STN: 125752
Proper Name: COVID-19 Vaccine, mRNA
Tradename: SPIKEVAX
Manufacturer: Moderna Tx, Inc
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
- September 6, 2024 Approval Letter – SPIKEVAX
- August 22, 2024 Approval Letter – SPIKEVAX
- April 19, 2024 Approval Letter – SPIKEVAX
- September 11, 2023 Approval Letter – SPIKEVAX
- September 11, 2023 Clinical Review – SPIKEVAX
- September 11, 2023 Statistical Review – SPIKEVAX
- May 9, 2023 Approval Letter – SPIKEVAX
- January 31, 2022 Approval Letter – SPIKEVAX
- January 30, 2022 Summary Basis for Regulatory Action – SPIKEVAX
- Approval History, Letters, Reviews, and Related Documents – SPIKEVAX
Spikevax Safety and Effectiveness FAQ
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Content current as of:
09/06/2024
