FDA approves Novavax COVID-19 shot but with unusual restrictions [View all]
Source: AP
Updated 10:21 PM EDT, May 17, 2025
WASHINGTON (AP) — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older.
But late Friday, the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19. Vaccines made by Novavax’s competitors Pfizer and Moderna already are fully licensed for use in anyone 12 and older, and also are authorized for use in children as young as 6 months.
Next month, influential advisers to the Centers for Disease Control and Prevention were set to debate if yearly COVID vaccines still should be recommended for everyone or only certain people at higher risk. The Novavax decision suggests the Trump administration may already have decided how to proceed in advance of that meeting.
Novavax chief executive John C. Jacobs welcomed the licensure. “Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” he said.
Read more: https://apnews.com/article/novavax-covid19-vaccine-fda-a477c1aa612ceb293e70d904b46611b0
Link to FDA page on this - NUVAXOVID
Link to approval LETTER (PDF) - https://www.fda.gov/media/186545/download?attachment
This means it is no longer considered under an "Emergency Use Authorization" but is now fully licensed (and would use a "brand name" which is now "Nuvaxoivid" ).
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