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Text Content

SORRY, YOUR BROWSER DOES NOT SUPPORT JAVASCRIPT!

English Español
Indication Authorized Use Important Safety Info

Report Adverse Event

Report an Adverse Event to VAERS† Report an Adverse Event to Pfizer

Prescribing Info & Fact Sheets for Vaccination Providers

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 & Up) –
DILUTE BEFORE USE, Purple Cap EUA Fact Sheet for Vaccination Providers (12 Years
& Up) – DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers (5
Through 11 Years Of Age) - DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for
Vaccination Providers (6 Months Through 4 Years of Age) - DILUTE BEFORE USE,
Maroon Cap

Updates to non-English Full Prescribing Information and Fact Sheets may be
delayed.

Español - Full Prescribing Information (16 Years of Age and Older) - DILUTE
BEFORE USE, Purple Cap Español - Full Prescribing Information (16 Years of Age
and Older) - DO NOT DILUTE, GRAY Cap Español - EUA Fact Sheet for Vaccination
Providers (12 Years & Up) – DILUTE BEFORE USE, Purple Cap Español - EUA Fact
Sheet for Vaccination Providers (12 Years & Up) – DO NOT DILUTE, Gray Cap
Español - EUA Fact Sheet for Vaccination Providers (5 Through 11 Years) –DILUTE
BEFORE USE, Orange Cap

Fact Sheets for Recipients & Caregivers

Fact Sheet for Recipients & Caregivers (12 Years & Up) Fact Sheet for Recipients
& Caregivers (5 Through 11 Years of Age) Fact Sheet for Recipients & Caregivers
(6 Months Through 4 Years of Age)

Updates to non-English Fact Sheets may be delayed.

Español - EUA Fact Sheet for Recipients & Caregivers (12 Years & Up) Español -
EUA Fact Sheet for Recipients & Caregivers (5 Through 11 Years of Age)
 * 16 Years &
   Up
 * AUTHORIZED USE
   12 Through 15 Years
 * AUTHORIZED USE
   5 Through 11 Years
 * AUTHORIZED USE
   6 Months to 4 Years
 * AUTHORIZED USE
   Booster Dose Eligibility Booster Dose Eligibility

FDA APPROVED for 16 years & older as a primary vaccination series to help
protect against COVID-19




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.

The COVID-19 vaccine from Pfizer and BioNTech is also called COMIRNATY for
people 12 years of age and older


STAY INFORMED VACCINE FINDER*



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 12 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

COMPLETING THE PRIMARY SERIES

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What is the primary series immunization schedule for the vaccine for people 16
years of age and older?

FDA-Approved or FDA-Authorized Vaccination Schedule

The FDA has approved COMIRNATY for individuals 16 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 has provided guidance that differs from the FDA-approved primary series
dosing interval above. On February 22, 2022, the CDC updated its Interim
Clinical Considerations for Use of COVID-19 Vaccines  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, adults ages 65 years and older, and others who need rapid
   protection due to increased concern about community transmission or risk of
   severe disease.

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 16 years of age and older receive their second primary series
dose of the vaccine?

FDA-Approved or FDA-Authorized Vaccination Schedule

The FDA has approved COMIRNATY for individuals 16 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 has provided guidance that differs from the FDA-approved primary series
dosing interval above. On February 22, 2022, the CDC updated its Interim
Clinical Considerations for Use of COVID-19 Vaccines  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, adults ages 65 years and older, and others who need rapid
   protection due to increased concern about community transmission or risk of
   severe disease.

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 or FDA-Authorized Vaccination Schedule

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

 * COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA approved in people 16 years of age
   and older to be administered as a 2-dose primary series given 3 weeks apart
 * COMIRNATY has received Emergency Use Authorization by the FDA to be
   administered to people 12 years of age and older as a 2-dose primary series
   given 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 or
FDA-authorized primary series dosing interval above. On February 22, 2022, the
CDC updated its Interim Clinical Considerations for Use of COVID-19 Vaccines 
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, adults ages 65 years and older, and others who need rapid
   protection due to increased concern about community transmission or risk of
   severe disease

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

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.

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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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 unless the declaration is terminated or
authorization revoked sooner.

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

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 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.




Where can I learn more?

For more information about COVID-19 vaccination, please visit the CDC website.

--------------------------------------------------------------------------------


IMPORTANT SAFETY INFORMATION AND INDICATION/AUTHORIZED USES

COMIRNATY® 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 16 years of
age and older.

 * COMIRNATY® is administered as a 2-dose primary series

COMIRNATY® AUTHORIZED USES

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

Primary Series
 * 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 with
   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 Pfizer-BioNTech COVID-19 Vaccine or
   COMIRNATY®
 * 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

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 5 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series
 * 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 12 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.

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

 * Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) may
   not protect all vaccine recipients
   
   
 * You 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 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, 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
   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
   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 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
   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, 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 and Prescribing Information for individuals 12 years of age and
older:

Recipients and Caregivers Fact Sheet (12 years of age and older)
COMIRNATY® Full Prescribing Information (16 years of age and older), DILUTE
BEFORE USE, Purple Cap
COMIRNATY® 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), DILUTE
BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT
DILUTE, Gray Cap





--------------------------------------------------------------------------------


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

CALL YOUR HEALTHCARE PROVIDER
FOR ANY ADDITIONAL QUESTIONS

General Product Inquiries
Call 1-877-829-2619.

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


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

 * Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) may
   not protect all vaccine recipients
 * You 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 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, 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
   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
   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 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
   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, 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 and Prescribing Information for individuals 12 years of age and
older:

Recipients and Caregivers Fact Sheet (12 years of age and older)
COMIRNATY® Full Prescribing Information (16 years of age and older), DILUTE
BEFORE USE, Purple Cap
COMIRNATY® 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), 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

COMIRNATY® 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 16 years of
age and older.

 * COMIRNATY® is administered as a 2-dose primary series

COMIRNATY® AUTHORIZED USES

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

Primary Series
 * 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 with
   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 Pfizer-BioNTech COVID-19 Vaccine or
   COMIRNATY®
 * 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

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 5 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series
 * 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 12 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.

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.



Manufactured by
Pfizer Inc.
New York, NY 10017

Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
Emergency Use Authorization Holder

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary
mRNA technology, was developed by both BioNTech and Pfizer.

Terms of Use Privacy Policy Contact Us

© 2022 Pfizer Inc. All rights reserved. PP-CVV-USA-1136

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary
mRNA technology, was developed by both BioNTech and Pfizer.

--------------------------------------------------------------------------------

This site is intended only for US residents. The products discussed in this site
may have different product labeling in different countries. The information
provided is for educational purposes only and is not intended to replace
discussions with a healthcare provider.

New FDA Fact Sheet Effective: 06/17/2022


The FDA has authorized a 3-dose primary series of the Pfizer-BioNTech COVID-19
Vaccine for children 6 months through 4 years of age.

A 3-dose vaccination series is Authorized for Emergency Use in individuals 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.

The vaccine may not protect everyone.

To learn more, please see the Recipients and Caregivers Fact Sheet (6 months
through 4 years of age) here.

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.

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