Novavax COVID-19 vaccine gains FDA approval for at-risk populations: Key details for clinicians and researchers

Novavax announced a significant regulatory milestone: the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid™, its recombinant protein-based, non-mRNA COVID-19 vaccine. This development marks a pivotal addition to the U.S. COVID-19 vaccine portfolio, especially as the 2025–2026 respiratory virus season approaches. Scope of FDA approval The FDA’s approval covers: Adults aged 65 years and older Individuals aged 12 through 64 with at least one underlying health condition that increases their risk for severe COVID-19 outcomes. Qualifying conditions include asthma, cancer, diabetes, obesity, and smoking, among others. This decision is based on robust Phase 3 clinical trial data demonstrating Nuvaxovid’s efficacy and safety in preventing COVID-19, with particular value for populations at heightened risk of severe disease. Scientific and clinical significance Nuvaxovid™ is now the only protein-based, non-mRNA COVID-19 vaccine available in the United States. Its approval provides a critical alternative for individuals who cannot or prefer not to receive mRNA-based...