The Vaccine Is Authorized for Individuals 5 Through 11 Years of Age

​​​​​​​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.

Find a COVID‑19 Vaccine Near You

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."


Why You Should Consider Vaccinating Your Child

According to the CDC, although children are at a lower risk of becoming severely ill with COVID-19 compared with adults, children can
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    •   Be infected with the virus that causes COVID-19
    •   Get very sick from COVID-19
    •   Have both short- and long-term health complications from COVID-19
    •   Spread COVID-19 to others
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Children with underlying medical conditions are more at risk for severe illness from COVID-19 compared with children without underlying medical conditions.​​​


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Getting Your Vaccine

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How is the vaccine given?

The Pfizer-BioNTech COVID-19 Vaccine will be given to your child as an injection into the muscle. The vaccine is administered as a 2-dose series, 3 weeks apart. The vaccine may not protect everyone.

When your child gets the first dose, you will get a vaccination card to show when to return for your child’s next dose(s) of the vaccine. Remember to bring the card when your child returns.
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What should you mention to your child’s vaccination provider before your child gets the vaccine?

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 your child’s immune system
  • is pregnant
  • is breastfeeding
  • has received another COVID-19 vaccine
  • has ever fainted in association with an injection

Knowing More About the Vaccine​​​​​​​

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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 a dose of the vaccine. For this reason, your child’s vaccination provider may ask your child to stay at the place where your child 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 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 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.

What should I do about side effects?

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.
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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

Who should not get the vaccine?

You should not get the the 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 vaccine vial orange cap?

 The 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), tromethamine, tromethamine hydrochloride, sucrose, and sodium chloride. 

Has the vaccine been used before?

Millions of individuals 12 years of age and older have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. In a clinical trial, approximately 3,100 individuals 5 through 11 years of age have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. In other clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the vaccine. The vaccine that is authorized for use in children 5 through 11 years of age includes the same mRNA and lipids but different inactive ingredients compared to the vaccine that has been used under EUA in individuals 12 years of age and older and that has been studied in clinical trials. The use of the different inactive ingredients helps stabilize the vaccine under refrigerated temperatures and the formulation can be readily prepared to deliver appropriate doses to the 5 through 11 year-old population.

Will the vaccine give my child COVID-19?

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

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.

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.