The U.S. Food and Drug Administration (FDA) has granted full approval for Novavax's COVID-19 vaccine, but with significant restrictions that limit its use to adults 65 and older or individuals aged 12 to 64 who have at least one health condition that increases their risk from COVID-19.
The decision, announced on May 17, 2025, marks an unusual regulatory approach for the protein-based vaccine, which until now had been available under emergency authorization for anyone 12 and older. This contrasts with vaccines from competitors Pfizer and Moderna, which maintain full licensure for all individuals 12 and older, along with emergency authorization for children as young as 6 months.
Restricted Approval Raises Questions
The FDA did not provide a detailed explanation for the restrictions in its approval letter, though the decision aligns with skepticism about vaccines expressed by Health Secretary Robert F. Kennedy Jr. and other Trump administration officials. According to sources familiar with the situation, the FDA had previously been on track to grant Novavax full approval without restrictions by its April 1 target date.
John C. Jacobs, Novavax's chief executive, framed the decision positively: "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."
Additional Studies Required
In an unusual regulatory move, the FDA is requiring Novavax to conduct several post-approval studies. These include investigations into whether the vaccine might be associated with certain heart conditions and an assessment of the benefits of continued vaccination in 50- to 64-year-olds who don't have health problems that increase their COVID-19 risk.
The timing of this decision is notable, as CDC advisers are scheduled to meet next month to debate whether yearly COVID vaccines should still be recommended for everyone or only for higher-risk populations. The Novavax approval suggests the administration may have already determined its preferred approach ahead of this meeting.
Unique Vaccine Technology
Novavax's vaccine uses a traditional protein-based technology that differs from the mRNA approach employed by Pfizer and Moderna. The company originally demonstrated the vaccine's safety and efficacy in a 30,000-person clinical trial, which had previously satisfied regulatory requirements for emergency use authorization.
For patients seeking alternatives to mRNA vaccines, Novavax has represented an important option in the U.S. vaccine landscape. The protein-based formulation uses a laboratory-grown version of the coronavirus spike protein combined with an immune-boosting adjuvant.
Implications for Vaccine Access
The restricted approval could impact vaccine access for certain populations, particularly younger individuals without qualifying health conditions who might have preferred the protein-based formulation. Healthcare providers will need to adjust their vaccination protocols to comply with these new limitations.
This decision comes at a time when the U.S. is also seeing advances in other areas of medical diagnostics, including the FDA's recent approval of the first blood test to help diagnose Alzheimer's disease, highlighting the evolving landscape of medical technology and regulatory approaches under the current administration.
