STAT+: Novavax wins narrowed approval for its Covid-19 shot after delay
Covid shots are facing greater scrutiny from top federal health officials like RFK Jr. and the FDA's Marty Makary.
The Food and Drug Administration has finally approved Novavax’s Covid-19 vaccine, but in doing so has placed restrictions on it that its two competitors in the U.S. market do not face.
The long-awaited license limits use of the vaccine to people 65 and older and people aged 12 to 64 who have at least one medical condition that puts them at higher risk of severe illness if they contract Covid. The vaccine has been available under an emergency use authorization.
The FDA missed an April 1 deadline to rule on Novavax’s application. It was reported that political appointees in Commissioner Marty Makary’s office overrode career staff, who recommended issuing the license. Novavax’s stock price is down 21% since the start of the year.
