities used for indoor or outdoor sports and recreational fitness activities
16. (1) Facilities used for indoor or outdoor sports and recreational fitness activities may open if they comply with the
following conditions:
1. In the case of an indoor facility, the total number of members of the public, other than spectators in an area for
spectators, who are permitted to be in the facility at any one time must be limited to 50 per cent of the capacity of
those areas of the facility that are not areas for spectators, as determined in accordance with subsection 3 (3) of
Schedule 1.
2. REVOKED: O. Reg. 698/21, s. 2 (1).
3. Every indoor spectator must wear a mask or face covering in a manner that covers their mouth, nose and chin, unless
they are entitled to any of the exceptions set out in subsection 2 (4) of Schedule 1.
4. Every outdoor spectator must wear a mask or face covering in a manner that covers their mouth, nose and chin, unless
they are entitled to any of the exceptions set out in subsection 2 (4) of Schedule 1, or are seated with members of their
own household only, and every member of the household is seated at least two metres from every person outside their
household.
5. The person responsible for the facility, or, where there is no such responsible person, the person holding a permit for
the use of the facility must post a sign in a conspicuous location visible to the public that states the capacity limits
under which the facility is permitted to operate.

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6. The person responsible for the facility, or, where there is no such responsible person, the person holding a permit for
the use of the facility, must,
i. record the name and contact information of every member of the public who enters the facility,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
7. The person responsible for the facility or, where there is no such responsible person, the person holding a permit for
the use of the facility, must actively screen individuals who enter the facility in accordance with the advice,
recommendations and instructions of the Office of the Chief Medical Officer of Health before they enter the facility.
8. Prior to permitting any participants in an organized sports league or event to practise or play the sport in the facility,
the facility must ensure that the league or event has prepared a safety plan in accordance with section 3.3 of Schedule
1.
(2) For the purposes of paragraph 4 of subsection (1), the references to “indoor area” in clauses 2 (4) (i) and (l) of
Schedule 1 shall be read as “outdoor area”, and for greater certainty, spectators are permitted to remove a mask or face
covering temporarily to consume food or drink, or as may be necessary for the purposes of health and safety.
(3) Every non-spectator in an indoor area of the facility must maintain a physical distance of at least two metres from
every other person in the facility other than from their caregiver or from members of the person’s household, except when,
(a) engaging in sports or games at the facility; or
(b) any of the exceptions set out in subsection 3.1 (5) of Schedule 1 would apply.
(4) Paragraphs 1, 3, 4, 6, 7 and 8 of subsection (1), and subsection (3), do not apply to any part of the facility that is being
used,
(a) for a day camp or overnight camp for children described in section 19;
(b) by a provider of child care within the meaning of the Child Care and Early Years Act, 2014; or
(c) for the purpose of the provision of social services.
(5) For greater certainty, the facility must prepare a safety plan in accordance with section 3.3 of Schedule 1.
(6) Subsection 3.1 (4) of Schedule 1 does not apply to members of the public engaged in sports or games at facilities for
indoor or outdoor sports and recreational fitness activities or to seated spectators at a seated event at such a facility.
(7) For greater certainty, the requirement to wear a mask or face covering set out in subsection 3.1 (1) of Schedule 1
applies to persons at indoor areas of the facility, unless they are subject to any of the exceptions set out in subsection 2 (4) of
that Schedule, including the one set out in subclause (i) (ii) of that subsection.
Recreational amenities
Indoor recreational amenities
17. Indoor recreational amenities may open if they comply with the conditions set out in section 16.
Outdoor recreational amenities
18. Outdoor recreational amenities may open, if they comply with the following conditions, where applicable:
1. The total number of members of the public permitted to be in any indoor clubhouse at the outdoor recreational amenity
at any one time must be limited to the number that can maintain a physical distance of at least two metres fi'om every
other person in the indoor clubhouse and in any event may not exceed 50 per cent of the capacity of the clubhouse, as
determined in accordance with subsection 3 (3) of Schedule 1.
2. If the person responsible for an indoor clubhouse at the outdoor recreational amenity rents its space, the conditions in
section 4 of Schedule 1 apply.
3. The person responsible for the outdoor amenity must post a sign in a conspicuous location visible to the public that
states the capacity limits under which the indoor clubhouse is permitted to operate.
Camps for children
Camps for children
19. (1) Day camps for children may open if they operate in a manner consistent with the safety guidelines for COVID-19
for day camps produced by the Office of the Chief Medical Officer of Health.
(2) Camps that provide supervised overnight accommodation for children may open if they operate in a manner consistent
with the safety guidelines for COVID-l9 for overnight camps produced by the Office of the Chief Medical Officer of Health.

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Media industries
Film and television production
20. (1) Commercial film and television production, including all supporting activities such as hair, makeup and wardrobe,
may open if they comply with the following conditions:
1. Persons who provide hair or makeup services must wear appropriate personal protective equipment.
2., 3. REVOKED: O. Reg. 698/21, s. 2 (3).
4. If there is a studio audience, the person responsible for the film or television production must prepare a safety plan in
accordance with section 3.3 of Schedule 1.
5. The person responsible for the film or television production must ensure that the production operates in accordance
with the guidance document titled “Film and television industry health and safety during COVID-19” issued by the
Film and Television Health and Safety Advisory Committee of the Ministry of Labour, Training and Skills
Development, as amended fi'om time to time.
(2) For greater certainty, for the purposes of this section, the film or television set may be located in any business or place,
including any business or place that is otherwise required to be closed under this Order.
Photography studios and services .

2]. (1) Photography studios and services may open if they comply with the following conditions:
1. If the studio or the place where the service is provided is indoors, individuals must be actively screened in accordance
with the advice, recommendations and instructions of the Office of the Chief Medical Officer of Health before they
enter the establishment.
2. The person responsible for the studio or service must post a sign in a conspicuous location visible to the public that
states the capacity limits under which the establishment is permitted to operate.
(2) For greater certainty, the total number of patrons permitted indoors at the studio or the place where the service is
provided must be limited to the number that can maintain a physical distance of at least two metres from every other person
in the establishment.
Entertainment
Concert venues, theatres and cinemas
22. (1) Concert venues, theatres and cinemas may open if they comply with the following conditions:
1.-4. REVOKED: O. Reg. 698/21, s. 2 (4).
5. Every member of the public who is outdoors at a concert, event, performance or movie must wear a mask or face
covering in a manner that covers their mouth, nose and chin, unless they are entitled to any of the exceptions set out in
subsection 2 (4) of Schedule 1, or are seated with members of their own household only, and every member of the
household is seated at least two metres from every person outside their household.
6. No member of the public may attend a seated concert, event, performance or movie within the concert venue, theatre
or cinema unless they have made a reservation to do so.
7. REVOKED: O. Reg. 698/21, s. 2 (4).
(2) For the purposes of paragraph 5 of subsection (1), the references to “indoor area” in clauses 2 (4) (i) and (l) of
Schedule 1 shall be read as “outdoor area”, and for greater certainty members of the public are permitted to remove a mask or
face covering temporarily to consume food or drink, or as may be necessary for the purposes of health and safety.
(3) For greater certainty, the person responsible for the concert venue, theatre or cinema must prepare a safety plan in
accordance with section 3.3 of Schedule 1.
Drive-in or drive-through venues
23. Outdoor drive-in or drive-through concert venues and theatres and drive-in cinemas may open if they comply with the
following conditions:
1. The driver of a motor vehicle at the drive-in cinema or the drive-in or drive-through concert, event or performance
must ensure that it is positioned at least two metres away from other motor vehicles.
Museums, etc.
24. (1) Museums, galleries, aquariums, zoos, science centres, landmarks, historic sites, botanical gardens and similar
attractions may open if they comply with the following conditions:
1. The number of members of the public in the outdoor ticketed area of the attraction at any one time must not exceed 75
per cent capacity, as determined in accordance with subsection 3 (2) of Schedule 1.
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The number of members of the public in the indoor ticketed area of the attraction at any one time must be limited to
the number that can maintain a physical distance of at least two metres from every other person in the indoor ticketed
area of the attraction and in any event may not exceed 50 per cent capacity, as determined in accordance with
subsection 3 (3) of Schedule 1.
The number of members of the public at a seated event or activity within the attraction at any one time must not
exceed,
i. 50 per cent of the usual seating capacity for the event or activity, in the case of events or activities indoors, or
1,000 persons, whichever is less, and
ii. 75 per cent of the usual seating capacity for the event or activity, in the case of events or activities outdoors, or
15,000 persons, whichever is less.
The number of members of the public at an outdoor event or activity at the attraction at any one time must not exceed
75 per cent capacity, as determined in accordance with subsection 3 (2) of Schedule 1, or 5,000 persons, whichever is
less.
The number of members of the public permitted to be in a particular room in the indoor portion of the attraction at any
one time must be limited to the number that can maintain a physical distance of at least two metres from every other
person in the room and in any event may not exceed 50 per cent capacity of the room in the attraction, as determined in
accordance with subsection 3 (3) of Schedule 1, or if it is a seated event or activity taking place in the room, must be
limited in accordance with subparagraph 3 i of this subsection, and the total capacity for the particular room cannot be
added to increase the total capacity of the indoor ticketed area as provided for under paragraph 2 of this subsection.
If a concert, event, performance or movie is held at the park, the conditions in section 22 apply with respect to the
concert, event, performance or movie, except that the maximum capacity permitted under section 22 may not be added
to the maximum capacity permitted under this section so as to increase the capacity permitted under this section.
No member of the public may attend a seated event or activity within the attraction or an indoor event or activity
within the attraction unless they have made a reservation to do so.
Any indoor amusement rides operated by the attraction must be operated to enable every person on the ride to maintain
a physical distance of at least two metres from every other person on the ride, except where necessary,
i. to facilitate payment, or
ii. for the purposes of health and safety.
Any indoor tour vehicles operated by the attraction must be operated to enable every person on the tour vehicle,
including tour guides, to maintain a physical distance of at least two metres fiom every other person, except where
necessary,
1. to facilitate payment, or
ii. for the purposes of health and safety.
10. Paragraphs 8 and 9 do not apply in respect of a group of persons if the persons are all,
i. members of the same household,
ii. a member of one other household who lives alone, or
iii. a caregiver for any member of either household.
11. The person responsible for the attraction must post a sign in a conspicuous location visible to the public that states the
capacity limits under which the attraction is permitted to operate and the capacity limits of any seated event or activity
within the attraction.
(2) For greater certainty, the person responsible for the attraction must prepare a safety plan in accordance with section 3.3
of Schedule 1.
(3) For greater certainty, every person on an indoor amusement ride or indoor tour vehicle must wear a mask or face
covering in a manner that covers their mouth, nose and chin, unless they are entitled to any of the exceptions set out in
subsection 2 (4) of Schedule 1.
Casinos, bingo halls and gaming establishments
25. (1) Casinos, bingo halls and other gaming establishments may open if they comply with the following conditions:
1. The number of members of the public in the establishment at any one time must be limited to the number that can
maintain a physical distance of at least two metres fi'om every other person and in any event may not exceed 50 per
cent of the maximum occupancy of the establishment, as determined in accordance with subsection 3 (3) of Schedule
1.

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2. If a concert, event, performance or movie is held at the establishment, the conditions in section 22 apply with respect
to the concert, event, performance or movie, except that the maximum capacity permitted under section 22 may not be
added to the maximum capacity permitted under this section so as to increase the capacity permitted under this section.
3. Members of the public who enter the establishment must not be permitted to loiter in any area of the establishment or
congregate at or around any of the tables where games are played.
4. Patrons must be separated from table game employees by plexiglass or some other impermeable barrier.
4.1 The establishment must be configured so that patrons at gaming tables or slot machines are separated by,
i. a distance of at least two metres, or
ii. plexiglass or some other impermeable barrier.
5. If the casino, bingo hall or establishment houses an attraction, the conditions in section 24 apply with respect to the
attraction.
6. The person responsible for the establishment must post a sign in a conspicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
7. The person responsible for the establishment must,
1. record the name and contact information of every patron that enters an area of the establishment,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
8. The person responsible for the establishment must actively screen patrons in accordance with the advice,
recommendations and instructions of the Office of the Chief Medical Officer of Health before they enter the premises
of the establishment.
(2) For greater certainty, any general requirements for cleaning at the establishment apply with respect to chips, cards,
dice, card holders and other table game equipment.
(3) For greater certainty, the person responsible for the establishment must prepare a safety plan in accordance with
section 3.3 of Schedule 1. .

Racing venues
26. (1) Horse racing tracks, car racing tracks and other similar venues may open if they comply with the following
conditions:
1.-3. REVOKED: O. Reg. 698/21, 5. 2(5).
4. Every member of the public in an outdoor area of the venue must wear a mask or face covering in a manner that covers
their mouth, nose and chin, unless they are entitled to any of the exceptions set out in subsection 2 (4) of Schedule 1,
or are seated with members of their own household only, and every member of the household is seated at least two
metres from every person outside their household.
5. No member of the public may attend a seated event or activity within the venue or an indoor event or activity within
the venue unless they have made a reservation to do so.
6. REVOKED: O. Reg. 698/21, s. 2 (5).
(2) For the purposes of paragraph 4 of subsection (1), the references to “indoor area” in clauses 2 (4) (i) and (l) of
Schedule 1 shall be read as “outdoor area”, and for greater certainty members of the public are permitted to remove a mask or
face covering temporarily to consume food or drink, or as may be necessary for the purposes of health and safety.
(3) For greater certainty, the person responsible for the venue must prepare a safety plan in accordance with section 3.3 of
Schedule 1.
Amusement parks
27. (1) Amusement parks and waterparks may open if they comply with the following conditions:
1. The number of members of the public in the outdoor area of the park at any one time must not exceed 75 per cent
capacity, as determined in accordance with subsection 3 (2) of Schedule 1.
2. The number of members of the public in the indoor area of the park at any one time must be limited to the number that
can maintain a physical distance of at least two metres from every other person in the indoor area of the park and in
any event may not exceed 50 per cent capacity, as determined in accordance with subsection 3 (3) of Schedule 1.

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The number of members of the public at any particular outdoor attraction within the park at any one time must not
exceed 75 per cent capacity, as determined in accordance with subsection 3 (2) of Schedule 1.
The number of members of the public at any particular indoor attraction within the park at any one time must be
limited to the number that can maintain a physical distance of at least two metres from every other person in the indoor
attraction and in any event may not exceed 50 per cent capacity, as determined in accordance with subsection 3 (3) of
Schedule 1.
No member of the public may attend a seated event within the park or an indoor event or activity within the park
unless they have made a reservation to do so.
If a concert, event, performance or movie is held at the park, the conditions in section 22 apply with respect to the
concert, event, performance or movie, except that the maximum capacity permitted under section 22 may not be added
to the maximum capacity permitted under this section so as to increase the capacity permitted under this section.
Any indoor amusement rides at the park must be operated to enable every person on the ride to maintain a physical
distance of at least two metres from every other person on the ride, except where necessary,
i. to facilitate payment, or
ii. for the purposes of health and safety.
Paragraph 7 does not apply in respect of a group of persons if the persons are all,
i. members of the same household,
ii. a member of one other household who lives alone, or
iii. a caregiver for any member of either household.
The person responsible for the park must post a sign in a conspicuous location visible to the public that states the
capacity limits under which the park is permitted to operate and the capacity limits of any seated event or activity
within the park.
(2) For greater certainty, the person reSponsible for the park must prepare a safety plan in accordance with section 3.3 of
Schedule 1.
(3) For greater certainty, every person on an indoor amusement ride, other than a water ride, must wear a mask or face
covering in a manner that covers their mouth, nose and chin, unless they are entitled to any of the exceptions set out in
subsection 2 (4) of Schedule 1.
Fairs, rural exhibitions, festivals
28. (1) Fairs, rural exhibitions, festivals and similar events may open if they comply with the following conditions:
I. The number of members of the public in the outdoor area of the facility where the event takes place at any one time
must not exceed 75 per cent capacity, as determined in accordance with subsection 3 (2) of Schedule 1.
The number of members of the public in the indoor area of the facility where the event takes place at any one time
must be limited to the number that can maintain a physical distance of at least two metres from every other person in
the indoor area of the facility and in any event may not exceed 50 per cent capacity, as determined in accordance with
subsection 3 (3) of Schedule 1.
The number of members of the public at any particular outdoor attraction within the facility at any one time must not
exceed 75 per cent capacity, as determined in accordance with subsection 3 (2) of Schedule 1.
The number of members of the public at any particular indoor attraction within the facility at any one time must be
limited to the number that can maintain a physical distance of at least two metres from every other person in the indoor
attraction and in any event may not exceed 50 per cent capacity, as determined in accordance with subsection 3 (3) of
Schedule 1.
If a concert, event, performance or movie is held at the facility, the conditions in section 22 apply with respect to the
concert, event, performance or movie, except that the maximum capacity permitted under section 22 may not be added
to the maximum capacity permitted under this section so as to increase the capacity permitted under this section.
Any indoor amusement rides at the facility must be operated to enable every person on the ride to maintain a physical
distance of at least two metres from every other person on the ride, except where necessary,
i. to facilitate payment, or
ii. for the purposes of health and safety.
Paragraph 6 does not apply in respect of a group of persons if the persons are all,
i. members of the same household,

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ii. a member of one other household who lives alone, or

iii. a caregiver for any member of either household.
8. The person responsible for the event must post a sign in a conspicuous location visible to the public that states the
capacity limits under which the event is permitted to operate.
(2) For greater certainty, the person responsible for the event must prepare a safety plan in accordance with section 3.3 of
Schedule 1.
(3) For greater certainty, every person on an indoor amusement ride, other than a water ride, must wear a mask or face
covering in a manner that covers their mouth, nose and chin, unless they are entitled to any of the exceptions set out in
subsection 2 (4) of Schedule 1.
Tour and guide services
29. Businesses that provide tour and guide services, including guided hunting trips, tastings and tours for wineries,
breweries and distilleries, fishing charters, trail riding tours, walking tours and bicycle tours may open if they comply with
the following conditions:
1. The number of members of the public on the tour must not exceed the number of persons that would permit every
person on the tour, including tour guides, to maintain a physical distance of at least two metres from every other
person.
2. The person responsible for the business must,
i. record the name and contact information of every patron that participates in the tour,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
3. The person responsible for the business must actively screen employees and any performers in accordance with the
advice, recommendations and instructions of the Office of the Chief Medical Officer of Health.
Boat tours
30. Businesses that provide boat tours in which the passengers are required to embark and disembark within the province
of Ontario and that are not otherwise prohibited from opening by an order made by the Minister of Transport (Canada) under
the Canada Shipping Act, 2001 may open if they comply with the following conditions:
1. The total number of members of the public permitted on the boat at any one time must be limited to the number that
can maintain a physical distance of at least two metres from every other person on the vessel, and in any event must
not exceed 50 per cent of the usual maximum number of passengers that may be carried on board, as indicated on the
vessel’s inspection certificate or Passenger Ship Safety Certificate issued under the Vessel Certificates Regulations
(Canada) or on an equivalent certificate issued by a foreign government.
2. The person responsible for the business must post a sign in a conspicuous location visible to the public that states the
capacity limits under which the boat tour is permitted to operate.
3. No member of the public may go on the boat tour unless they have made a reservation to do so.
4. The person responsible for the business must,
i. record the name and contact information of every patron that participates in the tour,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
5. The person responsible for the business must actively screen employees and any performers in accordance with the
advice, recommendations and instructions of the Office of the Chief Medical Officer of Health.
Marinas, boating clubs etc.
31. Marinas, boating clubs and other organizations that maintain docking facilities for members or patrons may open if
they comply with the following conditions:
1. Any indoor fitness centres or other indoor recreational facilities on the premises must be in compliance with section
16.
Strip clubs
32. (1) Strip clubs may open if they comply with the following conditions:

21
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1. The total number of patrons permitted to be seated at the establishment, whether indoors or outdoors, must be limited
to the number that can maintain a physical distance of at least two metres from every other person at the establishment.
2. The establishment must be configured so that patrons seated at different tables are separated by,
i. a distance of at least two metres, or
ii. plexiglass or some other impermeable barrier.
3. Performers at the establishment must maintain a physical distance of at least two metres from patrons.
4. The person responsible for the establishment must post a sign in a conSpicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
5. The person responsible for the establishment must actively screen patrons in accordance with the advice,
recommendations and instructions of the Office of the Chief Medical Ofiicer of Health before they enter the indoor
premises of the establishment.
6. The person responsible for the establishment must,
i. record the name and contact information of every patron that enters an area of the establishment, unless the
patron temporarily enters the area to place, pick up or pay for a takeout order,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
(2) For greater certainty, the person responsible for the establishment must prepare a safety plan in accordance with
section 3.3 of Schedule 1.
(3) The physical distancing described in subsections 3 (1) and 3.1 (4) of Schedule 1 is not required when patrons are
seated together at a table in the establishment.
Bathhouses, sex clubs
33. (l) Bathhouses and sex clubs may open if they comply with the following conditions:
1. Staff of the establishment must wear appropriate personal protective equipment.
2. The total number of members of the public permitted to be in the establishment at any one time must be limited to the
number that can maintain a physical distance of at least two metres from every other person in the establishment and in
any event may not exceed 25 per cent of the capacity of the establishment, as determined in accordance with
subsection 3 (4) of Schedule 1, or 250 persons, whichever is less.
3. The person responsible for the establishment must post a sign in a conspicuous location visible to the public that states
the capacity limits under which the establishment is permitted to operate.
4. The person responsible for the establishment must actively screen any patrons in accordance with the advice,
recommendations and instructions of the Office of the Chief Medical Officer of Health before they enter the indoor
premises of the establishment.
5 The person responsible for the establishment must,
i. record the name and contact information of every patron that enters an area of the establishment,
ii. maintain the records for a period of at least one month, and
iii. only disclose the records to a medical officer of health or an inspector under the Health Protection and
Promotion Act on request for a purpose specified in section 2 of that Act or as otherwise required by law.
(2) For greater certainty, the person responsible for the establishment must prepare a safety plan in accordance with
section 3.3 of Schedule 1.
(3) Section 3.1 (4) of Schedule 1 continues to apply to patrons of the bathhouse or sex club, except when physical
distancing cannot be maintained while participating in the activities for which patrons normally frequent such an
establishment.
(4) Patrons of the establishment must wear a mask or face covering in a manner that covers their mouth, nose and chin
during any period in which they come within two metres of another person, except,
(a) when masks or face coverings cannot be worn while participating in the activities for which patrons normally fiequent
such an establishment, or
(b) if the patron is entitled to any of the exceptions set out in subsection 2 (4) of Schedule 1.
Campgrounds

22
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34. Campgrounds may open if they comply with the following condition:
1. Any indoor fitness centres or other indoor recreational facilities on the premises must be in compliance with section
16.
O. Reg. 520/21, s. 6; O. Reg. 524/21, s. 1; O. Reg. 541/21, s. 6; O. Reg. 630/21, s. 2; O. Reg. 678/21, s. 2; O. Reg. 698/21, s.
2.
SCHEDULE 3
ORGANIZED PUBLIC EVENTS AND CERTAIN GATHERINGS AT STEP 3
Gatherings
l. (1) Subject to sections 2 to 5, no person shall attend,
(a) an organized public event of more than,
(i) 25 people if the event is held indoors, or
(ii) 100 people if the event is held outdoors;
(b) a social gathering of more than,
(i) 25 people if the event is held indoors, or
(ii) 100 people if the event is held outdoors; or
(c) a social gathering associated with a wedding, a funeral or a religious service, rite or ceremony of more than,
(i) 25 people if the event is held indoors, or
(ii) 100 people if the event is held outdoors.
(2) For greater certainty, the limits in clause (1) (c) apply to a social gathering associated with a wedding, a funeral or a
religions service, rite or ceremony, such as a wedding reception, while the limits that apply to the wedding, funeral or
religious service, rite or ceremony itself are set out in sections 6 and 7.
(3) For greater certainty, subsections (1) and (2) apply with respect to an organized public event or social gathering even if
it is held at a private dwelling, including houses, apartment buildings, condominium buildings and post-secondary student
residences.
'

Exceptions, single household

2. Section 1 does not apply with respect to,
(a) a gathering of members of a single household;
(b) a gathering that includes members of a household and one other person from another household who lives alone; or
(c) a gathering that includes persons described in clause (a) or (b), and a caregiver for any of those persons.
Exception, retirement homes
3. Section 1 does not apply with respect to a gathering in a retirement home within the meaning of the Retirement Homes
Act, 2010 if it is in compliance with the policies or guidance, if any, issued by the Retirement Homes Regulatory Authority.
Exceptions from organized public event requirements
4. The prohibitions on attendance at an organized public event in clause 1 (1) (a) do not apply with respect to attendance
at,
(a) an event at a business or place to which a capacity limit set out in Schedule 1 or 2 applies, if the event is held in
accordance with that capacity limit;
(b) a day camp or overnight camp for children that is in compliance with section 19 of Schedule 2; or
(c) a drive-in cinema, or a business or place that provides drive-in or drive-through concerts, artistic events, theatrical
performances and other performances, that is in compliance with section 23 of Schedule 2.
Exceptions from social gathering requirements
5. The prohibitions on attendance at a social gathering in clauses 1 (1) (b) and 1 (1) (c) do not apply with respect to
attendance at,
(a) a meeting or event space, including a conference centre or convention centre, operating in compliance with section 4
of Schedule 1; or
(b) a food or drink establishment operating in compliance with sections 1 and 2 of Schedule 2.

23
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Indoor wedding, funeral or religious service, rite or ceremony

6. (1) This section applies with respect to gatherings for the purposes of a wedding, a funeral or a religious service, rite or
ceremony, if the gathering is held in a building or structure other than a private dwelling.
(2) No person shall attend a gathering to which this section applies unless the following conditions are met:
1. The number of persons occupying any room in the building or structure while attending the gathering must be limited
to the number that can maintain a physical distance of at least two metres from every other person in the room.
2. All persons attending the gathering must comply with public health guidance on physical distancing.
Outdoor wedding, funeral or religious service, rite or ceremony
7. (1) This section applies with respect to outdoor gatherings for the purposes of a wedding, a funeral or a religious
service, rite or ceremony.
(2) No person shall attend a gathering to which this section applies unless the following condition is met:
1. All persons attending the gathering must comply with public health guidance on physical distancing.
O. Reg. 520/21, s. 7; O. Reg. 524/21, s. 2; O. Reg. 541/21, s. 7.
ROADMAP EXIT STEP
SCHEDULE 4
GENERAL RULES AT THE ROADMAP EXIT STEP
Closures
1. (1) Each person responsible for a business or place, or part of a business or place, that Schedule 5 describes as being
permitted to open if certain conditions set out in that Schedule are met shall ensure that the business or place, or part of the
business or place, either meets those conditions or is closed.
(2) Each person responsible for a business or place, or part of a business or place, that does not comply with sections 1 to
5 of this Schedule shall ensure that it is closed.
(3) Despite subsections ( 1) and (2), temporary access to a business or place, or part of a business or place, that is required
to be closed is authorized, unless otherwise prohibited by any applicable law, for the purposes of,
(a) performing work at the business or place in order to comply with any applicable law;
(b) preparing the business or place to be reopened;
(c) allowing for inspections, maintenance or repairs to be carried out at the business or place;
((1) allowing for security services to be provided at the business or place; and
(e) attending at the business or place temporarily,
(i) to deal with other critical matters relating to the closure of the business or place, if the critical matters cannot be
attended to remotely, or
(ii) to access materials, goods or supplies that may be necessary for the business or place to be operated remotely.
(4) Nothing in this Order precludes a business or organization from operating remotely for the purpose of,
(a) providing goods by mail or other forms of delivery, or making goods available for pick—up; and
(b) providing services online, by telephone or other remote means.
(5) Nothing in this Order precludes operations or delivery of services by the following in Ontario:
1. Any government.
2. Any person or publicly-funded agency or organization that delivers or supports government operations and services,
including operations and services of the health care sector.
General compliance
2. (1) The person responsible for a business or organization that is open shall ensure that the business or organization
operates in accordance with all applicable laws, including the Occupational Health and Safety Act and the regulations made
under it.
(2) The person responsible for a business or organization that is open shall operate the business or organization in
compliance with the advice, recommendations and instructions of public health officials, including any advice,
recommendations or instructions on physical distancing, cleaning or disinfecting.

