FDA

FDA approves Nuvoxavid 2025-26 COVID-19 vaccine formulation

August 28, 2025

On August 27, 2025, FDA approved the 2025-2026 formulation of Nuvaxovid (COVID-19 vaccine, adjuvanted) for the prevention of COVID-19 in individuals ≥65 years of age, or 12 years through 64 years of age with ≥1 underlying condition that puts them at high risk for severe outcomes from COVID-19.

In a press release, Novavax said that clinical and preclinical data had previously shown that Nuvaxovid is safe and effective for the prevention of COVID-19. These data confirm that vaccination with the JN.1 strain induces immunity across currently circulating JN.1 lineage strains, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7 and XEC.

Sources:

Novavax’s Nuvaxovid™ 2025-2026 formula COVID-19 vaccine approved in the US. [News release]. 2025. https://ir.novavax.com/press-releases/2025-08-27-Novavaxs-Nuvaxovid-TM-2025-2026-Formula-COVID-19-Vaccine-Approved-in-the-U-S