THE ASSOCIATION OF GYNAECOLOGISTS AND

OBSTETRICIANS OF TANZANIA
(Affiliate of International Federation of Gynaecologists and Obstetricians FIGO)

Statement on COVID-19 vaccination of pregnant or lactating women

Authors: Fatma Suleiman, Amani Kikula, Chrisostom Lipingu, Chuor de Garang, Berno Mwambe,
Matilda Ngarina, Chetan Ramaiya, Getrude Ng’ingo, Shweta Jaiswal, Muzdalifat Abeid on behalf of the
Association of Gynaecologist & Obstetricians of Tanzania (AGOTA)
Date: 17th August 2021
Introduction
Since the outbreak of COVID-19 pandemic in December 2019 a lot has emerged. It is now known that
pregnant women are at increased risk of severe COVID-19 associated illness compared with non-
pregnant women. Severe illness includes illness that requires hospitalization, intensive care, or a
ventilator or special equipment to breathe, or illness that results in death. Additionally, pregnant women
with COVID-19 are at increased risk of preterm birth and might be at increased risk of other adverse
pregnancy outcomes compared with pregnant women without COVID-19 (CDC, 2021).
Pregnant women were not specifically included in the phase three clinical trials of COVID-19 vaccines,
however some pregnancies did occur inadvertently during trials of all vaccines that now have WHO
Emergency Use Listing (EUL).
Studies in animals receiving a Moderna, Pfizer-BioNTech, or J&J/Janssen COVID-19 vaccine before or
during pregnancy found no safety concerns in pregnant animals or their babies. In addition, since roll out
in other countries, hundreds of thousands of pregnant have received different COVID-19 vaccines and
been tracked by public health authorities such as the CDC of USA or the Royal College of Obstetricians
in the UK. These, and other similar agencies, have issued statements in support of offering COVID-19
vaccines to pregnant or lactating women. The World Health Organization Strategic Advisory Group of
Experts on Immunization (WHO SAGE) has issued vaccine-specific recommendations that also permit
use of EUL vaccines in pregnancy, where the benefit in preventing severe disease outweighs the risks.
AGOTA does recognise the dilemma facing the women and their health care providers at this time, due
to the limits in clinical vaccine trial evidence pregnant and lactating women. This statement outlines the
society position on COVID-19 vaccination. The Ministry of Health, Community Development, Gender,
Elderly and Children Tanzania (MoHCDEC) so far authorized the use of Pfizer, Moderna, Johnson &
Johnson, Sinovac and Sinopharm vaccines for covid-19 prevention in our country. Information on this
statement is related specifically to those vaccines, which have also received WHO EUL, and is subject
to change should new evidence arise.

HEAD OFFICE: Muhimbili University of Health and Allied Sciences(MUHAS) , CHPE Building 4th floor,
P.O. Box 65222, Dar es Salaam Tanzania.
Tel: +255 22 2152929, Fax: +255 22 2152929 E-mail: [email protected]
President Vice President President Elect Honorary General Secretary Publicity Secretary Treasurer
Dr. Matilda Ngarina Dr. Chetan Ramaiya Dr. Yahya Kapona Dr. Muzdalifat Abeid Dr. Ali Said Dr. Peter Majinge
[email protected] [email protected] [email protected] [email protected] [email protected] [email protected]
 THE ASSOCIATION OF GYNAECOLOGISTS AND
OBSTETRICIANS OF TANZANIA
(Affiliate of International Federation of Gynaecologists and Obstetricians FIGO)

Statement agreed upon

1. AGOTA recommends vaccination should be offered to pregnant and lactating women, when the
benefits of vaccination to the pregnant or lactating woman outweigh the potential risks, and if no
contraindication to the specific vaccine under consideration.
2. AGOTA recommends all approved vaccine by Ministry of Health of Tanzania should be offered to
all pregnant and lactating woman, provided all that guidelines had been kept in priority to pregnant and
lactating woman.
3. AGOTA recommends the decision to vaccinate or not should be based on individual choices, personal
values, understanding the benefits in protecting against the risk of infection and/or morbidity &
mortality of COVID-19 and undescribed risk of being vaccinated during pregnancy and lactating.
4. All Pregnant and lactating women should be eligible to receive vaccination, if they are in a group
eligible to receive vaccine, given the increased risk of morbidity from COVID-19 infection
Safety of COVID 19 vaccine to pregnant mothers
The Moderna and Pfizer-BioNTech vaccines are mRNA vaccines that do not contain the live virus that
causes COVID-19 and therefore, cannot give someone COVID-19. Additionally, mRNA vaccines do
not interact with a person’s DNA or cause genetic changes because the mRNA does not enter the
nucleus of the cell, which is where most of our DNA is kept (e.g we have mitochondrial DNA as well,
which is the basis of mitochondrial DNA replacement therapy).
The J&J/Janssen COVID-19 Vaccine is a viral vector vaccine, meaning it uses a modified version of a
different virus (the vector) to deliver important instructions to our cells. Vaccines that use the same viral
vector have been given to pregnant women in all trimesters of pregnancy, including in a large-scale
Ebola vaccination trial. No adverse pregnancy-related outcomes, including adverse outcomes that
affected the infant, were associated with vaccination in these trials. (CDC, 2021)
Data from USA CDC tracking (USA CDC) continues to confirm safety in pregnancy for mRNA
vaccines and J&J/Janssen (those in use in the USA). Specific study of mRNA vaccines confirms this
(Shimabukuro et al).
In a study on 131 people who have received the vaccine, vaccine-induced antibody is equivalent
between pregnant and non-pregnant participants. Vaccine-induced antibodies were at higher titres than
COVID-19 infection induced antibodies. Vaccine-induced antibodies were present in umbilical cord and
breastmilk (Grey et al). However, until such time when a clinical benefit to the newborn is confirmed,
the primary indication for administration of a COVID-19 vaccine to a pregnant individual remains for
maternal protection. For now, there is no data to guide administration at a particular gestational age and
vaccination may be considered at any gestational age, including the first trimester.

