Proper Name: COVID-19 Vaccine, mRNA
Manufacturer: BioNTech Manufacturing GmbH
- 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) in individuals 12 years of age and older.
- Package Insert – COMIRNATY (purple cap)
- Package Insert – COMIRNATY (gray cap)
- 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.
- 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