24
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(2.1) The person responsible for a business or organization that is open shall operate the business or organization in
compliance with any advice, recommendations and instructions issued by the Office of the Chief Medical Officer of Health,
or by a medical officer of health after consultation with the Office of the Chief Medical Officer of Health,
(a) requiring the business or organization to establish, implement and ensure compliance with a COVID-19 vaccination
policy; or
(b) setting out the precautions and procedures that the business or organization must include in its COVID-19 vaccination
policy.
(2.2) In subsection (2.1),
“medical officer of health” means a medical officer of health as defined in subsection 1 (1) of the Health Protection and
Promotion Act.
(3) The person responsible for a business or organization that is open shall operate the business or organization in
compliance with any advice, recommendations and instructions issued by the Office of the Chief Medical Officer of Health,
or another public health official, on screening individuals by, among other things, posting signs at all entrances to the
premises of the business or organization, in a conspicuous location visible to the public, that inform individuals on how to
screen themselves for COVID-19 prior to entering the premises.
(4) The person responsible for a business or organization that is open shall ensure that any person in the indoor area of the
premises of the business or organization, or in a vehicle that is operating as part of the business or organization, wears a mask
or face covering in a manner that covers their mouth, nose and chin during any period when they are in the indoor area unless
subsection (5) applies to the person in the indoor area.
(5) Where there is any requirement under this Order that a person wear a mask or face covering, the requirement does not
apply to a person who,
(a) is a child who is younger than two years of age;
(b) is attending a school or private school within the meaning of the Education Act that is operated in accordance with a
return to school direction issued by the Ministry of Education and approved by the Office of the Chief Medical Officer
of Health;
(c) is attending a child care program at a place that is in compliance with the child care re-opening guidance issued by the
Ministry of Education;
((1) is attending a day camp or overnight camp for children that is in compliance with section 2 of Schedule 5;
(e) is receiving residential services and supports in a residence listed in the definition of “residential services and
supports” in subsection 4 (2) of the Services and Supports to Promote the Social Inclusion of Persons with
Developmental Disabilities Act, 2008;
(f) is in a correctional institution or in a custody and detention program for young persons in conflict with the law;
(g) is performing or rehearsing in a film or television production or in a concert, artistic event, theatrical performance or
other performance;
(h) has a medical condition that inhibits their ability to wear a mask or face covering;
(i) is unable to put on or remove their mask or face covering without the assistance of another person;
(j) needs to temporarily remove their mask or face covering while in the indoor area,
(i) to receive services that require the removal of their mask or face covering,
(ii) to engage in an athletic or fitness activity,
(iii) to consume food or drink, or
(iv) as may be necessary for the purposes of health and safety;
(k) is being accommodated in accordance with the A ccessibilityfor Ontarians with Disabilities Act, 2005;
(l) is being reasonably accommodated in accordance with the Human Rights Code;
(m) performs work for the business or organization, is in an area that is not accessible to members of the public and is able
to maintain a physical distance of at least two metres from every other person while in the indoor area; or
(n) is a patron at a sex club or bathhouse and cannot wear a face mask or covering while participating in the activities for
which patrons normally frequent such an establishment.
(6) Subsection (4) does not apply with respect to premises that are used as a dwelling if the person responsible for the
business or organization ensures that persons in the premises who are not entitled to an exception set out in subsection (5)

25
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wear a mask or face covering in a manner that covers their mouth, nose and chin in any common areas of the premises in
which persons are unable to maintain a physical distance of at least two metres from other persons.
(7) The person responsible for a business or organization shall ensure that every person who performs work for the
business or organization and whose mask or face covering is temporarily removed to consume food or drink under subclause
(5) (j) (iii) is separated fi'om every other person by,
(a) a distance of at least two metres; or
(b) plexiglass or some other impermeable barrier.
(8) For greater certainty, it is not necessary for a person to present evidence to the person responsible for a business or
place that they are entitled to any of the exceptions set out in subsection (5).
(9) A person shall wear appropriate personal protective equipment that provides protection of the person’s eyes, nose and
mouth if, in the course of providing services, the person,
(a) is required to come within two metres of another person who is not wearing a mask or face covering in a manner that
covers that person’s mouth, nose and chin during any period when that person is in an indoor area; and
(b) is not separated by plexiglass or some other impermeable barrier from a person described in clause (a).
(10) Where directives, policies or guidance that apply to a long-term care home within the meaning of the Long-Term
Care Homes Act, 2007 are issued by the Office of the Chief Medical Officer of Health, the Minister of Long-Term Care or
the Ministry of Long-Term Care, such directives, polices or guidance apply despite anything in this Order.
Requirements that apply to individuals
3. (1) Every person on the premises of a business or organization that is open shall wear a mask or face covering in a
manner that covers their mouth, nose and chin during any period in which they are in an indoor area of the premises.
(2) Subsection ( 1) does not require a person to wear a mask or face covering if they are subject to an exception set out in
subsection 2 (5).
Safety plan
4. (1) The person responsible for a business that is open shall prepare and make available a safety plan in accordance with
this section, or ensure that one is prepared and made available, no later than seven days after the requirement first applies to
the person. ~ ,

(2) The safety plan shall describe the measures and procedures which have been implemented or will be implemented in
the business to reduce the transmission risk of COVID-19.
(3) Without limiting the generality of subsection (2), the safety plan shall describe how the requirements of this Order will
be implemented in the location including by screening, masks or face coverings, and the wearing of personal protective
equipment.
(4) The safety plan shall be in writing and shall be made available to any person for review on request.
(5) The person responsible for the business shall ensure that a copy of the safety plan is posted in a conspicuous place
where it is most likely to come to the attention of individuals working in or attending the business.
Collection of names and contact information
5. Any provisions in Schedule 1 or 2 that require persons responsible for a business or organization to record names and
contact information, maintain those records and disclose them to medical officers of health or inspectors under the Health
Protection and Promotion Act continue to apply, subject to any clarifications or exceptions set out in those Schedules.
O. Reg. 541/21, s. 8; O. Reg. 577/21, s. 2.
SCHEDULE 5
SPECIFIC RULES AT THE ROADMAP EXIT STEP
Cannabis retail stores
1. Cannabis retail stores operating under the authority of a retail store authorization issued under the Cannabis Licence
Act, 2018 may open if they provide products to patrons through in-person sales or through an alternative method of sale, such
as curbside pick-up or delivery.
Camps for children
2. (1) Day camps for children may open if they operate in a manner consistent with the safety guidelines for COVID-19
for day camps produced by the Office of the Chief Medical Officer of Health.
(2) Camps that provide supervised overnight accommodation for children may open if they operate in a manner consistent
with the safety guidelines for COVID-19 for overnight camps produced by the Office of the Chief Medical Officer of Health.

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Schools and private schools

3. (1) Schools and private schools within the meaning of the Education Act may open if they comply with the following
conditions:
1. They must be operated in accordance with a return to school direction issued by the Ministry of Education and
approved by the Office of the Chief Medical Officer of Health.
2. If a person who holds a study permit issued under the Immigration and Refugee Protection Act (Canada) and who
entered Canada on or after November 17, 2020 attends the school, in-person teaching or instruction may only be
provided to that person if the school or private school,
i. has a plan respecting COVID-19 that has been approved by the Minister of Education, and
ii. operates in accordance with the approved plan.
(2) The condition set out in paragraph 1 of subsection (1) does not apply to a school operated by,
(a) a band, a council of a band or the Crown in right of Canada;
(b) an education authority that is authorized by a band, a council of a band or the Crown in right of Canada; or
(c) an entity that participates in the Anishinabek Education System.
0. Reg. 541/21, s. 8.

Francais
Back to top

27
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This is the administrative version of Order in Council No. 1173-2021

made on September 1 2021. In the event of discrepancy, the version
to be published in the Gazette officielie du Quebec takes precedence.

Ordering of measures to protect the health of the

population amid the COVID-19 pandemic situation

---oooOooo---

WHEREAS the World Health Organization declared COVID-19 to be a

pandemic on 11 March 2020;

WHEREAS, under section 118 of the Public Health Act (chapter S 2.2),
the Government may declare a public health emergency in all or part of the territory of
Quebec where a serious threat to the health of the population, whether real or imminent,
requires the immediate application of certain measures provided for in section 123 of the
Act to protect the health of the population;

WHEREAS the pandemic constitutes a serious and real threat to the

health of the population that requires the immediate application of certain measures
provided for in section 123 of the Act;

WHEREAS, while the public health emergency is in effect, despite any

provision to the contrary, the Government or the Minister of Health and Social Services, if
the Minister has been so empowered, may, without delay and without further formality,
take any of the measures provided for in subparagraphs 1 to 8 of the first paragraph of
section 123 of the Act to protect the health of the population;

WHEREAS, by Order in Council 177-2020 dated 13 March 2020, the

Government declared a public health emergency and took certain measures to protect the
health of the population;
 082

WHEREAS the public health emergency has consistently been

renewed since that date by various Orders in Council, including by Order in Council
1172-2021 dated 1 September 2021;

WHEREAS that latter Order in Council provides that the measures set
out in Orders in Council 177-2020 dated 13 March 2020, 222-2020 dated 20 March 2020,
460-2020 dated 15April 2020, 505-2020 dated 6 May 2020, 566-2020 dated 27 May 2020,
615-2020 dated 10 June 2020, 651-2020 dated 17 June 2020, 885—2020 dated 19 August
2020, 943-2020 dated 9 September 2020, 964-2020 dated 21 September 2020, 135-2021
dated 17 February 2021 and 885-2021 dated 23 June 2021, and by Ministerial Orders
2020-004 dated 15 March 2020, 2020-007 dated 21 March 2020, 2020-008 dated 22
March 2020, 2020 014 dated 2 April 2020, 2020-015 dated 4 April 2020, 2020-016 dated
7 April 2020, 2020-017 dated 8 April 2020, 2020-019 and 2020-020 dated 10 April 2020,
2020-022 dated 15 April 2020, 2020-023 dated 17 April 2020, 2020-026 dated 20 April
2020, 2020-027 dated 22 April 2020, 2020-028 dated 25 April 2020, 2020-029 dated 26
April 2020, 2020-030 dated 29 April 2020, 2020 032 dated 5 May 2020, 2020-033 dated
7 May 2020, 2020-034 dated 9 May 2020, 2020-035 dated 10 May 2020, 2020-037 dated
14 May 2020, 2020-039 dated 22 May 2020, 2020-042 dated 4 June 2020, 2020-044
dated 12 June 2020, 2020-049 dated 4 July 2020, 2020-060 dated 28 August 2020, 2020—
061 dated 1 September 2020, 2020 062 dated 4 September 2020, 2020-064 dated 17
September 2020, 2020-067 dated 19 September 2020, 2020-069 dated 22 September
2020, 2020-076 dated 5 October 2020, 2020-084 dated 27 October 2020, 2020-087 dated
4 November 2020, 2020-091 dated 13 November 2020, 2020-097 dated 1 December
2020, 2020-099 dated 3 December 2020, 2020-102 dated 9 December 2020, 2020-107
dated 23 December 2020, 2021-003 dated 21 January 2021, 2021-005 dated 28 January
2021, 2021-010 dated 5 March 2021, 2021 017 dated 26 March 2021, 2021 022 dated 7
April 2021, 2021-024 dated 9 April 2021, 2021-027 dated 16 April 2021, 2021-028 dated
17 April 2021, 2021-032 dated 30 April 2021, 2021-036 dated 15 May 2021, 2021 039
dated 28 May 2021, 2021—040 dated 5 June 2021, 2021-046 dated 16 June 2021, 2021-
049 dated 1 July 2021, 2021-050 dated 2 July 2021, 2021-051 dated 6 July 2021, 2021-
052 dated 7 July 2021, 2021-053 dated 10 July 2021, 2021 054 dated 16 July 2021, 2021-
055 dated 30 July 2021, 2021 057 dated 4 August 2021, 2021-058 dated 13August 2021,
2021-059 dated 18 August 2021, 2021-060 dated 25 August 2021 and 2021—061 dated
31 August 2021, except to the extent that they were amended by those Orders in Council
or Orders, continue to apply until 10 September 2021 or until the Government or the
Minister of Health and Social Services modifies or terminates them;

WHEREAS it is advisable to order certain measures to protect the

health of the population;

This is the administrative version of Order in Council No. 1173-2021 made on

September 1 2021. In the event of discrepancy, the version to be published in
the Gazette officialle du Québec takes precedence.
 083

IT IS ORDERED, therefore, on the recommendation of the Minister of

Health and Social Services:
THAT, for the purposes of this Order in Council, a person be
considered "adequately protected against COVID-19" if the person

(1) has received two doses of either the Moderna or Pfizer-BioNTech

mRNA vaccine or two doses of the AstraZeneca/COVIDSHIELD vaccine, with an interval
of no fewer than 28 days between the doses and the last dose being received at least 7
days earlier;

(2) contracted COVID-19 and has received, at least 7 days earlier, a

dose of either vaccine described in subparagraph 1 after an interval of at least 21 days
following the illness; or

(3) has received the single-dose Janssen vaccine at least 14 days

earlier;

THAT a person also be held to be adequately protected against

COVID-19 if the person

(1) has a contraindication to vaccination against the illness certified by

a health professional qualified to make such a diagnosis and entered in the vaccination
registry maintained by the Minister of Health and Social Services; or

(2) has taken part in the Medicago inc. clinical trial seeking to validate
the safety or efficacy of a COVID-19 vaccine candidate;

THAT every member of the public 13 years of age or older be required

to be adequately protected against COVID-19, to provide protection status by producing
an identity document and the QR code received for that purpose from the government of
Québec, and to permit verification of that status by means of the VaxiCode Verif
application, so that he or she may participate in the following activities or be admitted to
the following places:

(1) an outdoor event open to the public at which more than 50 persons
may be present or participate, other than

This is the administrative version of Order in Council No. 1173-2021 made on

September 12021. in the event of discrepancy, the version to be published in
the Gazette offlcielle du Québec takes precedence.
 084

(a) an event that takes place in a drive-in theatre or other place used
for similar purposes; or
(b) an event or amateur training activity at which a maximum of 500
persons may be present when seated in the grandstands or bleachers or in any other type
of seating arrangement allowing the persons to be seated in assigned seats;

(2) a movie theater, a room or hall in which performing arts are

presented, including broadcast venues, a production, an audio-video filming, an indoor
performance and an indoor training activity or sports event, other than an event or amateur
training activity at which a maximum of 25 persons may be present or a maximum of 250
persons may be seated in the grandstands or bleachers or in any other type of seating
arrangement allowing the persons to be seated in assigned seats;
(3) a biodome, a planetarium, an insectarium, a botanical garden, an
aquarium and a 200;

(4) a casino, gaming house or place where bingo is played;

(5) a bar, discotheque, microbrewery, distillery, restaurant and food

court a
in shopping centre or food store, including any terrace of such a place, except
when a take-out or drive-through order is to be picked up;
'

(6) an arcade, theme park, amusement park or centre, recreational

centre and water park, and venues for games of bowling, darts, billiard or other games of
the same nature;

(7) a scenic or recreational cruise;

(8) a convention or conference;

(9) any indoor place for the purpose of playing a sport or engaging in a
physical activity, other than

(a) such a sport or activity forming part of sport-study or art-study

programs, physical education and health and sports concentration curriculums and other
special school projects of the same nature provided as part of educational services in
general education for youth or adult general education by a school service centre, a school
board or a private educational institution, other than sporting competitions, league events
or tournaments;
'

This is the administrative version of Order in Council No. 1173-2021 made on

September 12021. in the event of discrepancy, the version to be published in
the Gazette officielle du Québec takes precedence.
 085

(b) such a sport or activity forming part of sports and recreation

curriculums in college or university educational programs, other than sporting
competitions, league events or tournaments; or

(c) a professional or high-level sport in a protected environment

complying with subparagraph fof subparagraph 21 of the fourteenth paragraph of Order
in Council 885-2021 dated 23 June 2021, amended by Ministerial Orders 2021-049 dated
1 July 2021, 2021-050 dated 2 July 2021, 2021-053 dated 10 July 2021, 2021-055 dated
30 July 2021, 2021-057 dated 4 August 2021 , 2021-058 dated 13 August 2021, 2021-059
dated 18 August 2021, 2021-060 dated 24 August 2021 and 2021-061 dated 31 August
2021;

(10) a physical activity involving frequent or extended contact, or a

team sport played outdoors, other than

(a) to play such a sport or engage in such an activity forming part of

sport-study or art-study programs, physical education and health and sports concentration
curriculums and other special school projects of the same nature provided as part of
educational services in general education for youth or adult general education by a school
service centre, a school board or a private educational institution, other than sporting
competitions, league events or tournaments; ’

(b) to play such a sport or engage in such an activity forming part of

sports and recreation curriculums in college or university instructional programs, other
than sporting competitions, league events or tournaments;

(c) to engage in such an activity or sport played individually; or

(d) to play a professional or high-level sport in a protected environment

complying with subparagraph fof subparagraph 21 of the fourteenth paragraph of Order
in Council 885-2021 dated 23 June 2021, as amended;

THAT students at the elementary or secondary school level in general

education for youth, in colleges, private educational institutions and other institutions
providing college-level instructional services not be required to be adequately protected
or to produce protection status or an identity document as a prerequisite to admittance to
any place where they receive educational services offered by a school service centre,
school board, private educational institution, college, private educational institution or
other institution providing college-level instructional services;

This is the administrative version of Order in Council No. 1173-2021 made on

September 12021. in the event of discrepancy, the version to be published in
the Gazette official/e du Quebec takes precedence.
 086

THAT the organizer of an activity and the operator of a place described

in the third paragraph be required to use the VaxiCode Verif application to verify that every
member of the public 13 years of age or older wishing to participate in the activity or be
admitted to the place is adequately protected against COVID-19 and to verify that person's
identity, subject to the exceptions under in the third and fourth paragraphs;

THAT the verification a person's identity pursuant to the third and the
preceding paragraph be done by means of an identity document issued by a government
department, a public body or organization or an educational institution and, for a person
16 years of age or older and under 75 years of age, that contains a photograph of the
person;

THAT the organizer of an activity and the operator of a place described

in the third paragraph allow a member of the public 13 years of age or older to participate
in the activity or access the place only if verification of the person's QR code, done using
the VaxiCode Verif application, establishes that the person is adequately protected
against COVID-19, subject to the exceptions under in the third and fourth paragraphs;

THAT the organizer of an activity and the operator of a place described

in subparagraph 9 or 10 of the third paragraph may, in connection with a recurrent activity
requiring a person to register, and if the person gives consent, do the verifications referred
to in the preceding paragraphs only at the time of the person's first presence, and record
the information obtained;

THAT, when a person ceases taking part in an activity, the organizer

or operator referred to in the preceding paragraph destroy all recorded information
concerning the person;

THAT, subject to the eighth paragraph, no person keep all or any

portion of the information obtained for the purpose of verification pursuant to this Order in
Council;

THAT, despite the third, fifth and seventh paragraphs, a member of the
public 13 years of age or older residing outside Québec may participate in activities or be
admitted to places described in the third paragraph if the person produces an identity
document and official proof of status issued by the authorities of the person's province,
territory or country of residence and drafted in French or in English, attesting that the
person has received the single-dose Janssen vaccine or two doses of another COVID-19
vaccme;

This is the administrative version of Order in Council No. 1173-2021 made on

September 12021. in the event of discrepancy, the version to be published in
the Gazette officielle du Québec takes precedence.
 087

THAT the identity document produced in accordance with the

preceding paragraph be issued by a government department, a public body, agency or
organization or an educational institution, establish that the person resides outside
Québec and, for a person 16 years of age or older and under 75 years of age and contain
a photograph of the person;
THAT this Order in Council not operate to prevent homeless persons
from being admitted to a restaurant or food court in a shopping centre or food store;

THAT, as regards this Order in Council, the penal offences set out in
section 139 of the Public Health Act (chapter S-2.2) apply only to offences committed on
or after 15 September 2021.
THAT the Minister of Health and Social Services be empowered to
order any modification or clarification of the measures provided for in this Order in Council.

This is the administrative version of Order in Council No. 1173-2021 made on

September 1 2021. In the event of discrepancy, the version to be published in
the Gazette officielle du Québec takes precedence.
 088

COVID-19 n ural immunity

Scientific brief
10 May 20 1 11’\‘J World Health
ivmganization

Key Messages:
' Within 4 weeks following infection, 90-99% of individuals infected with the SARS-CoV-Z virus develop detectable
neutralizing antibodies.
' The strength and duration of the immune responses to SARS-CoV-2 are not completely understood and currently available
data suggests that it varies by age and the severity of symptoms. Available scientific data suggests that in most people
immune responses remain robust and protective against reinfection for at least 6-8 months afier infection (the longest
follow up with strong scientific evidence is currently approximately 8 months).
' Some variant SARS-CoV—Z viruses with key changes in the spike protein have a reduced susceptibility to neutralization
by antibodies in the blood. While neutralizing antibodies mainly target the spike protein, cellular immunity elicited by
natural infection also target other viral proteins, which tend to be more conserved across variants than the spike protein.
The ability of emerging virus variants (variants of interest and variants of concem) to evade immune responses is under
investigation by researchers around the world.
° There are many available serologic assays that measure the antibody response to SARS-CoV-Z infection, but at the present
time, the correlates of protection are not well understood.

Objective of the scientific brief

This scientific briefreplaces the WHO Scientific Brief entitled “’lmmunity passports' in the context of COVID-l9", published 24
April 2020.l This update is focused on what is currently understood about SARS-CoV-2 immunity from natural infection. More
information about considerations on vaccine certificates or “passports“will be covered in an update of WHO interim guidance, as
requested by the COVID-l9 emergency committee.2

Methods
A rapid review on the subject was undertaken and scientificjournals were regularly screened for articles on COVID-l9 immunity
to ensure to include all large and robust studies available in the literature at the time of writing.

COVID-19 immune responses to natural infection

Prior exposure to SARS-CoV-Z can be assessed by detecting the presence of virus-specific antibodies in serum. Functional
neutralizing antibodies (NAb) are those able to neutralize the virus by blocking its entry into the cell.

Large cohort studies have reported that 90-99% of SARS-CoV-Z infected individuals develop neutralizing antibodies within 2-4
weeks afier infection?7 A small proportion of individuals do not develop NAh alter SARS-CoV-Z infection for reasons that are
unclear.7 individuals with mild or asymptomatic infection tend to have lower antibody levels than those with severe disease, and
some studies have suggested that in some individuals waning of antibody levels occurs within several months after infection.6'w
Studies aimed to detect immunological memory including the assessment of cellular immunity by testing for the presence of memory
B cells, and CD4‘ and CD8+ T cells, observed robust immunity at 6 months post-infection in 95% of subjects under study, which
included individuals with asymptomatic, mild. moderate and severe infections.'1
 COVID-19 natural immunity: Sciggfific brief

Correlates of protection against disease

How much cellular versus humoral immunity contributes to protection afier natural infection is not fully understood. Studies point
at NAb as a key element of immunoprotection, with cellular immunity likely to provide additional longer-terrn protection especially
against severe disease and death.'2"5 How long overall protection may last remains unclear, and this may differ depending on the
disease severity? For other human coronaviruses (hCoV), hCoV-OC43, hCoV-229E, hCoV-NL63 and hCoV-HKU-l , which cause
the common cold, antibodies last for at least a year after infection with significant inter-human variability,l6 while antibodies to
more closely related MBRS-CoV and SARS-CoV-l, which cause, respectively, middle east respiratory syndrome and severe acute
respiratory syndrome, can be detected for years.”'”

Reinfection
Though rarely reported to date, reinfection with SARS—CoV-Z can occur. Four large studies from the United Kingdom, the United
States of America and Denmark estimated that infection with SARS-CoV-2 provided 80-90% protection fi'om reinfection up to 7
months, and up to 94% protection against symptomatic disease.”25 The level of protection against re-infection as assessed by PCR
positivity was estimated to be 50% in people aged over 65 years old.24

SARS-CoV-2 variants and implications for immunity

The more the SARS-CoV-2 virus circulates, the more opportunities it has to change through natural evolution. The emergence of
virus variants can pose new challenges. Currently, three virus variants, B. 1.1.7, B.1.351 and PJ , with increased transmissibility or
potential to partially escape immunity, are characterized as global Variants of Concern (VOC) by WHO and are circulating in many
countries. Evidence of reduced susceptibility to neutralization by serum antibodies of some SARS-CoV-Z variants (e.g. RI and
B.l .351) to natural (or vaccine-induced) neutralizing antibodies has been reported,”29 raising the concern that reinfection afier
natural infection (or breakthrough infection after vaccination) may increase in settings where these variants broadly circulate.30 Of
note, recent studies found that current global VOCs are unlikely to have an impact on CD4+ and CD8+ T cell reactivity in COVID-
19 exposed donors and vaccinees, but how this observation applies to protection against reinfection or breakthrough infection after
vaccination remains unclear.
Measuring immune responses
The immune response following infection with a virus can be measured by the detection of virus-specific antibodies such as IgA,
IgM, lgG or total antibodies through immunoassays, as well as by the detection of sensitized memory B cells and/or CD4+ and
CD8+ T cells, which require more complicated assays. The most commonly measured immune response is the presence of antibodies
in serum. Serologic assays to detect the antibody response are usually based on enzyme immunoassays, which detect the presence
of virus-specific antibodies in the blood or by live or pseudo-virus neutralization assays, which detect functional NAb. While
serologic testing has limited use in clinical management because it does not capture active infection, it can be very useful in
determining the extent of infection or estimating attack rates in given populations.
Interpreting the results of serologic testing, however, is complex: there are several antibody types and subtypes and multiple
antigenic determinants/epitopes that can be used to target these antibodies, and the results may differ substantially depending on the
combinations chosen. The results will also depend on the manufacturing specifics of the assay used. The most frequently used assays
for detection of antibodies to SARS-CoV-2 are enzyme-linked immunosorbent tests, chemiluminescent tests, and lateral flow rapid
diagnostic tests (RDTs). Advice on the use of RDTs for antibody detection is available on the WHO website.32

Conclusions
Current evidence points to most individuals developing strong protective immune responses following natural infection with SARS-
CoV-2. However, inaccurate immunodiagnostic tests may falsely indicate infected individuals as naive to the virus (not previously
infected) or may falsely label non-infected people as positive for immune markers of recent infection.
To conclude, available tests and current knowledge do not tell us about the duration of immunity and protection against reinfection,
but recent evidence suggests that natural infection may provide similar protection against symptomatic disease as vaccination, at
least for the available follow up period.33 The emergence of variants of concern poses challenges and their potential to evade
immunity elicited by either natural infection or by vaccination, needs to be closely monitored.
 COVID—19 natural immunity: Semiflc brief

Plans for updating

WHO continues to monitor the situation closely for any changes that may affect the information in this Scientific brief. Should any
factors change, WHO will issue a further update. Otherwise, the validity of this brief will be reviewed 3 months after the date of
publication.

