The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, but with significant limitations. While the company’s shot had previously been available under emergency use authorization for individuals aged 12 and older, the FDA's full approval now applies only to adults aged 65 and above, or individuals between 12 and 64 who have at least one underlying health condition that increases their risk from COVID-19.
Novavax's vaccine is the only protein-based COVID-19 vaccine currently available in the U.S., offering an alternative to the mRNA vaccines produced by Pfizer and Moderna. Those two vaccines are fully licensed for individuals 12 and older and authorized for use in children as young as six months.
The FDA did not publicly elaborate on the rationale behind its restrictions in its Friday announcement. However, the decision reflects a shift in the agency's stance and appears to align with growing skepticism toward COVID-19 vaccines from some Trump administration figures, including Health Secretary Robert F. Kennedy Jr. This move comes ahead of a Centers for Disease Control and Prevention (CDC) advisory meeting next month, where experts will consider whether annual COVID-19 vaccinations should remain broadly recommended or be limited to high-risk groups.
Novavax CEO John C. Jacobs praised the FDA's decision, calling it a "significant milestone" and a key step in making the company’s traditional vaccine available to populations most likely to seek seasonal COVID-19 protection. He cited CDC data indicating that older adults and those with underlying conditions are more inclined to continue getting vaccinated.
Despite initially showing strong safety and efficacy results in a 30,000-participant clinical trial, Novavax faced delays in gaining full approval. According to sources familiar with the matter, the FDA had originally planned to grant unrestricted approval by April 1. However, the agency later requested additional post-approval studies, including investigations into potential heart-related side effects and an assessment of the vaccine’s effectiveness in lower-risk adults aged 50 to 64.
These added requirements are seen as highly unusual and mark a cautious approach to the vaccine’s broader rollout.