COMIRNATY
STN: 125742
Proper Name: COVID-19 Vaccine, mRNA
Tradename: COMIRNATY
Manufacturer: BioNTech Manufacturing GmbH
Indication:
- COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 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
- 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