COMIRNATY
STN: 125742
Proper Name: COVID-19 Vaccine, mRNA
Tradename: COMIRNATY
Manufacturer: BioNTech Manufacturing GmbH
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.
Product Information
- Package Insert and Patient Package Insert - COMIRNATY
- Dear Health Care Provider letter - COMIRNATY
- Demographic Subgroup Information – COVID-19 Vaccine, mRNA (COMIRNATY)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Latest Safety Information
Supporting Documents
- August 27, 2025 Approval Letter - COMIRNATY
- August 26, 2025 Center Director Decisional Memo - COMIRNATY
- June 25, 2025 Approval Letter - COMIRNATY
- October 10, 2024 Approval Letter - COMIRNATY
- August 28, 2024 Approval Letter - COMIRNATY
- December 6, 2023 Approval Letter - COMIRNATY
- October 17, 2023 Approval Letter - COMIRNATY
- September 22, 2023 Approval Letter - COMIRNATY
- September 11, 2023 Approval Letter COMIRNATY
- September 11, 2023 Clinical Review Memo - COMIRNATY
- Statistical Review - COMIRNATY
- April 20, 2023 Approval Letter COMIRNATY
- August 25, 2022 Approval Letter - COMIRNATY
- July 8, 2022 Approval Letter - COMIRNATY
- July 8, 2022 Clinical Review Memo - COMIRNATY
- Statistical Review - COMIRNATY
- December 16, 2021 Approval Letter - COMIRNATY
- November 8, 2021 Summary Basis for Regulatory Action - COMIRNATY
- August 23, 2021 Approval Letter - COMIRNATY
- Approval History, Letters, Reviews, and Related Documents - COMIRNATY