Novavax has at last gained full Food and Drug Administration approval for its COVID-19 vaccine, but the OK comes with limitations not specified for other COVID shots available in the U.S.
Dubbed Nuvaxovid, the vaccine is cleared for use in people 65 years and older as well as for individuals between 12 and 64 years who have an underlying condition that puts them at higher risk of severe disease.
The vaccine, which uses an older protein technology than the mRNA shots of Pfizer and Moderna, has been available in the U.S. since 2022 under emergency use authorization.
While narrower, the approved indication is no more restrictive than what Leerink Partners analyst Daina Graybosch expects advisers to Centers for Disease Control and Prevention will recommend next month. In an April meeting, a panel of those advisers discussed adjusting their recommendations for COVID vaccination.
News of the FDA’s approval send Novavax shares higher by double digits Monday.
"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,” Novavax CEO John Jacobs said in a statement. “This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.”
An FDA approval deadline for Novavax’s shot came and went last month, as reports indicated new leaders at the FDA had intervened in the agency’s review of the company’s application.
The FDA is requiring Novavax conduct a new placebo-controlled “Phase 4” trial to assess Nuvaxovid’s safety and efficacy in people aged 50 to 64 years who are not at high risk. Late-stage testing in 2021 showed the shot to be roughly 90% effective, but Commissioner Martin Makary questioned whether that data remains relevant today, writing on the social media platform X that “new products require new clinical studies.”
The added requirement comes as vaccines more broadly get closer scrutiny under Health and Human Services Secretary Robert F. Kennedy Jr., who has for years objected to U.S. vaccination policies. The agency recently said all new vaccine applications must include data from placebo-controlled trials before approval.
Novavax’s commitments won’t restrict a commercial launch for the upcoming fall and winter seasons, according to Jefferies analyst Roger Song, who wrote in a client note that he sees the approval as a win for the company. Novavax said its ready to deliver the shot in the fall pending strain recommendations from an FDA advisory panel that’s set to meet later this week.
The approval triggers a milestone payment of $175 million from Novavax’s partner Sanofi, which signed a licensing deal last year.