HEAD OFFICE: Muhimbili University of Health and Allied Sciences(MUHAS) , CHPE Building 4th floor,
P.O. Box 65222, Dar es Salaam Tanzania.
Tel: +255 22 2152929, Fax: +255 22 2152929 E-mail: [email protected]
President Vice President President Elect Honorary General Secretary Publicity Secretary Treasurer
Dr. Matilda Ngarina Dr. Chetan Ramaiya Dr. Yahya Kapona Dr. Muzdalifat Abeid Dr. Ali Said Dr. Peter Majinge
[email protected] [email protected] [email protected] [email protected] [email protected] [email protected]
 THE ASSOCIATION OF GYNAECOLOGISTS AND
OBSTETRICIANS OF TANZANIA
(Affiliate of International Federation of Gynaecologists and Obstetricians FIGO)

Administration with other vaccines offered during pregnancy

Clients should wait 14 days after any other vaccine before receiving a COVID-19 vaccine. However,
given the context of the global pandemic, simultaneous or closer interval of administration may be
considered for individuals at higher risk. After receiving a COVID-19 vaccine dose, where possible
client should wait for 28 days before receiving any other vaccine, unless a vaccine is required urgently
due to an exposure to a virus such as Hepatitis B. Again, given the global pandemic and condensed
timelines of pregnancy this may not be possible. Time-sensitive interventions such as administration of
anti-D immunoglobulin and blood products should not be delayed on account of recent COVID-19
vaccination and could be given simultaneously” (“SOGC Statement on COVID-19 Vaccination in
Pregnancy,”).
Vaccine Side Effects
Side effects can occur after receiving any of the available COVID-19 vaccines, especially after the
second dose for vaccines that require two doses. Pregnant people have not reported different side effects
from non-pregnant people after vaccination. If she experiences fever following vaccination she should
take paracetamol because of fever. For any reason vaccination has not been associated with adverse
pregnancy outcomes.
Although rare, some people have had allergic reactions after receiving a COVID-19 vaccine. Health care
providers should ask the history of allergic reaction to any other vaccine or injectable therapy
(intramuscular, intravenous, or subcutaneous). Staff and kits for managing the very rare acute
anaphylactic reactions should be available at vaccination sites. If there is any allergic reaction after
receiving a COVID-19 vaccine during pregnancy, provider should manage reaction accordingly.
COVID 19 Vaccine During Breastfeeding
Breastfeeding has substantial benefits for the newborn and mother, it should continue. The effectiveness
is thought to be similar in breastfeeding women as with other adults. No safety data available for
breastfeeding mother and their neonate but unlikely to cause any harm to the newborn or the mother.
Based on how these vaccines work in the body, COVID-19 vaccines are thought not to be a risk to
lactating women or their breastfeeding babies. Therefore, lactating women can receive a COVID-19
vaccine. Recent reports have shown that lactating women who have received COVID-19 mRNA
vaccines have antibodies in their breastmilk, which could help protect their babies. More data are needed
to determine what protection these antibodies may provide to the baby.
People Who would like to conceive
There is currently no evidence that any vaccines, including COVID-19 vaccines, cause female or male
fertility problems—problems getting pregnant. CDC does not recommend routine pregnancy testing
before COVID-19 vaccination. If a person is trying to become pregnant, she should not need to avoid
pregnancy after receiving a COVID-19 vaccine (CN Matter et al, 2021)

HEAD OFFICE: Muhimbili University of Health and Allied Sciences(MUHAS) , CHPE Building 4th floor,
P.O. Box 65222, Dar es Salaam Tanzania.
Tel: +255 22 2152929, Fax: +255 22 2152929 E-mail: [email protected]
President Vice President President Elect Honorary General Secretary Publicity Secretary Treasurer
Dr. Matilda Ngarina Dr. Chetan Ramaiya Dr. Yahya Kapona Dr. Muzdalifat Abeid Dr. Ali Said Dr. Peter Majinge
[email protected] [email protected] [email protected] [email protected] [email protected] [email protected]
 THE ASSOCIATION OF GYNAECOLOGISTS AND
OBSTETRICIANS OF TANZANIA
(Affiliate of International Federation of Gynaecologists and Obstetricians FIGO)

