What you need to know about the 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.

Frequently Asked Questions

​​​​​​​Completing the Primary Series

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What is the primary series immunization schedule for the vaccine for people 12 years of age and older?

FDA-Approved Vaccination Schedule

The FDA has approved COMIRNATY for individuals 12 years of age and older as a primary series of 2 doses given as an injection into the muscle 3 weeks apart.

Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine Primary Series

The CDC has provided guidance that differs from the FDA-approved primary series dosing interval above. The CDC updated its guidance  for healthcare professionals to include consideration of an extended interval, up to 8 weeks, between the first and second doses of an mRNA COVID-19 vaccine primary series schedule for people who are not moderately or severely immunocompromised. This applies to some people ages 12 years and older—especially males 12 to 39 years of age—as they may have a small risk of myocarditis (inflammation of the heart muscle) associated with mRNA COVID-19 vaccines. The CDC states that increasing the interval between the first and second dose of the vaccine may help reduce this risk, while also increasing vaccine effectiveness.

  • The CDC continues to recommend a 3-week interval between the first and second dose of the vaccine for people who are moderately or severely immunocompromised.

Your healthcare or vaccination provider will help you decide the timing of the second primary series dose that is right for you.

When do people 12 years of age and older receive their second primary series dose of the vaccine?

FDA-Approved Vaccination Schedule

The FDA has approved COMIRNATY for individuals 12 years of age and older as a 2-dose primary series given as an injection into the muscle 3 weeks apart.

Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine Primary Series

The CDC has provided guidance that differs from the FDA-approved primary series dosing interval above. The CDC updated its guidance  for healthcare professionals to include consideration of an extended interval, up to 8 weeks, between the first and second doses of an mRNA COVID-19 vaccine primary series schedule for people who are not moderately or severely immunocompromised. This applies to some people ages 12 years and older—especially males 12 to 39 years of age—as they may have a small risk of myocarditis (inflammation of the heart muscle) associated with mRNA COVID-19 vaccines. The CDC states that increasing the interval between the first and second dose of the vaccine may help reduce this risk, while also increasing vaccine effectiveness.

  • The CDC continues to recommend a 3-week interval between the first and second dose of the vaccine for people who are moderately or severely immunocompromised.

Your healthcare or vaccination provider will help you decide the timing of the second primary series dose that is right for you.

What if the second primary series dose cannot be provided at 3 weeks?

You should contact your healthcare or vaccination provider or the location where you received your first dose to discuss the appropriate timing of your second primary series dose.

I've seen news reports that the CDC has provided guidance that people may wait a longer time between their first and second dose of an mRNA COVID-19 vaccine. Has the interval between doses changed?

FDA-Approved Vaccination Schedule

The FDA-approved interval between the first and second dose has not changed, and is as follows:

  • COMIRNATY (COVID-19 Vaccine, mRNA) is FDA approved in people 12 years of age and older to be administered as a 2-dose primary series given as an injection into the muscle 3 weeks apart.

Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine Primary Series

The CDC has provided guidance that differs from the FDA-approved primary series dosing interval above. The CDC updated its guidance  for healthcare professionals to include consideration of an extended interval, up to 8 weeks, between the first and second doses of an mRNA COVID-19 vaccine primary series schedule for people who are not moderately or severely immunocompromised. This applies to some people ages 12 years and older—especially males 12 to 39 years of age—as they may have a small risk of myocarditis (inflammation of the heart muscle) associated with mRNA COVID-19 vaccines. The CDC states that increasing the interval between the first and second dose of the vaccine may help reduce this risk, while also increasing vaccine effectiveness.

  • The CDC continues to recommend a 3-week interval between the first and second dose of the vaccine for people who are moderately or severely immunocompromised.

Your healthcare or vaccination provider will help you decide the timing of the second primary series dose that is right for you.

What is the primary series immunization schedule for people who are immunocompromised?

If you are immunocompromised, you may be eligible to receive a third dose of the vaccine under the emergency use authorization. Consult with your healthcare provider. Click here to learn more.

To learn more about the Booster Series, click here.

​​​​​​​Getting Your Vaccine

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If I'm pregnant or breastfeeding, can I receive the vaccine?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider. Available data on COMIRNATY administered to pregnant women is insufficient to inform vaccine-associated risks in pregnancy.

Breastfeeding:

It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion.

