What you need to know about the vaccine

Frequently Asked Questions

Considerations before getting your child vaccinated


What is Emergency Use Authorization?

According to FDA, during a public health emergency, 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.

Has Pfizer-BioNTech COVID-19 Vaccine been used before?

Yes. Millions of individuals 5 years of age and older have received Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. In a clinical trial, about 1,200 individuals 6 months through 23 months of age, about 1,800 individuals 2 through 4 years of age, and about 3,100 individuals 5 through 11 years of age have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. In another clinical trial, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine.

​​​​​​​Getting the vaccine

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How many doses of Pfizer-BioNTech COVID-19 Vaccine are needed for my child?

Pfizer-BioNTech COVID-19 Vaccine is authorized 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.

How is Pfizer-BioNTech COVID-19 Vaccine given?

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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What should I tell my child’s vaccination provider?

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
Who should not get the vaccine?

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
Will Pfizer-BioNTech COVID-19 Vaccine give my child COVID-19?

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

How long after receiving Pfizer-BioNTech COVID-19 Vaccine will my child be protected?

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

Can my child receive Pfizer-BioNTech COVID-19 Vaccine at the same time as other vaccines?

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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What are the benefits of vaccinating young children?

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

What are the risks 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 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 Pfizer-BioNTech COVID-19 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.

What should I do if my child experiences 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.

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

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS) and Pfizer Inc.



  • Patients should always ask their doctors for medical advice about adverse events.
  • You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://vaers.hhs.gov/reportevent.html or call 1-800-822-7967.

IMPORTANT SAFETY INFORMATION AND INDICATION/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 of age and older.

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 of age and older
  • A third primary series dose to individuals 5 years of age and older 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
  • A first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • A first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • A second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • A second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved 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 either individuals 6 months of age through 4 years. 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 of 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 or COMIRNATY® (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients

  • The vaccine recipient should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) if you have 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 or COMIRNATY®

  • There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) 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, more commonly in adolescent males and adult 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
    Seek medical attention right away if the vaccine recipient has any of the following symptoms after receiving the 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

  • Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). 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 or COMIRNATY® (COVID-19 Vaccine, mRNA)

  • 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, and fainting in association with injection of the vaccine

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


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. 1-877-829-2619

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

Important Safety Information

Tell your vaccination provider about all of 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 or COMIRNATY® (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients
  • The vaccine recipient should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) if you have 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 or COMIRNATY®
  • There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) 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, more commonly in adolescent males and adult 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
    Seek medical attention right away if the vaccine recipient has any of the following symptoms after receiving the 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
  • Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). 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 or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • 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, and fainting in association with injection of the vaccine

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:



Indication/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 of age and older.

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 of age and older
  • A third primary series dose to individuals 5 years of age and older 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
  • A first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • A first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • A second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • A second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved 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 though 4 years. 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.