FDA Grants Full Approval To Novavax’s COVID-19 Vaccine, But With New Restrictions

May 19, 2025

The AP (5/17, Neergaard) reported that the FDA “has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions.” The AP added, “Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from [the] FDA for use in anyone 12 and older.” However, “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.” Also covering the story were the New York Times (5/17, Jewett, Mandavilli), Reuters (5/18, Erman, Shah, Singh), CNN (5/17, Dillinger).