Novavax, COVID-19 and FDA
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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.
The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.
Covid shots are facing greater scrutiny from top federal health officials like RFK Jr. and the FDA's Marty Makary.
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.