Novavax Nuvaxovid secures 3-market approvals as protein vaccine gains ground

Novavax's partners won approvals for the XFG-adapted Nuvaxovid in the U.S., EU and Japan for the 2026-27 season, the company said Aug. 28.

"Sanofi and Takeda are well-positioned for this commercial season, with Sanofi expanding its U.S. campaign and launching in additional markets," John C. Jacobs, president and chief executive officer of Novavax, said.

Under the 2024 collaboration and license agreement, Novavax earns royalties on Sanofi's net sales across most major markets. Takeda, which commercializes Nuvaxovid in Japan, made the vaccine the second-most used COVID-19 shot there in the 2025-26 season, with delivery volumes and vaccination sites rising year over year. Novavax also earns annual milestones tied to regulatory approvals under its May 2025 agreement with Takeda.

The approvals let Novavax collect royalties without carrying its own commercial infrastructure, a model the company says creates value. COVID-19 remains a public health challenge among older adults and high-risk populations, and the protein-based, non-mRNA option gives providers an alternative to mRNA shots from Pfizer and BioNTech and Moderna.

Sanofi's Phase 4 COMPARE study, a head-to-head evaluation of Nuvaxovid against a next-generation mRNA COVID-19 vaccine, showed Nuvaxovid's favorable tolerability profile, a factor the company says matters to providers and patients choosing shots.

The vaccine is protein-based, made by creating copies of the SARS-CoV-2 spike protein, and uses Novavax's Matrix-M adjuvant to enhance the immune response. It is packaged in pre-filled syringes and stored at 2 to 8 degrees Celsius, allowing use of existing cold-chain channels.

The approvals follow the U.S. Food and Drug Administration's selection of the XFG variant as the preferred COVID-19 vaccine composition for fall 2026. Pfizer and BioNTech's COMIRNATY, also adapted to XFG, won FDA approval Aug. 27 for adults 65 and older and high-risk individuals ages 5 to 64, with more than five billion doses distributed globally to date.

Sanofi, Novavax's largest partner, leads Nuvaxovid commercialization across most major markets and plans launches in Germany, Canada and other international markets from 2026 onward.

The approvals confirm Novavax's royalty-based model can generate revenue without a sales force, a key test for holders watching the company's shift from direct commercialization. Investors will track Sanofi's U.S. campaign and Takeda's Japan rollout through the fall season for signs of market share gains against mRNA rivals.

This article is for informational purposes only and does not constitute investment advice.