Eight Key Recommendations for COVID-19 Vaccination

Sites

It is recommended that all eligible persons, including pregnant and lactating individuals, receive a COVID-19 vaccine or vaccine
series. While pregnant individuals are encouraged to discuss vaccination considerations with their clinical care team when
feasible, documentation of such a discussion should not be required prior to receiving a COVID-19 vaccine. Further, pregnant
individuals should not be denied COVID-19 vaccine(s) because of their pregnancy status alone. COVID-19 vaccination sites
should consider the recommendations below clinical guidance regarding vaccinating pregnant individuals.

1 Pregnant individuals should be vaccinated against COVID-19.

While pregnant individuals are encouraged to discuss vaccination considerations with their
2 clinical care team when feasible, documentation of such a discussion should not be required
prior to receiving a COVID-19 vaccine.

Pregnancy testing should not be a requirement prior to receiving any EUA-

3 approved COVID-19 vaccine.

Similar to their non-pregnant peers, pregnant individuals can receive a COVID-19 vaccine in
any setting authorized to administer these vaccines. This includes any clinical setting and
4 nonclinical community-based vaccination sites such as schools, community centers, and
other mass vaccination locations.

Precautions should be discussed with any individual who reports a history of any
immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular,
5 intravenous, or subcutaneous vaccines or therapies not related to a component of
COVID-19 vaccines
or polysorbate).

If anaphylaxis is suspected in a pregnant individual after receiving a COVID-19 vaccination,

6 anaphylaxis should be managed the same as in non-pregnant individuals (CDC).

Pregnant individuals who experience fever following vaccination should be counselled to

7 take paracetamol. Paracetamol has been proven to be safe for use in pregnancy and does
not appear to impact antibody response to COVID-19 vaccines.

Pregnant individuals who receive a COVID-19 vaccine should be educated about and
8 encouraged to consent

Reference: ACOG’s Practice Advisory on COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care

and CDC’s Clinical Considerations

HEAD OFFICE: Muhimbili University of Health and Allied Sciences(MUHAS) , CHPE Building 4th floor,
P.O. Box 65222, Dar es Salaam Tanzania.
Tel: +255 22 2152929, Fax: +255 22 2152929 E-mail: [email protected]
President Vice President President Elect Honorary General Secretary Publicity Secretary Treasurer
Dr. Matilda Ngarina Dr. Chetan Ramaiya Dr. Yahya Kapona Dr. Muzdalifat Abeid Dr. Ali Said Dr. Peter Majinge
[email protected] [email protected] [email protected] [email protected] [email protected] [email protected]
 THE ASSOCIATION OF GYNAECOLOGISTS AND
OBSTETRICIANS OF TANZANIA
(Affiliate of International Federation of Gynaecologists and Obstetricians FIGO)

References
CDC, 2021. Vaccination Considerations for People Pregnant or Breastfeeding [WWW Document].
Centers for Disease Control and Prevention. URL https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/recommendations/pregnancy.html (accessed 8.7.21).
https://www.cdc.gov/mmwr/volumes/70/wr/mm7024e2.htm
RCOG Statement: https://www.rcog.org.uk/covid-vaccine
WHO SAGE link is https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-
materials

SOGC Statement on COVID-19 Vaccination in Pregnancy, n.d. 10.

http://www.who.int/docs/default-source/world-patient-safety-day/health-worker-safety-charter-wpsd-17-
september-2020-3-1.pdf, https://www.who.int/publications/i/item/9789240011588,
https://www.who.int/teams/immunization-vaccines-and-biologicals/policies/who-recommendations-for-
routine-immunization---summary-tables
Gray KJ, Bordt EA, Atyeo C, et al. Covid-19 vaccine response in pregnant and lactating women: A
cohort study. medRxiv. 2021:2021.03.07.21253094. Available at
http://medrxiv.org/content/early/2021/03/08/2021.03.07.21253094.abstract).

USA CDC https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafepregnancyregistry.html

Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, et al. Preliminary
Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. New England Journal of Medicine.
2021;384(24):2273-82. https://www.nejm.org/doi/full/10.1056/NEJMoa2104983

CN Matter et al 2021 https://www.medrxiv.org/content/10.1101/2021.05.23.21257686v1.abstract

HEAD OFFICE: Muhimbili University of Health and Allied Sciences(MUHAS) , CHPE Building 4th floor,
P.O. Box 65222, Dar es Salaam Tanzania.
Tel: +255 22 2152929, Fax: +255 22 2152929 E-mail: [email protected]
President Vice President President Elect Honorary General Secretary Publicity Secretary Treasurer
Dr. Matilda Ngarina Dr. Chetan Ramaiya Dr. Yahya Kapona Dr. Muzdalifat Abeid Dr. Ali Said Dr. Peter Majinge
[email protected] [email protected] [email protected] [email protected] [email protected] [email protected]