Comirnaty

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Important Safety Information

Do not administer COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

Management of Acute Allergic Reactions

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of COMIRNATY.

Myocarditis and Pericarditis

Postmarketing data from use of authorized or approved mRNA COVID-19 vaccines, including COMIRNATY, have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY.

Limitation of Vaccine Effectiveness

COMIRNATY may not protect all vaccine recipients.

Adverse Reactions

Most commonly reported adverse reactions after a dose:

12 years of age and older (≥10%) were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).
5 years through 11 years of age (≥5%) were pain at the injection site (up to 83.8%), fatigue (up to 51.9%), headache (up to 38.4%), injection site redness (up to 25.9%), injection site swelling (up to 20%), muscle pain (up to 18.1%), chills (up to 13.3%), fever (up to 7.8%), and joint pain (up to 7.6%).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or https:/www.pfizersafetyreporting.com or VAERS at 1-800-822-7967 or https://vaers.hhs.gov

Please click for COMIRNATY Full Prescribing Information and Patient Information.

Indication

COMIRNATY 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).

COMIRNATY is approved for use in individuals who are:

65 years of age and older, or

5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.