08:32 AM EDT, 05/19/2025 (MT Newswires) -- (Updates with information throughout.)

Novavax ( NVAX ) said Monday that the US Food and Drug Administration has approved the Biologics License Application for its COVID-19 vaccine Nuvaxovid.

The FDA approved the vaccine for patients aged 65 and older, as well as patients aged 12 through 64 who have underlying medical conditions, the company said.

The approval is a "significant milestone," Novavax ( NVAX ) Chief Executive John Jacobs said in a statement.

The company also said the FDA has requested a new postmarketing commitment to conduct a phase 4 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 French pharmaceutical firm Sanofi ( SNY ) to assess funding and execution of the phase 4 trial.

Novavax ( NVAX ) shares were more than 19% higher in recent premarket trading.