Contributors
Lorenzo Subissi, Mick Mulders, Martin Friede, Maria Van Kerkhove, Mark Perkins.
Acknowledgments
We thank Stanley Perlman for critical reading of this scientific brief.

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23. Lumley SF, O’Donnell D, Stoesser NE, et al. Antibody Status and Incidence of SARS-CoV-2 Infection in Health Care
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© World Health Organization 2021. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence.
WHO reference number: WHO/2019-nCoV/Sci_Brief/Natural_immunity/2021.l
 in cm...aims
Received: 2 February 2021
I Revised: 10 February 2021 Accepted: 11 February 2021 092
DOI: 10.111 lleci.]3520

ORIGINAL ARTICLE WILEY

SARS-CoV-2 re-infection risk in Austria

Stefan Pilzl | Ali Chakeriz | John PA Ioannidis3 I Lukas Richter2 I

Verena Theiler-Schwetz1 I Christian 'I‘rummer1 I Robert Krause4 I Franz Allerberger2
1Division of Endocrinology and
Abstiéac'g'
3 '
"
‘

Diabetology, Department of Internal

Medicine, Medical University of Graz, 1 Background, A ke 11 co‘"”erningti“.
coronaVirus (COVID
disease 2019 I9) is?
Graz, Austria
2Austrian Agency for Health and Food
2 how effective and:bug ,. immumtyagainstthis is in
disease individualsWho"
Safety (AGES), Vienna, Austria
were previously infected
,evere acute respiratory syndrome coroiiai‘drus 2.
3Departments of Medicine, Epidemiology
and Population Health, Biomedical Data
. (SARS-CoV-Z) aimed
; [general populationinAustri
We
,aluate' theriskof
.
SARS--CoV-2 re-infections‘111
the

Science, and Statistics and Meta-Research

Innovation Center at Stanford (METRICS),
Methods: Thisis retrospective
‘

a observational
study using national SARS-CoV-2
infection
data
frOm theAustrianepidemiological reporting system. As the primary
‘

Stanford University, Stanford, CA, USA

“Section of Infectious Diseases and Tropical foutCome, aim to we compare
the odds of SARS-CoV-2 ire-infections or COVID- 19
Medicine, Medical University of Graz,
Graz, Austria
survivors of thefirst
wave
(February to April 30,2020)versus the odds of firstin-

Correspondence
fections the
in
remainder
generalpopulation by tracking polymeraSe chain reaCtion
(PCR)-confirm_e'dinfections of both groups during the second wave from September
Stefan Pilz, Division of Endocrinology l to November 30, 2020.
Rte-infection
counts are tentative, since it cannot be ex-
'

and Diabetology. Department of Internal

cluded that the positive PCRinthe first and/or second wave might have been a false .
Medicine, Medical University of Graz,
Auenbruggerplatz 15, 8036 Graz, Austria. . positive.
Email: [email protected] 1
Results: We recorded 40tentativere-mfectionsin 14840 COVID-19 survivors of
the firstwave (0.27%) and 253 581infections'in 8 885 640 individuals of the re-
3

Correction added on 26 February 2021,

after first online publication: Author
spelling is corrected to John PA Ioannidis
maining generalpopulation (2.
interVal) of 0.09 (o97 85%) tranSlating into an odds ratio (95% confidence
so relatively re-mfection of SARS in
‘13.).- .

'

Conclusions: We observe low rate CoV-2

the
highest es
available on
imates vaccine
efficacies.Furtherwell-de31gnedresearch
on thisissue is urgently needed forimproving evidence-based decisionson
,

health measures andvaccinationstrategies.

111115ka
KEYWORDS
H

7,

COVID- 19, epidemiology, PCR, re-infection, Risk, SARS-CoV-2

Stefan Pilz and Ali Chaken' contributed equally asfirst authors

to this manuscript
........................................................................................................................
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use. distribution and reproduction in any medium,
provided the original work is properly cited and is not used for commercial purposes.
© 2021 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal
Foundation .

EurJ Cliu Invest. 2021;51:el3520. wileyonlinelibrary.comljoumalleci l of 7

https:lldoi.orgl10.l l l lleci. 13520
fll—WI LEY
1 I INTRODUCTION -- '
_- H—._._- _._.'_.....' ._.'__'.,_¢_--‘
' '

Key messages :3
The coronavirus disease 2019 (COVID-19) pandemic is a

«hi—£3
major public health crisis."2 A key question concerning meas- o In this study in the whole general population in -;

ures against COVID-19 is the strength and durability of immu- Austria with a follow-up of over half a year, those
nity against this disease in individuals previously infected with individuals with a previous SARS-CoV-2 infec- I“
severe acute respiratory syndrome coronavirus 2 (SARS-CoV- tion had a significant reduction by 91% for the if
2).3'10 Vaccination strategies, considerations regarding herd im- odds of a re-infection versus the odds of a first {,5
munity, and overall simulations for the pandemic depend on the infection in the remainder general population.
efficacy and the time course of immunity against COVID-19.5 0 Protection against SARS-CoV-2 after natural in-
Data on immune responses to COVID-19 are limited by ] fection is comparable with the highest available
knowledge gaps regarding their dynamics over time and their estimates on vaccine efficacies.
"

clinical significance with reference to protection against re- -.=.—1»'—..k

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infections}10 There is evidence for re-infections from numerous
case reports, but it is occasionally challenging to differenti- among others data on hospitalization status and COVID-I9
ate true re-infeetions from prolonged viral shedding that may deaths.” Ethical approval for this study was obtained from
last for up to about 4 months.“ 1'12 Notably, a study of 12 541 the ethics committee at the Medical University of Graz, Graz,
healthcare workers in the UK recently found major protec- Austn'a.
tion against re-infeetion for those who had anti-SARS-CoV-2 Patients who had a positive polymerase chain reaction
antibodies determined by anti-spike and anti-nucleocapsid (PCR) test during both, the first and second infection wave
assays versus those who did not.13 After a follow-up of up to are referred to here as patients with ‘tentative re-infeetions’.
31 weeks, they calculated a rate ratio of 0.11 (95% confidence We use the term ‘tentative’ re-infection because a certain
interval (CI): 0.03 to 0.44; P =.002) for re-infections in sero- number of these cases might reflect false-positive results in
positive healthcare workers versus first infections in healthcare the testing during the first and/or second wave. This is based
workers with negative antibody status.‘3 Similarly, another re- on the consideration that the specificity (with 95% confi-
cent study among healthcare workers from the UK reported no dence region) of PCR tests (nucleic acid amplification tests)
re-infection case in 1038 individuals with evidence of previous for SARS-CoV-2 is less than 100%, with 98.1% (95.9 to
SARS-CoV-2 infection based on PCR tests and/or antibody 99.2%) according to a recent meta-analysis.16 '

status.lo While these studies suggest a high protection against The group size of ‘COVID-19 survivors’ was calcu-
SARS-CoV-2 re-infections in healthcare workers, the risk of re- lated as all individuals who had a positive PCR test result
infections in the general population remains uncertain. for SARS-CoV-2 minus all reported COVID-19 deaths from
Austria was hit very early in this pandemic with a first February 22 to April 30. The control group (‘general popu-
wave occurring from 22 February to 30 April 2020 (all fur- lation group’) are the remainder Austrian residents that we
ther dates refer to the year 2020). Data on the re-infection calculated as the reported Austrian population on January 1
rate during the second wave from September 1 to November with 8 901 064 individuals (the closest approximation for the
30 can therefore provide, as a rough estimate, evidence on population size) minus all patients tested SARS-CoV-2 pos-
the immunity against SARS-CoV-2 over more than half a itive during the first wave.17 In Austria, population changes
year.”15 Therefore, we investigated data from the Austrian from year to year are usually significantly less than 1%.'7The
epidemiological reporting system (ERS) provided by the observation period for tracking SARS-CoV-2 infections was
Austrian Agency for Health and Food Safety (AGES).15 As from September 1 to November 30 (the pre-speeified date
the primary outcome, we compared the odds for SARS-CoV-2 for our analyses), corresponding to what we term the second
re-infections in COVID-19 survivors versus first infections in wave. Automated matching of records in the first and sec-
the remainder general population during the second infection ond wave to detect tentative re-infeetions was done by using
wave. In addition, we also evaluate data on hospitalization IDs consisting of the first two initials of the first name, the
status during both infection waves and on COVID-19 deaths first three initials of the surname and the date of birth (eg
during the second wave, in order to obtain measures of dis- ST.PIL.15.12.1979). All entries with the identical ID were
ease severity. then carefully and manually checked including data such as
full names and laboratory dates to evaluate whether the crite-
ria for a re-infection were met.
2 I METHODS We did not primarily track tentative re-infeetions of
COVID-19 survivors from May to August as it may be un-
Data for this study were derived from the Austrian ERS that clear whether positive SARS-CoV—2 tests represented re-
is tracking SARS-CoV-2 infection data in Austria, including infection or persistent infection when considering long-term
PILZ Er AL
WILEM
General population in Austria
Enrollment n=8,901,064

I
First infection
wave (February
to April 30, 2020)

SARS-CoV-Z positive=15.424
kt—[JSARS-CoV—Z negative/not tested=8,885,640

.
Excluded
COVID-19 deaths=584

Second infection
V V
wave (September 1
o SARS-CoV-Z positive (re-infection)=40 a SARS-CoV-Z positive (first infection)=253,581
to November 30,
o SARS-CoV—Z negative/not tested=14.800 2020) o SARS-CoV-Z negative/not tested=8,632,059

Analysis
\

I I
Odds for re-infection = 40 / 14,800 Odds for first infection = 253,581 /8,632,059

V I
Odds ratio for re-infections in COVID-19
survivors versus first infections in the general
population = 0.09 (95% confidence interval:
0.07 to 0.13)

FIGURE 1 Analysis plan for calculating the odds ratio for re-infections versus first infections with SARS-CoV-Z in the general population in
Austria

viral shedding for up to about 4 months5'7 This 4 month in- analyses were performed by using SPSS Version 25.0 (IBM
terval was also the main consideration to separate the time SPSS Inc, Chicago, IL. USA).
frame for the two waves. Of note. there were only relatively
few documented SARS-CoV-2 cases (<0.15% of the Austrian
population) from May to August.‘5 3 I RESULTS
Regardless of the main reason for hospitalization. any
hospitalized patient who was tested SARS-CoV—Z positive From 15 424 patients with SARS-CoV-2 positive tests in
was classified as hospitalized in the ERS. All persons who the first wave, 584 were recorded as COVID-19 deaths, so
were tested SARS-CoV-2 positive and died for whatever rea- that our COVID-l9 survivor group consists of 14 840 pa-
son within 28 days after the last positive test were classified tients (see Figure 1 for our analysis plan). Excluding the
as COVID-l9 deaths. COVID-19 survivor group. the number of individuals of the
As our primary outcome analysis, we calculated the odds general population group resulted in 8 885 640 individuals.
ratio (OR) (with 95% confidence interval [CI]) of SARS- During the observation period from September 1 to
CoV-2 re-infections in the COVID-l9 survivor group versus November 30, we recorded 40 tentative rc-infcctions in the
first infections in the general population group. Statistical COVID-l9 survivor group (0.27%). and 253 581 new infections
mm | W1 LEY napalm/u.

Hospitalization TAB
LE 1 . Characteristics of 40 patients
With re-infection
Age at first Time between Second
Gender infection(years) infections (days) First wave wave
Female 84 148 Yes No
Female 53 223 No No
Female 54 183 No No
Male 34 215 Yes No
Female 31 200 Unknown Unknown
Female 25 206 No No
Male 89 196 No No
Female 39 175 No No
Male 52 222 No Unknown
Male 22 251 No Unknown
Female 84 148 Yes Yes
Male 79 238 Yes Unknown
Female 23 236 No Unknown
Female 55 214 No No
Female 37 203 No No
Female 23 222 No No
Male 15 235 No No
Female 76 219 Yes Yes
Male 52 206 No No
Female 72 172 No No
Male 24 207 No No
Female 51 22] No No
Male 19 210 No No
Female 43 246 No No
Male 61 246 No Unknown
Male 25 221 Yes Yes
Male 47 232 No No
Female 34 222 No Yes
Female 31 231 No No
Female 30 213 No No
Female 54 173 Yes Yes
Male 27 203 No No
Female 23 172 No No
Female 40 214 No Unknown
Male 25 221 No No
Female 93 237 Yes Unknown
Female 26 227 No No
Female 41 226 No No
Female 48 216 No No
Male 27 243 No No

in the general population group (2.85%). The OR (with 95% CI) Characteristics of the 40 re-infection cases are tabu-
for infections in the COVID-19 survivor group versus the gen- lated in Table 1. Of the patients with tentative re-infeetions.
eral population group was 0.09 (95% CI. 0.07 to 0113). 62.5% were women and the median age (with 25th to 75111
PILZETAL
W1 LE?galfl
percentile; minimum—maximum) at the first infection was SARS-CoV—2 PCR and antibody test data from 66 001 pa-
39.8 (25.9 to 54.5; 15.4 - 93.8) years. The mean (1- standard tients from a laboratory in south-west London documented
deviation) time from the first to the tentative re-infection was 8 patients with evidence of re-infections, and calculated a
212 :t 25 days. Of the 40 tentative re-infections, 4, 12 and relative risk of re-infections versus first infections of 0.0578
24 were documented in September, October and November, (95% c1: 0.0288 to 0.1160)18 which is also compatible with
respectively (among 18 106, 61 384 and 174 131 total infec- our estimate.
tions, respectively). Our data do not include detailed clinical characteristics
Hospitalization status in numbers of patients coded as of the patients with tentative re-infections but it is notewor-
yes, no and unknown was 8, 31 and l for the first infection thy that these patients covered both genders with a wide age
and 5, 27 and 8 for the tentative re-infection, respectively. range and included also several hospitalized patients. These
Four patients were hospitalized during both infection waves. data are of interest since previous studies indicate a high
Unknown hospitalization data during the second wave are correlation between neutralizing antibodies against SARS-
probably mainly due to a delay in hospitalization data entry CoV-2 and COVID-19 severity. This in turn suggests that
into the ERS. those patients with more severe infections may develop a
With follow-up on mortality available until December 23, stronger protective humoral immune response against SARS-
only one 72—year—old woman died two days after her tentative CoV—2 compared to those with less severe infections. This hy-
re-infection diagnosis. She was not hospitalized and accord- pothesis is, however, not strongly supported by our findings
ing to her medical records her cause of death (‘acute vascu- as several patients with tentative re-infections were already
lar occlusion of an extremity with rhabdomyolysis’) was not hospitalized during their first infection.8 Regarding duration
causally attributed to COVID-19. of acquired immunity against SARS—CoV-2 re-infections, we
provide data with a median follow-up time of about 7 months.
Importantly, there was no clear sign of decreasing protection
4 l DISCUSSION against re-infections in descriptive analyses of monthly strat-
ified re-infection cases.
We documented a relatively low re-infection risk for SARS- In view of ongoing discussions on vaccination approaches
CoV-2 in the general population of Austria by using data regarding SARS-CoV-Z, our data suggest that the protection
from the ERS. Patients with re-infections covered both gen- against SARS-CoV-2 after natural infection is roughly similar
ders, a wide age range and included also patients who were to the highest estimates of SARS-CoV-2 vaccine efficacies
hospitalized during both infections. among vaccines that have been authorized to-date, although a
Our study is, to the best of our knowledge, the first system- direct comparison cannot be made due to differences in study
atic investigation of tentative re-infection risk with SARS- designs and study populations.'9'20 Nevertheless, we believe
CoV-2 in a large national population. Several case reports on that based on our findings, waving urgent recommendations
SARS-CoV-2 re-infections in the general population indicate to undergo SARS-Cov-2-vaccination for persons with PCR-
that there is at least some risk of re—infection, but they did documented previous COVID-l9 infection seems prudent as
not provide quantification of re-infection risk that requires a long as any shortage of vaccines is present.
standardized comparison to the ‘background’ infection risk Our findings on a significant protection against SARS-
in the general population.3'5 While data on immune responses CoV—2 re-infections, provide also evidence for the rapid
to previous SARS-CoV—2 infections exist, they can only be evolution of the pandemic towards ‘herd immunity’, in par-
regarded a proxy for a previous infection and the associated ticular because of a huge underreporting of SARS-CoV-Z
clinical protection against re-infections, thus requiring stud- cases?"22 Therefore, the relatively high prevalence of in-
ies like ours to address the question to what extent patients dividuals who were already infected with SARS-CoV—2
who experienced PCR confirmed SARS-CoV—2 infections along with the currently rapidly increasing number of
are protected against re-infections.3'5 Importantly, the study vaccinated individuals may work in concert towards an en-
by Lumley et al in 12 541 healthcare workers documented suring ‘herd immunity’ that will hopefully bend this pan-
protection against re-infection for those who had anti-SARS- demic within the near future.2’23’24 This may already be the
CoV-2 antibodies with a rate ratio (0.1 1) very similar to what casein some countries such as India, where seroprevalence
we observed.13 While the investigation by Lumley et al was rose rapidly from 0.7% in May to 7% in August and 60%
restricted to a specific population of predominantly healthy in November in national surveys.”27 Accordingly, the ep-
adult healthcare workers 65 years of age or younger, and was idemic wave in India (both for documented cases and for
based on only two re—infections in seropositive individuals, COVID-l9 deaths) has largely abated by February 2021. It
our study extends this knowledge by data from a much larger must, however, be noted that the concept of herd immunity
population based survey using solely PCR-confirmed SARS- has recently been challenged by resurgence of COVID-l9
CoV-2 infection cases.I3 Importantly, a recent study using in Manaus, Brazil, a region in which seroprevalence data
MW] LEY (19.;le Kr AL

suggested that about 76% of the population had been in- AUTHOR CONTRIBUTIONS
fected with SARS-CoV-2 by October 2020.28 It is unknown All authors have substantially contributed to the design, per-
whether there was an error with over-estimation of the first formance, analysis and reporting of the work. AC, LR and
wave seroprevalence, or the resurgence can be explained by FA contributed to data collection. SP and JPAI analysed the
the advent of a new strain (P1) that has a high propensity data and wrote the manuscript.
for re-infection. Careful monitoring for new strains and for
their ability to evade existing natural immune responses ORCID
and vaccine-induced immunity is needed. Stefan Pilz ”I? https://orcid.org/0000-0002-7959-131l
Our findings are limited due to lack of detailed clinical John PA Ioannidis httpszllorcid.
characteristics, the observational nature of our study design, org/0000-0003-3l 18-6859
and the strong dependence on the data quality of the ERS. The
40 tentative re-infections have quite similar demographics to REFERENCES
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to vaccine efficaciess’w‘20 These data may be useful for deci- ahead of print
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urgently needed to improve our knowledge on SARS-CoV-2 Emerg Microbes Infect. 2020;9(1):2571-2577.
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ACKNOWLEDGMENT Incidence of SARS-CoV-2 Infection in Health Care Workers. N
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17. www.statistik.at/web_de/statistikenlmenschen_und_gesellschaft/ survey, May-June 2020. Indian J Med Res. 2020:1520 & 2):48-60.
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zu_jahres-_quartalsanfang/index.html. Accessed December 29, 2020. tibody seroprevalence in India, August—September, 2020: findings
18. Breathnach DAS, Riley PA, Cotter MP, Houston AC, Habibi MS, from the second nationwide household serosurvey. Lancet Glob
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of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. india-is-missing-about-90-infections-for-every-covid-case-latest-
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20. Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety 28. Sabino EC, Buss LF, Carvalho MPS, et al. Resurgence of
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22. Ioannidis IPA. The infection fatality rate of COVID-l9 inferred JP, et al. SARS-CoV-2 re-infection risk in Austria. Eur
from seroprevalence data. Bull WHO. 2021;99:19-33F.
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 COVID-19

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NIH RESEARCH MATTERS

January 26,2021

Lasting immunity found after recovery from COVID~19

At a Glance

. The immunesystems of more than

eight months after infection.
95% of people who recovered from COVID-19 had durable memories of the virus up to

The results provide hope that people receiving SARS-CoV-Z vaccines will develop similar lasting immune memories after
vaccination.
 election i'iticrograpli of a cell, isolated from a patient sample, that is itch. inlettct . ll SARSrCov-Z \lll
us particles (red). MAID
in wt Dutii't Aim 1

After people recover from infection with a virus, the immune system retains a memory of it. Immune cells and proteins that circulate in
body can recognize and kill the pathogen if it‘s encountered again, protecting against disease and reducing illness seventy.

This long-term immune protection involves several components. Antibodies—proteins that circulate in the blood—recognize foreign
substances like viruses and neutralize them. Different types oiT cells help recognize and kill pathogens. B cells make new antibodies when
the body needs them.

All of these immune-system components have been found in people who recover from SARS-CoV-Z. the virus that causes COVID-19. But the
details of this immune response and how long it lasts after infection have been unclear. Scattered reports of reinfection with SARS-CoV-Z
have raised concerns that the immune response to the virus might not be durable.

To better understand immune memo of SARS-CoVQ, researchers led by Drs. Daniela Weiskopf, Alessandro Sette, and Shane Crotty from
the La Jolla Institute for Immunology analyzed immune cells and antibodies from almost 200 people who had been exposed to SARS-CoV-Z
 101
and recovered.

Time since infection ranged from six days after symptom onset to eight months later. More than 40 participants had been recovered for
more than six months before the study began. About 50 people provided blood samples at more than one time after infection.

The research was funded in part by NIH's National Institute of Allergy and Infectious Diseases (NIAID) and National Cancer Institute (NCI).
Results were published onJanuary 6, 2021, in Science.

The researchers found durable immune responses in the majority of people studied. Antibodies against the spike protein of SARS-CoV—Z,
which the virus uses to get inside cells, were found in 98% of participants one month after symptom onset. As seen in previous studies, the
number of antibodies ranged widely between individuals. But, promisingly, their levels remained fairly stable over time, declining only
modestly at 6 to 8 months after infection.

Virus-specific B cells increased over time. People had more memory B cells six months after symptom onset than at one month afterwards.
Although the number of these cells appeared to reach a plateau after a few months, levels didn't decline over the period studied.

Levels ofT cells for the virus also remained high after infection. Six months after symptom onset, 92% of participants had CD4+ T cells that
recognized the virus. These cells help coordinate the immune response. About half the participants had CD8+ T cells, which kill cells that are
infected by the virus.

As with antibodies, the numbers of different immune cell types varied substantially between individuals. Neither gender nor differences in
disease severity could account for this variability. However, 95% of the people had at least 3 out of 5 immune-system components that
could recognize SARS-CoV—Z up to 8 months after infection.

"Several months ago, our studies showed that natural infection induced a strong response, and this study now shows that the responses
last," Weiskopf says. "We are hopeful that a similar pattern of responses lasting over time will also emerge for the vaccine-induced
responses."

—by Sharon Reynolds

Related Links

0 Experimental Coronavirus Vaccine Highly Effective (https://www.nih.gov/news-events/nih-research-matters/experimental-

coronavirus-vaccine-highly-effective)

. Antibodies and T Cells Protect Against SARS-CoV-Z (https://www.nih.gov/news-events/nih-research-matters/antibodies-t-cells-

protect-against—sars-cov-Z)

. Immune Cells for Common Cold May Recognize SARS-CoV-Z (https://www.nih.gov/news-events/nih-research-matters/immune-cells-

common-cold-may-recognize-sars-cov-Z)

o Potent Neutralizing Antibodies Target New Regions of Coronavirus Spike (httpszllwwwnih.gov/news-events/nih-research-

matters/potent-neutra|izing—antibodies-target-new-regions-coronavirus-spike)
o PotentAntibodles Found in People Recovered from COVID-19 (https://www.nih.gov/news-events/nih-research-matters/potent-
antibodies-found-people-recovered-covid-19)

. Novel Coronavirus Structure Reveals Targets for Vaccines and Treatments (https://www.nih.gov/news-events/nih—research-
matters/novel-coronavirus-structure-reveals-ta rgets-vaccines-treatments)

o Coronavirus (COVID-19) (httpszllcovidl9.nih.gov/)

. Coronavirus Prevention Network (https://www.coronaviruspreventionnetwork.org/)

 102
o Coronavirus (COVID-19) (https://www.coronavirus.gov/)

References: Immunological memory to SARS-CoV-Z assessed for up to 8 months after infection. DanJM, Mateus], Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni
A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire E0, Smith DM, Weiskopf D, Sette A, Crotty S.
Science. 2021jan 61eabf4063. doi: 10.1126/science.abf4063. Online ahead of print. PMID: 33408181.

Funding: NIH's National Institute of Allergy and Infectious Diseases (NIAID) and National Cancer Institute (NCI); La jolla Institute for Immunology;John and
Mary Tu Foundation; Bill and Melinda Gates Foundation; Mastercard: Wellcome; Emergent Ventures; Collaborative Influenza Vaccine Innovation Centers;jPB
Foundation; Cohen Foundation; Open Philanthropy Project.

In this Edition
Physician-pharmacist collaboration may improve care for opioid addiction

Acute heart transplant rejection detected earlier with new test

Lasting immunity found after recovery from COVID-19

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 104

NEDPAGE TODAY fl

— Antibody testing and proof of prior infection can allow more people to return to
normal

by Jeffrey Klausner, MD, MPH, and Noah Kojima, MD

May 28, 2021
Epidemiologists estimate over 160 million people worldwide have recovered from COVID—
19. Those who have recovered have an astonishingly low frequency of repeat infection,
disease, or death. That immunity from prior infection protects many people now where
vaccines are not yet available.

Earlier this month the World Health Organization released a scientific update stating that
most people who have recovered from COVID-19 develop a strong protective immune
response. Importantly, they summarize that within 4 weeks of infection, 90% to 99% of
people who recover from COVID-19 develop detectable neutralizing antibodies.
Furthermore, they conclude -- given the limited amount of time to observe cases -- that
the immune response remains strong for at least 6 to 8 months after infection.

This update echoes what the NIH reported in January 2021: The immune response of more
than 95% of people who recovered from COVID-19 had durable memories of the virus up to
8 months after infection. The NIH went further to state that those findings "provide hope"
that people who get vaccinated will develop similar lasting immunity.

So why are we so focused on vaccine-induced immunity -- in our goals to reach herd

immunity, our gatekeeping on travel, public or private events, or mask use -- while ignoring
natural immunity? Shouldn't those who have natural immunity also be able to return to
"normal" activities?

