FDA Grants Novavax COVID-19 Vaccine Full Approval
WASHINGTON (AP) – The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, but with significant and unusual limitations on its use.
Novavax produces the only protein-based COVID-19 vaccine currently available in the U.S., offering an alternative to the mRNA vaccines developed by Pfizer and Moderna. Until now, Novavax’s vaccine had been authorized for emergency use in individuals aged 12 and older.
On Friday, the FDA officially approved the Novavax vaccine but restricted its use to adults aged 65 and older or to individuals aged 12 to 64 who have at least one underlying health condition that increases their risk of severe COVID-19.
In contrast, the Pfizer and Moderna vaccines have full FDA approval for anyone 12 and older and are also authorized for children as young as six months.
The timing of this decision comes just ahead of a scheduled CDC advisory meeting in June, where experts will debate whether annual COVID-19 vaccinations should be recommended for everyone or only for high-risk groups. The FDA’s move may signal the direction federal health policy is headed ahead of that discussion.
Novavax CEO John C. Jacobs praised the approval and its focus on vulnerable populations.
“Research shows that older adults and people with health conditions are the most likely to seek seasonal COVID-19 vaccinations,” he said. “This approval reflects our ongoing commitment to offering a protein-based vaccine option for those who need it most.”
Despite the milestone, the FDA did not publicly explain its rationale for restricting the vaccine’s use. According to insiders familiar with the agency’s internal discussions, the FDA had originally been on track to issue unrestricted approval by April 1. However, plans changed when the agency requested that Novavax conduct additional studies post-approval—an uncommon move for a product that already passed large-scale trials.
Novavax had previously demonstrated the safety and efficacy of its vaccine in a 30,000-person clinical trial. Yet, the FDA is now requiring the company to launch several follow-up studies. One of these will examine potential links between the vaccine and certain heart conditions. Another will evaluate the effectiveness of continued vaccination among people aged 50 to 64 who do not have preexisting health risks.
This development sets Novavax apart as a more narrowly targeted option in the U.S. COVID-19 vaccine landscape and could influence future recommendations about who should receive annual booster shots.