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.

Product Information 

• 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.

Supporting Documents 

• 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