Novavax, Inc. (NASDAQ:NVAX), the American biotechnology company, announced that its commercial partners have secured regulatory approvals for an updated COVID-19 vaccine across the United States, the European Union (EU), and Japan for the 2026 to 2027 vaccination season.
The regulatory clearances authorize the updated Nuvaxovid formulation to target the XFG variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ahead of the fall immunization period.
The approvals position Novavax to collect ongoing royalties on net product sales while avoiding the operational costs of maintaining its own internal commercial infrastructure.
Sanofi, the global healthcare company and primary commercial partner of Novavax, is leading distribution across most major territories, including expanded marketing in the United States and new rollouts in Canada and Germany.
Clinical findings from a Phase 4 study conducted by Sanofi demonstrated that the protein-based shot showed a favorable tolerability profile when tested head-to-head against a next-generation messenger RNA (mRNA) vaccine.
Novavax is eligible to earn continuing sales royalties under a collaboration and license agreement (CLA) originally struck with Sanofi in 2024.
Takeda, the Japanese pharmaceutical company, distributes the shot in Japan, where Nuvaxovid became the second-most used COVID-19 vaccine during the 2025 to 2026 season.
Under an agreement announced in May 2025, Novavax receives annual regulatory milestone payments alongside net sales royalties from Takeda in the Japanese market.