Novavax secures full US approval for COVID-19 vaccine

19 May 2025

After a prolonged wait, American company Novavax (Nasdaq: NVAX) has received full approval from the US regulator for its protein-based COVID-19 vaccine, Nuvaxovid (COVID-19 vaccine, adjuvanted).

The Food and Drug Administration  green light arrives more than six weeks after the original decision deadline, and the authorization is notably narrower than those granted to mRNA vaccines.

Nuvaxovid is now cleared for adults aged 65 and over, as well as those aged 12 to 64 who have at least one underlying health condition that increases their risk of severe COVID-19. This stands in contrast to the broader approvals for Moderna’s (Nasdaq: MRNA) Spikevax and Pfizer (NYSE: PFE) and BioNTech’s (Nasdaq: BNTX) Comirnaty, both of which are available to all individuals 12 and older, regardless of risk factors.

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