Novavax Stock Rips 23% After FDA Approves COVID-19 Vaccine, Analysts Say Restrictions On Expected Lines

Shares of pharmaceutical giant Novavax surged over 23% on Monday morning after the company’s COVID-19 vaccine bagged a long-awaited approval from the U.S. Food and Drug Administration (FDA).

While the FDA added age-specific restrictions to the vaccine use, analysts noted that it is on expected lines.

According to a Reuters report, BTIG analyst Thomas Shrader said that although the FDA conditions on the label are unusual, they are consistent with chatter so far.

Meanwhile, Leerink Partners analysts also had similar views and said that the FDA conditions are “no more restrictive than we expected.”

People aged between 12 and 64 are also allowed to use the vaccine, provided they have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Novavax CEO John C. Jacobs called the approval a “significant milestone” as the company seeks to make its protein-based COVID-19 vaccine commercially available.

"Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” he said.

The FDA approval was based on Phase 3 clinical trial data that demonstrated the effectiveness of the Nuvaxovid vaccine.

However, the agency has also sought a postmarketing commitment from Novavax for Phase 4 trials in individuals aged 50 to 64 for severe COVID-19.

FDA’s approval of Nuvaxovid has also triggered a $175 million milestone payment from Sanofi to Novavax, based on a May 2024 agreement between the companies.

Novavax said it is eligible to receive royalties from sales of the COVID-19 vaccine for all future vaccination seasons.

The company said it expects Nuvaxovid, based on the 2025-26 COVID-19 vaccine formula, to be available for commercial use this fall.

The vaccine has been available under the U.S. government’s Emergency Use Authorization since 2022. It is available across the U.S., U.K., European Union, Japan, Canada, Australia, Taiwan, and Singapore.

Novavax’s stock has declined by over 16% in 2025 so far.

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Editor's note: This story has been updated with analyst commentary on the vaccine.