← Back to The Docket AUG 27 2026
APPROVED · 33 DAYS AGO
— Nuvaxovid (Nuvaxovid)
$NVAX
for COVID-19 prevention
BLA
FDA approved the XFG-adapted formulation of Nuvaxovid for the 2026-2027 vaccination season on August 27, 2026. US indication restricted to adults 65 and older, or people ages 12-64 with a qualifying underlying condition. BLA holder: Novavax Inc. Commercial partners: Sanofi (US and most international markets), Takeda (Japan).
About
COVID-19 is a contagious disease caused by the coronavirus SARS-CoV-2, which spread worldwide in early 2020 and led the World Health Organization to declare a global health emergency. Nuvaxovid is a vaccine that delivers a harmless piece of the virus's spike protein, teaching the immune system to recognize and attack SARS-CoV-2. Because that spike protein is what the virus uses to enter cells, priming the body against it may help prevent COVID-19 and reduce the chance of severe illness.