Novavax, Inc. (Nasdaq: NVAX) announced that its partners have received regulatory approvals for an XFG variant-targeted formulation of Nuvaxovid for the 2026-2027 COVID-19 vaccination season in the U.S., European Union, and Japan, according to a company press release.

Sanofi, Novavax's largest partner, leads commercial activities for Nuvaxovid across most major markets. For the upcoming season, Sanofi plans to expand its U.S. marketing campaign and launch the vaccine in Germany, Canada, and other international markets. Novavax is eligible to receive royalties on net sales under a 2024 collaboration and license agreement with Sanofi.

Takeda commercializes Nuvaxovid in Japan, where the vaccine ranked as the second-most used COVID-19 vaccine during the 2025-2026 season. Delivery volumes and the number of sites receiving the vaccine increased year over year. Under terms announced in May 2025, Novavax earns annual milestones tied to regulatory approvals and royalties on net sales from Takeda.

"With these approvals, Novavax is eligible for continued royalties on partner sales without carrying commercial infrastructure of our own," said John C. Jacobs, President and Chief Executive Officer of Novavax.

Nuvaxovid is a protein-based, non-mRNA vaccine that uses Novavax's recombinant nanoparticle technology combined with its Matrix-M adjuvant. The vaccine is stored at 2° to 8°C and packaged in pre-filled syringes. Sanofi's Phase 4 COMPARE study, a head-to-head evaluation of Nuvaxovid against a next-generation mRNA COVID-19 vaccine, reported a favorable tolerability profile for Nuvaxovid.