The U.S. Food and Drug Administration (FDA) has issued full approval for a new protein-based COVID-19 vaccine aimed at seniors and younger high-risk individuals. Previously, this vaccine was authorized only for emergency use.

Nuvaxovid™ from Novavax is now approved for COVID-19 immunization for adults aged 65 and older, as well as people between the ages of 12 and 64 with at least one underlying condition putting them at high risk for severe outcomes from COVID-19. These conditions include asthma, cancer, diabetes, obesity, and smoking.

Full approval for the vaccine was based on Phase 3 clinical trial data demonstrating Nuvaxovid’s safety and efficacy in preventing COVID-19. The FDA has also requested a postmarketing Phase 4 prospective, randomized, double-blind, placebo-controlled trial to document efficacy and safety in individuals ages 50 to 64 who do not have high-risk conditions for severe COVID-19 infection. 

“Market research and U.S. CDC [Centers for Disease Control and Prevention] statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” said Novavax president and CEO.

Novavax expects to deliver the 2025–2026 vaccine formula for use this fall. The vaccine is already fully approved elsewhere, including the European Union, United Kingdom, and Canada.