COMIRNATY® Prescribing Info

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COMIRNATY® (COVID-19 Vaccine, mRNA) Indication, Authorized Use, and Important Safety Information

COMIRNATY® (COVID-19 Vaccine, mRNA) Indication, Authorized Use, and Important Safety Information

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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 USE

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

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) 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) 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) or Pfizer-BioNTech COVID-19 Vaccine. 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 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). 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)
  • 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
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REPORT VACCINE SIDE EFFECTS

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

Report to VAERS
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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 to VAERS

Report an adverse event to
Pfizer Inc.

Report to Pfizer
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VACCINE AUTHENTICITY:

WHAT YOU NEED TO KNOW

WHAT YOU NEED
TO KNOW

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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
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FOR MORE INFORMATION

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Call your healthcare provider with any additional questions.

General Product Inquiries:

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

Call 1-877-829-2619

Medical Information:

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

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