Numerous scientists have found that there is a decreased risk of re-infection and extremely
low rates of hospitalization and death due to repeat infection. The range of reduction of re-
infection from COVID-19 was between 82% to 95% among six studies that encompassed
near|y1 million people conducted in the US, the UK, Denmark, Austria, Qatar, and among
US. Marines. The study in Austria also found that the frequency of re-infection from
(MD-1Q mused hncnifali7afinn in nnlv five nnf of 14 sun in 02°13 npnnlp and death in nnp

' Get Breaking Medical News Straight to your inbox

 105

lVEDPAGE TODAY .
v

As public health policymakers reduce the discussion of immunity to vaccination status,

largely ignored are the complexities of the human immune system. There are multiple
highly encouraging research reports showing that blood cells in our body, so called "B cells
and T cells," contribute to the cellular immunity after COVID-19. If SARS-CoV—Z immunity is
similar to other severe coronavirus infections like SARS-CoV—i immunity, that protection
could last at least 17 years. However, tests to measure cellular immunity are complex and
expensive, making them hard to get and preventing their use in routine medical practice or
in public health surveys of the population.

Read Next
lNFECTIOUS DISEASE

Two Factors Tied to Risk of Antibiotic Failure in Pneumonia Patients

INFECTIOUS DISEASE

FDA Panel Endorses Booster for All 18:] Recipients

INFECTIOUS DISEASE

Bill Clinton Hospitalized; Califf to Again Lead FDA? Global TB Deaths Rise Again

The FDA has authorized numerous antibody tests. As with any test, they require financial
costs and time to obtain results, and there are important differences in the performance of
each test in terms of what the positive antibodies actually represent. A critical distinction is
that some tests only detect antibodies found after natural infection, "N" antibodies, and
some cannot differentiate between natural or vaccine—induced antibodies, "S" antibodies.
Doctors and patients should beware of this and ask which antibodies the tests actually
measure.
Last week, on May 19, the FDA issued a public safety communication stating that while
SARS-CoV-Z antibody tests play an important role in identifying people who have been
exposed to the SARS-CoV-Z virus and may have developed an adaptive immune response,
antibody tests should not be used to determine immunity or protection against COVID—19.
Huh?
 106

lVEDPAGE TODAY °°
I a v

used to determine immunity or protection against COVID-19. The FDA statement went on
to say that antibody tests should be used by those experienced with antibody testing. Not
helpful.

Like many aspects of the Federal Government's response to COVID-19, the FDA's comment
lags behind the science. Given that 90% to 99% of people who recover from COVID-19
develop detectable neutralizing antibodies, doctors can use the correct test to inform
people of their risk. We can counsel patients that those who have recovered from COVID-19
have a strong protective immunity, protecting them from repeat infection, disease,
hospitalization, and death. In fact, that protection is similar to or better than vaccine-
induced immunity. Putting that together, people who have recovered from prior infection
or those with detectable antibodies should be considered protected, similarly to someone
who is vaccinated.

Moving forward, policymakers should include natural immunity as determined by an

accurate and reliable antibody test or the documentation of prior infection (previous
positive PCR or antigen test), as evidence of immunity equal to that of vaccination. That
immunity should be given the same societal status as vaccine-inducted immunity. Such a
policy will greatly reduce anxiety and increase access to travel, events, family visits, and
more. The updated policy will allow those who have recovered to celebrate their recovery
by informing them of their immunity, allowing them to safely discard their masks, show
their faces, and join the legions of those vaccinated.

Jeffrey Klausner, MD, MPH, is a clinical professor of preventive medicine at the University
of Southern California Keck School of Medicine in Los Angeles, and a former CDC medical
officer. Noah Kojima, MD, is an internal medicine resident at University of California Los
Angeles.

Disclosures

Klausner is medical director of Curative, a testing company, and disclosed fees from Danaher, Roche, Cepheid, Abbott, and

Phfl Scientific. He has previously received funding from the NIH, CDC, and private test manufacturers and pharmaceutical
com-Banies to study new ways to detect and treat infectious diseases.
Kojima has received payments from Curative for clinical research services.
 107

h--.”,-,--NEPPAGEI_QPAY
 108

Public
Health
Santé.
publique
Ontario Ontario
WEEKLY SURVEILLANCE SUMMARY

Adverse Events Following Immunization (AEFls)

for COVID-19 in Ontario: December 13, 2020 to
October 10, 2021
This report provides a summary of adverse events following immunization (AEFls) that are temporally
associated (i.e., occur after receiving the vaccine) with receipt of COVID-19 vaccine and meet the
provincial surveillance definitions (i.e., confirmed).1 It is important to note that AEFIs described in this
report are defined as any untoward medical occurrences that followed immunization and do not
necessarily have a causal relationship with the vaccine.

This weekly summary includes AEFIs reported in the Public Health Case and Contact Management
Solution (CCM) as of October 10, 2021. Doses administered up to and including October 11,2021 are
extracted from the COVaon application (see technical notes for details on data sources).

Background
In Ontario, AEFIs are reported to local public health units (PHUs) by health care providers and vaccine
recipients.Z PHUs investigate and assess all AEFI reports, which are then entered into the provincial
electronic reporting system according to provincial surveillance guidelines.1 Please see the following
resources for more information:

a Public Health Ontario’s (PHO) overview of vaccine safety surveillance for more information on
vaccine safety surveillance in Ontario3

0 The technical annex of PHO’s annual vaccine safety report for technical details on vaccine safety
surveillance data analysis in Ontario4

- The government of Canada’s COVID-19 vaccine safety webpage for national data on COVID-19
vaccine safety5

- PHO’s COVID—19 vaccine webpage for resources and data on Ontario’s COVID—19 vaccine
program

Note the following updates to the vaccine names for the three COVID»19 vaccines in use in Ontario:

- Pfizer-BioNTech Comirnaty‘” COVID-19 vaccine (referred to as Pfizer-BioNTech in the report)

-- Moderna Spikevax” COVID-19 vaccine (referred to as Moderna in the report)

AstraZeneca Vaxzevriaw /COVISH|ELD COVID-19 vaccine (referred to as

AstraZeneca/COVISHIELD in the report)

Adverse Events Following Immunization (AEFls) for COVIDJQ in Ontario 1

 109

Highlights
0 There are a total of 13,741 AEFI reports received following 22,019,697 doses of COVID-19
vaccines administered in Ontario to date with a reporting rate of 62.4 per 100,000 doses
administered (0.06% of all doses administered)

0 This represents an increase of 322 AEFI reports compared to previous week

0 Of the total 13,741 AEFI reports received to date:

0 12,977 AEFI reports are non-serious (94.4% of total AEFI reports)
0 764 AEFI reports meet the serious definition (5.6% of total AEFI reports)

0 The most commonly reported adverse events are allergic skin reactions and other severe
or unusual events, reported in 24.3% and 21.9% of the total AEFI reports respectively
0 992 reports include a COVID-19 vaccine-specific adverse event of special interest, in which
475 reports also meet the serious definition (see Adverse events of special interest section
for more information)

0
21 reports of thrombosis with thrombocytopenia syndrome (ITS) after receipt of
AstraZeneca/COVISHIELD vaccine, of which 16 are vaccine-induced immune thrombotic
thrombocytopenia (VITT) (see 'I'I'SlVlTT section for more information)

o 438reports of myocarditis or pericarditis after receipt of mRNA vaccine (see

Myocarditis/pericarditis section for more information)

0 Ontario is continuing to monitor all AEFIs reported following receipt of COVID-19 immunization
in collaboration with its partners

In Ontario, AEFIs that meet the serious definition are events that required hospital admission
and reports of death. Please see the technical notes for a full definition of serious AEFIs.

Several adverse events have been identified as COVID-19 vaccine-specific adverse events of
special interest ‘(AESls). The list of COVID-19 specific AESIs are listed in the technical notes.

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 2

 110

Summary of AEFI reports in Ontario

An AEFI report refers to a report received by the PHU, which pertains to one individual vaccine recipient
who reported at least one adverse event after receiving the COVID-19 vaccine (i.e., temporally
associated with the vaccine). See Table 1 for a summary of all AEFI reports received to date in Ontario.

Table 1. Summary of AEFI reports by vaccine product: Ontario, December 13, 2020 to October
10, 2021
j AstraZeneca/ All vaccine
Pfizer-BioNTech Moderna
,
1 COVISHIELD products
vaccme vaccme .
vaccine combined

Total number of AEFI 7,945 4,290 1,502 13,741

reports

Number of non—serious 7,538 4,046 1,389 12,977

reports

Number of serious reports 407 244 113 764

Proportion of total AEFI 5.1% 5.7% 7.5% 5.6%

reports that are serious

Doses administered 15,312,138 5,619,296 1,088,263 22,019,697

Total reporting rate per 51.9 76.3 138.0 62.4

100,000 doses administered
Serious reporting rate per 2.7 4.3 10.4 3.5
100,000 doses administered
Note: Four AEFI reports did not specify vaccine product received. Data corrections or updates can result in AEFI
reports being removed and/or updated from past reports and may result in counts differing from past publicly
reported AEFls.
Data Source: CCM, COVaxOMsee technical notes for details on data sources)

Adverse Events Following Immunization (AEFls) for COVID»19 in Ontario 3

 111
Table 2. Number of AEFI reports and reporting rates by age group and gender: Ontario,
December 13, 2020 to October 10, 2021

Number of AEFI reports Reporting rate per 100,000

received to date doses administered

Gender: Female 10,193 898

Gender: Male 3,244 30.5

Ages: 12-17 years 486 30.7

Ages: 18-24 years 899 42.0

Ages: 25-29 years 861 50.8

Ages: 30-39 years 2,124 65.1

Ages: 40—49 years 2,746 88.3

Ages: 50-59 years 2,762 78.0

Ages: 60-69 years 2,143 66.4

Ages: 70-79 years 1,069 50.0

Ages: 80 years and over 632 50.1

Note: Age represents age at time of immunization. Sex was used when gender was missing. Some AEFI reports and
doses administered records have unknown gender or age; these reports are excluded from gender and age-specific
counts and reporting rates. Data corrections or updates can result in AEFI reports being removed and/or updated
from past reports and may result in counts differing from past publicly reported AEFls.
Data Source: CCM, COVaXon(see technical notes for details on data sources)

Adverse Events Following Immunization (AEFls) for COVID-19 in Ontario 4

 112
Figure 1. Number of AEFI reports and closes administered by week of vaccine administration:
Ontario, December 13, 2020 to October 10, 2021

1000
900
- Non-serious reports r"

l
Serious reports —Doses administered

2,000,000
1,800,000

800 1,600,000

700 1,400,000
600 1,200,000

1,000,000
500
.-. r
400 L.
- - 800,000
7‘

300 600,000
of
Number repots AEFI

200 -
'
400,000

of
II
100

Number dose
. 200,000
0 0

adminster
51532 4 6 810121416182022242628303234363840

Vaccine administration week

Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from
—
week 51 (Dec 13 — 19, 2020) to week 40 (Oct 3 9, 2021). Week 41 which includes October 10, 2021 Is not shown
in the figure as it is not yet a full week. The number of AEFI reports for the recent reporting weeks are subject to
reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be
reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or
updated from past reports and may result in counts differing from past publicly reported AEFIs.
Data Source: CCM, COVaxou (see technical notes for details on data sources)

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario

 113

Table 3. Number of AEFI reports and reporting rates by vaccine product and dose number:
Ontario, December 13, 2020 to October 10, 2021

Pfizer-BioNTech Moderna
vaccrne vaccme
Acsévlzsfligfapl
vaccine
Agizzzme
combined

Total number of AEFI 7,945 4,290 1,502 13,741

reports

Dose 1 5,924 2,937 1,439 10,301

Dose 2 1,991 1,308 55 3,355
Dose 3 5 23 0 28

Number of serious reports 407 244 113 764

Dose 1 242 85 107 434

Dose 2 163 154 6 323

Dose 3 1 3 0 4

Total reporting rate per 51.9 76.3 138.0 62.4

100,000 doses administered
Dose 1 71.1 143.0 166.4 91.5

Dose 2 28.8 37.2 24.6 31.5

Dose 3 8.4 49.2 0.0 26.3

Serious reporting rate per 2.7 4.3 10.4 3.5

100,000 doses administered
Dose 1 2.9 4.1 12.4 3.9

Dose 2 2.4 4.4 2.7 3.0

Dose 3 1.7 6.4 0.0 3.8

Note: As some AEFI reports have unknown dose number, the sum of dose number-specific counts of AEFI reports
will not equal to the total. These reports with unknown dose number are excluded from dose number-specific
counts and reporting rates. Data corrections or updates can result in AEFI reports being removed and/or updated
from past reports and may result in counts differing from past publicly reported AEFls.
Data Source: CCM, COVaxou (see technical notes for details on data sources)

Adverse Events Following Immunization (AEFls) for COVID-19 in Ontario 6

 114

Adverse Event Descriptions

For all COVID-19 vaccine products combined, the most commonly reported adverse events are allergic
skin reactions and other severe or unusual events, reported in 24.3% and 21.9% of the total AEFI reports
respectively. Figure 2 shows the ten most frequently reported adverse events for all COVID~19 vaccines.

Figure 2. Ten most frequently reported adverse events for all COVID-19 vaccines: Ontario,
December 13, 2020 to October 10, 2021

Allergic skin reactions

Other severe or unusual events

Pain/iedness/swelling at the injection site

Rash

Anaesthesia/paraesthesia

Adenopathy/Iymphadenopathy

Severe vomiting/diarrhea

Fever in coniunction with another reportable event

Artlrriris/anhralgia

AESI Myocardiiis/pencarditis
»

500 1000 1500 2000 2500 3000 3500

o

Number of Al'il reports

Note: An AEFI report may contain multiple adverse events. Thus the sum of all adverse event-specific counts may
not equal to the total number of AEFI reports.
Data Source: CCM

Allergic skin reaction was the most frequently reported adverse event for the Pfizer-BioNTech vaccine
(14.4 per 100,000 doses administered) while pain/redness/swelling at the injection site was the most
frequently reported adverse event for the Moderna vaccine (26.2 per 100,000 doses administered). The
'other severe or unusual events’ category was the most frequently reported adverse event for the
AstraZeneca/COVISHIELD vaccine (35.4 per 100,000 doses administered). The number of AEFI reports
and reporting rate for each adverse event are presented in Appendix A.

The ‘other severe or unusual events’ category includes reports of adverse events that are clinically
important or epidemiologically interesting, and do not meet any other pre-defined events outlined in
the Infectious Diseases Protocol: Appendix 8.1 These events usually require medical attention but do not
necessarily need to meet the serious AEFI definition. Serious AEFIs are described in the Serious AEFI
section.

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 7

 115

Medically Important Events

Some selected adverse events are defined as ”medically important," based on the World Health
Organization’s (WHO) guidance, regardless of whether they meet the serious AEFI definition. These
types of events mayjeopardize the patient or may require intervention to prevent an outcome
described in the serious definition. The full list of medically important events are listed in the technical
notes.

There were 540 reports with medically important events, representing 3.9% of all reports. The 540
reports include 422 reports of events managed as anaphylaxis, in which 30 met the definition of a
serious AEFI. Of all 422 reports of events managed as anaphylaxis: 376 received epinephrine, 363 were
seen in the emergency department and 320 were fully recovered at the time of reporting. All reports of
events managed as anaphylaxis undergo an assessment using the Brighton Collaboration standard
definition of anaphylaxis.5The most recent breakdown of reports by Brighton level of diagnostic
certainty is available in the enhanced epidemiological summary on reports of events managed as
anaphylaxis.

The Public Health Agency of Canada (PHAC) and Health Canada are actively monitoring reports of GBS
following AstraZeneca COVID-19 vaccination and have observed a higher number of cases than would
normally be expected in the general population.5 In Ontario, 30 reports of GBS have been reported to
date, including 15 following AstraZeneca/COVISHIELD vaccine. All reports of GBS are assessed using the
Brighton Collaboration standard definition of GBS. 7'8 0f the 30 reports, one report met level 2 of the
Brighton Collaboration case definition of GBS. Five did not meet the Brighton Collaboration case
definition of GBS and 24 had insufficient evidence to meet level 1, 2 or 3 (i.e., met level 4 diagnostic
certainty) of the case definition.

Adverse events of special interest (AESls) for COVID-19 vaccines

Several adverse events of special interest (AESIs) for COVID-19 vaccines have been identified by
international health authorities based on a theoretical rationale for a possible association with COVID-19
vaccines. Reporting of AESIs for COVID-19 vaccines enables enhanced monitoring of events which may
otherwise not be captured in a passive surveillance system.

There were 992 reports with COVID-19 vaccine—specific AESIs, representing 7.2% of all reports. Of the
992 reports, 475 met the definition of a serious AEFI. The number of AEFI reports and reporting rate for
each AESI by vaccine product are presented in Appendix A.

THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS) AND VACCINE-

INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT)
Thrombosis with Thrombocytopenia Syndrome (TTS) is a condition characterized by the presence of
acute venous or arterial thrombosis with new onset thrombocytopenia (low levels of platelets), and no
known recent exposure to heparin.9 Vaccine-Induced Immune Thrombotic Thrombocytopenia (VI'I'I')
refers to the clinical syndrome of TTS, in addition to laboratory tests that confirm platelet activation (i.e.,
anti-platelet 4 antibodies). Vl'l'l' has been reported following immunization with COVID-19 adenoviral
vector vaccines, including AstraZeneca/COVISHIELD vaccine. Out of an abundance of caution due to an
observed increase in reports of TTS/VITT in Ontario, the province announced a pause on the
administration of first doses of the AstraZeneca vaccine on May 11, 2021. More information on 'I'I'S and
VITT can be found on PHO’s Synthesis on COVID-19 Viral Vector Vaccines and Rare Blood Clots.10

To date, there have been 21 reports of TTS following the first dose of AstraZeneca/COVISHIELD vaccine
in Ontario (including one probable 1T5); of these, 16 are confirmed as VITT with positive anti-PF4
antibody test results. The remaining five 'l'l'S events that are not classified as Vl'l'l’ have had Vl'l'l' ruled
out through testing (n=4) or did not have confirmatory tests ordered (n=1). The most recent event had a

Adverse Events Following Immunization (AEFls) for COVID-19 in Ontario 8

 116

vaccination date of May 6, 2021. There were no reports of 'l'l'S/Vl'l'l' following second dose of
AstraZeneca/COVISHIELD vaccine. See Appendix A for the number of TTS/VITT reports by vaccine
product.

There has been one report of death recorded in CCM that has occurred in an individual with VITT. The
investigation of this death is ongoing and a cause of death has not been determined at this time. Based
on the number of first doses of AstraZeneca/COVISHIELD vaccines administered in Ontario to date, the
reporting rate of TTS based on 21 reports is 2.4 per 100,000 first doses administered (approximately 1 in
41,000). The reporting rate of VITT (as a subtype of TI’S) based on 16 reports is 1.9 per 100,000 first
doses administered (approximately 1 in 54,000).

MYOCARDITlS/PERICARDITIS
There have been international reports, including from the United States and Israel, of myocarditis
(inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart)
following vaccination with COVID-19 mRNA vaccines.“13 Information to date indicates that these events
occur more commonly after the second dose, within the week following vaccination (typically within 4-5
days), mainly in adolescents/young adults and more often in males than females.14

Vaccine safety surveillance data in Canada suggest relatively higher rates of myocarditis/pericarditis
reported after Moderna vaccine compared to Pfizer-BioNTech vaccine.15 Similar trends have been
observed in Ontario’s vaccine safety data where the reporting rates of myocarditis/pericarditis was
observed to be higher following vaccination with Moderna compared to Pfizer-BioNTech in the 18 to 24
year old age group, particularly among males. Out of an abundance of caution, Ontario issued a
preferential recommendation of the use of Pfizer-BioNTech vaccine for individuals aged 18 to 24 year
olds on September 29, 2021.15 Ontario is continuing to monitor these events in collaboration with its
partners and weekly updates can be found within this report and on the PHAC website.5 For more
information on this topic please see PHO's At A Glance: Mvocarditis and Pericarditis Following COVID-19
mRNA Vaccines and additional in-depth analysis in‘Mvocarditis and Perica rditis Following Vaccination
with COVID-19 mRNA Vaccines in Ontario: December 13, 2020 to August 7I 2021.“18

As of October 10, 2021, there have been 438 reports of myocarditis or pericarditis following receipt of
COVID-19 mRNA vaccines in Ontario. These reports have been identified through case-level review of all
reported AEFIs. Of these, 122 (27.9%) were diagnosed with myocarditis and 197 (45.0%) were diagnosed
with pericarditis. The remaining 119 (27.2%) were diagnosed with perimyocarditis (n=19),
myopericarditis (n=97) and myocarditis/pericarditis (n=3). The 122 reports of myocarditis have been
assessed using the Brighton Collaboration case definition for myocarditis; 114 reports met Brighton
levels of diagnostic certainty 1, 2 or 3 (93.4%) and six reports had insufficient evidence to meet level 1, 2
or 3 of the case definition (4.9%).19 Two reports could not be assessed due to lack of information. Of the
197 reports of pericarditis assessed using the Brighton Collaboration case definition for pericarditis, 107
reports met Brighton levels of diagnostic certainty 1, 2 or 3 (54.3%), 59 reports had insufficient evidence
to meet level 1, 2 or 3 of the case definition (29.9%), and 30 reports did not meet the Brighton
Collaboration case definition for pericarditis (15.2%).19 One report could not be assessed due to lack of
information. See Table 3 for further characteristics of myocarditis/pericarditis reports. The remaining
119 reports were assessed against both Brighton Collaboration case definition for myocarditis and
pericarditis to see if they meet either one of two definitions; of these, 108 (90.8%) met Brighton levels
of diagnostic certainty 1, 2 or 3 for either myoca rditis or pericarditis.

Of the 438 reports of myocarditis or pericarditis, 242 (55.3%) reports had a hospital admission with
some variation by age group. Among the 210 reports where both the date of admission and discharge
was available for review, the median length of stay was two days.
Based on 438 reports of myocarditis or pericarditis, the overall crude reporting rate is 20.9 per million
doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 9

 117

(12-17 and 18-24 years) and among males. The highest reporting rate was observed for males aged 18-
24 years of age following dose 2, at 173.3 events per million doses administered. Table A3 in Appendix A
presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number. The
reporting rates are calculated by including all reports of myocarditis or pericarditis identified through
case-level review, regardless of whether they meet the Brighton Collaboration case definition for
myocarditis or pericarditis.

Table 4. Characteristics of myocarditis/pericarditis reports following COVID-19 mRNA

vaccines: Ontario, December 13, 2020 to October 10, 2021

Mvocarditis or Mvocarditis or
.
pericarditis .
. reports . . . reports
pericarditis
Total
(n-438)
after close 1 (n=153) after dose 2 (n=285) '

Pfizer-BioNTech vaccine 119 140 259

Moderna vaccine 34 145 179

Median age, years (range) 26 (12 — 80) 23 (12 — 87) 24 (12 — 87)
Median time to onset, days (range)* 7 (O -— 38) 2 (0 — 35) —
3 (0 38)

Gender: male (%) 102 (66.7%) 221(77.5%) 323 (73.7%)

Note: Eighteen reports with unknown time to onset and 19 reports with time to onset of greater than 42 days have
been excluded from the calculation of median time to onset and range.
Data Source: CCM

Adverse Events Following Immunization (AEFIs) for COVID-l9 in Ontario 10

 118

Serious AEFls
In Ontario, AEFls that meet the serious definition are events that required hospital admission and
reports of death (see the technical notes for a full definition).

There were 764 AEFI reports classified as serious, representing 5.6% of all AEFI reports and a serious
AEFI reporting rate of 3.5 per 100,000 doses administered for all vaccine products combined. Of the 764
reports meeting the serious definition, 756 reports had a hospital admission related to the adverse
event and eight were reports of deaths.The serious reporting rate was 2.7 and 4.3 per 100,000 doses
administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious
reporting rate for the AstraZeneca/COVISHIELD vaccine was 10.4 per 100,000 doses administered. As a
comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged
from 2.8% and 5.0% between 2012 and 2018.20

AEFI REPORTS REQUIRING HOSPITALIZATION

Of the 756 reports of hospitalization, 271 recovered at the time of reporting, 346 were not yet
recovered when the investigation was completed but likely to recover, and 80 reported persistent or
significant disability/incapacity related to the adverse event. Due to the relatively short follow-up time
for AEFIs reported in CCM, it is uncertain whether these disability/incapacity will eventually resolve, but
had not yet resolved at the time of reporting. The remaining reports had unknown outcome at the time
of reporting.

AEFI REPORTS WITH FATAL OUTCOME

There are eight reports of death temporally associated with receipt of COVID-19 vaccine that met the
provincial surveillance definition. Reports of death that meet the provincial case definition are events
temporally associated with vaccine that have not been clearly attributed to other causes; these reports
should not be interpreted as causally related with vaccine. The reports of deaths are as follows:

1. Resident of a health-care institution with significant comorbidities. The cause of death was not
attributed to the vaccine.

2. Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI
may have contributed to but was not the underlying cause of death.

3. Community dwelling senior with multiple comorbidities including heart disease and an
autoimmune disorder. The cause of death was not attributed to the vaccine.

4. An individual with Vl'l'l' with death recorded in CCM (described above under Vaccine-Induced
Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia
Syndrome (TTS)).

5. Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.

6. Community dwelling senior with a complex cardiovascular history. The AEFI may have
contributed to but was not the underlying cause of death.

7. Community dwelling senior with multiple comorbidities, wherein the AEFI may have
contributed to but was not the underlying cause of death.

8. Community dwelling senior with severe aortic stenosis. The AEFI may have contributed to but
was not underlying cause of death.

Adverse Events Following Immunization (AEFls) for COVID-19 in Ontario 11

 119

Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public
health units are thoroughly investigated and reported to PHO. As of October 10, 2021, there are 34
reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as
'persons under investigation’ as they do not currently meet the provincial surveillance definition. These
investigations are ongoing and additional information including a cause of death (e.g., autopsy or
Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals
with multiple co-morbidities which may be related to the cause of death. There has been no association
with vaccine identified at this time. ‘

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents
have been a focus for vaccination efforts. In this population, it was expected that deaths may occur
close to the time of vaccination and require further evaluation to determine the cause of death. After
reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19
vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety
subcommittee concluded that ”the current reports do not suggest any unexpected or untoward increase
in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following
administration of Pfizer—BioNTech COVID-19 vaccine”.21 The Centres for Disease Control (CDC) also
presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory
Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high
and substantial numbers of deaths in this population are expected, unrelated to vaccination.22 PHO
continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its
partners, including individual case review of all serious AEFIs including reports of death temporally
association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and
weekly reporting on the PHO website and to the Public Health Agency of Canada.

