GHealth News – The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, but with limited use: it’s only approved for adults 65 and older, or for those 12 to 64 with underlying health conditions that raise their risk from COVID-19. Previously, Novavax’s vaccine had emergency use authorization for all individuals 12 and older.
Unlike mRNA vaccines from Pfizer and Moderna, which are fully approved for those 12+ and authorized for children as young as 6 months, Novavax uses a more traditional protein-based approach, making it unique among available options in the U.S.
The FDA did not explain the reasoning behind the unusual restrictions, though the decision aligns with skepticism from Trump administration officials, including Health Secretary Robert F. Kennedy Jr. The move comes ahead of a CDC advisory panel meeting next month, which will evaluate whether annual COVID vaccines should be recommended for everyone or just high-risk groups, suggesting a possible preemptive policy direction.
Novavax CEO John C. Jacobs emphasized that the approval supports the vaccine’s role in protecting older adults and those with health conditions, populations most likely to seek seasonal COVID-19 vaccination.
Although Novavax had demonstrated safety and efficacy in a 30,000-participant trial, and was expected to receive unrestricted approval by April 1, the FDA unexpectedly delayed its decision and requested additional post-approval trials. These include studies on potential cardiac risks and the value of vaccination in healthy 50–64-year-olds, which is a rare move for an approved vaccine.