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 16 years of age and older.
- Package Insert - 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.
- November 8, 2021 Summary Basis for Regulatory Action - Comirnaty
- August 23, 2021 Approval Letter - Comirnaty
- Approval History, Letters, Reviews, and Related Documents - COMIRNATY