SPIKEVAX
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).
SPIKEVAX is approved for use in individuals who are:
- 65 years of age and older, or
- 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
- Package Insert - SPIKEVAX
- Patient Package Insert - SPIKEVAX
- Demographic Subgroup Information – COVID-19 Vaccine, mRNA (SPIKEVAX).
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.
- September 26, 2025 Chair Review Memorandum - SPIKEVAX
- August 27, 2025 Approval Letter - SPIKEVAX
- August 26, 2025 Center Director Decisional Memo - SPIKEVAX
- July 9, 2025 Center Director Decisional Memo - SPIKEVAX
- July 9, 2025 Approval Letter - SPIKEVAX
- July 9, 2025 Clinical Review Memo - SPIKEVAX
- July 9, 2025 Statistical Review - SPIKEVAX
- June 25, 2025 Approval Letter - SPIKEVA
- January 27, 2025 Approval Letter - SPIKEVAX
- 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
- Letters, Reviews, and Related Documents - SPIKEVAX
Spikevax Safety and Effectiveness FAQ