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 12

 120

Geography

Table 5. Number of AEFI reports and reporting rates by public health unit and region: Ontario,
December 13, 2020 to October 10, 2021

Number of AEFI reports Reporting rate per 100,000

1 Public Health Unit Name received to date doses administered

Northwestern Health Unit 122 102.3

Thunder Bay District Health Unit 89 38.5

TOTAL NORTH WEST 211

Algoma Public Health 115

North Bay Parry Sound District Health 138 72.4

Unit

Porcupine Health Unit 111 92.2

Public Health Sudbury & Districts 291 96.9

Timiskaming Health Unit 91 192.7

TOTAL NORTH EAST 746 89.6

Eastern Ontario Health Unit 274

Hastings Prince Edward Public Health 147 59.9

Kingston, Frontenac and Lennox & 273 85.2

Addington Public Health

Leeds, Grenville & Lanark District 294 101.6

Health Unit

Ottawa Public Health 1,333 84.8

Renfrew County and District Health 199 131.3

Unit

TOTAL EASTERN 2,520

Durham Region Health Department 1,556 147.3

Haliburton, Kawartha, Pine Ridge 109.2

District Health Unit

Peel Public Health 956 41.9

Peterborough Public Health 211 96.0

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 13

 121

Number of AEFI reports Reporting rate per 100,000

Public Health Unit Name
received to date doses administered

Simcoe Muskoka District Health Unit 469 53.6

York Region Public Health 986 55.2

TOTAL CENTRAL EAST 4,493 69.0

Toronto Public Health 1,701 38.5

TOTAL TORONTO 1,701 38.5

Chatham-Kent Public Health 66 43.7

Grey Bruce Health Unit 112

Huron Perth Public Health 157 74.4

Lambton Public Health 461 248.4

Middlesex-London Health Unit 35.5

Southwestern Public Health 346 112.9

Windsor—Essex County Health Unit 260

TOTAL SOUTH WEST 1,670

Brant County Health Unit 125

City of Hamilton Public Health 397 47.5

Services

Haldimand-Norfolk Health Unit 40 24.3

Halton Region Public Health 622

Niagara Region Public Health 318

Region of Waterloo Public Health and 571

Emergency Services

Wellington-Dufferin—Guelph Public 327

Health

TOTAL CENTRAL WEST 2,400 57.2

TOTAL ONTARIO 13,741 62.4

Note: Orientation of AEFI reports by geography is based the case's public health unit of residence at the time of adverse event.
This does not represent the location of vaccine administration. Reporting rates should not be interpreted as incidence rates. In
the context of a passive AEFI surveillance system, a higher overall reporting rate of AEFIs does not necessarily suggest a vaccine
safety concern; rather, it is an indicator of a robust passive vaccine safety surveillance system. Reporting rates are valuable
estimates for comparing to other passive surveillance systems and for monitoring reporting trends over time.
Data Source: CCM
Adverse Events Following Immunization (AEFIs) for COVID-l9 in Ontario 14
 122

Technical Notes

Data Sources
The data for this report were based on:

o AEFI information from the Public Health Case and Contact Management Solution (CCM)
extracted on October 12, 2021 at approximately 9:00 am.

0 Doses administered data from Ontario Ministry of Health’s COVaxon application extracted
on October 12 at approximately 7:00 am. Doses administered out of province and doses
administered with non-Ontario stock were excluded from the doses administered data
used for this report. Methodology used to calculate the number of doses administered are
documented in PHO’s COVID-19 Vaccine Uptake in Ontario report.“

Data Caveats
Data presented in this report only represent AEFIs reported to public health units and recorded
in CCM. As a result, all counts will be subject to varying degrees of reporting bias.,lncluding
underreporting, particularly for mild or common reportable events, as well as stimulated
(elevated) reporting, which can occur in response to media coverage and increased public
awareness.
CCM and COVaxou are dynamic reporting systems which allow ongoing updates to data previous
entered. As a result, data extracted from CCM and COVaxon represent a snapshot at the time of
data extraction and may differ from previous or subsequent reports.

Methods
For provincial surveillance reporting, an adverse event must occur after receiving the vaccine
and meet the MOH AEFI case definition.1 Data presented in this report only includes AEFI
reports with a confirmed case classification and an association with a COVID-19 vaccine in CCM
at the time of data extraction.

AEFI reports from CCM where the Disposition was reported as ENTERED IN ERROR, DOES NOT
MEET DEFINITION or DUPLICATE - DO NOT USE, or any variation on these values have been
excluded. AEFI reports from CCM where the Status was reported as MERGED-OBSOLETE have
also been excluded.

AEFI reports with a missing date of vaccine administration have been excluded.

Each AEFI report refers to an individual who reported an adverse event after receiving a close of
COVID-19 vaccine. An AEFI report may contain multiple adverse events. Therefore, the total
number of adverse events can exceed the number of individual AEFI reports reported in a given
time frame. AEFI reports that did not have an adverse event reported at the time of data
extraction have been excluded.

AEFI reporting rates are calculated using the number of COVID-19 vaccine-specific AEFls
reported in a given time period in Ontario divided by doses of COVID-19 vaccines administered
in the same time period in Ontario.

Dose number is extracted from CCM. It represents the dose number of the immunization that is
associated with the adverse event. Since close number was not a system-mandatory field in CCM
during the initial implementation of the system, there are records with missing dose number
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 15
 123
information. When a dose number was missing or reported as unknown in CCM, the individual’s
immunization records in COVaon application were examined to identify the dose number of the
immunization that was associated with the AEFI, if available.

0 Serious AEFIs are defined using the World Health Organization (WHO) standard definition:24 an
AEFI that results in death, is life-threatening, requires in-patient hospitalization or prolongs an
existing hospitalization, results in persistent or significant disability/incapacity, or in a congenital
anomaly/birth defect. Due to data limitations and the relatively brief follow-up period of AEFIs
reported in Ontario, AEFI reports that meet the serious definition typically have an in-patient
hospitalization or death reported. ln-patient hospitalization is defined as having a hospital
admission recorded in CCM. Deaths are defined as reporting 'fatal’ in the outcome field in CCM.

0 Some selected adverse events can be defined as ”medically important,” based on the World
Health Organization's (WHO) guidance, regardless of whether they meet the serious AEFI
definition. These types of events may jeopardize the patient or may require intervention to
prevent an outcome described in the serious definition (e.g., hospitalization); ”medically
important” events may be defined after applying medical and scientificjudgement. In Ontario,
the specific events under surveillance that align with this definition include: acute disseminated
encephalomyelitis (ADEM), events managed as anaphylaxis, encephalitis/encephaIopathy,
Guillain-Barré syndrome (GBS), intussusception, meningitis, myelitis/transverse myelitis and
thrombocytopenia.

o All reports of events managed as anaphylaxis, GBS, TTS/Vl'l'l' and myocarditis are further
assessed using the internationally recognized case definition for anaphylaxis following
vaccination from the Brighton Collaboration.5'7""9'19 An independent review of these cases is
completed and a preliminary score is assigned based on this case definition. This score is not a
measure of severity but rather reflects the level of diagnostic certainty, with level 1 being the
most highly specific for the condition.

0 Several adverse events of special interest (AESI) following administration of COVID-19 vaccine(s)
were selected for surveillance.25 These are: vaccine-associated enhanced disease, multisystem
inflammatory syndrome in children and adults, acute respiratory distress syndrome, acute
cardiovascular injury, myocarditis/pericarditis, coagulation disorder (including thrombotic
events), thrombosis with thrombocytopenia syndrome (TTS) and vaccine-induced immune
thrombotic thrombocytopenia (VITT), acute kidney injury, acute liver injury, anosmia and/or
ageusia, chilblain-like lesions, single organ cutaneous vasculitis, erythema multiforme, acute
pancreatitis, rhabdomyolysis, and subacute thyroiditis.

o Orientation of case counts by geography is based on the Permanent Health Unit in CCM.
Permanent Health Unit refers to the case's public health unit of residence at the time of adverse
event. Cases for which the Permanent Health Unit was reported as MOH-PHO (to signify a case
that is not a resident of Ontario) have been excluded from the analyses.

0 For reports with hospitalization, length of hospital stay was calculated using the difference
between the discharge date and the admission date (if both are available). If a client reported
multiple hospital admissions, the length of stay of the earliest hospital admission was used.

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 16

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References
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Ontario Agency for Health Protection and Promotion (Public Health Ontario). COVID-19 vaccines
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Ontario Agency for Health Protection and Promotion (Public Health Ontario). Focus on: how
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Government of Canada. COVID-19 vaccine safety in Canada [Internet]. Ottawa, ON: Government
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infobase.canada.ca/covid-19/vaccine-safetv/

RiiggebergJU, Gold MS, Bayas J-M, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: case
definition and guidelines for data collection, analysis, and presentation of immunization safety
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Task Force for Global Health, Brighton Collaboration. Guillain Barré and Miller Fisher Syndromes:
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[cited 2021 Jul 05]. Available from: https:[[brightoncollaboration.us[wp-
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Guide V1.0 format12062-1.pdf

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Task Force for Global Health, Brighton Collaboration. Interim case definition of thrombosis with
thrombocytopenia syndrome (TTS) [Internet]. Decatur, GA: Task Force for Global Health; 2021
[cited 2021 Apr 26]. Available from: https://brightoncollaboration.us/wp-
content/uploads/ZOZ1/01/COVID-19-updated-AESl-list.pdf

10. Ontario Agency for Health Protection and Promotion (Public Health Ontario). COVID-19 viral
vector vaccines and rare blood clots — vaccine safety surveillance in action. Toronto, ON: Queen’s
Printer for Ontario; 2021 [cited 2021 Oct 13]. Available from:
https://www.publicheaIthontario.ca/-/media/documents/ncov/vaccines/2021j07/covid-19-viral-
vector-vaccines-rare-blood-clots.pdf?sc lang=en

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 17

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11. Public Health Agency of Canada; National Advisory Committee on Immunization. An Advisory
Committee Statement (ACS) National Advisory Committee on Immunization (NACI):
recommendations on the use of COVID-19 vaccines [Internet]. Ottawa, ON: Government of
Canada; 2021 [cited
2021
Apr 26]. Available from:
'
https:[[www.canada.calcontentldamlphac-
-committee--on--immunization-
naci recommendations-use-covid-19-vaccines recommendations-use-covid-19-vaccines-en. df

12. World Health Organization. COVID-19 subcommittee of the WHO Global Advisory Committee on
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[Internet]. Geneva: World Health Organization; 2021 [cited 2021 Jun 3]. Available from:
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13. Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices
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vast%2Ftechnical-report-2021-05-17.html

14. Centers for Disease Control and Prevention, National Center for Immunization 8: Respiratory
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Shimabukuro-508.pdf

15. Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health
(CCMOH): update on COVID-19 vaccines and the risk of myocarditis and pericarditis [Internet]. '

Ottawa, ON: Government of Canada; 2021 [cited 2021 Oct 05]. Available from:
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medical-officers—of—heaIth—ccmoh-u date-on-covid-19-vaccines-and-the-risk-of—m ocarditis-and-
pericarditis.html

16. Government of Ontario. Statement: Ontario recommends the use of Pfizer-BioNTech COVID-19
vaccine for individuals aged 18-24 years old [Internet]. Toronto, ON: Queen’s Printer for Ontario;
2021 [cited 2021 Oct 05]. Available from:
. news.ontario.ca en statement 1000907 ontario-recommends-the-use-of—
covid-19-vaccine-for-individuals-aged—18-24-years-old

17. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Myocarditis and
pericarditis following COVID-19 mRNA vaccines. Toronto, ON: Queen‘s Printer for Ontario; 2021
[cited 2021 Jun 14]. Available from: hflmllwwwpublichealthontario.ca/-
[medialdocumentslncovlvaccines[2021[06[covid-19-mrna-vaccines-myocarditis-
perica rditis.pdf?la=en.

18. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Mvocarditis and
pericarditis following vaccination with COVID-19 mRNA vaccines in Ontario: December 13, 2020 to
August 7, 2021. Toronto, ON: Queen‘s Printer for Ontario; 2021 [cited 2021 Aug 30]. Available
from: https://www.publichealthontario.ca/-/media/documents/ncov/epi/covicLlQ-mvocarditis-
pericarditis-vaccines-epi.pdf?sc Iang=en

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19. Task Force for Global Health, Brighton Collaboration. Myocarditis/Pericarditis Case Definition
(myocarditis_version_1.5.0_16.JuIy.2021 and pericarditis_version_1.0.0_15.July.2021) [Internet].
Decatur, GA: Task Force for Global Health; 2021 [cited 2021 Jul 19]. Available from:
bri htoncollaboration.us m ocarditis-case-definition-u date

20. Ontario Agencyfor Health Protection and Promotion (Public Health Ontario). Annual report on
vaccine safety in Ontario, 2018 [Internet]. Toronto, ON: Queen’s Printer for Ontario; 2019 [cited
2021 Jan 26]. Available from: https:[[www.publichealthontariocaz-
[medialdocuments[a[2019[annual-vaccine-safety-report-2018.pdf?la=en

21. World Health Organization. GACVS COVID-19 Vaccine Safety subcommittee meeting to review
reports of deaths of very frail elderly individuals vaccinated with Pfizer BioNTech COVID-19
vaccine, BNT162b2 [Internet]. Geneva: World Health Organization; 2021 [cited 2021 Feb 22].
Available from: https://www.who.int/news/item/22-01-2021-gacvs-review-deaths-pfizer-
biontech-covid;19-vaccine—bnt162b2

22. Centers for Disease Control and Prevention, National Center for Immunization 8: Respiratory
Diseases. COVID—19 vaccine safety update: Advisory Committee on Immunization Practices (ACIP)
[Webinar]. Atlanta, GA: Centers for Disease Control and Prevention; 2021 [presented 2021 Jan 27;
cited 2021 Feb 22]. Available from:
htt s: www.cdc. ov vaccines aci meetin 5 downloads slides-2021-01 06-COVID-
Shimabukuropdf

23. Ontario Agency for Health Protection and Promotion (Public Health Ontario). COVID-19 vaccine
uptake in Ontario: December 14, 2020 to March 27, 2021 [cited 2021 Mar 29]. Toronto, ON:
Queen‘s Printer for Ontario; 2021. Available from: https://www.publichealthontario.ca/-
[medialdocumentszncovZepi[covid-19-vaccine-uptake-ontario-epi-summarv.pdf?la=en

24. ICH Expert Working Group. ICH harmonised tripartite guideline: clinical safety data management:
definitions and standards for expedited reporting E2A [Internet]. Version 4. Geneva: ICH; 1994
[cited 2021 Jan 16]. Available from: httpsfidatabase.ich.org[sites[defauIt[files[E2A Guidelinepdf

25. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Adverse events of
special interest (AESIs) for COVID-19 vaccines surveillance. Toronto, ON: Queen's Printer for
Ontario; 2020 [cited 2021 Jul 19]. Available from: httpszl/www.publichealthontario.ca/-
zmediaZdocumentszncovlvaccineszzozoz12(covid-19-guidance-aesis.pdf?la=en

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Appendix A

Table A1. Number of AEFI reports by adverse event and vaccine product: Ontario, December
13, 2020 to October 10, 2021

1v Adverse Pfizer-
BioNTech
Moderna AstraZeneca/
COVISHIELD
All vaccine
products
‘
event .
vaccine vaccme vaccine combined

Allergic skin reactions 2,203 868 263 3,336

Other severe or unusual eventst 1,913 715 385 3,013

Pain/redness/swelling at the 936 1,473 291 2,701
injection site

Rash 831 542 165 1,538

Anaesthesia/paraesthesia 699 228 192 1,119

Adenopathy/Iymphadenopathy 454 215 43 712

Severe vomiting/diarrhea 378 177 138 694

Fever in conjunction with another 274 214 161 650

reportable event

Arthritis/arthralgia 403 135 91 629

AESI
— Myocarditis/pericarditis‘l‘ 268 182 5 455

Event managed as anaphylaxis* 308 93 21 422

AESI — Coagulation disorder 159 63 67 289

(including thrombotic events)

Syncope (fainting) with injury 199 65 8 272

Cellulitis 38 179 19 236

Bell's Palsy 159 63 13 235

AESI - Acute cardiovascular injury 76 37 15 128

Convulsions/seizure 76 29 12 117

Module 15 30 21 66

Thrombocytopenia" 36 11 17 64

Guillian-Barré syndrome (GBS)* 10 5 15 30

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 20

 128

Pfizer- Moderna AstraZeneca] All vaccine

. Adverse
,
event
_
BioNTech
vaccme
.
vaccme COVISHIELD
vaccme
.
products
.
combIned

AESI
— Anosmia, ageusia 18 7 4 29

Paralysis 19 1 9 29

AESI — TTS/VITT 4 3 21 28

AESI — Acute liver injury 15 8 2 25

Oculorespiratory syndrome (ORS) 13 4 2 19

Myelitis/transverse myelitis* 11 2 3 16

—
AESI Single organ cutaneous
vasculitis
8 4 3 15

AESI — Acute kidney injury 6 5 2 13

AESI
— Erythema multiforme 4 6 1 11
AESI
— Chilblain—like lesions 7 2 1 10
AESI
— Acute pancreatitis 4 3 1 8

Encephalopathy/encephalitis* 5 2 1 8

AESI — Subacute thyroiditis 6 1 0 7

Infected abscess 0 S 0 5

AESI
—
Multisystem inflammatory
syndrome in children/adults
2 2 0 4

AESI — Rhabdomyolysis 2 2 O 4

AESI — Acute respiratory distress 3 O 0 3

syndrome

Sterile abscess 1 2 0 3

—
AESI Vaccine-associated 1 1 0 2
enhanced disease

Acute disseminated 0 O 1 1
encephalomyelitis (ADEM)*

Hypotonic-hyporesponsive episode 1 O O 1
(HHE)

Meningitis" 1 0 O 1

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 21

 129
Note: An AEFI report may contain multiple adverse events. Thus the sum of all adverse event-specific counts may
not equal to the total number of AEFI reports. Some AEFI reports did not specify vaccine product received; these
are included in the counts for all vaccine products combined.
iThis category includes reports of death that are temporally associated with immunization and where no other
clear cause of death was established; these reports should not be interpreted as causally related with vaccine.
These reports are described in the Serious AEFI section.
* represents a medically important event.
—
1‘ The number of reports with ’AESI Myocarditis/pericarditis' presented in this table is based on CCM data entry
and may be different from the number of myocarditis or pericarditis reports that are presented in the
Myocarditis/Pericarditis section, which is based on case-level review. With the latter process, additional reports
may be identified in those that are not yet classified as 'AESI - Myocarditis/pericarditis’ or reports may be excluded
if the case information does not support the report being classified as 'AESI — Myocarditis/pericarditis’. Refer to
the Mvocarditis/Pericarditis section for accurate number of myocarditis or pericarditis reports.
Data Source: CCM

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 22

 130

Table A2. Reporting rate per 100,000 doses administered by adverse event and vaccine
product: Ontario, December 13, 2020 to October 10, 2021

Pfizer- Moderna AstraZeneca] All vaccine

Adverse event BioNTech . COVISHIELD products
vaccine vaccme vaccine combined

Allergic skin reactions 14.4 15.4 24.2 15.2

Other severe or unusual eventsi 12.5 12.7 35.4 13.7

Pain/redness/swelling at the 6.1 26.2 26.7 12.3

injection site

Rash 5.4 9.6 15.2 7.0

Anaesthesia/paraesthesia 4.6 4.1 17.6 5.1

Adenopathy/lymphadenopathy 3.0 3.8 4.0 3.2

Severe vomiting/diarrhea 2.5 3.1 12.7 3.2

Fever in conjunction with another 1.8 3.8 14.8 3.0

reportable event

Arthritis/arthralgia 2.6 2.4 8.4 2.9

AESI — Myocarditis/pericarditist 1.8 3.2 0.5 2.1

Event managed as anaphylaxis" 2.0 1.7 1.9 1.9

—
AESI Coagulation disorder 1.0 1.1 6.2 1.3
(including thrombotic events)

Syncope (fainting) with injury 1.3 1.2 0.7 1.2

Cellulitis 0.2 3.2 1.7 1.1
Bell's Palsy 1.0 1.1 1.2 1.1
AESI - Acute cardiovascular injury 0.5 0.7 1.4 0.6

Convulsions/seizure 0.5 0.5 1.1 0.5

Nodule 0.1 0.5 1.9 0.3

Thrombocytopenia" 0.2 0.2 1.6 0.3

Guillian-Barre’ syndrome (GBS)* 0.1 0.1 1.4 0.1

AESI — Anosmia, ageusia 0.1 0.1 0.4 0.1
Paralysis 0.1 0.0 0.8 0.1

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 23

 131

Pfizer- AstraZeneca] All vaccine

Moderna
. Adverse event BioNTech COVISHIELD products
vaccine
vaccine vaccine combined

AESI — TTS/VITT 0.0 0.1 1.9 0.1

AESI
— Acute liver injury 0.1 0.1 0.2 0.1
Oculorespiratory syndrome (ORS) 0.1 0.1 0.2 0.1
Myelitis/tra nsverse myelitis‘ 0.1 0.0 0.3 0.1
AESI Single organ cutaneous
— 0.1 0.1 0.3 0.1
vasculitis

AESI —Acute kidney injury 0.0 0.1 0.2 0.1

AESI — Erythema multiforme 0.0 0.1 0.1 0.0
AESI
— Chilblain-Iike lesions 0.0 0.0 0.1 0.0
AESI — Acute pancreatitis 0.0 0.1 0.1 0.0
EncephaIopathy/encephalitis* 0.0 0.0 0.1 0.0
AESI — Subacute thyroiditis 0.0 0.0 0.0 0.0
Infected abscess 0.0 0.1 0.0 0.0
AESI —
Multisystem inflammatory 0.0 0.0 0.0 0.0
syndrome in children/adults

AESI — Rhabdomyolysis 0.0 0.0 0.0 0.0

—
AESI Acute respiratory distress 0.0 0.0 0.0 0.0
syndrome

Sterile abscess 0.0 0.0 0.0 0.0

AESI — Vaccine-associated enhanced 0.0 0.0 0.0 0.0
disease

Acute disseminated 0.0 0.0 0.1 0.0

encephalomyelitis (ADEM)*

Hypotonic-hyporesponsive episode 0.0 0.0 0.0 0.0

(HHE)

Meningitis* 0.0 0.0 0.0 0.0

Note: An AEFI report may contain multiple adverse events. Thus the sum of all adverse event-specific counts may
not equal to the total number ofAEFI reports. Some AEFI reports did not specify vaccine product received; these
are included in the counts for all vaccine products combined.

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 24

 132
tThis category includes reports of death that are temporally associated with immunization and where no other
clear cause of death was established; these reports should not be interpreted as causally related with vaccine.
These reports are described in the Serious AEFI section.
* represents a medically important event.

1 The number of reports with 'AESI — Myocarditis/pericarditis‘ presented in this table is based on CCM data entry
and may be different from the number of myocarditis or pericarditis reports that are presented in the
Myocarditis/Pericarditis section, which is based on case-level review. With the latter process, additional reports
may be identified in those that are not yet classified as ‘AESI — Myocarditis/pericarditis’ or reports may be excluded
if the case information does not support the report being classified as ’AESI - Myocarditis/pericarditis’. Refer to
the Myocarditis/Pericarditis section for accurate number of myocarditis or pericarditis reports.
Data Source: CCM, COVaxON (see technical notes for details on data sources)

Table A3. Mvocarditis/pericarditis crude reporting rates per million doses administered
following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to October 10, 2021

1 Age
group get/Niler: A" A"
gender: gender:
Females: Females: Females:
All
Males:
All
Males: Males:
(years)
Ck7:5"es Dose 1 Dose 2 doses Dose 1 Dose 2 doses Dose 1 Dose 2
‘

12-17 55.0 41.3 70.0 19.3 19.8 18.8 89.8 62.1 120.0
18-24 64.9 33.0 100.1 25.5 23.7 27.6 103.9 42.2 173.3

25-29 26.6 21.5 32.1 10.8 11.6 10.0 42.2 31.3 54.2

30—39 19.7 10.7 29.3 15.8 8.3 23.8 23.9 13.4 35.3

40-49 11.2 11.7 10.7 5.3 6.9 3.8 17.8 17.2 18.4

50—59 10.7 10.1 11.3 10.9 10.2 11.5 10.5 9.9 11.1
60-69 6.7 5.2 8.2 4.0 2.8 5.2 9.7 7.8 11.5

70-79 6.7 5.8 7.7 4.5 5.5 3.6 9.3 6.2 12.4

80+ 32 1.6 5.1 1.3 0.0 2.9 6.0 4.1 8.4

Total 20.9 14.7 27.3 10.6 9.5 11.8 32.2 20.5 44.1
Note: Includes all reports of myocarditis or pericarditis identified through case-level review (n=438), regardless of
the reports meeting the Brighton Collaboration case definition for myocarditis or pericarditis.
Data Source: CCM, COVaxon (see technical notes for details on data sources)

Adverse Events Following Immunization (AEFIs) for COVID»19 in Ontario 25

 133

Citation
Ontario Agency for Health Protection and Promotion (Public Health Ontario). Weekly summary: adverse
events following immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to October 10, 2021.
Toronto, ON: Queen’s Printer for Ontario; 2021.

