The FDA has approved the Biologics License Application for Nuvaxovid (NVX-CoV2373), the first recombinant protein-based COVID-19 vaccine, for use in adults aged 65 years and older and in individuals aged 12 through 64 years with at least one underlying condition associated with increased risk for severe COVID-19.
The approval is based on Phase 3 clinical trial data demonstrating the vaccine’s safety and efficacy in preventing COVID-19. Nuvaxovid contains a recombinant SARS-CoV-2 spike protein and is adjuvanted with Matrix-M to enhance the immune response. It is supplied as a ready-to-use liquid formulation and stored at 2°C to 8°C, supporting broad distribution through standard refrigeration.
Pending strain selection by the FDA, the companies expect to be ready to deliver the 2025–2026 formulation later this year.
As part of the approval, the FDA has requested an additional postmarketing commitment: a Phase 4 randomized, double-blind, placebo-controlled clinical trial evaluating safety and efficacy in adults aged 50 through 64 years who do not have underlying high-risk conditions. Novavax and Sanofi are evaluating funding and operational planning for the study.
Reported adverse reactions include injection site tenderness, headache, fatigue, myalgia, fever, and nausea. The vaccine is contraindicated in individuals with a history of severe allergic reactions to any component of the vaccine or to a previous dose. Risks identified during postmarketing surveillance include myocarditis, pericarditis, and syncope following injection. Immunocompromised individuals may experience reduced vaccine efficacy, and effectiveness is not guaranteed for all recipients.
Nuvaxovid has been available in the United States under Emergency Use Authorization since July 2022. It has also received full market approval in the European Union, United Kingdom, Japan, Canada, Australia, Taiwan, and Singapore. The vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in approved populations. Adverse events may be reported to Novavax or through the Vaccine Adverse Event Reporting System (VAERS).
Source: Novavax Inc.