Comirnaty® (COVID-19 Vaccine, mRNA)

For people 12 years of age & older to

HELP PROTECT AGAINST
COVID-19 AND SEVERE
ILLNESS TOO^†

The vaccine may not protect everyone.

^†Given as a 2-dose primary series, 3 weeks apart.

The most widely used COVID-19 vaccine in
the U.S.^‡

^‡CDC data for Pfizer and BioNTech as of 8/19/2022.

Primary Series for 12 years of Age & Older

1^st

Dose

2^nd

Dose

3^rd

Dose

21 days

28 days

FDA APPROVED

The vaccine is administered as a primary series of 2 doses that are given 3 weeks apart.

FDA AUTHORIZED

For individuals with certain kinds of immunocompromise, a third primary series dose may be administered at least 28 days after the second dose.

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 aged 6 months and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination series.

More Information for Immunocompromised Individuals

FIND A VACCINE APPOINTMENT NEAR YOU

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

Vaccine Finder*

YOUR QUESTIONS ABOUT THE VACCINE —- ANSWERED

If you're considering the vaccine for yourself or your child 12 and older,
the information below can help you get started.

Getting your vaccine

Expand All +

Collapse All -

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

What is the halal status of the vaccine?

COMIRNATY is produced under the supervision of the Islamic Food and Nutrition Council of America (IFANCA). The vaccine is manufactured and packed on clean equipment using validated cleaning, and the materials used to manufacture the vaccine have been reviewed and approved to meet the halal guidelines.

Completing the
primary series

Expand All +

Collapse All -

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

FDA-Approved Vaccination Schedule

FDA has approved COMIRNATY for individuals 12 years of age and older as a primary series of 2 doses given 3 weeks apart.

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

The CDC updated its COVID-19 Vaccine Interim COVID-19 Immunization Schedule 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 but elevated 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 and adults ages 65 years and older

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

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 3 weeks apart

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

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 and adults ages 65 years and older

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 dose cannot be provided at 3 weeks (21 days)?

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

COMIRNATY®: 12 years & older

The most widely used COVID-19 vaccine in
the U.S.^‡

^‡CDC data for Pfizer and BioNTech as of 8/19/2022.

Primary Series for 12 years of Age & Older

1^st

2^nd

3^rd

FIND A VACCINE APPOINTMENT NEAR YOU

YOUR QUESTIONS ABOUT THE VACCINE —- ANSWERED

Getting your vaccine

Completing the
primary series

INDICATION, AUTHORIZED USES, AND
IMPORTANT SAFETY INFORMATION

INDICATION, AUTHORIZED USES, AND IMPORTANT SAFETY INFORMATION

INDICATION AND AUTHORIZED USES

IMPORTANT SAFETY INFORMATION

REPORT VACCINE SIDE EFFECTS

VACCINE AUTHENTICITY:

WHAT YOU NEED TO KNOW

WHAT YOU NEED
TO KNOW

FOR MORE INFORMATION

COMIRNATY®: 12 years & older

The most widely used COVID-19 vaccine inthe U.S.‡

‡CDC data for Pfizer and BioNTech as of 8/19/2022.

Primary Series for 12 years of Age & Older

1st

2nd

3rd

FIND A VACCINE APPOINTMENT NEAR YOU

YOUR QUESTIONS ABOUT THE VACCINE —- ANSWERED

Getting your vaccine

Completing the primary series

INDICATION, AUTHORIZED USES, AND IMPORTANT SAFETY INFORMATION

INDICATION, AUTHORIZED USES, AND IMPORTANT SAFETY INFORMATION

INDICATION AND AUTHORIZED USES

IMPORTANT SAFETY INFORMATION

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

Updated FDA Fact Sheet

(12 & Older)

EFFECTIVE: 08/31/2022

REPORT VACCINE SIDE EFFECTS

VACCINE AUTHENTICITY:

WHAT YOU NEED TO KNOW

WHAT YOU NEED TO KNOW

FOR MORE INFORMATION

The most widely used COVID-19 vaccine in
the U.S.^‡

^‡CDC data for Pfizer and BioNTech as of 8/19/2022.

1^st

2^nd

3^rd

Completing the
primary series

INDICATION, AUTHORIZED USES, AND
IMPORTANT SAFETY INFORMATION

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

WHAT YOU NEED
TO KNOW