Authorized Use: 6 months through 4 years

Pfizer-BioNTech COVID-19 Vaccine

FOR CHILDREN
6 MONTHS OF
AGE
THROUGH
4 YEARS

The vaccine may not protect everyone.


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 12 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 Pfizer-BioNTech COVID-19 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 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 Pfizer-BioNTech COVID-19 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 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.

Pfizer-BioNTech COVID-19 Vaccine has received emergency authorization from the FDA to provide

Primary Series for 6 months of age through 4 years

1st

Dose

2nd

Dose

3rd

Dose

21 days

56 days

FDA AUTHORIZED

The initial 2 doses of the vaccine are administered 3 weeks apart.

 

A third dose is administered at least 8 weeks after the second dose.

FIND A VACCINE APPOINTMENT NEAR YOU

Take the next step toward helping to protect against COVID-19.

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YOUR QUESTIONS ABOUT THE VACCINE - ANSWERED

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

Getting Pfizer-BioNTech
COVID-19 Vaccine

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Pfizer-BioNTech COVID-19 Vaccine is authorized under an Emergency Use Authorization (EUA) by FDA to provide a 3-dose primary vaccination series to children 6 months through 4 years of age. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose.

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

Preparations for the
next doctor visit

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

  • has any allergies
  • has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • has a fever
  • has a bleeding disorder or is on a blood thinner
  • is immunocompromised or is on a medicine that affects their immune system
  • has received another COVID-19 vaccine
  • has ever fainted in association with an injection
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Your child should not get Pfizer-BioNTech COVID-19 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
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No. Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give your child COVID-19.

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The duration of protection against COVID-19 is currently unknown.

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Data have not yet been submitted to FDA on administration of Pfizer-BioNTech COVID-19 Vaccine at the same time with other vaccines. If you are considering to have your child receive Pfizer-BioNTech COVID-19 Vaccine with other vaccines, discuss the options with your child’s healthcare provider.

Knowing more about
Pfizer-BioNTech
COVID-19 Vaccine

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Pfizer-BioNTech COVID-19 Vaccine has been shown to help prevent COVID-19. The duration of protection against COVID-19 is currently unknown.

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There is a remote chance that 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 Pfizer-BioNTech COVID-19 Vaccine. For this reason, your child’s vaccination provider may ask your child to stay at the place where your child received Pfizer-BioNTech COVID-19 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 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 the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of Pfizer-BioNTech COVID-19 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 Pfizer-BioNTech COVID-19 Vaccine, particularly during the 2 weeks after your child receives a dose of Pfizer-BioNTech COVID-19 Vaccine:

  • 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

Side effects that have been reported with Pfizer-BioNTech COVID-19 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/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
  • Irritability

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

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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 child’s healthcare provider if your child has any side effects that bother your child 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.pfizersafetyreporting.com
Fax number: 1-866-635-8337
Telephone number: 1-800-438-1985

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AUTHORIZED USES AND IMPORTANT
SAFETY INFORMATION

AUTHORIZED USES AND IMPORTANT SAFETY INFORMATION

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AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine is 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 through 11 years of age.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:


Primary Series

  • a 3-dose primary series to individuals 6 months through 4 years of age
  • a 2-dose primary series to individuals 5 years through 11 years of age
  • a third primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise

Booster Series

  • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine

EMERGENCY USE AUTHORIZATION

Emergency uses of Pfizer-BioNTech COVID-19 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 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.

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all the vaccine recipient’s medical conditions, including if the vaccine recipient:

  • has any allergies
  • has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • has a fever
  • has a bleeding disorder or is on a blood thinner
  • is immunocompromised or is on a medicine that affects the immune system
  • is pregnant, plans to become pregnant, or is breastfeeding
  • has received another COVID-19 vaccine
  • has ever fainted in association with an injection
  • Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
  • The vaccine recipient should not receive Pfizer-BioNTech COVID-19 Vaccine if the vaccine recipient had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine
  • There is a remote chance that Pfizer-BioNTech COVID-19 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 vaccination provider may ask the vaccine recipient to stay at the place where the vaccine was administered for monitoring after vaccination. If the vaccine recipient experiences a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if the vaccine recipient has 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 the vaccine, particularly 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age

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 Pfizer-BioNTech COVID-19 Vaccine. 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 Pfizer-BioNTech COVID-19 Vaccine
  • Additional side effects include rash, itching, hives, swelling of the face, injection site pain, tiredness, feeling weak or lack of energy, 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, and irritability

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

  • You should always ask your healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov/reportevent.html. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Fact Sheets for individuals 6 months through 4 years of age:

Fact Sheets for individuals 6 months through 4 years of age:

AUTHORIZED USES

IMPORTANT SAFETY INFORMATION

Vector

AUTHORIZED USES

Vector

Pfizer-BioNTech COVID-19 Vaccine is 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 through 11 years of age.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

  • a 3-dose primary series to individuals 6 months through 4 years of age
  • a 2-dose primary series to individuals 5 years through 11 years of age
  • a third primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise

Booster Series

  • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine

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) for use in individuals 6 months 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.



Read Full Authorized UsesArrow


IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all the vaccine recipient’s medical conditions, including if the vaccine recipient:

  • has any allergies
  • has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • has a fever
  • has a bleeding disorder or is on a blood thinner
  • is immunocompromised or is on a medicine that affects the immune system
  • is pregnant, plans to become pregnant, or is breastfeeding
  • has received another COVID-19 vaccine
  • has ever fainted in association with an injection
  • Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
  • The vaccine recipient should not receive Pfizer-BioNTech COVID-19 Vaccine if the vaccine recipient had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine
  • There is a remote chance that Pfizer-BioNTech COVID-19 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 vaccination provider may ask the vaccine recipient to stay at the place where the vaccine was administered for monitoring after vaccination. If the vaccine recipient experiences a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if the vaccine recipient has 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 the vaccine, particularly 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age

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 Pfizer-BioNTech COVID-19 Vaccine. 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 Pfizer-BioNTech COVID-19 Vaccine
  • Additional side effects include rash, itching, hives, swelling of the face, injection site pain, tiredness, feeling weak or lack of energy, 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, and irritability

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

Read Full Important Safety InformationArrow


Updated FDA Fact Sheet (12 & Older)
EFFECTIVE: 08/31/2022

Updated FDA Fact Sheet

(12 & Older)

EFFECTIVE: 08/31/2022

The FDA has granted Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), as a single booster dose for eligible people 12 years of age and older.

It is now available as a single booster dose administered at least 2 months after:

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine

The vaccine may not protect everyone.

Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the original SARS-CoV-2.


Emergency Use Authorization

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 12 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.

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REPORT VACCINE SIDE EFFECTS

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

Report to VAERS*
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Report an adverse event to
Pfizer Inc.

Report to Pfizer

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
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VACCINE AUTHENTICITY:

WHAT YOU NEED TO KNOW

WHAT YOU NEED
TO KNOW

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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
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FOR MORE INFORMATION

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Call your healthcare provider with any additional questions.

General Product Inquiries

Call 1-877-829-2619

Medical Information

Visit PfizerMedicalInformation.com or call 1-800-438-1985

*By clicking this link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.