An Additional Dose of the Vaccine Is Authorized for Persons Who Meet the Guidelines Below

Third Dose:
​​​​​​​
In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.
Booster Dose:
A single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID‑19 Vaccine or COMIRNATY®.

A single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID‑19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series.

​​​​​​​Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

    What you need to know about the vaccine​​​​​​

    ​​​​​​​​​​​​​Frequently Asked Questions

    ​​​​​

    What Is Emergency Use Authorization?

    According to the FDA, “During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.”

    What is the Difference Between a Third Dose and a Booster Dose?

    A third dose is administered to individuals who have been determined to have certain kinds of immunocompromise. CDC recommends that people with moderately to severely compromised immune systems receive an additional dose of the vaccine.

    According to the CDC, a booster shot is administered when a person has completed their vaccine series and protection against the virus has decreased over time.



    ​​​​​​

    Getting Your Vaccine Booster Dose

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    What should I mention to my vaccination provider before I get the booster dose?

    Tell the vaccination provider about all of your medical conditions, including if you:
    • have any allergies
    • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
    • 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
    • have ever fainted in association with an injection

    How do I know if I qualify for a booster dose?

    A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMINRATY® to individuals 16 years of age and older.
    ​​​​​​​
    A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Please check with your healthcare provider regarding timing of the booster dose.

    Please check with your healthcare provider regarding eligibility for, and timing of, the booster dose.

    Can I get the Pfizer-BioNTech COVID-19 Vaccine booster dose if the original vaccine I received was not the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)?

    A single booster dose of the vaccine may be administered to certain individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Please check with your healthcare provider regarding eligibility for, and timing of, the booster dose.

    Where can I get a booster dose?

    To learn about where you can get a booster dose, visit www.vaccines.gov.

    Getting Ready for Your Third Dose

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    What if I am immunocompromised?

    According to the Emergency Use Authorization Fact Sheet for Recipients and Caregivers, if you are immunocompromised, you may receive a third dose of the vaccine. The third dose may still not provide full immunity to COVID‑19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID‑19. In addition, your close contacts should be vaccinated as appropriate.

    When do I receive my third dose of the vaccine?

    In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

    Knowing More About the Vaccine

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    Is the Pfizer-BioNTech COVID-19 Vaccine the same as COMIRNATY® (COVID-19 Vaccine, mRNA)?

    When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns.

    Individuals 5 through 11 years can only receive the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation identifiable with an orange cap.

    What are the risks of the vaccine?

    There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting the single booster dose. For this reason, your vaccination provider may ask you to stay at the place where you received your booster dose for monitoring after vaccination. 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
    Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: ​​​​​​​
    • Chest pain
    • Shortness of breath
    • Feelings of having a fast-beating, fluttering, or pounding heart
    Side effects that have been reported with the vaccine include:
    • severe allergic reactions
    • non-severe allergic reactions such as rash, itching, hives, or swelling of the face
    • myocarditis (inflammation of the heart muscle)
    • pericarditis (inflammation of the lining outside the heart)
    • injection site pain 
    • tiredness
    • headache
    • muscle pain
    • chills
    • joint pain
    • fever
    • injection site swelling
    • injection site redness
    • nausea
    • feeling unwell
    • swollen lymph nodes (lymphadenopathy)
    • decreased appetite
    • diarrhea
    • vomiting
    • arm pain
    • fainting in association with injection of the vaccine
    These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.

    What should I do about side effects?

    If you experience a severe allergic reaction or other severe symptom, 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.

    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 either “COMIRNATY® (COVID-19 Vaccine, mRNA)” or “Pfizer-BioNTech COVID-19 Vaccine EUA”, as appropriate, 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: www.pfizersafetyreporting.com
    Fax number: 1-866-635-8337
    Telephone number: 1-800-438-1985​​​​​​​

    Who should not get the booster dose?

    You should not get the single booster dose 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​​​​​​​

    Is there preservative in the vaccine?

    No, the vaccine does not contain preservative.

    Are the components of the vaccine vial made with latex?

    The vial stoppers are not made with natural rubber latex.

    Where can I learn more?

    For more information about COVID-19 vaccination, please visit the CDC website.



    IMPORTANT SAFETY INFORMATION AND INDICATION & AUTHORIZED USE

    INDICATION & AUTHORIZED USE



    ​​​​​​​​​​​​​​HOW IS THE VACCINE GIVEN?


    The vaccine will be given to you as an injection into the muscle.

    Primary Series: 
    In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart.
    In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

    Booster Dose:
    • A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® to individuals 16 years of age and older 
    • A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Please check with your healthcare provider regarding timing of the booster dose 

    WHAT IS THE INDICATION AND AUTHORIZED USE?

