COMIRNATY
STN: 125742
Proper Name: COVID-19 Vaccine, mRNA
Tradename: COMIRNATY
Manufacturer: BioNTech Manufacturing GmbH
Indication:
- 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.
Product Information
- Package Insert and FDA Approved Patient Labeling - 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.
Supporting Documents
- 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