10:40 AM EDT, 05/19/2025 (MT Newswires) -- Novavax ( NVAX ) on Monday said it received approval from the US Food and Drug Administration for its Nuvaxovid COVID-19 vaccine.

The FDA approved the firm's biologics license application for the product for adults aged 65 and older, as well as for individuals 12 through 64 years with at least one underlying condition that puts them at high risk of severe illnesses from COVID-19.

The BLA approval was based on data from a phase three clinical study, which showed that the vaccine was safe and effective in preventing COVID-19, according to Novavax ( NVAX ). The company's stock climbed 8% in intraday trading.

"Market research and US (Centers for Disease Control and Prevention) statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally," Novavax ( NVAX ) Chief Executive John Jacobs said in the statement. "This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."

Nuvaxovid gained authorization for emergency use in the US in July 2022 and has full market approvals in the European Union, the UK, Japan, Canada, Australia, Taiwan, and Singapore.

The BLA approval activates a $175 million milestone payment to the company from French drugmaker Sanofi ( SNY ) . In May 2024, the two companies entered into a collaboration and license agreement to co-commercialize Novavax's ( NVAX ) adjuvanted COVID-19 vaccine and develop combination vaccines that also protect against influenza.

Sanofi ( SNY ) will lead on the commercialization of the vaccine beginning this year. Novavax ( NVAX ) will be eligible to receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales for all future vaccination seasons, the company said.

Novavax ( NVAX ) expects to be ready for the commercial delivery of the vaccine formula in the US for the 2025-2026 season this fall, subject to strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting on Thursday.

Additionally, the FDA requested a new post-marketing commitment to conduct a phase four trial of Nuvaxovid in people aged 50 through 64, who do not have high-risk conditions for severe COVID-19. Novavax ( NVAX ) said it is working with Sanofi ( SNY ) to evaluate funding and execution of the proposed new study.

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