Novavax Receives Japan Approval for COVID-19 Vaccine, Triggers Payment from Takeda

Novavax received regulatory approval in Japan for its COVID-19 vaccine, Nuvaxovid, resulting in a milestone payment from Takeda. The approval covers the Nuvaxovid Intramuscular injection, a 1 mL dose for adults 18 years and older. Novavax is a US-based biotech company, while Takeda is a Japanese multinational pharmaceutical company.

GAITHERSBURG, Md., Sept. 4, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a US-based biotech company, has received regulatory approval in Japan for its COVID-19 vaccine, Nuvaxovid. This approval has triggered a milestone payment from Takeda (NYSE: TAK), a Japanese multinational pharmaceutical company. The approval covers the Nuvaxovid Intramuscular injection, a 1 mL dose designed to combat the SARS-CoV-2 Omicron variant LP.8.1, for adults 18 years and older.

The approval marks a significant milestone for Novavax, as it expands the availability of its protein-based, non-mRNA COVID-19 vaccine option in Japan, the third largest healthcare market globally. The vaccine is intended for initial immunization and booster shots for adults, providing a valuable addition to Japan's public health arsenal.

Novavax is eligible to receive royalties on net sales of Nuvaxovid from Takeda during this vaccination season. A portion of the milestone payment can be credited towards future royalty payments, reflecting the updated and significantly improved terms of their collaboration and licensing agreement, announced earlier this year.

John C. Jacobs, President and Chief Executive Officer of Novavax, stated, "By achieving this milestone in our agreement with Takeda, we are ensuring access to a protein-based, non-mRNA COVID-19 vaccine option in Japan, while simultaneously advancing our corporate growth strategy. We are pleased that Japan's Ministry of Health, Labour and Welfare has approved our vaccine, which has a history of clinical use in many countries around the world and provides value for public health."

The milestone payment, while not disclosed due to contractual confidentiality agreements, is part of Novavax's ongoing efforts to expand its vaccine portfolio and strengthen its partnership with Takeda. The approval of Nuvaxovid in Japan further solidifies Novavax's position in the global vaccine market and underscores the potential of its technology platform.

References:
[1] https://seekingalpha.com/news/4492295-novavax-gets-japan-nod-for-its-covid-19-vaccine-triggers-takeda-payment
[2] https://ir.novavax.com/press-releases/2025-09-04-Nuvaxovid-R-Now-Approved-in-Japan-Triggering-Takeda-Milestone-Payment
[3] https://www.marketscreener.com/news/nuvaxovid-now-approved-in-japan-triggering-takeda-milestone-payment-ce7d59d8d88ff126