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Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 26

 134
Articles

Vaccine side-effects and SARS-CoV-Z infection after @‘i ®

vaccination in users of the COVID Symptom Study app
CrossMark

in the UK: a prospective observational study

Cristina Menni‘, Kerstin Klaser*, Anna May, Lorenzo Polidori,joan Capdevila, Panayiotis Louca, Carole H Sudre, Long H Nguyen, David A Drew,
jordi Merino, Christina Hu, Somesh Selvachandran, Michela Antonelli, Benjamin Murray, Liane S Canas, Erika Molteni, Mark S Graham,
Marc Modat, Amit Djoshi, Massimo Mangino, Alexander Hammers, Anna L Goodman, Andrew T Chan,jonathan Wolf, Claire) Steves,
Ana M Valdes, Sebastien Ourselin, Tim D Spector

Summary
Background The Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdel nCoV-19) COVID-19 vaccines Lancet Infect Dis 2021;
have shown excellent safety and efficacy in phase 3 trials. We aimed to investigate the safety and effectiveness of these 21: 939-49
vaccines in a UK community setting. Published Online
April 27. 2021
https:lldoi.orgl10.1016/
Methods In this prospective observational study, we examined the proportion and probability of self-reported systemic Sun-309900002243
and local side-effects within 8 days of vaccination in individuals using the COVID Symptom Study app Who See Comment page 890
received one or two doses of the BNT162b2 vaccine or one dose of the ChAdel nCoV-19 vaccine. We also compared ‘Contributed equally
infection rates in a subset of vaccinated individuals subsequently tested for SARS-CoV-Z with PCR or lateral flow tests Department ofTwin Research 8r
with infection rates in unvaccinated controls. All analyses were adjusted by age (555 years vs >55 years), sex, health-care Genetic Epidemiology
worker status (binary variable), obesity (BMI <30 kg/m2 vs 230 kg/ml), and comorbidities (binary variable, with or (C Menni PhD, P Louca MSc,
without comorbidities). M Mangino PhD, Cj Stoves PhD,
Prof A M Valdes PhD,
meT D Spector MD) and School
Findings Between Dec 8, and March 10, 2021, 627383 individuals reported being vaccinated with 655590 doses: of Biomedical Engineering&
282103 received one dose of BNT162b2, of whom 28 207 received a second dose, and 345 280 received one dose of . Imaging Sciences (K Klaser MSc,

.
ChAdel nCoV-19. Systemic side-effects were reported by 13 5% (38155 of 282 103) of individuals after the first dose C H Sudre PhD, M Antonelli PhD,
B Murray MSc, L S Canas PhD,

-
-
of BNT162b2, by 22-0% (6216 of 28 207) after the second dose of BNT162b2, and by 33 7% (116473 of 345 280) after
the first dose of ChAdel nCoV-19. Local side-effects were reported by 71 9% (150023 of 208 767) of individuals after
E Molteni PhD, M S Graham PhD,
M Modat PhD,
-
the first dose of BNT162b2, by 68 5% (9025 of 13 179) after the second dose of BNT162b2, and by 587% (104 282 of
177655) after the first dose of ChAdel nCoV-19. Systemic side-effects were more common (1- 6 times after the first
Prof A Hammers PhD,
Prof S Ourselin PhD), King's
College London, London, UK;
dose of ChAdel nCoV-19 and 2- 9 times after the first dose of BNT162b2) among individuals with previous ZOE Global, London, UK
SARS-CoV-Z infection than among those without known past infection. Local effects were similarly higher in (A May MA, L Polidori MSc,
individuals previously infected than in those without known past infection (1 -4 times after the first dose of ChAdel jCapdevila PhD, C Hu BA,
nCoV-19 and 12 times after the first dose of BNT162b2). 3106 of 103 622 vaccinated individuals and 50 340 of S Selvachandran Meng,
jWolf MA); Medical Research
464356 unvaccinated controls tested positive for SARS-CoV-Z infection. Significant reductions in infection risk were
Council Unit for Lifelong
seen starting at 12 days after the first dose, reaching 60% (95% CI 49-68) for ChAdel nCoV-19 and 69% (66—72) for Health and Ageing,
BNT162b2 at 21—44 days and 72% (63—79) for BNT162b2 after 45—59 days. Department of Population
Science and Experimental
Medicine, and Centre for
Interpretation Systemic and local side-effects after BNT162b2 and ChAdel nCoV-19 vaccination occur at frequencies Medical Image Computing,
lower than reported in phase 3 trials. Both vaccines decrease the risk of SARS-CoV-Z infection after 12 days. Department of Computer
Science, University College
London, London, UK
Funding ZOE Global, National Institute for Health Research, Chronic Disease Research Foundation, National
(C H Sudre); Clinical &
Institutes of Health, UK Medical Research Council, Wellcome Trust, UK Research and Innovation, American Translational Epidemiology
Gastroenterological Association. Unit (L H Nguyen MD,
0 A Drew PhD, A Djoshi PhD,
Prof AT Chan MD) and Division
Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0
of Gastroenterology,
license. Department of Medicine
(L H Nguyen, D A Drew, A D joshi,
Introduction )an 4, 2021, respectively.‘ In late December, 2020, based Prof AT Chan), Massachusetts
The UK's Medicines and Healthcare products Regulatory General Hospital and Harvard
on advice from the Joint Committee on Vaccination and Medical School, Boston, MA,
Agency has given emergency use authorisation to Immunisation,2 the UK Government decided to delay the USA; Diabetes Unit and Center
three COVID-19 vaccines: the Pfizer-BioNTech mRNA administration of second doses. for Genomic Medicine,
vaccine (BNT162b2), the Oxford-AstraZeneca adenovirus- Phase 3 trials reported the BNT162b2 vaccine to have Massachusetts General
Hospital, Boston, MA, USA
vectored vaccine (ChAdel nCoV-19), and the Moderna an efficacy of 52% at 12 days after the first dose and (J Merino PhD),- Department of
mRNA vaccine (mRNA-1273). The first two vaccines have of 95% after the second dose if administered 3-4 weeks Medicine, Harvard Medical
been rolled out across the UK since Dec 8, 2020, and apart in participants without previous SARS-CoV-Z

www.thelancet.com/infection Vol 21 july2021 939

 135
Articles

School, Boston, MA, USA

(J Merino); Program in Medical ; Research in context
and Population Genetics, Broad
Reported Side-effects were minor in severity andofshort
I-Evidence’ beforethis study
'

Institute, Cambridge, MA, USA ,

(I Merino); National Institute ’ We searched PubMed for‘ articles published uptoMarch 10,2021, , duration. Headache and fatigue were more common in women '

for Health Research (NIHR) usIngtheterms("BNT162b2“ ORmRNACowd-19Vachne OR than in men, in people aged 55 years or younger than in people
'

Biomedical Research Centre at

Guy's and StThomas'
'
“ChAde1nCoV-19"OR adenovrms-vectoredCovrd—19 older than 7'55 years, and afterthe second than after the'firSt
FoundationTrust, London, UK
1'
vacone") AND (”effectiveness 0Rreinfection OR "side-effects" close. Individuals with known past SARS-COV-Zinfection‘were
(M Mangino); Nottingham OR "adverseeffectsf' OR reactogenICIty"OR phase IV")We did more likely to have adverseeffects afterthe first dose than were
NIHR Biomedical Research
f3 not restnctoursearch by language ortype ofpublication. Besides those without known past infection; We found, in a community
Centre at the School of
the original phase 1—3trials,we found one published article and "setting,that self-reported infection rates of those vaccinated
‘
’

Medicine, University of
Nottingham, Nottingham City two preprints on data from Israel investigatingthe effectiveness With the BNT162b2 or ChAd0x1 nCoV-19 vaccines were
Hospital, Nottingham, UK ofthe Pfizer-BIoNTechvaccine (BNT162b2),a preprint from the significantly lower than infection ratesIn UnVacc'inated
(Prof A M Valdes); Department
of Infection, Guy's and
1 UK
exploringthe effectiveness _of both the BNT162b2.and V. . controls.Dotumented infection rates' our app after a single
In
Oxford-AstraZeneca (ChAd0x1 nCoV-19) vaccines inindividuals vaccine dose decreased by 58% (95%CI 54-62) at 12-20 days,.
‘

StThomas' FoundationTrust, ,

StThomas Hospital, London,

'
aged 70years orolder'In the community,and a studythat linked 169%(66472) at 2144days, and 72% (63-79) after 45—59 days
UK (A LGoodman DPhiI) 3 health records
for all vaccinated people"InScotlandto investigate followingBNT162b2, and 39%(21.-53)at 12'-20 daysand
‘

Correspondence to: 3 COVID-19 hosprtaIIsatIon and mortalityaftervaccinatron 60%(49-68)at 21—44 days following ChAde‘l nCoV-19‘,
,

DrCristina Menni, Department f Nostudy investigated the prevalenceof adverse

effects of the compared with Unvaccinated controls.‘
' g

vaccines to
ofTwin Research 8. Genetic
vaccines and all studies
reportedboth highly
be
all
-Implications of the available evidence
‘

Epidemiology, King's College

effective
'
I

.7

are
London, London SE1 7EH, UK
cristIna.menni@|Icl.ac.uII
. Localisedand systemicside-afiects after vaccination less
Added value study
of thIs ":5 (commOn in a real-Warld community setting than reportedIn
7

we
.
In thislargeprospectiveobservational study, assessed phase 3trials, mostly minor in severity, and self-limiting.
‘

Our data Will

,
enable
prediction of side-effects based onage,
at the time ofertIn'(BNT162b2
and ChAde1 nCoV-19), as sex} and paSt COVID419
status tothehelppopulation
update gUIdanceto
‘

as one doSe artwo reassure

,

well self-reportedInfectIon rates followmg

doses of BNT162b2 and onedose ofChAde1nCoV-19
:3 ’1 ’7healthprofessionalsto
7

safety of vaccines. about the

.
»

infection.’ The effectiveness of this vaccine in reducing March, 2021, and reported symptoms in real-time via the
infection, severe disease, hospitalisation, and death with COVID Symptom Study app." A subset of individuals also
COVID-19 has been reported for the whole of Israel,‘ reported receiving a PCR or lateral flow test.
with reanalysis of the data from Israel revealing it to be
90% effective 2 weeks after the first dose.5 The ChAdel Methods
nCoV-19 trial found efficacy against symptomatic disease Study design and participants
of 76% at 22—90 days after at least one standard dose.“ The COVID Symptom Study app“ was developed by
Surveillance in the general population is necessary at health data company ZOE Global, with input from
this stage during vaccination rollout.’ The OpenSAFELY King’s College London (London, UK), the Massachusetts
collaboration” implemented a framework for monitoring General Hospital (Boston, MA, USA), Lund University
vaccine rollout and coverage in the UK via record linkage, (Lund, Sweden), and Uppsala University (Uppsala,
Public Health England has reported early data on Sweden). In the UK, it was launched in English
effectiveness in the older population prioritised for on March 24, 2020. The app enables self-reported
vaccination,“ and a prospective observational study information related to SARS-CoV-Z infection to be
investigated the association between the rollout of the captured. Individuals older than 18 years can sign up to
first vaccine dose and COVID-19 hospital admission in the app without any restrictions. Individuals can
Scotland.12 Other surveys, such as the SIREN study"in also record information for dependents younger than
health-care workers, will also link directly to health 18 years. Use of the app was driven by referrals or word
records to assess the real-life effectiveness and safety of of mouth, the media, and eventually partnerships with
the various phases of vaccine rollout. However, it takes charities and the Welsh and Scottish Governments." On
time for such studies to come to fruition. Real-time data first use, the app records self-reported location, age, and
from app users can provide a faster view of the safety and core health risk factors (body-mass index [BMI], smoking
effectiveness of COVID-19 vaccines. status, race or ethnicity, and presence of comorbidities,
The aim of this study was to investigate the adverse effects including cancer, diabetes, eczema, heart disease, lung
and infection rate of vaccinated people in a community disease, kidney disease, and hay fever), as well as
(general population app users) scenario. We used data employment status, such as being a health-care worker.
from 627 383 individuals who received the BNT162b2 or With continued use. participants provide daily updates
ChAdel nCoV-19 vaccines between December, 2020, and on symptoms experienced, SARS-CoV-Z test results

940 www.theIancet.com/infection Vol 21 july 2021

 136

Articles

(negative, pending, or positive), vaccines administered, The occurrence of adverse effects was studied for both
and whether they are self-quarantining or seeking health BNT162b2 doses and the first ChAdel nCoV-l9 dose.
care, including the level of intervention and related We compared the probability of having adverse effects
outcomes. Individuals without symptoms are encouraged between the first and second BNT162b2 doses, the first
to report through the app every day. Through direct BNT162b2 and the first ChAdel nCoV-19 doses, and the
updates to the app, new or modified questions are added second BNT162b2 and the first ChAdel nCoV-19 doses.
in real time to capture data to test emerging hypotheses As different people received different vaccines, we used
about COVID-19 symptoms and treatments. Pearl’s back-door adjustment" to account for differences
Versions 2.1.0—2.4.0 of the app were in use during the within the populations. Backdoor adjustments are used
study period. when there are both causal and non-causal paths between
Participants were asked if they had been vaccinated for predictors (eg, vaccine treatment (V1) and an outcome.
COVID-19 and, if so, to record the type of vaccine and Because of the observational (non-interventional) nature
date of administration. We included all UK app users of the study, the non-causal paths between outcomes
reporting having received at least one dose of the and predictors that might involve age, sex, BMI, or See Onli ne for appendix
two available vaccines (appendix p 2). Users reporting health status need to be adjusted statistically. Backdoor
vaccination were then asked daily for the following 8 days adjustment methods essentially condition on these
whether they experienced adverse effects, including both variables, cutting out the non-causal (indirect) links
systemic (whole body) and local effects. Systemic between a predictor and an outcome:
solicited side-effects included headache, fatigue, chills
and shiver, diarrhoea, fever, arthralgia, myalgia, and
nausea; solicited local side-effects included local pain,
swelling, tenderness, redness, itch, warmth, and swollen
armpit glands (appendix p 6). Users were also permitted
P(R |do[V])
=2 P(Rl S,V)P(S)

to report no symptoms by leaving the box unchecked. where R is adverse effects, Sis stratum, and P(R I S,V) is
Ethical approval for use of the app for research the probability of having adverse effects in a given
purposes in the UK was obtained from King’s stratum after receiving a vaccine.
College London Ethics Committee (review reference We used the following strata: age (555 years vs
LRS-19/20-18210), and all users provided consent for >55 years), in line with stratification in the BNT162b2
non-commercial use of their data. and ChAdel nCoV-19 phase 3 trials,’ sex, health-care
worker status (binary variable), obesity (BMI <30 kg/mz
Outcomes vs 230 kg/mz). and comorbidities (binary variable,
Our primary outcome was the proportion of app users with or without comorbidities). Adjusted odds
reporting adverse effects within 8 days after vaccination ratios (0st were computed after Pearl’s back-door
and the probability of having an adverse event. Our adjustment was applied to the raw rates (see appendix
secondary outcome was infection rates in individuals after p 15 for the formula). 95% Cls for ORs were
receiving a first dose of either the BNT162b2 or ChAdel obtained by bootstrapping 50 times on the vaccinated
nCoV-19 vaccines. We did not collect information on why population.
individuals were tested, so not all tested individuals were Logistic regressions were used for each of the specified
necessarily experiencing COVID-19-associated symptoms strata to investigate whether adverse effects varied
at testing, and some individuals might have been routinely across different participant groups, and in individuals
tested while being asymptomatic. who had previously reported a positive test for COVID-19
(PCR or lateral flow positive at least 6 months before
Statistical analysis vaccination, PCR or lateral flow positive within the
We used x1 and Student’s t tests to compare the
demographic characteristics of individuals who received
6 months before vaccination, and no previously detected
infection).
BNT162b2 versus those who received ChAdel nCoV-19. Finally, in a subanalysis of vaccinated participants who
We investigated the evolution of systemic and local reported having had the first dose of the BNT162b2
adverse effects within 8 days from the vaccination vaccine or one dose of the ChAdel nCoV-19 vaccine and
date, computing the percentage of users experiencing were then subsequently tested for SARS-CoV-Z infection,
side-effects after having received the vaccine. Vaccinated we investigated the change in infection rates after the
individuals who logged their systemic or local effects (or first vaccine dose. We compared the outcomes of PCR or
the absence of them) at least once within 8 days from the lateral flow tests in individuals who had been vaccinated
vaccination date were included in the adverse effects with the first dose with those of unvaccinated individuals
analysis (appendix p 2). We estimated the ratio of the who reported having a COVID-19 test in the same week
daily number of users reporting at least one adverse as a vaccinated app user. We computed the difference in
effect (systemic or local) after vaccination to the total days between when participants had the vaccine and
number of vaccinated users logging into the app that day. when they were tested, and we used this metric to group

www.the|ancet.comlinfection Vol 21 july2021 941

 137

BNTiszhz ChAdel nCoV~19

Firstdose (N=282103) Second dose (N=28 107) Firstdose(N=345 280)

Sex‘
Female 173866 (616%) 1964o(69-6%) 19926967719
Male 108 237 (384%) 8567 (so-4%) 146011(41-3%)
AeeryearS’t 620(14-3); 64(54772) 61 0(17 3); 59(4976) 633 (11.5),» 65 (59771)
Body-mass index, kg/m’t 26-8 (5-5) 26-5 (5-3) 26-8 (5-3) (

‘
Health-care workers“ 31996(11-3%) 8828(31-3%) 9746 (18%)
Comorbidities“ 77 433 (174%) 7617 (270%) 88 453 (256%)
PreviousCOVlD-lS’ 14369 (5 1%) 2251(8 0%) 14231(4-1%)

ll
Systemic side-effects
Any 33155 (13.5%) 6216 (22.0%) 116473 (337%)
Headache 21910 (78%) 3731 (137%) 78734 (218%) l
Fatigue 23 674 (84%) 4064 (144%) 72924 (211%) (

(hills and shiver 7166 (25%) 1812 (64%) 50761 (147%)

Diarrhoea 3885 (14%) 416 (15%) 7546 (2.2%)
Fever 4236 (15%) 1076 (318%) 28268 (81%)
l
Arthralgia 9021 (32%) 1978 (70%) 39 648 (115%)
Myalgia 6479 (13%) 1415 (510%) 24 274 (70%)
Nausea 5926 (11%) 981(3~5%) 19 509 (517%)
Lotal side-effettSS
Any 150023 (719%) 9025 (615%) 104252 (58 7%)
Pain 61 016 (291%) 4515 (34 3%) 33 939(19-1%)
Swelling 13 264 (64%) 1285 (9 8%) 9769 (55%)
Tenderness 11943167204) 6705 (SO-9%) 87 609 (AB-3%)
itch 6242 (30%) 840 (6 4%) 6934 (19%)
Swollen armpitglands 2178 (1 1%) s49 (xi-2%) 1994 (1.1%)
Redness 7891 (3 8%) 953 (71%) 7431 (xi-2%)
Warmth 14 014 (67%) 1245 (9 4%) 14 033 (79%)
Bruising 1872 (o 9%) 64 ((3.5%) 4269 (14%)
Allergic reactions
Rash 682 (0.2%) 103 (0 4%) 1432 (04%)
Skin burning 2075 (07%) 324 (11%) 5940 (17%)
Red welt: on face and lips 469 (01%) 59 (012%) 846 (02%)
Data are n (7.), unless otherwise lndKaled, 'p<O-OS for the difference between the first dose of BNT162b2 and the first dose at ChAdOKl nCoV»15 (Student's ttest for
continuous variables and X’ test for categorical variables). than are mean (51)); median (IoR). tData are mean (so). SDenominalors are 203767 iorthe first BNT162b2 dose,
1317960rthe second BNT162hz dose, and 177655 furthe first (hAdel nCoV~19 dose.

Table: Demographic characteristics orthe study population

users. lfa person reported more than one PCR test or collection period,'7 we also included incidence as a
lateral flow result after being vaccinated, we selected the covariate in the Poisson regression model, with incidence
positive test, or if none were positive, the latest negative calculated as previously described.“ We defined the
test. Since the BNT162b2 phase 3 trial showed a decrease adjusted infection risk reduction (RR) as follows:
in infections from 12 days after vaccination,‘ we analysed
infection rates at 0—4, 5—11, 12—20, 21—44, and 45—59 days RR = risk ratio”, —1
after vaccination. For each of the vaccines and for
different timepoints from the vaccination date, we used where i is BNT162b2 or ChAdel nCoV—19 vaccine, 7) is
Poisson regressions to model the rates of positive tests the number of days since vaccination (0—4, 5—11, 12—20,
in vaccinated individuals compared with those in the 21—44, 45—59), and the risk ratio is the coefficient of the
unvaccinated population, adjusting for the number of vaccine status variables in the Poisson regression model.
tests. This model allowed us to control for the number of We further tested the role of covariates in risk of
follow-up days for each group. Moreover, as there was a infection after vaccination by running stratified Poisson
two-times increase in daily incidence in England followed models (adjusted for confounders). For this analysis, we
by a decrease of 3 similar proportion during the data. considered all app responders who were vaccinated with

942 www.melanretrom/infectlon Vol 11 july 2021

 138
Articles

BNT162b2 or ChAdel nCoV-19 vaccines at least 12 days

before having a test for SARS-CoV-Z positivity. Due to a
relatively small sample size in some of the strata, we did Systemic adverse effect - -
— Headache
not differentiate between vaccine types but pooled all
———— Fever

—-—
vaccinated contributors. Fatigue
2°_ Chillsor shivers
Data were extracted and preprocessed using ExeTera Nausea
version 0.3.2,‘9 a Python library developed at King’s — Diarrhoea
College London, and we did statistical analysis using — Unusual muscle pains
— Unusualjoint pains
Python version 3.7 (pandas, NumPy, and SciPy). 15-

Role of the funding source

ZOE Global developed the app for data collection as a 10-
not-for—profit endeavour. The funder had no role in study
design, data analysis, data interpretation, or writing of
the report.
stneoivrpP
) 6 9(
advers ytmic with
Results
Between Dec 8, 2020, and March 10, 2021, 655 590 vaccine
doses were logged in the app in the UK, corresponding to
282103 individuals (aged 16—99 years) who reported D E
having received the first dose of the BNT162b2 vaccine,
of whom 28207 reported having had both doses of the
50' Local adverse
effect
-
BNT162b2 vaccine (a median of 41 days [lQR 21—63]
apart), and 345 280 individuals who reported having had 50' f)‘
j —-— Redness
.4
Pain
..
—
l ‘( — Swelling \
the first dose of ChAdel nCoV-19. Participants joined [r ‘ Swollen armpit 3' \
the COVID Symptom Study app 3 mean of 288 days . .glands
(SD 96) before being vaccinated. Users started logging
40- i \ —-( Warmth '
: \
i

adverse effects reports 0-79 days (SD 1-2) after they had
j l — Itch
j l
l,
———- Bruising
Tenderness
the vaccine. 1607620 users were active in the app during 30"
:
—
the study period (logged at least an assessment since
Dec 8), which represents 2-4% of the UK population. I
ll
The mean age of app users was 50 6 years (SD 19 . 2), and
-
77683 (48%) of them were health-care workers.
Users who reported receiving a BNT162b2 vaccine were
10- "
(96)

slightly younger, had more comorbidities, and were more

Proptin adves nt withloca

frequently female than users who reported receiving a

ChAdel nCoV-l‘) inoculation (table). Moreover, health- I l l
I -’fi—r4r—r—rfi-r-
care workers were more likely to receive a BNT162b2 0 1 2 3 4 5 6 7 0 1 2 3 4567 t)
1 2 3 4 S 6 7
Time since vaccination (days) Time since vaccination (days) Time since vaccination (days)
vaccine than ChAdel nCoV-19 (appendix p 8). The age
distribution of the included individuals is presented in the Figure 1:Proportion of participants self-reporting adverse effects to the COVID Symptom Study app within
appendix (p 3). 8 days after vaccination
The top row shows systemic effects and the bottom row shows local effects within 8 days after receipt of the first
Among vaccinated app users, 159101 (ZS-4%)
dose (A, D) or seconddose (8, E) of the BNT162b2 vaccine or the first dose of the ChAdel nCoV-19 vaccine
of 627 383 indicated having one or more systemic adverse (C, F). Shading indicates 95% Cls.
effect, and 257209 (66-2%) of 388430 reported one or
more local adverse effect (table). The most commonly
reported systemic side-effects were fatigue and headache assessed the association between symptom reporting
overall (table) and by strata (appendix p 9). These were and socioeconomic status measured as index of multiple
most frequently reported within the first 24 h after deprivation,” and we found a modest association (120.021
vaccination and lasted a mean of 101 days (SD 0-1; [95% CI 0-019—0-025]), corresponding to 0-04% of the
figure 1). Tenderness and local pain around the injection variance in symptoms reporting.
site were the most frequently reported local effects (table), In the 28207 individuals who reported having
occurring most often on the day after injection and lasting two BNT162b2 doses, 3325 (ll-7%) reported at least
a mean of 1-02 days (SD 0-15; figure 1). Other side-effects. one systemic effect after the first dose compared
including allergic skin reactions such as skin burning, with 6216 (22.0%) after the second dose (p<0.0001;
rashes, and red welts on the lips and face, were reported by figure 2). When comparing systemic effects after one
10 860 (1-7%) of 627 383 users across both types of vaccine dose of each vaccine, reactogenicity was significantly
(table; appendir p 9). In an exploratory analysis, we higher in individuals who had one dose of the ChAdel

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16733 (20-7%) of 80 879 people aged 55 years or younger

nIN reported at least one systemic efi'ect compared with
Systemic effects 21422 (10-6%) of 201224 people older than 55 years
BNT162b2 second dose vs 6216/28 207 G 243 (206-249)
(OR 2-19 [95% Cl 2-14-2-24]; p<0-0001). For ChAdel
BNT162b2 first dose 38 155/282 103 nCoV-19, 30487 (46-9%) of 65 034 people aged 55 years or
ChAdel nCoV-19 first dose vs 116473545 280 333 (319-337)
younger reported at least one systemic effect after the
9 first dose compared with 85 986 (307%) of 280243 older
BNT162b2 first dose 38 155/282 103
than 55 years (1-99 [1-96—2-03]; p<0-0001). Women
were more likely to report adverse effects than men
ChAdel nCoV-19 first dose vs
BNT162b2 second dose
116473/345 280
e 1'94(1'38-2-00)
(28 140 [16.2%] of173 866 vs 10015 [9.3%] of 108237 after
6216/28 207
the first dose of BNT162b2, OR 1-89 [95% Cl 1-85—1-94],
r—r——r—r—r—r—I—r- p<o.0001; 78222 [39.3%] of 199269 vs 38251 [262%]
1-5 2-0 2-5 3-0 3-5 4-0
0 0-5 1-0
OR (95% cu) of 146011 after the first dose of ChAdel nCoV-19, 1-82
[1-79~1-8S], p<0-0001). Although there were some
nIN differences between strata of BMI and co-morbidities,
Local effects
there was no clear trend across vaccines and doses
BNT162b2 second dose vs 9025/13 179 El 0-35 (ll-834137) (figure 3).
BNT162b2 first dose 150023/208 767 We observed the same trend for local effects as for
systemic effects, whereby app users aged 55 years or
ChAdeI nCoV-19 first dose vs 104 282/177 655 E] 0-72 (0-71-0-73) younger reported more localside-effects than participants
BNT162b2 first dose 150 023/208 767 older than 55 years (figure 3), and women were more
likely to report local side-effects than men (figure 3;
ChAdel nCoV-19 first dose vs 104 282/177 655 El 0-91 (0-89-0-93) appendix p 11). Similar levels of side-effects were seen
BNT162b2 second dose 9025/13 179
r—I— fi—w-fi—r—wfl
regardless of the levels of completeness of reporting by
0 0-5 1-0 1-5 2-0 2-5 30 35 ‘10 app users (appendix p 12).
OR (95% (I) Given preliminary evidence from small studies""’
suggesting that reactogenicity is higher among indi-
Figure 2:Comparison of adverse effects self-reported to the COVID Symptom Study app between vaccine viduals previously infected with SARS-CoV-Z, we investi-
types and doses
ORs for comparisons of the first or seconddoses of BNT162b2 versus the first dose of ChAdel nCoV-19 were
gated the extent to which previous SARS-CoV-Z infection
adjusted using Pearl's back-door method." ORaodds ratio. (based on self-reported previous positive PCR or lateral
flow result) was associated with reports of adverse effects.
Individuals vaccinated with a single dose of BNT162b2
nCoV-19 vaccine than in those who had one dose of the were more likely to report systemic effects if they had a
BNT162b2 vaccine (116 473 [33-7%] of 345 280 compared previous SARS-CoV-Z positive test than were those
with 38 155 [13- 5%] of 282 103; adjusted p<0-0001). without known past infection (5148 [35 8%] of 14369 vs
By contrast, local effects were less commonly reported 33 007 [12.3%] of 267734; OR 397 [95% c1 3-83—4-12],
after the second dose than after the first dose of p<0-0001). A similar effect was seen for ChAdel
BNT162b2 (9025 [68.5%] of 13179 vs 150023 [71.9%] nCoV—19 first dose inoculation (7551 [53 1%]of 14231with
of 208767; p<0-0001). Moreover, local effects were less past infection vs 108922 [329%] of 331049 without
-
commonly reported after the first ChAdel nCoV-19 past infection; 2-31 [2-23—2-38], p<0-0001; figure 3)
injection (104282 [58-7%] of 177655) than after the first and BNT162b2 second dose inoculation (859 [38-2%] of
BNT162b2 injection (adjusted p<0- 0001; figure 2). 2251 vs 5357 [20-6%] of 25956; 2-37 [2-17—2o60].
When comparing the second BNT162b2 dose with the p<0«0001). Local effects were similarly higher in
first ChAdel nCoV-19 dose, we found that systemic individuals previously infected than in those without
effects occurred more frequently after the first ChAdel known past infection for both vaccines (figure 3). No
nCoV-19 dose than after the second BNT162b2 dose consistent difference in occurrence of systemic or local
(adjusted p<0o0001; figure 2), whereas local effects were adverse effects was observed between individuals who
less likely to appear after the first ChAdel nCoV-19 reported a positive test result within the past 6 months
injection than after the second BNT162b2 dose (adjusted and those who reported they received a posifive test
p<0~0001; figure 2). result at least 6 months ago (figure 3).
We then tested whether adverse effects varied across We also investigated infection rates after the first
individuals’ characteristics, such as age and BMI groups, vaccine dose in a subset of 67 293 app users who received
sex, and health status. The proportion of participants BNT162b2 and 36 329 who received ChAdel nCoV-19 in
who reported at least one systemic effect after the the study period and logged at least one PCR or lateral
first dose was significantly higher among people aged flow test after vaccination. We compared the test results
55 years or younger than among those older than 55 years of this population with those of 464 356 unvaccinated app
for both vaccines. After the first dose of BNT162b2, users who had a PCR or lateral flow test result between

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A amszbz first dose B BNT162b2 first dose

Sex
Female
Male
Age
:55years
>55years
BMI
<30 kg/m'
230 kglm'
Comorbidities
Yes
No
Past SARS-CoV-Z infection

Timing of past SARS-(oV-Z infection

56 months ago
>6 months ago

o'3
I I I I
0'2 0'5 0 0-25 0-50
0

Proportion with adverse effect (95% Cl)

H-

Proportion with adverse effect (95% CI)

C BNT162h2second dose BNT162b2second dose

Sex
Female
Male
Age
555 years
>55years
BMI
<30 kg/m’
:30 kg/m’
Comorbidities

Past SARS-CoV-Z infection

Yes
No
Timing of past SARS-(ova infection
56 months ago
>6 months ago

:
I
I 0-4
l
0-5
l 0
0-2 03
025 0-50
Proportion with adverse effect (95% Cl) Proportion with adverse effect (95% Cl)

E (hAde‘l nCoV—19 first dose F ChAdel nCoV-19 first dose

—

Age
s55 years
>55years
BMI
<30 kg/m'
230 kg/m’
Comorbidities
Yes
No
Past SARS-CoV-Z infection
m.“
.- z.--~.-v, -,—_. . r
m
- ».-
' twvrmc at
wm
Yes
No
Timing of past SARS-CoV-z infection
56 months ago
>6 months ago

o-'4
I

02 0:3 (I) O'IZS 03.50

Proportion with adverse effect (95% Cl) Proportion with adverse effect (95% Cl)

Figure3:Adverse effects self-reported to the COVID Symptom Study app after COVID-19 vaccination, stratified by sex, age, BMl, health status, and previous SARS-CoV-Z test status
Proportions with systemic adverse effects (A, C, E) and local adverse effects (8, D, F) are shown. Error bars represent 95% Cls. Numbers in each strata are reported in the appendix (pp 13-14).
BMI=body-mass index. ‘p<O-01.fp<0805.

