Proper Name: COVID-19 Vaccine, mRNA
Manufacturer: Moderna Tx Inc.
- 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
- 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 11, 2023 Clinical Review - SPIKEVAX
- September 11, 2023 Statistical Review - SPIKEVAX
- September 11, 2023 Approval Letter - 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