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

• Active immunization against coronavirus disease 2019 (COVID-19) caused by the SARS‑CoV-2 virus in persons 18 years of age and older.

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.

Supporting Documents

• January 31, 2022 Approval Letter - SPIKEVAX
• January 30, 2022 Summary Basis for Regulatory Action - SPIKEVAX
• Approval History, Letters, Reviews, and Related Documents - SPIKEVAX

Related Information

• Q&A for Spikevax (COVID-19 Vaccine mRNA)