After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.

Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating their protein-based vaccine technology. The approval positions Novavax as the only non-mRNA COVID-19 vaccine with full FDA approval, offering a differentiated alternative amid growing mRNA fatigue.

While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the company.

Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID-19 vaccine, albeit with new conditions, which helped allay some investor concerns over the future of the shot.

The Food and Drug Administration (FDA) vaccine advisory group today recommended sticking with a monovalent JN.1 lineage vaccine for COVID vaccines for the upcoming US respiratory virus season, though the experts didn't recommend a specific sublineage.

FDA COVID vaccine update is stirring major public attention as a new policy limits fall COVID-19 booster shots to seniors and high-risk individuals. While the FDA met to decide if vaccine formulas should change for fall 2025,

WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.