)an 4, and March 10, 2021 (appendix pp 4, 8). 3106 of the time of the vaccination than unvaccinated participants
103622 vaccinated individuals and 50340 of 464356 (RR for BNT162b2 -64% [95% CI —69 to -59]; RR for
unvaccinated controls tested positive for SARS-CoV-Z ChAdel nCoV-19 —52% [95% c1 -65 to _341). We
infection. As UK guidelines stipulate that individuals observed that 5—11 days after vaccination, the infection
need to be free of symptoms to be vaccinated, we found rates in the vaccinated group were only slightly below
vaccinated participants to have a lower infection risk at those of the unvaccinated group (figure 4), whereas

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after one dose of ChAdel nCoV—19 compared with

BNTiGlbl
unvaccinated controls was —60% (95% Cl —68 to —49) at
21—44 days after vaccination.
Finally, we tested the role of covariates in risk of
infection after vaccination. We observed a larger risk
reduction in vaccinated participants aged 55 years or
younger (RR -70% [95% Cl —72 to —68) than in those
older than 55 years (—61% {—64 to -57]). Similarly,
individuals without comorbidities had a larger risk
reduction (—69% {—71 to —68]) than those with at least
one comorbidity (—54% {—59 to —48]). Borderline
differences were observed for BMI (RR for BMI
<30 kg/m2 —69% [95% Cl —71 to -67]; RR for EM]
230 kg/mz —63% {—67 to —S9)) and sex (RR for female
risk (st)

—69% [95% Cl —71 to —67]; RR for male —61% {—66 to

reduction If

~57]; appendix p 5).

Discussion
In this large-scale,community-based study in the UK, we
have investigated adverse effects and infection rates
(hAdel "(OVAIB following administration of the two COVID-19 vaccines
that are in use in the UK. The overall mean age of the
vaccinated app users was higher than that of the general
.10
_ population (40- 3 years)“ yet was lower than those of the
samples within other UK COVID-19 effectiveness
.10- studies,‘U2 largely because of the presence of a small
proportion of health-careworkers among the participants
.30.. of this study. However, our study population was
considerably older than the study populations of the
.40 _ phase 3 irials.W We found that systemic adverse effects,
including headache and fatigue, affected fewer than
.50 _ one in four people and were less common in the

n oi t c u d e r
community than expected from clinical trials. For
_ example, in phase 3 clinical trials of the BNT162b2
risk (is)

.50
vaccine,’ the most common events after the first dose
Infectio

.70 _ were injectionsite pain 01—83%), fatigue (34—47%). and

headache (ZS—42%). However, in our community
analysis, less than 30% of users complained of injection-
0-4 days 5—11 days 12-20days 21-44 days 44—59 days site pain and less than 25% of fatigue and headache after
Tlme since vaccination (days) the first dose. Although side-effects were significantly
Figure4: Infection rlsk reduction afterthe rm dose in app users who have been vaccinated and subsequently
more prevalent in women than in men, in people aged
tested, as a function of days since vaccination 55 years or younger than in those older than 55 years,
The bar chart represents the risk reduction for infection of the vaccinated groups (those who logged at least and after the second than after the first dose, they
one PCR or lateral flow test result after vaccination) compared with the unvaccinated group, by vaccine type and occurred at much lower frequencies than expected from
days since vaccination. The black lines Show 95% (Is.
the published literature For instance, whereas 51—59% of
participants reported fatigue after the second BNT162b2
12-20 days after vaccination, infection risk in the dose in the phase 3 trial of that vaccine,’ fatigue was
vaccinated group was significantly lower than in the reported by less than 15% of participants after the
unvaccinated group (RR for BNT162b2 -58% [95% CI second dose in our study. Additionally, our data provide
—62 to —54]; RR for ChAdel nCoV-19 —39% [95% CI evidence from the community to support early reports of
—53 to —21]), after adjusting for population differences in higher frequency of side-effects in younger than in older
the vaccinated groups using Poisson regressions. We individuals."7
observed a further reduction in infection risk after one Similarly, rates of side-effects following the ChAdel
dose of the BNT162b2 vaccine when compared with nCoV—19 vaccine were lower than expected.7 The
unvaccinated controls at 21—44 days after vaccination phase 2—3 trial of the ChAdel nCoV-19 vaccine7 reported
(RR —69% [95% c1 —72 to —66]) and at 45—59 days systemic adverse effects in 88% of participants aged
after vaccination (7.72% [779 to 763]; figure 4). The RR 18—55 years who received the first injection, whereas we

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found a lower rate of 33.7% after the first dose in symptoms than others, and there is the potential for
the overall sample and 46-9% in individuals aged users to drop out of reporting in the app. Participants
18—55 years (data not shown). Individuals vaccinated using the app were a self-selected group and not
with the ChAdel nCoV-19 vaccine were more likely to representative of the general population, as has been
experience systemic side-effects than those who had observed in other digital platform studies.” Users of a
been given the BNT162b2 vaccine, but in our study participatory platform (as well as participants in all
89% of respondents who logged at least one systemic voluntary studies, including clinical trials) are likely
effect after the ChAdel nCoV-19 vaccine did not report to be more interested in health, and might behave
any systemic effects after 3 days, and 983% did not differently to the general population as a result. Previous
report any after 1week. work has shown that data from our app is able to produce
Individuals with evidence of past SARS-CoV-Z infection estimates of population-level disease prevalence that
were also more likely to have adverse effects than those agree well with surveys with random, representative
without evidence of past infection with both vaccines. It designs,1m suggesting that behavioural issues are not
is possible, although it remains to be tested, that this substantially biasing our app population. As with other
increased reactogenicity relates to increased immuno- studies examining COVID-19 vaccine effects in the
genicity. It has been shown that vaccines have increased general community, our data are limited by the vaccine
immunogenicity in individuals with past infection and rollout’s focus on health-care workers, elderly people,
these people have higher antibody titres than those and people who are clinically vulnerable.’ Moreover, our
without previous infection?“25 results might havebeen affected by collider bias (ie,when
We observed an infection risk reduction at 21—44 days a risk factor and an outcome both affect the likelihood of
after vaccination in all vaccinated users compared with being sampled)” if both vaccination status and COVID
unvaccinated controls (RR was —69% [95% Cl —72 to -66] positivity influenced the probability of participation
for BNT162b2 and -60% {—68 to -49] for ChAdel in the app. However, given that strong reductions in
nCoV-19). The reduction of infection was lower in COVID hospitalisations after vaccination were observed
individuals older than 55 years than those aged 55 years in nationwide studies in Scotland12 and England,“ we
or younger, in those with one or more comorbidities than believe that collider bias is unlikely to underlie the
in those without comorbidities, and in individuals with a reduction in infections seen in our data. Recipients of the
BMI of 30 kg/m2 or higher than in those with a BMI of ChAdel nCoV-19 vaccine might differ from recipients
less than 30 kg/m2 (appendix p 5). A preprint based on of the BNT162b2 vaccine by age or dependency. Although
data from Israel suggested that a single dose of BNT162b2 we adjusted for population differences across the
might not provide enough protection;26 however, a BNT162b2, ChAdel nCoV-19, and unvaccinated control
re-analysis of the same dataset indicated that after groups, our estimates of infection rates after vaccination
14 days the effectiveness of a single dose of vaccine was might not have fully adjusted for case-mix and therefore
about 90%.5 Although our data, due to their observational are preliminary. Furthermore, because the ChAdel
nature, does not allow us to comment directly on nCoV-19 vaccine started being rolled out in Ianuary, 2021,
effectiveness, the observed decrease of infection over and the second dose is to be administered at 12weeks, no
time seems to be in line with efficacy reported in app users had received two doses of ChAdel nCoV-19 at
the BNT162b2 phase 3 trial’ and supports the UK the time of this report. The completeness of reporting
Government’s decision to delay the timing of the second was higher for systemic effects than for local effects,
injection to 12 weeks to maximise the number of people which might have introduced some bias (appendix p 12).
receiving at least one dose. Long-term surveillance for Some severe side-effects might have been missed if app
SARS-CoV-Z protection in individuals who have received users experiencing them were unable to use the app to
delayed second doses of BNT162b2 compared with those report side-effects. However, we saw substantially lower
receiving second doses according to initial guidelines rates of severe and mild side-effects than observed in
(ie, 21 days after the first dose) will be required to phase 3 trials, making the missing of severe side-effects
determine whether these initial protection estimates an unlikely explanation for the lower prevalence of side-
persist. effects seen in our data. Furthermore, we cannot rule out
Strengths of our study include its large sample size; the presence of selection bias in who was tested after
capture of data on SARS-CoV-Z RT-PCR or lateral flow vaccination, as we know that health-care workers are
test results, regardless of symptoms; the prospective real- tested more frequently than people in the general
time capture of information on symptoms; and the population, even if they are asymptomatic. This is an
availability of both BNT162b2 and ChAdel nCoV-19 observational study, with data captured during a specific
vaccines in the UK, which allowed cross-vaccine timeframe, and our study design does not allow an
comparison. Our study also has several limitations. We inference of causality. Also, we evaluated only short-term
used self-reported data, which can introduce information adverse effects, and long-term surveillance in the general
bias, including misclassification, or effect bias exposure. population will be required to investigate possible future
Also, some participants might be more likely to report effects. Finally, the systemic side-effects were collected

www.thelancet.com/infection Voi21 July 2021 947

 143

from daily reports within 1 week from the injection date, Engineering and Physical Sciences Research Council (EPSRC) Centre for
Medical Engineering (W'I'203148/Z/16/Z) and the Wellcome Flagship
so we cannot rule out that these effects might not be
vaccine related. We also had insufficient power to assess Programme (WI'213038/Z/18/Z). CM is funded by the CDRF and the
MRC AIMHY project grant. CHS is an Alzheimer's Society junior fellow
differential rates by ethnic group. (AS-)F-IJ-OII). The School of Biomedical Engineering 8: Imaging Sciences
In conclusion, short-term adverse effects of both is supported by the Wellcome EPSRC Centre for Medical Engineering at
vaccines are moderate in frequency, mild in severity, and King's College London (WT203148/Z/16/Z) and the Department of Health
via the NIHR comprehensive Biomedical Research Centre award to Guy’s
short-lived. Adverse effects are more frequently reported and St Thomas’ NHS Foundation Trust. in partnership with King's College
in younger individuals, women, and among those who London and King’s College Hospital NHS Foundation Trust. ATC is a
previously had COVID-19. The post-vaccine symptoms Stuart and Suzanne Steele MGH Research Scholar. LHN is supported by
(both systemic and local) often last 1-2 days from the an NIH K23DK125838 award. the American Gastroenterological
Association Research Scholar Award. and the Crohn's and Colitis
injection. Our data could be used to inform people on the Foundation Career Development Award. DAD and LHN are supported by
likelihood of side-effects on the basis of their age and sex the American Gastroenterologioel Association-Takeda COVID-19 Rapid
and the type of vaccine being administered. Furthermore, Response Research Award (AGAZOZl-SIOZ). DAD is supported by
NIH/National Institute of Health Diabetes and Digestive and Kidney
our data support results from randomised controlled Diseases (K01DK120742). ATC, LHN. and DAD are supported by the
trials in a large community-based scenario showing Massachusetts Consortium on Pathogen Readiness. IM is partially
evidence of reduction in infection after 12 days and supported by the NIH (DK40561) and the Amerimn Diabetes Association
substantial protection after 3 weeks. (7-21-IDFM-005). PL is funded by the cons. AMV is funded by a um
and MRC Oovid-Rapid Response grant (MR/V027883/l). We thank all
Contributors participants. including study volunteers enrolled in cohorts within the
IW and TDS acquired funding. CM and TDS conceptualised the study. COPE consortium. We thank the staff of ZOE Global, the Department of
KK, AM. LP, and 1C analysed the data. BM and 1C curated the data. Twin Research 8: Genetic Epidemiology at King’s College London, the
PL. CHS. LHN, DAD. JM, MA. LSC. EM. MSG. MMo. AD]. MMa. AH. Clinical 8c Translational Epidemiology Unit at Massachusetts General
ATC. CIS, SO, SS, and CH contributed data and software. CM, 1C. and Hospital, and researchers and staff at Lund University in Sweden for their
TDS verified the underlying data. CM. KK. AM. LP. AMV. ALG. and TDS tireless work in contributing to the running of the study and data
wrote the first draft of the manuscript. All authors reviewed and edited collection.
revisions of the manuscript, had full access to all the data in the study,
and had final responsibility for the decision to submit for publication. References
1 Public Health England. COVID-19 vaccination programme.
Declaration of interests Nov 27. 2020. https:/[www.gov.uk/government/collections/covid-19-
CM reports grants from Chronic Disease Research Foundation (CDRF) vaccination-programme (accessed Feb 18. 2021).
during the conduct of the study. 1W, AM. LP. CH. SS. and IC report 2 Department of Health and Social Care. Priority groups for
being employees of ZOE Global during the conduct of the study. ATC coronavirus (COVID-19) vaccination: advice from the JCVI.
reports grants from Massachusetts Consortium on Pathogen Readiness 30 December 2020. Dec 30, 2020. https://www.gov.uk/govemment/
during the conduct of the study. and personal fees from Bayer Pharma. publications/priority-groups-for-coronavirus-covid~19«vaccination~
Pfizer, and Boehringer lngelheim. outside the submitted work. DAD advice-from-the—icvi-30-december-2020?utm_source-flde4cdl-935e-
reports grants from National Institutes of Health (NIH). Massachusetts 4aSe-b539-3b37cd92e598 (accessed Feb 18, 2021).
Consortium on Pathogen Readiness, and American Gastroenterological 3 Polack FP. Thomas S), Kitchin N. et al. Safety and efl'icacy of the
BNT162b2 mRNA COVID-l9 vaccine. N Engl] Med 2020:
Association. during the conduct of the study, and that he served as a
co—investigator on an unrelated nutrition trial sponsored by ZOE Global. 383: 2603-15.
CHS reports grants from Alzheimer’s Society during the conduct of the 4 Dagan N, Barda N. Kepten E. et a1. BNT162b2 mRNA COVID-19
study. AMV reports grants from Medical Research Council (M RC) and vaccine in a nationwide mass vaccination setting. N Eng!1 Med
2021; published online Feb 24. https://doi.org/10.1056/
personal fees from ZOE Global. during the conduct of the study. neimoa2101765.
ALG reports having shares in AstraZeneca and receiving grants from
5 Hunter PR. Brainard I. Estimating the effectiveness of the Pfizer
Novavax. outside the submitted work. Cls reports grants from CDRF. COVI D-19 BNT162b2 vaccine after a single dose. A reanalysis of a
MRC. and Wellcome Trust. during the conduct of the study. SO reports study of “real-world" vaccination outcomes from Israel. mcdeiv
grants from Wellcome Trust. UK Research and Innovation (UKRI), and 2021; published online Feb 3. https://doi.org/10.1101/
CDRF, during the conduct of the study. TDS reports being a consultant 2021.02.01.21250957 (preprint).
for ZOE Global, during the conduct of the study. All other authors 6 Voysey M. Clemens SAC. Madhi SA. et al. Safety and efficacy of
declare no competing interests. the ChAdel nCoV-19 vaccine (AZDIZZZ) against SARS-CoV-Z:
Data sharing an interim analysis of four randomised controlled trials in Brazil.
South Africa, and the UK. Lancet 2021; 397: 99—111.
Anonymised research data are shared with third parties via Health Data
Research UK (HDRUK.ac.uk). US investigators are encouraged to 7 Ramasamy MN. Minassian AM. Ewer K]. et a]. Safety and
immunogenicity of ChAdel nCoV-19 vaccine administered in a
coordinate data requests through the Coronavirus Pandemic prime-boost regimen in young and old adults (COVOOZ): a single~blind.
Epidemiology (COPE) consortium (www.monganinstitute.org/cope- randomised. controlled. phase 2/3 trial. Lancet 2021; 396: 1979-93.
consortium). Data updates can be found at https://covid.ioinzoe.com. 8 Voysey M. Clemens SAC. Madhi SA, et al. Single-dose
Acknowledgments administration and the influence of the timing of the booster dose
ZOE Global provided in-Idnd support for all aspects of building, running, on immunogenicity and efficacy of ChAdel nCoV-19 (AZD1222)
vaccine: a pooled analysis of four randomised trials. Lancet 2021;
and supporting the app and service to all users worldwide.
The Department of Twin Research 8: Genetic Epidemiology at King's 397: 881-91.
College London receives grant support from the Wellcome Trust 9 Public Health England. COVID-19: vaccine surveillance strategy.
(212904/2/18/2). the MRC British Heart Foundation Ancestry and Ian 11. 2021. https://www.gov.uk/government/publicatiens/covid-
19-vaccine-surveillance—strategy (accessed March 17, 2021).
Biological Informative Markers for Stratification of Hypertension (AIMHY;
MR/M016560/1). the European Union, CDRF, ZOE Global, NIH, the 10 The OpenSAFELY Collaborative, MacKenna B, Curtis H]. et al.
Trends, regional variation. and clinical characteristics of
National Institute for Health Researdt (NIHR)-funded BioResource. and COVID-19 vaccine recipients: a retrospective cohort
Clinical Research Facility and Biomedical Research Centre based at Guy's study in 23-4 million patients using OpenSAFELY.
and St Thomas’ National Health Service (NHS) Foundation Trust. in mcdeiv 2021; published online Ian 26. httpszlldoi.
partnership with King's College London. 80 is funded by the Wellcome org/10.1101[2021.01.25.21250356 (preprintl.

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26: 1037—40. BNT162b2 dose in previously SARS-CoV-Z-infected individuals.
15 Drew DA. Nguyen LH, Steves C). et al. Rapid implementation of Lancet 2021: 397: 1057—58.
mobile technology for real-time epidemiology of COVID-19. Science 26 Chodick G. Tene L. Patalon T, et al. The effectiveness of the first
2020: 368: 1362-61 dose of BNT162b2 vaccine in reducing SARS»CoV-2 infection
16 Pearl 1. Causality. Cambridge: Cambridge University Press, 2009. 13-24 days after immunization: real-world evidence. medet'v 2021:
17 Office for National Statistics. Coronavirus (COVID-19) Infection published online Ian 29. https://doi.org/10.1101/2021.01.2121250612
Survey. March 12, 2021. https://www.ons.gov.uk/ (preprint).
peoplepopulationandcommunity/healthandsocialcare/ 27 Baltrusaitis K. Santillana M, Crawley AW. Chunara R. Smolinski M.
conditionsanddiseases/datasets/ Brownstein IS. Determinants of participants’ follow-up and
coronaviruscovid19infectionsurveydata[2021 (accessed characterization of representativeness in flu near you. a participatory
March 16. 2021). disease surveillance system.jMIR Public Health Surveill 2017: 3: e18.
18 Varsavsky '1', Graham MS. Canas LS, et al. Detecting COVID-19 28 Bowyer RCE, Varsavsky '1‘. Thompson E). et al. Geo-social gradients
infection hotspots in England using largeoscale self-reported data in predicted COVID.19 prevalence in Great Britain: results from
from a mobile application: a prospective. observational study. 1960 242 users of the COVID-19 Symptoms Study app. Thorax
2020:
Lancet Public Health 2021; 6: e21-29. published online Dec 29. http://dx.doi.org/10.1136/
19 Murray B, Kerfoot E. Graham MS. et al. Accessible data curation thoraxjnl-ZOZO-215119.
and analytics for international-scale citizen science datasets. arXiv 29 Grifiith G]. Mon'is TT. Tudball M], et al. Collider bias undermines
2020; published online Nov 2. http:l/andv.org/abs/2011.00867 our understanding of COVID-19 disease risk and severity.
(preprint). Nat Commun 2020;11: 5749.
20 Ministry of Housing. Communities, and Local Government.
English indices of deprivation 2019. Sept 26. 2019. https://www.gov.
uk/govemment/statistics/english-indices-ofdeprivation-ZOE
(accessed Feb 12. 2021).

www.thelancet.com/infection Vol 21 July2021 949

 145

Brief Report
Self-Reported Real-World Safety and Reactogenicity of
COVID-19 Vaccines: A Vaccine Recipient Survey

Alexander G. Mathioudakis 1'21 , Murad Ghrew “'5, Andrew Ustianowski 5'6, Shazaad Ahmad 7, Ray Borrow 8,
Lida Pieretta Papavasileiou 9, Dimitrios Petrakis 1“ and Nawar Diar Bakerly 3'11”

Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of
Manchester, Manchester M23 9LT, UK; alexandcr.mathioudakis®manchestor.ac.uk
North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester
Academic Health Science Centre, Manchester M23 9LT, UK
Department of Respiratory Medicine, Salford Royal Hospital NHS Foundation Trust,
Manchester M6 8HD, UK; murad [email protected]
Department of Intensive Care Medicine, Salford Royal Hospital NHS Foundation Trust,
Manchester M6 SHD, UK
Faculty of Biology, Medicine 8: Health, School of Biological Sciences, The University of Manchester,
Manchester M13 9PL, UK; Andrew.Ustiarrowski®pahnhsuk
Regional Infectious Diseases Unit, North Manchester General Hospital, Manchester M8 SRB, UK
Department of Virology, Manchester Medical Microbiology Parmership, Manchester University NHS
check (or Foundation Trust, Manchester M13 9WL, UK; [email protected]
updates
Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester University NHS
Citation: Mathioudokis, AIL; Foundation Trust, Manchester Academic Health Science Centre, Manchester M13 9WL, UK;
Ghrew, M.; Ustianowski, A; Ahmad, [email protected]
5.; Borrow, it; Fapavasilciou, LP; Department of Cardiology, Hygeia Hospital, 15123 Athens, Greece; Iidapieretta®hormailcom
Allergy Clinic, Petrakis Allergy Care, 55133 Thessaloniki, Greece: [email protected]
S

Pctrakis, D.; Bakerly, ND.

Self-Reported Real-World Safety and ” School ofI' ” Sciences, " '
" Correspondence: NawanBakerly®srft.nhs.uk
Iv‘ , " 1...; c. l. ,Manchester M15 6BH, UK
Reactogenicity of COVID-19 Vaccines:

A Vaccine Recipient Survey. Li]: 2021,

Abstract: An online survey was conducted to compare the safety, tolerability and reactogenicity of
II, 249. https://doi.org/IO.339II/
available COVID-19 vaccines in different recipient groups. This survey was launched in February
lift'11030249
2021 and ran for 11 days. Recipients of a first COVID—19 vaccine dose 27 days prior to survey

Academic Editors:
completion were eligible. The incidence and severity of vaccination side effects were assessed. The
Theodoros Rampias, survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior
Apostolos Beloukas and COVID-19 infection was associated with an increased risk of any side effect (risk ratio 1.08, 95%
Pavlos Pavlidis confidence intervals (105—1.11)), fever (2.24 (1.86—2.70)), breathlessness (2.05 (128—3.29)), flu-Iike
illness (1.78 (1.51—2.10)), fatigue (1.34 (1.20—1.49» and local reactions (1.10 (1.06—1.15». It was also
Received: 24 February 2021 associated with an increased risk of severe side effects leading to hospital care (1.56 (114—2.12)).
Accepted: 16 March 2021 While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01—1.11))
Published: 17 March 2021 compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local
reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic
Publisher's Note: MDI’I stays neutral
with regard to jurisdictional claims in
reactions (RR < 0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue
published maps and institutional affil- and of side effects requiring hospital care (0.42 (031—058)). Our study confirms the findings of
recent randomised controlled trials (RCTs) demonstrating that COVID~19 vaccines are generally safe
lotions.
with limited severe side effects. For the first time, our study links prior COVIDA19 illness with an
increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder,
less frequent systemic side effects but more local reactions.

Copyright: c 2021 by the authors.

Keywords: Coronavirus Disease 2019; COVID-19; COVID-19 vaccine; safety; reactogenicity; tolera-
Licensee MDPI, Basel, Switzerland.
bility; adverse events
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https'//
creativecommons.org/llcenscs/by/
4.0/l.

Life 2021, 11, 249. https://doi.org/10.3390/lif911030249 httpsz/ /www.mdpi.com /ioumal/life

 146

Life 2021, 11, 249 20f 13

1. Introduction
Coronavirus Disease 2019 (COVID-19) rapidly became a leading cause of death and
short and long-term morbidity among people over the age of 45 [1,2], posing an un-
precedented burden to healthcare systems with worldwide economic consequences and
prolonged lockdowns [3]. Vaccines currently being rolled out are anticipated to signifi-
cantly modify these trends. While their effectiveness and safety have been proven in recent
studies [4—6], data in specific groups remain lacking. Generally, people with a previous
history of COVID-19 in whom vaccination is currently advised [7] were excluded from
the clinical trials [4—6]. Whilst it is accepted that prior infection with COVID-19 induces a
natural immunity potentially lasting for at least six months [8], it is unknown if previous
infection may be associated with a greater number of vaccination side effects. Moreover,
the safety and reactogenicity of the different types of vaccines (mRNA or viral vector-based)
have not been compared head-to-head. This anonymized online survey was conducted to
compare the safety profiles of available COVID-19 vaccines and evaluate their side effects
in different groups of vaccine recipients.

