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. Product Information 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. Latest Safety Information FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination June 25, 2025 Supporting Documents 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 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 Approval History, Letters, Reviews, and Related Documents - SPIKEVAX Spikevax Safety and Effectiveness FAQ Spikevax (COVID-19 Vaccine, mRNA)