​​​​​​​COMIRNATY® (COVID‑19 Vaccine, mRNA) is

FDA APPROVED

for 16 years & older

COMIRNATY® (COVID‑19 Vaccine, mRNA) is also known as Pfizer‑BioNTech COVID‑19 Vaccine*

For individuals 12 years and older, Comirnaty® has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine (purple cap and gray cap formulation) and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.

Individuals 5 through 11 years can only receive the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation identifiable with an orange cap.
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​​​​​​​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) 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.

​​​​​​​Frequently Asked Questions

Getting Your Vaccine

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If I’m pregnant, can I receive the vaccine?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider. 

According to the CDC, COVID‑19 vaccination is recommended for all people 12 years and older, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. Evidence about the safety and effectiveness of COVID‑19 vaccination during pregnancy has been growing. These data suggest that the benefits of receiving a COVID‑19 vaccine outweigh any known or potential risks of vaccination during pregnancy. There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in women or men. Pregnant and recently pregnant people are more likely to get severely ill with COVID-19 compared with non-pregnant people. Getting a COVID‑19 vaccine can protect you from severe illness from COVID‑19.

For more information, visit the CDC website

If I’m breastfeeding, can I receive the vaccine?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

For more information, visit the CDC website and the Pfizer-BioNtech COVID-19 Frequently Asked Questions

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

Completing the Primary Series

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What is the primary series of the vaccine?

The vaccine is administered as a 2-dose series, 3 weeks apart.

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.

When do I receive my second dose of the vaccine?

The vaccine is administered as a 2-dose series, 3 weeks apart.

When you get your first dose, you should receive a vaccination card that indicates when to return for your second dose of the vaccine. Remember to bring your card when you return.

What if the second dose cannot be provided at 3 weeks (21 days)?

Per the Full EUA Prescribing Information, the second dose of the vaccine should be given 3 weeks after the first dose. For more information, contact your vaccination provider or the location where you received your first dose.

What if I am 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.

Getting Ready for Your Booster Dose

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What is a booster?

According to the CDC, a booster shot is administered when a person has completed their vaccine series and protection against the virus has decreased over time.

How do I know if I qualify for a booster dose?

A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals 18 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.​​​​​​​
Please check with your healthcare provider regarding eligibility for, and timing of, the booster dose. You can also click here to learn more.

When can I receive a booster dose?

A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series.

Can I get the Pfizer-BioNTech COVID-19 Vaccine booster dose if the original vaccine I received was not the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)?

A single booster dose of the vaccine may be administered to certain individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Please check with your healthcare provider regarding eligibility for, and timing of, the booster dose.

Can I get a different COVID-19 vaccine for my booster if I completed the primary series with the Pfizer-BioNTech COVID‑19 Vaccine or COMIRNATY® (COVID‑19 Vaccine, mRNA)?

Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization. Please check with your healthcare provider regarding eligibility for, and timing of, the booster dose.

Where can I get a booster dose?

To learn about where you can get a booster dose, visit www.vaccines.gov.

Knowing More About the Vaccine

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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.”

The EUA is in effect from the time of EUA authorization for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the vaccine. 

The Emergency Use of the vaccine is authorized for use in individuals 5 years and older and includes a 3rd dose for immunocompromised individuals ages 12 years and older.

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

For individuals 12 years and older, COMIRNATY® has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine (purple cap and gray cap formulation) and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.

Individuals 5 through 11 years can only receive the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation identifiable with an orange cap.

Will the vaccine give me COVID-19?

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

Can the vaccine cause infertility?

According to the CDC, "There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems (problems trying to get pregnant) in women or men."

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: 1-866-625-8337
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

What are the ingredients in the vaccine?

The vaccine in the purple cap 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), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

​​​​​​​The vaccine in the gray cap 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, and sucrose.

The vaccine in the orange cap 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.

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 investigate 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 ethically diverse backgrounds.
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16 yrs+ Diversity Table

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 to individuals 18 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 18 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 18 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.


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)
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 to individuals 18 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 18 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 18 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: 11/19/21

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 to individuals 18 years of age and older. Click here to view.


Selected Safety Information Update

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.


Talk to your vaccination provider if you have questions. The vaccine may not protect everyone.

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.