2. Materials and Methods

This online survey, developed in plain English language and piloted by experts and lay
people, captured basic epidemiological data, details on COVID-19 exposure, vaccination
history and the incidence and severity of the respective side effects (Appendix A: Table A1).
More specifically, we enquired about the following symptoms: localized reactions (pain,
swelling, tenderness, redness, itching or other), fever, skin rash, shortness of breath, tingling
in the mouth, face, body/ extremities, swelling in the face or mouth, generalized swelling,
anaphylaxis (severe allergic reaction with face swelling and breathlessness), tiredness or
fatigue, flu-like illness or any other side effects. It was launched via Google Forms on
3 February 2021 for 11 days and was shared within the institutions of the investigators
through professional contacts and social media. The only inclusion criterion was the receipt
of the first dose of any COVID-19 vaccine at least seven days prior to survey completion.
The main objectives were to evaluate the differences in the incidence and severity
of vaccination side effects among (i) people with versus without previously reported
COVID-19 infection and (ii) those who received different vaccine types. Moreover, we
explored the differences in self-reported side effects between the first and second vaccine
dose among different ethnicities and among those with different preconceptions toward
the vaccine. Finally, we explored the impact of the interval between COVID-19 exposure
and vaccination and the incidence of side effects.
For our main analysis, a positive COVID-19 history was considered in cases of (a) a
self-reported history of symptoms consistent with COVID-19 disease provided that COVID-
19 was not excluded by a negative PCR test, (b) a positive COVID—19 PCR test or (c) a
positive COVID-19 antigen test. In a sensitivity analysis, a COVID-19 infection was only
considered valid if it was confirmed by PCR or antigen testing while patients with an
uncertain exposure (clinical history not confirmed by laboratory testing) were excluded.
Between group differences were assessed using chi-squared and Mann—Whitney U
tests for dichotomous and continuous variables, respectively, after a Shapiro-Wilk test
excluded the normal distribution of the latter. Between group differences in the incidence
of side effects are presented as risk ratios (RR) with the respective 95% confidence intervals
(CI). Predictors of the incidence and severity of side effects were evaluated in univariate
followed by multivariate binomial logistic regression and cumulative link models for
ordinal data, respectively. Age, gender, ethnicity, vaccine type, prophylactic analgesia or
other medication use prior to vaccination, vaccine preconceptions and prior COVID-19
exposure were evaluated as potential confounding factors. Unless otherwise specified, the
analyses were based on side effect profiles from the first dose of the vaccine.
Ethics approval was not necessary for this anonymized survey.
 147

Lift: 2021, 11, 249 30f13

3. Results
Within 11 days, this online survey was completed by 2002 participants (Table A2,
Figure Al), mostly health professionals of a working age (median: 45, interquartile range
[IQR]: 35—50 years). A total of 532 (26.6%) had a history of a previous COVID-19 infection
of whom 366 (68.8%) were confirmed by PCR (ii = 273) and/or antigen testing (ii = 162). A
COVID-19 infection preceded the first vaccination dose by a median of 87 (IQR: 47—223)
days The majority of respondents were Caucasians (88.3%) mostly from the UK (78.6%)
and Greece (16.6%). As anticipated, a prior history of a COVID-19 infection was more
prevalent among frontline workers, health professionals and people from the UK where
a very high incidence of COVID—19 was documented [0]. Moreover, recipients of a viral
vector-based vaccine (mainly the AstraZeneca vaccine) were relatively older (Figure A2,
[,1 < 0.001) and were mostly based in the UK (89.7% compared with 76.4% of those that
received viral mRNA vaccines, p < 0001). Finally, doctors were more likely to have received
an mRNA—based vaccine compared with the other groups (p < 0.001).
A prior COVID-19 infection was associated with an 8% increase in the risk of having
any side effects after the first vaccine dose (RR 1.08, 95% CI (1.05—1.11), Table 1, Figure i).
We also observed a significantly increased risk of self-reported fever (2.24 (1.86—2.70)),
breathlessness (2.05 (1.28—3.29)), flu-like illness (1.78 (1.51—2.10)), fatigue (1.34 (1.2—1.49)),
local reactions (110 (106—115)) and ”other” side effects (1.46 (1.16—1.82)). Among those
experiencing side effects, a prior COVID-19 infection was associated with an increased
severity of any side effect, local side effects or fatigue (p < 0001). More importantly,
a prior COVID-19 infection was associated with the risk of experiencing a severe side
effect requiring hospital care (1 .56 (114—2.12)). These observations remained significant in
multivariate analyses and our sensitivity analysis (Table AS). A similar increase in the risk
of any side effects following the second dose in those with a prior COVID-19 infection was
also noted (1.08 (1 .05—1.11)), although the lack of significant associations with specific side
effects may have resulted from the limited sample included in this analysis.

Table 1. Differences in the incidence and severity of side effects after the first dose of Lhe COVID-19 vaccine among
participants who had or did not have a prior COVlD-l9 infection.
In id n fS'd Incidence of Side Severity of Side Severity of Side
. Effect
Side
c e
Effects:ce 0 l
Risk Ratio
(95% CI) e Effects: Multivariate
. . Regression,
Logistic . Effects: Univariate
l . R‘isk
Cumu itive
Effects: Multivariate
Cumu
1 . R'isk
ative
Coefficient (pi-Value) Models (1)-Value) Models (1)—Value)
Any side effect 1.08 (1.05—1.11) 0.575 (0.004) <0.001 <0.001
Localized reaction 1.10 (1.06—1.15) 0.45 (0.003) <0.001 0.003
Fever 2.24 (1.86—2.70) 0.876 (<0.001) NS NS
Flu-like illness 1.78 (1.51—2.10) 0.558 (<0.001) NS NS
Shortness of breath 2.05 (11842.29) 0.651 (0.011) NS NS
Skin rash 1.04 (0.54—2.00) NS NS NS
Tingling 1.26 (0.83—1.91) NS NS NS
Swelling 1.00 (0.32—3.14) NS NS NS
Generalized swelling 1.84 (0.94—3.60) NS NS NS
Anaphylaxis 0.55 (0064.72) NS NS NS
Fatigue or tiredness 1.34 (1.2—1.49) 0.418 (<0.001) <0.001 <0.001
Other 1.46 (1.16—1.82) 0.349 (0.013) NS NS
Worse outcomes associated with a prior COVID-19 infection
 148

Life 1021, 11, 249 4of13

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Figure 1. Incidence and severity of self-reported side effects after the first dose of the COVID-19 vaccine among participants who had or did not have a known prior COVID-l9 infection.
Risk ratios less than 1 favoured those that did not have a prior COVID-19 infection.
 149

Lifr 202i, ii, 249 Sof13

Furthermore, significant differences were observed between the side effect profiles
of mRNA versus viral vector vaccines (predominantly Pfizer versus AstraZeneca, Table 2,
Figure 2). Overall, the recipients of mRNA vaccines reported a higher incidence of any
self—reported side effects (1.06 (1.01—1.11)), which were, however, of significantly milder
severity compared with those who received viral vector vaccines. While mRNA vaccines
were associated with an increased incidence of reported local reactions (129 (119—140)),
they were associated with a considerably lower incidence of self-reported systemic side
effects including anaphylaxis (019 (004—062)), fever (0.28 (024—0.34)), swelling in the
face or mouth (0.29 (010—080)) or generalized swelling (0.29 (0.15—0.56)), flu»like illness
(0.34 (0.29—0.40)), breathlessness (0.43 (026—070)), fatigue (056 (051—062)) or other side
effects (0.67 (0.52—0.86)). These observations were corroborated by multivariate analyses.
Most importantly, mRNA vaccines were associated with a significantly lower incidence of
severe side effects (requiring hospital care, RR 042 (031—058)).

Table 2. Differences in the incidence and severity of side effects among people who received an mRNA or a viral vector
vaccine.

Incidence of Side Incidence of Side Severity of Side Severity of Side

. Effect . Ratio
. Effects: Multivariate Effects: Univariate Effects: Multivariate
Side Effects: Risk . . . .
. Risk . Risk
.
95% CI) Logistic Regression,
Coefficient (ii-Value)
Cumulative
Models (fr-Value)
Cumulative
Models (p-Value)
Any side effect 1.06 (1.01—1.11) NS <0.001 <0.001
Localized reaction 1.29 (1.19—1.40) 0.892 (<0.001) NS NS
Fever 0.28 (0.24—0.34) —1.993 (<0.001) <0.001 NS
Flu-like illness 0.34 (0.29—0.40) A1795 (<0.001) <0.001 NS
Shortness of breath 0.43 (0.26—0.70) —0.853 (0.002) NS NS
Skin rash 0.86 (0.40—1.83) NS NS NS
Tingling 0.68 (0.43-1.09) NS NS NS
Swelling 0.29 (010—080) #1326 (0.015) NS NS
Generalized swelling 0.29 (0.15—0.56) —1i423 (<0.001) NS NS
Anaphylaxis 0.19 (0.04—0.94) —1.890 (0.024) NS NS
Fatigue or tiredness 0.56 (0.51—0.62) —1.331 (<0.001) <0.001 NS
Other 0.67 (0.52—0.86) —0.471 (0.004) NS Ns
mRNA vaccines superiority
Viral vector vaccines superiority

In general, the second dose of the vaccine was associated with a higher incidence of
side effects (Table 3). More specifically, respondents reported experiencing more frequently
any side effects (1.04 (101—1.07)), skin rash (2.25 (1.4—3.62)), fever (172 (146—202)), flu-like
illness (167 (145—191)) and fatigue (1.40 (1.28—1.53)). In addition, a multivariate regression
demonstrated that participants who had side effects after the first vaccine dose were at
a significantly higher risk of having the same side effects after the second dose. Among
those experiencing side effects, the severity did not significantly differ between the two
doses. However, the likelihood of having a severe side effect requiring hospital care was
significantly decreased (0.58 (038—088)).
Stratification by ethnicity revealed that white participants reported a lower incidence
of fever (0.62 (OAS—0.79)) and flu-like illness (078 (062—097)) compared with the remaining
participants (Table A1). Finally, those reporting a pre-vaccination concern about the safety
of the vaccine reported more often tingling (2.23 (145—342)), breathlessness (1.73 (1.00—
2.98)) and fatigue (1.17 (103—1.34)) (Table A5).
 150

-—
Life 2021, 11, 249 60f13

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Figure 2. Incidence and severity of side effects after the first dose of (1) an mRNA or (2) a viral vector vaccine. Risk ratios less than 1 favoured the mRNA vaccine.
 151

Li]: 2021, 11, 249 7of13

Table 3. Differences in the incidence and severity of side effects after the second or the first dose of the vaccine.

Incidence of Side Severity of Side Severity of Side

Incidence of Side
Effects: Multivariate Effects: Univariate Effects: Multivariate
Side Effect Effects: Risk Ratio
Logistic Regression, Cumulative Risk Cumulative Risk
(95% CD Coefficient (p-Value) Models (p-Value) Models (p-Value)
Any side effect 104 (1.01—1.07) NS NS NS
Localized reaction 0.98 (0.94—1.03) 2.469 (<0.001) NS NS
Fever 1.72 (1.45—2.02) 1.3 (<0.001) NS Ns
Flu-like illness 1.67 (1.45—1.91) 0.979 (0.001) NS NS
Shortness of breath 0.95 (0.57—1.61) 4.491 (<0.001) NS NS
Skin rash 2.25 (1.4—3.62) 4,297 (<0.001) 0.05 NS
Tingling 1.3} (0.89—1.92) 3.096 (<0.001) NS NS
Swelling 2.03 (0.87—4.77) NS NS NS
Generalized swelling 1,2 (0.61—2.34) 4.925 (<0.001) NS NS
Anaphylaxis 2.54 (0.72—8.98) 4.747 (0.012) NS NS
Fatigue or tiredness 1.4 (1.28—1.53) 0.868 (<0.001) NS NS
Other 1.05 (0.83—1.32) 2.104 (<0.001) NS NS
Worse outcomes after the second COVID-19 vaccine dose

Multivariate analyses also revealed a strong negative association between age and
the self-reporting of any side effect, local reactions, fever, flu-like illness, rash, tingling,
generalized swelling and fatigue (p < 0.01). Finally, a history of allergy was associated
with an increased incidence of self-reported breathlessness and rash ()7 < 0.01). However,
as described in the previous paragraphs and tables, most of the associations observed in
univariate analyses remained significant in multivariate analyses accounting for these and
other potential confounding factors.

4. Discussion
People with a prior COVID-19 exposure were largely excluded from the vaccine tri-
als [VI—6] and, as a result, the safety and reactogenicity of the vaccines in this population
have not been previously fully evaluated, For the first time, this study demonstrated
a significant association between a prior COVID-19 infection and a significantly higher
incidence and severity of self—reported side effects after a vaccination for COVID-19. Con-
sistently, compared with the first dose of the vaccine, we found an increased incidence
and severity of self-reported side effects after the second dose when recipients had been
previously exposed to viral antigen, probably because they had already developed an
immunity against the antigens. This was supported by recent studies demonstrating that
seropositive individuals developed rapid immune responses with higher antibody titres
after the first vaccination dose compared with those without a previous COVID-19 in—
fection [10,1 1]. In View of the rapidly accumulating data demonstrating that COVID-19
survivors generally have an adequate natural immunity for at least six months, it may
be appropriate to re—evaluate the recommendation for the immediate vaccination of this
group. In the meantime, taking into account our findings as well as studies demonstrating
higher antibody titres among individuals with a prior COVID-19 infection, it might be
appropriate for a note to be included in the vaccine information sheets highlighting that
these people are more likely to experience non-serious side effects.
Moreover, this is the first head—terhead real»world comparison of the self-reported
safety of viral vector versus mRNA vaccines with the latter associated with a 58% decreased
incidence of self-reported severe side effects requiring hospital care, While a greater number
of recipients of mRNA vaccines reported at least one (any) side effect, the difference was
predominantly driven by the frequent local reactions. The incidence of the systemic side
effects evaluated (flu-like illness, pyrexia and fatigue), which are more burdensome to the
 152

Life 2021, 11, 249 80f 13

recipients, was significantly reduced. The recipients of the viral vector-based vaccines were
relatively older. However, differences in the incidence of adverse events were confirmed in
multivariate analyses accounting for the age of the respondents as a covariate. Moreover,
given that older people reported side effects less frequently, a potential bias due to age
difference would be expected to favour viral vector-based vaccines. These findings may
have an impact on vaccine choice and health policies. The cause of the observed imbalance
between the safety profiles of mRNA-based versus viral-vector vaccines was unclear and
should be evaluated in future studies.
The main strengths of our study included a large study population that better reflected
real-life compared with the populations studied in the clinical trials, the availability of
adequate details about the participants and the safety profiles of the vaccines and very
limited missing data. The potential bias of respondents is the main limitation of any
survey and as this survey was shared though social media, we were not able to estimate
the non-response rate. However, the bias of respondents was more likely to affect the
absolute incidence of side effects, which we did not evaluate here, rather than the relative
incidence and severity across different groups of people. Potential recall bias should also
be mentioned although all participants had been vaccinated within 10 weeks prior to
completing the survey. As noted, most respondents were from the UK and Greece due to
the ability of the investigators to establish contacts quickly to publicise this survey. The
UK has also been successful in rolling out COVID-19 vaccines quickly leading to more of
those invited being eligible to participate. It is not surprising that the Pfizer vaccine was
the most delivered vaccine as it was the first vaccine to be licensed within the UK, with
more individuals receiving it in total when the survey was circulated.
In conclusion, this extensive survey of over 2000 recipients of COVID-19 vaccines
confirmed the findings of recent randomised controlled trials (RCTs) demonstrating that
COVID-19 vaccines are generally safe with limited severe side effects. Moreover, it linked
previous COVID-19 illnesses with an increased incidence of vaccination side effects. It also
demonstrated that mRNA vaccines caused milder, less frequent systemic side effects but
more local reactions. These findings will need to be validated in clinical studies, preferably
randomized controlled trials including patients from multiple groups.

Author Contributions: Conceptualization, N.D.B. and M.G.; methodology, A.G.M., M.G., A.U., S.A.,
RB. and N.D.B.; Survey distribution A.G.M., M.G., A.U., S.A., R.B., L.P.P., DP. and N.D.B.; data
curation, A.G.M. and N.D.B.; formal analysis, A.G.M. and N.D.B.; writing—original draft preparation,
A.G.M. and N.D.B.; writing—review and editing, A.G.M. and N.D.B. All authors have read and
agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: An ethical review and approval were waived for this anony-
mous online survey. This was confirmed by the Research & Development Directorate of the Salford
Royal NHS Foundation Trust.
Informed Consent Statement: Patient consent was implied by the completion of this online survey.
Written consent was waived because this online survey was completely anonymous. This was
confirmed by the Research 81: Development Directorate of the Salford Royal NHS Foundation Trust.
Data Availability Statement: The data presented in this study are available on request from the
corresponding author.
Acknowledgments: A.G.M. was supported by the NIHR Manchester Biomedical Research Centre
(NIHR Manchester BRC). We are thankful to Matthew Snape (Oxford Vaccine Group, University of
Oxford) for his advice regarding vaccine safety and reactogenicity tracking and to the Coronavirus
Medical Group Greece for disseminating our survey among Greek health professionals.
 153

Life 2021, 11,249 90f 13

Conflicts of Interest: All authors have completed the ICMIE uniform disclosure form. None of the
authors has any conflict of interest in relation to this work. A.G.M. reports grants from Boehringer
Ingelheim outside the submitted work. R.B. reports contract research on behalf of Public Health
England for GlaxoSmithKline, Pfizer and Sanofi Pasteur outside the submitted work. N.D.B. reports
personal fees from TEVA Pharma, GSK, AstraZeneca, Boehringer Ingelheim and Chiesi Pharma
outside the submitted work.

Appendix A

Table A1. Definitions of the severity of side effects.

Severity Definition
Minimal Negligible impact
Mild No treatment needed
Moderate Needed
treatment advice
or from
professronal outside the hospital
healthcare
Severe Needed hospital care

Table A2. Baseline characteristics of the study participants. Continuous variables are presented as medians (IQR) and
categorical as n (%). Between group differences were anticipated and explained by the incidence of COVID-19 in different
subgroups. Characteristically, a higher incidence of a prior COVID-19 infection was observed among frontline workers,
health professionals and among British people (a very high incidence of COVID-19 was documented in the UK).

Participants with a Participants with N 0 Between Grou

Charactefist.“ Prior COVID-19 Known Prior Missing Differences P
1 Infection COVID-19 Infection Data ( -Value)
(n =532) (n =1470) P

Gender (Female) 393 (73.9%) 1051 (71.5%) 0.7% NS

Age 2 so (%) * 56 (10.5%)
202 (13.7%) 0.5% NS

Weight (kg) 75 (64—88) 74 (64—85) 4.0% NS

Height (cm) 168 (163—173) 168 (162-175) 2.2% NS
Country
Europe
UK 472 (88.7%) 1100 (74.8%)
Greece 38 (7.1%) 294 (20%) o
Other European countries 10 (1.9%) 30 (2.0%) 0'6 /° (0'001
Americas 5 (0.9%) 17 (1.2%)
Asia 5 (0.9%) 17 (1.2%)
Africa 0 (0%) 1(0.1%)
Ethnicity
White 464 (87.2%) 1303 (88.6%)
Asian 35 (6.6%) 63 (4.3%) 1.8% NS
Arab 21 (3.9%) 45 (3.1%)
Other 7 (1.3%) 28 (1.9%)
Role
Doctor 140 (26.3%) 486 (33.1%)
Nurse 125 (23.5%) 188 (12.8%) 3.2% <0.001
Other health professional 161 (30.3%) 382 (26.0%)
Not a health professional 105 (19.7%) 401 (27.8%)
Frontline workers 372 (69.9%) 795 (54.1%) 0.6% <0.001
 154

Life 2021, 11, 249 10 of 13

Table A2. Cont.

Partici ants with a Partici ants with No

Characteristics
PriorICOVID-D
Infection
Knl:)wn Prior
COVID-19 Infection
Missing
Data
Belgvi‘figz‘efigsm’
(p-Value)
(n = 532) (n =1470)
COVID-19 prior to vaccination
Laboratory confirmed exposure 366 (68.8%) NA 0"/
Consistent symptoms, not tested 166 (31.2%) NA °
No known exposure NA 1470 (100%)
Vaccine type
Pfizer 443 (83.3%) 1230 (83.7%)
Oxford AstraZeneca 80 (15.0%) 202 (13.7%) 0.5% NS
Other 4 (0.8%) 20 (1.4%)
Unknown 2 (0.4%) 3 (0.2%)
Vaccine preconception
Positive 343 (64.5%) 1027 (69.9%) 0 8% NS
Neutral 76 (14.3%) 174 (11.8%)
'

Negative 110 (20.7%) 259 (17.6%)

Second vaccine dose received 114 (21.4%) 411 (28.0%) 0% 0.004
Past medical history
Chronic cardiac disease 9 (1.7%) 25 (1.7%) NS
Chronic respiratory disease 74 (13.9%) 171 (11.6%) NS
Chronic kidney disease 4 (0.8%) 9 (0.6%) NS
Chronic liver disease 1 (0.2%) 6 (0.4%) NS
Chronic neurological disease 8 (1.5%) 17 (1.2%) NS
Active cancer 1 (0.2%) 9 (0.6%) 7 7% NS
‘

Asplenia 1 (0.2%) 4 (0.3%) ' NS

Allergy 56 (10.5%) 134 (9.1%) NS
Diabetes 17 (3.2%) 49 (3.3%) NS
Hay fever, eczema 114 (21 .4%) 251 (17.1%) 0.04
lmmunosuppression 14 (2.6%) 49 (33.3%) NS
Transplantation history 0 (0%) 0 (0%) NS
None 282 (53.0%) 825 (56.1%) NS
"Participants with a prior COVID-19 exposure were younger compared with those without a prior exposure. See Figure A1.
Table A3. Differences in the incidence and severity of side effects after the first dose of a COVID-19 vaccine among partici-
pants who had or did not have a prior self-reported COVID-19 infection. Sensitivity analysis only included participants
with a prior COVID-19 infection confirmed with a consistent PCR or antibody test (it = 366) versus those without any
suspicion of a prior COVID-19 infection (11 = 1470).

Incidence of Side Incidence of Side Severity of Side Severity of Side

. Effect . Ratio
. Effects: Multivariate Effects: Univariate Effects: Multivariate
Side Effects: Risk . . . . Risk
. . Risk
.
(95% CI) Logistic Regressmn, Cumulative Cumulative
Coefficient Value) Models Value) Models Value)
An side effect

_
7

NS
H

Localized reaction :5 ,_ .

Fever "
NS NS
Flu-like illness NS NS
Shortnessofbreath ,.
y, y

_ , . ~ g

NS NS
Skin rash 1.38 (0.7—2.71) NS NS NS
Tingling 1.22 (0.75—1.98) NS NS NS
Swelling 0.73 (0.16—3.28) NS NS NS
 155

Life 2021, 11,249 llof13

Table A3. Cont.

Incidence of Side Severity of Side Severity of Side

Incidence of Side Effects: Multivariate Effects: Univariate Effects: Multivariate
Side Effect Effects: Risk Ratio
(95% CI) Logistic Regression, Cumulative Risk Cumulative Risk
Coefficient (p-Value) Models (p-Value) Models (II-Value)
Generalized swelling 1.72 (OB—3.73) NS NS NS
Anaphylaxis 0.8 (009—685) NS NS NS
Fatigue or tiredness 1.39 (1.24—1.56) 0.459 (<0.001) <0.001 0.002
Other 1.45 (1.12—1.87) 0.288 (0.069) NS NS
Worse outcomes associated with a prior COVID-19 infection

Table A4. Differences in the incidence and severity of side effects among different ethnicities (white or other).

Incidence of Side Severity of Side Severity of Side

Incidence of Side
Effects: Multivariate Effects: Univariate Effects: Multivariate
Side Effect Effects: Risk Ratio
Logistic Regression, Cumulative Risk Cumulative Risk
(95 A) CD Coefficient (p—Value) Models (p-Value) Models (p-Value)

Any side effect 1.05 (0994.11) NS NS NS

Localized reaction 1.04 (0.97—1.12) NS NS NS
Fever 0.62 (0.48—0.79) —0.546 (0.003) NS NS
Flu»like illness 0.78 (0.62—0.97) NS NS NS
Shortness of breath 1.16 (054—2.5) NS NS NS
Skin rash 0.7 (0.32—1.56) NS NS NS
Tingling 1.69 (0.79—3.61) NS NS NS

Swelling 0.86 (0.2—3.81) NS NS NS

Generalized swelling 0.64 (0.27—1.53) NS NS NS
Anaphylaxis 0.66 (0.08—5.67) NS NS NS

Fatigue or tiredness 0.88 (0.76—1.02) NS NS NS

Other 1.38 (0.94—2.03) 0.446 (0.049) NS NS
Worse outcomes: non—white ethnicity
Worse outcomes: white ethnicity

among people with a different preconception toward

Table A5. Differences in the incidence and severity of side effects
the vaccine prior to vaccination and those who were keen to receive the vaccine versus those who were concerned about
receiving the vaccine.

Incidence of Side Severity of Side Severity of Side

Incidence of Side Effects: Multivariate Effects: Univariate Effects: Multivariate
Side Effect Effects: Risk Ratio Logistic Regression, Cumulative Risk Cumulative Risk
(95% Cl) Coefficient (p-Value) Models (p-Value) Models (ii-Value)
Any side effect 1.01 (0.9771 .06) NS <0.001 0.025
Localized reaction 0.99 (0.93—1.05) NS 0002 NS
Fever 1.19 (0.934153) NS 0.009 NS
Flu-like illness 1.07 (0.86—1.34) NS <0.001 NS
Shortness of breath 1.73 (LOO—2.98) —0.085 (0.03) NS NS
Skin rash 1.25 (0594.65) NS NS NS
Tingling 2.23 (1.45—3.42) —0.114 (0.001) NS NS
Swelling 0.4 (0.05e3.03) NS NS NS
 156

Life 2021, 11,249 12 of 13

Table A5. Cont.

.
Incidence of Side
. Ratio
.
Incidence of Side
Effects: Multivariate
Severity
of Side
Effects: Univariate
Severity of Side
Effects: Multivariate
Side Effect Effects: Risk . . Regressron,
. . . . .
(95% CI) Logistic Cumulative Risk Cumulative Risk
Coefficient (p-Value) Models (p-Value) Models (p-Value)
Generalized swelling 0.72 (0.26—2.04) NS NS NS
Anaphylaxis NA NS NS NS
Fatigue or tiredness 1.17 (1.03—1.34) NS 0.009 NS
Other 1.26 (0.96—1.66) —0.043 (0.045) NS Ns
Worse outcomes: concerned

l I

Had COVID

Did not have COVID

of
Percnt Total

l I I I
r x
2049 30-39 4049 5059 60-69 70-75 8085 >90
Age group

Figure A1. Age of the participants stratified by whether they had or did not have a previous
COVID»19 infection.

.
Viral vector
I

mRNA
Percnt oITal

I I l l I 1

20-29 3039 4049 50-59 6069 7079 5039 >90

Age group

Figure A2. Age of the participants stratified by the type of vaccine they received.
 157

Life 2021, 11, 249 13 of 13

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 Thisrs Exhibit “ C””refined to in the 158

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