SPIKEVAX

STN: 125752
Proper Name: COVID-19 Vaccine, mRNA
Tradename: SPIKEVAX
Manufacturer: Moderna Tx, Inc
Indication:

• SPIKEVAX is a vaccine indicated 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

• 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)