Novavax's Nuvaxovid COVID-19 Vaccine Approved for US Market

Novavax's Nuvaxovid COVID-19 vaccine, the only protein-based, non-mRNA vaccine available in the US, has been approved by the FDA for the 2025-2026 vaccination season. The vaccine is indicated for individuals 65 years and older, or 12-64 years with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes. The approval is based on clinical and preclinical data showing the vaccine is safe and effective in preventing COVID-19.

The U.S. Food and Drug Administration (FDA) has approved Novavax's (NASDAQ:NVAX) Nuvaxovid™ 2025-2026 Formula, marking a significant regulatory milestone for the company. This protein-based, non-mRNA COVID-19 vaccine is the only such alternative available in the U.S., providing a differentiated option for individuals and investors alike.

Nuvaxovid™ is now approved for adults aged 65 and older and individuals 12-64 years with high-risk conditions, capturing key demographics for COVID-19 vaccination. The vaccine's effectiveness against currently circulating JN.1 lineage strains, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7, and XEC, is particularly important as these variants represent the vast majority of global infections as of July 2025 [1].

Novavax's approval activates its commercial partnership with Sanofi, where Sanofi leads commercialization while Novavax receives ongoing tiered royalties from vaccine sales. This arrangement allows Novavax to generate revenue without shouldering the full commercial infrastructure costs. The standard safety warnings regarding myocarditis/pericarditis risks are consistent with other COVID-19 vaccines and don't represent unexpected regulatory hurdles [1].

This approval reinforces Novavax's market position with a differentiated technology platform that may appeal to individuals hesitant about mRNA vaccines, potentially capturing market share in specific demographic segments seeking alternatives to established mRNA options [1].

References:
[1] https://www.stocktitan.net/news/NVAX/novavax-s-nuvaxovid-tm-2025-2026-formula-covid-19-vaccine-approved-oimbiaxts0x3.html