NUVAXOVID
STN: 125817
Proper Name: COVID-19 Vaccine, Adjuvanted
Tradename: NUVAXOVID
Manufacturer: Novavax, Inc.
Indication:
NUVAXOVID 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).
NUVAXOVID is approved for use in individuals who are:
- 65 years of age and older, or
- 12 years 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 and Patient Package Insert - NUVAXOVID
- Demographic Subgroup Information – COVID-19 Vaccine, Adjuvanted (NUVAXOVID)
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.
- August 27, 2025 Approval Letter - NUVAXOVID
- August 26, 2025 Center Director Decisional Memo- NUVAXOVID
- Center Director Decisional Memo - NUVAXOVID
- May 16, 2025 Approval Letter - NUVAXOVID
- May 16, 2025 Addendum Memo to the Summary Basis for Regulatory Action (SBRA) - NUVAXOVID
- April 1, 2025 Summary Basis for Regulatory Action - NUVAXOVID
- Letters, Reviews, and Related Documents - NUVAXOVID