Scribd Logo
Upload

Welcome to Scribd!

  • 41 views

    Fact Sheet For Recipients and Caregivers

    Uploaded by

    api-537351752
    This document provides information about the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. It describes what is known about COVID-19 and the vaccine, including its benefits and risks. It addresses who should and should not get the vaccine, possible side effects, and the vaccination process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Fact Sheet For Recipients and Caregivers

    Uploaded by

    api-537351752
    41 views6 pages
    This document provides information about the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. It describes what is known about COVID-19 and the vaccine, including its benefits and risks. It addresses who should and should not get the vaccine, possible side effects, and the vaccination process.

    Original Title

    fact-sheet-for-recipients-and-caregivers

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides information about the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. It describes what is known about COVID-19 and the vaccine, including its benefits and risks. It addresses who should and should not get the vaccine, possible side effects, and the vaccination process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    41 views6 pages

    Fact Sheet For Recipients and Caregivers

    Uploaded by

    api-537351752
    This document provides information about the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. It describes what is known about COVID-19 and the vaccine, including its benefits and risks. It addresses who should and should not get the vaccine, possible side effects, and the vaccination process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 6

    FACT SHEET FOR RECIPIENTS AND CAREGIVERS

    EMERGENCY USE AUTHORIZATION (EUA) OF


    THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
    DISEASE 2019 (COVID-19)
    IN INDIVIDUALS 16 YEARS OF AGE AND OLDER

    You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus
    Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains
    information to help you understand the risks and benefits of the Pfizer-BioNTech
    COVID-19 Vaccine, which you may receive because there is currently a pandemic of
    COVID-19.

    The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting
    COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to
    prevent COVID-19.

    Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine.
    Talk to the vaccination provider if you have questions. It is your choice to receive the
    Pfizer-BioNTech COVID-19 Vaccine.

    The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks


    apart, into the muscle.

    The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.

    This Fact Sheet may have been updated. For the most recent Fact Sheet, please see
    www.cvdvaccine.com.

    WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE?

    WHAT IS COVID-19?
    COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of
    coronavirus has not been seen before. You can get COVID-19 through contact with
    another person who has the virus. It is predominantly a respiratory illness that can
    affect other organs. People with COVID-19 have had a wide range of symptoms
    reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to
    14 days after exposure to the virus. Symptoms may include: fever or chills; cough;
    shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or
    smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

    WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?


    The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent
    COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

    1 Revised: December 2020


    The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine
    to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use
    Authorization (EUA).

    For more information on EUA, see the “What is an Emergency Use Authorization
    (EUA)?” section at the end of this Fact Sheet.

    WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE


    YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE?
    Tell the vaccination provider about all of your medical conditions, including if
    you:
     have any allergies
     have a fever
     have a bleeding disorder or are on a blood thinner
     are immunocompromised or are on a medicine that affects your immune system
     are pregnant or plan to become pregnant
     are breastfeeding
     have received another COVID-19 vaccine

    WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?


    FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in
    individuals 16 years of age and older.

    WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE?


    You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
     had a severe allergic reaction after a previous dose of this vaccine
     had a severe allergic reaction to any ingredient of this vaccine.

    WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?


    The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: mRNA,
    lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2
    [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-
    phosphocholine, and cholesterol), potassium chloride, monobasic potassium
    phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

    HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN?


    The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the
    muscle.

    The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks


    apart.

    If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive
    a second dose of this same vaccine 3 weeks later to complete the vaccination series.

    2 Revised: December 2020


    HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?
    The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials,
    approximately 20,000 individuals 16 years of age and older have received at least 1
    dose of the Pfizer-BioNTech COVID-19 Vaccine.

    WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE?


    In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to
    prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection
    against COVID-19 is currently unknown.

    WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?


    Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine
    include:
     injection site pain
     tiredness
     headache
     muscle pain
     chills
     joint pain
     fever
     injection site swelling
     injection site redness
     nausea
     feeling unwell
     swollen lymph nodes (lymphadenopathy)

    There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a
    severe allergic reaction. A severe allergic reaction would usually occur within a few
    minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine.
    Signs of a severe allergic reaction can include:
     Difficulty breathing
     Swelling of your face and throat
     A fast heartbeat
     A bad rash all over your body
     Dizziness and weakness

    These may not be all the possible side effects of the Pfizer-BioNTech COVID-19
    Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19
    Vaccine is still being studied in clinical trials.

    WHAT SHOULD I DO ABOUT SIDE EFFECTS?


    If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

    Call the vaccination provider or your healthcare provider if you have any side effects
    that bother you or do not go away.

    3 Revised: December 2020


    Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System
    (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to
    https://vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19
    Vaccine EUA” in the first line of box #18 of the report form.

    In addition, you can report side effects to Pfizer Inc. at the contact information provided
    below.

    Website Fax number Telephone number

    www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985

    WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE?


    It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine.
    Should you decide not to receive it, it will not change your standard medical care.

    ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES


    PFIZER-BIONTECH COVID-19 VACCINE?
    Currently, there is no approved alternative vaccine available for prevention of COVID-19.
    FDA may allow the emergency use of other vaccines to prevent COVID-19.

    CAN I RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE WITH OTHER


    VACCINES?
    There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with
    other vaccines.

    WHAT IF I AM PREGNANT OR BREASTFEEDING?


    If you are pregnant or breastfeeding, discuss your options with your healthcare
    provider.

    WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?


    No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and
    cannot give you COVID-19.

    KEEP YOUR VACCINATION CARD


    When you get your first dose, you will get a vaccination card to show you when to
    return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bring
    your card when you return.

    4 Revised: December 2020


    ADDITIONAL INFORMATION
    If you have questions, visit the website or call the telephone number provided below.

    To access the most recent Fact Sheets, please scan the QR code provided below.

    Global website Telephone number


    www.cvdvaccine.com
    1-877-829-2619
    (1-877-VAX-CO19)

    HOW CAN I LEARN MORE?


     Ask the vaccination provider.
     Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
     Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-
    legal-regulatory-and-policy-framework/emergency-use-authorization.
     Contact your local or state public health department.

    WHERE WILL MY VACCINATION INFORMATION BE RECORDED?


    The vaccination provider may include your vaccination information in your state/local
    jurisdiction’s Immunization Information System (IIS) or other designated system. This
    will ensure that you receive the same vaccine when you return for the second dose. For
    more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

    WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?


    The Countermeasures Injury Compensation Program (CICP) is a federal program that
    may help pay for costs of medical care and other specific expenses of certain people
    who have been seriously injured by certain medicines or vaccines, including this
    vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the
    date of receiving the vaccine. To learn more about this program, visit
    www.hrsa.gov/cicp/ or call 1-855-266-2427.

    WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?


    The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available
    under an emergency access mechanism called an EUA. The EUA is supported by a
    Secretary of Health and Human Services (HHS) declaration that circumstances exist to
    justify the emergency use of drugs and biological products during the COVID-19
    pandemic.

    The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as
    an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are
    met, which includes that there are no adequate, approved, available alternatives. In
    addition, the FDA decision is based on the totality of scientific evidence available
    showing that the product may be effective to prevent COVID-19 during the COVID-19
    pandemic and that the known and potential benefits of the product outweigh the known
    5 Revised: December 2020
    and potential risks of the product. All of these criteria must be met to allow for the
    product to be used in the treatment of patients during the COVID-19 pandemic.

    The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the
    COVID-19 EUA declaration justifying emergency use of these products, unless
    terminated or revoked (after which the products may no longer be used).

    Manufactured by
    Pfizer Inc., New York, NY 10017

    Manufactured for
    BioNTech Manufacturing GmbH
    An der Goldgrube 12
    55131 Mainz, Germany

    LAB-1451-1.0

    Revised: December 2020

    6 Revised: December 2020

    You might also like