The Food and Drug Administration has officially approved Novavax’s Covid-19 vaccine, albeit with certain restrictions that differentiate it from its competitors in the U.S. market. The much-anticipated approval comes with a limitation on the vaccine’s use, specifically targeting individuals aged 65 and older, as well as those aged 12 to 64 who have underlying medical conditions that put them at a higher risk of severe illness if infected with Covid-19. This approval marks a significant milestone for Novavax, as the vaccine was previously available under an emergency use authorization.
The FDA’s decision to approve the Novavax vaccine comes after missing an April 1 deadline to review the application. Reports suggest that political appointees in Commissioner Marty Makary’s office overruled career staff who had recommended issuing the license. This delay and subsequent approval with restrictions have had an impact on Novavax’s stock price, which has seen a 21% decline since the beginning of the year.
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