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) in individuals 16 years of age and older.
Product Information
- 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.
Supporting Documents
- 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