Authorized Use: 5 through 11 years

For children 5 through 11 years of age as a primary series:

Pfizer-BioNTech
COVID-19 Vaccine

Now authorized as a single booster dose:

Pfizer-BioNTech
COVID-19 Vaccine,
Bivalent

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The vaccine may not protect everyone.

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For children 5 through 11 years of age
as a primary series:

Pfizer-BioNTech
COVID-19 Vaccine

Now authorized as a single booster dose:

Pfizer-BioNTech
COVID-19 Vaccine, Bivalent

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 aged 5 years 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.

Emergency uses of the vaccines 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 aged 6 months 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.

Emergency uses of the vaccines 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 aged 6 months 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.

Dosing schedule for ages 5 to 11 years

Dosing schedule for
ages 5 to 11 years


Please see Dosing Schedule Below for People with Certain
Immunocompromising Conditions
Please see Dosing Schedule Below
for People with Certain
Immunocompromising Conditions

Pfizer-BioNTech COVID-19 Vaccine

1st Dose

Dose

FDA AUTHORIZED

21 DAYS AFTER 1st DOSE

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Pfizer-BioNTech COVID-19 Vaccine

2nd Dose

Dose

FDA AUTHORIZED

AT LEAST 2 MONTHS

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Pfizer-BioNTech COVID-19 Vaccine,
Bivalent

Booster

boostericon boostericon

FDA AUTHORIZED

21 days

At least
2 months

12 Years Primary Arrow

Pfizer-BioNTech COVID-19 Vaccine

1st Dose

FDA AUthorized

21 Days after 1st Dose

Pfizer-BioNTech COVID-19 Vaccine

2nd Dose

FDA AUthorized

At least 2 months

Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Booster

green-boster-icon

FDA AUthorized

How is FDA-authorized Pfizer-BioNTech COVID-19 Vaccine given?

The vaccine is administered as a primary series of 2 doses that are given
3 weeks apart.

The vaccine is administered as a primary series of 2 doses that are given 3 weeks apart.

How is FDA-authorized Pfizer-BioNTech COVID-19 Vaccine, Bivalent given?

The bivalent booster can be given as a single booster dose to individuals 5 through 11 years of age at least 2 months after completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine.

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For people with certain immunocompromising
conditions

Pfizer-BioNTech COVID-19 Vaccine

1st Dose

Dose

FDA AUTHORIZED

21 DAYS AFTER 1st DOSE

arrow

Pfizer-BioNTech COVID-19 Vaccine

2nd Dose

Dose

FDA AUTHORIZED

28 DAYS AFTER 2nd DOSE

arrow

Pfizer-BioNTech COVID-19 Vaccine

3rd Dose

Dose

FDA AUTHORIZED

For individuals with certain kinds of immunocompromise, a third primary series dose may be administered at least 28 days after the second dose.

AT LEAST 2 MONTHS AFTER 3rd DOSE

arrowdsk

Pfizer-BioNTech COVID-19 Vaccine,
Bivalent

Booster

boostericon boostericon

FDA AUTHORIZED

21 days

28 days

At least
2 months

12 Years Primary Arrow

Pfizer-BioNTech COVID-19 Vaccine

1st Dose

FDA AUthorized

21 Days after 1st Dose

Pfizer-BioNTech COVID-19 Vaccine

2nd Dose

FDA AUthorized

28 Days after 2nd Dose

Pfizer-BioNTech COVID-19 Vaccine

3rd Dose

FDA AUthorized

For individuals with certain kinds of immunocompromise, a third primary series dose may be administered at least 28 days after the second dose.

At least 2 months after 3rd Dose

Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Booster

green-boster-icon

FDA AUthorized

How is FDA-authorized Pfizer-BioNTech COVID-19 Vaccine given to people with certain immunocompromising conditions?

The vaccine is administered as a primary series of 2 doses that are given 3 weeks apart. A third primary series dose may be administered at least 28 days after the second dose.

The vaccine is administered as a primary series of 2 doses that are given 3 weeks apart. A third primary series dose may be administered at least 28 days after the second dose.

How is FDA-authorized Pfizer-BioNTech COVID-19 Vaccine, Bivalent given?

The bivalent booster can be given as a single booster dose to individuals 5 through 11 years of age at least 2 months after completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine.

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Your questions
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If you’re considering the vaccine for your child, the information below can help you get started.

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The second dose of the vaccine should be given 3 weeks after the first dose.
For more information, contact your child’s vaccination provider or the
location where your child received their first dose.

Additional Questions

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, your child’s vaccination provider may ask your child to stay at the place where he or she 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 child’s 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. 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 your child has 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.

Your child should not get the vaccine if they:

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

No. The vaccine does not contain the virus that causes COVID-19.

If your child experiences 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 your child has 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 “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: www.pfizersafety
reporting.com

Fax number:
1-866-635-8337

Telephone number: 1-800-438-1985

Tell the vaccination provider about all of your child’s medical conditions, including if they:

  • 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 their 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

Individuals 5 years of age and older with immuno-compromising conditions may receive an additional primary series dose of vaccine 28 days after their second primary series dose. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and your child should continue to maintain physical precautions to help prevent COVID-19. In addition, your child’s close contacts should be vaccinated as appropriate.

Indication and Authorized Uses, and Important Safety Information

INDICATION AND AUTHORIZED USE

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older)

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

IMPORTANT SAFETY INFORMATION

Tell your 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 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 vaccines may not protect everyone
  • You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines
  • There is a remote chance that these vaccines 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, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms:

  • difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the 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 COMIRNATY® (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. 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

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

  • Chest pain
  • Shortness of breath or difficulty breathing
  • Feelings of having a fast-beating, fluttering, or pounding heart
  • Fainting
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin
  • Fainting can happen after getting injectable vaccines, including COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine
  • Some people with weakened immune systems may have reduced immune responses to COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Side effects that have been reported with these vaccines 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/tenderness
  • 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
  • Dizziness
  • Irritability

These may not be all the possible side effects of these vaccines. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Indication and Authorized Uses, and Important Safety Information

ExpandVector Vector MinimizeVector

INDICATION AND AUTHORIZED USE

IMPORTANT SAFETY INFORMATION

INDICATION AND AUTHORIZED USE

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older)

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


IMPORTANT SAFETY INFORMATION

Tell your 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 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 vaccines may not protect everyone
  • You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines
  • There is a remote chance that these vaccines 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, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms:

  • difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the 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 COMIRNATY® (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. 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

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

  • Chest pain
  • Shortness of breath or difficulty breathing
  • Feelings of having a fast-beating, fluttering, or pounding heart
  • Fainting
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin
  • Fainting can happen after getting injectable vaccines, including COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine
  • Some people with weakened immune systems may have reduced immune responses to COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Side effects that have been reported with these vaccines 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/tenderness
  • 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
  • Dizziness
  • Irritability

These may not be all the possible side effects of these vaccines. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.


Report Vaccine Side Effects

Report Vaccine
Side Effects

Report an adverse event to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

Report to VAERSLearn more right arrow

Report an adverse event to Pfizer Inc.

Report to PfizerLearn more right arrow

Report an adverse event to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

Report to VAERS

Report an adverse event to
Pfizer Inc.

Report to Pfizer

Vaccine Authenticity:
What You Need to Know

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

Call your healthcare provider with any additional questions.

General Product Inquiries:

CALL 1-877-829-2619phone