    The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
    • a 2-dose primary series to individuals 5 years of age and older
    • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series 

    COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
    • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older 
    • It is also authorized under EUA to provide:
      • a 2-dose primary series to individuals 12 through 15 years of age
      • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
      • a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
      • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series

    IMPORTANT SAFETY INFORMATION

    You should not get the vaccine if you or your child:
    • had a severe allergic reaction after a previous dose of this vaccine
    • had a severe allergic reaction to any ingredient of this vaccine
    Tell the vaccination provider about all medical conditions, including if you or your child:
    • have any allergies
    • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
    • have a fever
    • have a bleeding disorder or are on a blood thinner
    • are immunocompromised or are on a medicine that affects the immune system
    • are pregnant, plan to become pregnant, or are breastfeeding
    • have received another COVID-19 vaccine
    • have ever fainted in association with an injection
    The vaccine may not protect everyone.
    ​​​​​​
    ​​​​​​​Side effects reported with the vaccine include:
    • There is a remote chance that the vaccine could cause a severe allergic reaction
      • A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
      • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over your body, dizziness, and weakness
      • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital

    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
      • chest pain
      • shortness of breath
      • feelings of having a fast-beating, fluttering, or pounding heart

    • Additional side effects that have been reported with the vaccine include:
      • severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
    • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects that do not go away

    Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider.

    Patients should always ask their healthcare providers for medical advice about adverse events. Report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1‐800‐822‐7967. In addition, you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.​​​​​​​



    Vaccine Authenticity: What You Need to Know​​​​​​​​​​​​​​ 

    Around the world, Pfizer and BioNTech are working in partnership with government agencies to safely and efficiently distribute the vaccine. There are currently no legitimate COVID-19 vaccines produced by any manufacturer that are available for purchase by individuals.

    We urge everyone to be wary of any offers for COVID-19 vaccinations that do not come from an authorized source – meaning, from anyone other than a healthcare provider or local government health agency.

    The vaccine:
    • Is NOT sold online. Any sales of COVID-19 vaccines over the Internet, including from online pharmacies, are not legitimate
    • Cannot be purchased in individual doses
    • Is not taken by mouth and is not available in a capsule or tablet form
    • Can only be administered by licensed healthcare professionals at government-authorized vaccination centers – such as doctors' offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals.


    For more information

    General Product Inquiries
    Call
    1-877-829-2619.

    Medical Information
    Visit
    PfizerMedicalInformation.com
    ​​​​​​​or call
    1-800-438-1985.

    *This website is neither owned nor controlled by Pfizer. Pfizer does not endorse and is not responsible for the content or services of this site.

    The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

    This site is intended only for US residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

    Important Safety Information

    Indication & Authorized Use

    Important Safety Information

    You should not get the vaccine if you or your child:

    • had a severe allergic reaction after a previous dose of this vaccine
    • had a severe allergic reaction to any ingredient of this vaccine

    Tell the vaccination provider about all medical conditions, including if you or your child:

    • have any allergies
    • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
    • have a fever
    • have a bleeding disorder or are on a blood thinner
    • are immunocompromised or are on a medicine that affects the immune system
    • are pregnant, plan to become pregnant, or are breastfeeding
    • have received another COVID-19 vaccine
    • have ever fainted in association with an injection

    The vaccine may not protect everyone.
    ​​​​​​​

    Side effects reported with the vaccine include:

    • There is a remote chance that the vaccine could cause a severe allergic reaction
      • A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
      • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over your body, dizziness, and weakness
      • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
      • chest pain
      • shortness of breath
      • feelings of having a fast-beating, fluttering, or pounding heart
    • Additional side effects that have been reported with the vaccine include:
      • severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
    • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects that do not go away

    Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider.
    ​​​​​​​

    Patients should always ask their healthcare providers for medical advice about adverse events. Report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit  https://www.vaers.hhs.gov or call  1-800-822-7967. In addition, you can report side effects to Pfizer Inc. at  www.pfizersafetyreporting.com or by calling  1-800-438-1985.
    ​​​​​​​

    Click for  
    Fact Sheets and Prescribing Information for individuals 12 years of age and older 
            Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, Purple Cap
           
    Full Prescribing Information (16 years of age and older) DO NOT DILUTE, Gray Cap
            EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
            EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
            Recipients and Caregivers Fact Sheet (12 years of age and older)
    Fact Sheets for individuals 5 through 11 years of age
            EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
            Recipients and Caregivers Fact Sheet (5 through 11 years of age)

    Indication & Authorized Use

    HOW IS THE VACCINE GIVEN?

    The vaccine will be given to you as an injection into the muscle.

    Primary Series:
    In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. 
    In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

    Booster Dose:
    • A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® to individuals 16 years of age and older
    • A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Please check with your healthcare provider regarding timing of the booster dose 

    WHAT IS THE INDICATION AND AUTHORIZED USE?

    The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
    • a 2-dose primary series to individuals 5 years of age and older
    • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series

    COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. 
    • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older 
    • It is also authorized under EUA to provide:
      • a 2-dose primary series to individuals 12 through 15 years of age
      • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
      • a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
      • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series 

    New Label Effective: 12/9/2021

    ​​​​​​​Updated information is in teal.

    The Pfizer-BioNTech COVID-19 Vaccine Recipients and Caregivers Fact Sheet (12 years of age and older) has been updated with booster dose information. A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® to individuals 16 years of age and older. Click here to view.

    Emergency Use Authorization
    ​​​​​​​

    Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.