By Elsa Ohlen

Novavax finally won approval of a Covid-19 vaccine after facing setback after setback that caused the stock to plunge more than 50% in the past year.

The stock surged 20% to $8.06 in premarket trading Monday.

The vaccine, Nuvaxovid, had been available under an emergency-use authorization since July 2022. The full approval by the Food and Drug Administration could allow it to better compete with rivals such as Pfizer and Moderna.

Nuvaxovid is the U.S.'s only protein-based Covid-19 vaccine. It can be administered to anyone aged 65 or older, as well as to individuals aged 12 to 64 with at least one underlying condition. That contrasts with Moderna's Spikevax and Pfizer's and BioNTech's Comirnaty, both available to everyone over the age of 12 regardless of risk factors.

Those restrictions may reflect Washington's skepticism regarding vaccines under Secretary of Health and Human Services Robert F. Kennedy Jr., who has called Covid-19 vaccines the "deadliest vaccine ever made."

In early April, amid layoffs at the Department of Health and Human Services, including at the FDA, the regulator missed a deadline to act on a Novavax request to approve Nuvaxovid. Later that month, the drugmaker said the FDA had asked it to run a new trial after it gave the vaccine the full approval.

The approval triggers a $175 million milestone payment from France-based Sanofi under a license agreement between the two.

Write to Elsa Ohlen at elsa.ohlen@barrons.com

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May 19, 2025 09:27 ET (13:27 GMT)

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