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
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
Comirnaty Safety and Effectiveness FAQ
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Content current as of:
08/29/2024