According to the CDC,

  • People who are pregnant or recently pregnant are more likely to get severely ill with COVID-19 compared with people who are not pregnant
  • Getting a COVID-19 vaccine can help protect you from severe illness from COVID-19
  • COVID-19 vaccination is recommended for people who are pregnant, trying to get pregnant now, or might become pregnant in the future
  • People who are pregnant may receive a COVID-19 vaccine booster shot
  • COVID-19 vaccination is recommended for people who are breastfeeding

For more information, visit the CDC website.

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

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

​​​​​​​ Knowing More About the Vaccine

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Is the Pfizer-BioNTech COVID-19 Vaccine the same as COMIRNATY?

FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

Will the vaccine give me COVID-19?

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

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 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 your vaccine 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 vaccine?

You should not get 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
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.

Was the COVID-19 vaccine studied in diverse populations?

We are committed to ensuring that underrepresented populations participate in all our studies by sharing with our investigative sites the importance of recruiting people who fully represent the racial and ethnic diversity of their communities.

Individuals 16 years and older:
Approximately 42% of overall participants in the clinical study of the vaccine have racially and ethnically diverse backgrounds.


PARTICIPANTS

OVERALL STUDY

Asian

4.3%

Black

9.6%

Hispanic/Latinx

25.9%

Native American/Alaska Native

1.0%

50.9% of participants are male and 49.1% are female

Individuals 12 through 15:
Approximately 23% of overall participants in the clinical study of the vaccine aged 12 through 15 have racially and ethnically diverse backgrounds.

PARTICIPANTS

OVERALL STUDY

Asian

6.4%

Black

4.6%

Hispanic/Latinx

11.7%

Native American/Alaska Native

0.4%

50.1% of participants are male and 49.9% are female

IMPORTANT SAFETY INFORMATION AND INDICATION/AUTHORIZED USES

INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved 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.

HOW IS COMIRNATY® GIVEN?

COMIRNATY® is administered as an injection into the muscle as a 2-dose primary series, 3 weeks apart.

AUTHORIZED USES

COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization (EUA) to provide:

Primary Series
  • a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise
Booster Dose
  • a first booster dose to individuals 12 years of age and older who have completed a primary series with COMIRNATY® (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another 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
INTERCHANGEABILITY

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

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

COMIRNATY® (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

  • You should not receive 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 COMIRNATY® or Pfizer-BioNTech COVID-19 Vaccine

  • There is a remote chance that COMIRNATY® (COVID-19 Vaccine, mRNA) or 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 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 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 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

  • Fainting can happen after getting injectable vaccines, including COMIRNATY® (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask you 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) or Pfizer-BioNTech COVID-19 Vaccine

  • In people 12 through 15 years of age, the most common side effects (≥8%) were pain at the injection site, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling, and injection site redness

  • In people 16 through 55 years of age, the most common side effects (≥10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, fever, and injection site swelling

  • In people 56 years of age and older, the most common side effects (≥10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, and injection site redness

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.


  • Individuals should always ask their 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. In addition, individuals 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
VISIT CDC.GOV*
Learn more about the COVID-19 vaccination on the Centers for Disease Control and Prevention COVID-19 page.

*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 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

COMIRNATY® (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

  • You should not receive 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 COMIRNATY® or Pfizer-BioNTech COVID-19 Vaccine
  • There is a remote chance that COMIRNATY® (COVID-19 Vaccine, mRNA) or 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 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 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 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
  • Fainting can happen after getting injectable vaccines, including COMIRNATY® (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask you 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) or Pfizer-BioNTech COVID-19 Vaccine
  • In people 12 through 15 years of age, the most common side effects (≥8%) were pain at the injection site, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling, and injection site redness
  • In people 16 through 55 years of age, the most common side effects (≥10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, fever, and injection site swelling
  • In people 56 years of age and older, the most common side effects (≥10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, and injection site redness

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.

  • Individuals should always ask their 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. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

COMIRNATY Full Prescribing Information and EUA Fact Sheet for Vaccination Providers and Recipients and Caregivers Fact Sheet 12 years of age and older:

EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)
COMIRNATY® Full Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap
COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap


Indication/Authorized Uses

INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved 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.

HOW IS COMIRNATY® GIVEN?

COMIRNATY® is administered as an injection into the muscle as a 2-dose primary series, 3 weeks apart.

AUTHORIZED USES

COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization (EUA) to provide:

Primary Series
  • a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise
Booster Dose
  • a first booster dose to individuals 12 years of age and older who have completed a primary series with COMIRNATY® (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another 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
INTERCHANGEABILITY

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.