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.

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 U.S. Food and Drug Administration is warning that certain half-shell oysters that are frozen and raw harvested in South Korea may be potentially contaminated with norovirus.

The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

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.