Comirnaty FDA Approval History
FDA Approved: Yes (First approved August 23, 2021)
Brand name: Comirnaty
Generic name: COVID-19 Vaccine, mRNA
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Prevention of COVID-19
Last updated by Judith Stewart, BPharm on Aug 28, 2025.
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).
- 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. - The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains.
- Comirnaty is administered by intramuscular injection.
- Warnings and precautions associated with authorized or approved mRNA COVID19 vaccines include:
- an increased risk of myocarditis and pericarditis, particularly within the first week following vaccination.
- For Comirnaty, the observed risk is highest in males 12 through 24 years of age.
- Syncope (fainting) may also occur in association with administration of injectable vaccines, including Comirnaty. Procedures should be in place to avoid injury from fainting. - Common adverse reactions (≥10%) in participants 12 years of age and older include 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%).
Common adverse reactions (≥5%) in participants 5 years through 11 years of age include 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 20.0%), muscle pain (up to 18.1%), chills (up to 13.3%), fever (up to 7.8%), and joint pain (up to 7.6%).
Development timeline for Comirnaty
Further information
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