Comirnaty® (COVID-19 Vaccine, mRNA) | Stay Informed

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Indication and Authorized Uses, and Important Safety Information

INDICATION AND AUTHORIZED USE

COMIRNATY^® (COVID-19 Vaccine, mRNA) is a vaccine indicated 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. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

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

The vaccines may not protect everyone
You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines
There is a remote chance that these vaccines 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 COMIRNATY^® (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. 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

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

Chest pain
Shortness of breath or difficulty breathing
Feelings of having a fast-beating, fluttering, or pounding heart
Fainting
Unusual and persistent irritability
Unusual and persistent poor feeding
Unusual and persistent fatigue or lack of energy
Persistent vomiting
Persistent pain in the abdomen
Unusual and persistent cool, pale skin

Fainting can happen after getting injectable vaccines, including COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine
Some people with weakened immune systems may have reduced immune responses to COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Side effects that have been reported with these vaccines include:

Severe allergic reactions
Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
Myocarditis (inflammation of the heart muscle)
Pericarditis (inflammation of the lining outside the heart)
Injection site pain/tenderness
Tiredness
Headache
Muscle pain
Chills
Joint pain
Fever
Injection site swelling
Injection site redness
Nausea
Feeling unwell
Swollen lymph nodes (lymphadenopathy)
Decreased appetite
Diarrhea
Vomiting
Arm pain
Fainting in association with injection of the vaccine
Dizziness
Irritability

These may not be all the possible side effects of these vaccines. 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 Sheets for Vaccination Providers and Recipients and Caregivers Fact Sheets:

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), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), BIVALENT (Original and Omicron BA.4/BA.5), DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Vaccination Providers (12 years of age and older), 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 EUA Fact Sheet for Recipients and Caregivers (12 years of age and older) EUA Fact Sheet for Recipients and Caregivers (5 through 11 years of age) EUA Fact Sheet for Recipients and Caregivers (6 months through 4 years of age)

Indication and Authorized Uses, and Important Safety Information

Expand Minimize

INDICATION AND AUTHORIZED USE

IMPORTANT SAFETY INFORMATION

INDICATION AND AUTHORIZED USE

COMIRNATY^® (COVID-19 Vaccine, mRNA) is a vaccine indicated 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. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

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

The vaccines may not protect everyone
You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines
There is a remote chance that these vaccines 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 COMIRNATY^® (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. 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

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

Chest pain
Shortness of breath or difficulty breathing
Feelings of having a fast-beating, fluttering, or pounding heart
Fainting
Unusual and persistent irritability
Unusual and persistent poor feeding
Unusual and persistent fatigue or lack of energy
Persistent vomiting
Persistent pain in the abdomen
Unusual and persistent cool, pale skin

Fainting can happen after getting injectable vaccines, including COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine
Some people with weakened immune systems may have reduced immune responses to COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Side effects that have been reported with these vaccines include:

Severe allergic reactions
Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
Myocarditis (inflammation of the heart muscle)
Pericarditis (inflammation of the lining outside the heart)
Injection site pain/tenderness
Tiredness
Headache
Muscle pain
Chills
Joint pain
Fever
Injection site swelling
Injection site redness
Nausea
Feeling unwell
Swollen lymph nodes (lymphadenopathy)
Decreased appetite
Diarrhea
Vomiting
Arm pain
Fainting in association with injection of the vaccine
Dizziness
Irritability

These may not be all the possible side effects of these vaccines. 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

Report Vaccine Side Effects

Report Vaccine
Side Effects

Report an adverse event to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

Report an adverse event to Pfizer Inc.

Report to Pfizer

Report an adverse event to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

Report an adverse event to
Pfizer Inc.

Report to Pfizer

Vaccine Authenticity:
What You Need to Know

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 with any additional questions.

General Product Inquiries:

CALL 1-877-829-2619

Medical Information:

VISIT PfizerMedicalInformation.com

OR

CALL 1-800-438-1985