Japan’s Ministry of Health, Labour and Welfare has granted regulatory approval to Novavax’s protein-based COVID-19 vaccine, Nuvaxovid, for broad use in the country, marking a major entry for the U.S. biotech into the world’s third-largest healthcare market. This authorization covers Nuvaxovid’s latest 1 mL intramuscular formulation, which specifically targets the SARS-CoV-2 Omicron LP.8.1 variant. The vaccine is approved for primary immunization in individuals aged six years or older and as a booster for those aged 12 and above.
The regulatory approval immediately triggered a significant milestone payment from Takeda Pharmaceutical Company, Novavax’s Japanese partner. While the exact financial details remain confidential, the payment is part of a broader, recently updated collaboration and licensing agreement between Novavax and Takeda negotiated earlier in 2025. The agreement ensures Novavax will earn royalties on the net sales of Nuvaxovid during this vaccination season; a portion of this milestone payment is also allowed to be credited toward future royalties.
The development provides Japanese citizens with a non-mRNA, protein-based alternative for COVID-19 vaccination amid the ongoing evolution of the pandemic. “By achieving this milestone, we are ensuring access to a protein-based COVID-19 vaccine option in Japan and advancing our corporate growth strategy,” said Novavax CEO John C. Jacobs.
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