Nuvaxovid® Now Approved in Japan Triggering Takeda Milestone Payment

Rhea-AI Summary

Novavax (NASDAQ:NVAX) has announced that its COVID-19 vaccine Nuvaxovid® has received regulatory approval in Japan, triggering a milestone payment from Takeda. The vaccine is approved for initial immunization in ages 6+ and booster shots for ages 12+, specifically formulated to target the SARS-CoV-2 Omicron LP.8.1 variant.

The approval grants Novavax access to Japan's healthcare market, the world's third-largest. Under the collaboration agreement with Takeda, Novavax will receive undisclosed milestone payments and royalties on net sales, with a portion of the milestone payment applicable to future royalty payments.

Positive

• None.

Negative

• Specific payment amounts not disclosed due to confidentiality agreements

GAITHERSBURG, Md., Sept. 4, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced a milestone payment* from Takeda has been triggered by regulatory approval for Novavax's COVID-19 vaccine Nuvaxovid^® Intramuscular Injection 1 mL formulated to target SARS-CoV-2 Omicron LP.8.1 as an initial immunization (first and second vaccination) for those aged six years or older and a booster immunization (after the third vaccination) for those aged 12 years or older. 

"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, the third largest healthcare market in the world, while simultaneously advancing our corporate growth strategy," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We are pleased that Japan's Ministry of Health, Labour and Welfare has approved our vaccine, Nuvaxovid^®, which has a history of clinical use in many countries around the world and provides value for public health."

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

*Due to contractual confidentiality agreements, Novavax cannot share specific payment amounts. 

About Novavax
Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most significant health challenges by leveraging its scientific expertise in vaccines and its cutting-edge technology platform, including protein-based nanoparticles and its Matrix-M® adjuvant. The Company's growth strategy is focused on building new and diversified partnerships via the out-licensing of its technology platform and vaccine assets earlier in the development process. These strategic collaborations are fueled by smart investments in a growing early-stage pipeline starting with the Company's core expertise in infectious disease and potentially expanding into other disease areas. Please visit novavax.com and LinkedIn for more information.

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, the possible achievement and timing of achievement of milestone and receipt of royalties under the collaboration and licensing agreement, and our ability to operate effectively in the Japanese market, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, antigenic drift or shift in the SARS-CoV-2 spike protein, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com

Media
Giovanna Chandler
240-720-7804
media@novavax.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvaxovid-now-approved-in-japan-triggering-takeda-milestone-payment-302545744.html

SOURCE Novavax, Inc.

FAQ

What regulatory approval did Novavax (NVAX) receive in Japan?

Novavax received approval for Nuvaxovid® COVID-19 vaccine in Japan for initial immunization in ages 6+ and booster shots for ages 12+, specifically targeting the Omicron LP.8.1 variant.

What financial benefits will Novavax (NVAX) receive from the Japan approval?

Novavax will receive an undisclosed milestone payment from Takeda and ongoing royalties on net sales of Nuvaxovid in Japan.

What age groups are approved for Novavax's Nuvaxovid vaccine in Japan?

The vaccine is approved for initial immunization (first and second doses) for ages 6 and older, and as a booster shot (after third vaccination) for ages 12 and older.

How does this approval align with Novavax's corporate strategy?

The approval advances Novavax's corporate growth strategy by providing access to Japan, the third-largest healthcare market globally, while offering a non-mRNA COVID-19 vaccine option.