Novavax Receives Full Licensure From FDA for Use in All Adults Aged 65 or Older

The FDA has approved full licensure for Novavax’s COVID-19 vaccine, Nuvaxovid, which had been used since July 2022 under an emergency use authorization. CIDRAP has the news.

The FDA’s approval was narrowed, “limiting use to people ages 65 years and older and people ages 12 to 64 years old who have underlying health conditions that put them at greater risk for severe disease.” The FDA did not specify the underlying conditions. The agency has also requested a “post-approval randomized, double-blind, placebo-controlled efficacy and safety study in people ages 50 to 65 who don’t have high-risk conditions.”

Novavax’s vaccine is the “only protein-based option and contains the Matrix M adjuvant, which boosts a person’s immune response. It is indicated for use in people ages 12 and older. An FDA deputy commissioner asked Novavax for more data on the vaccine shortly after it submitted its application for full licensure in April, which was “an unusual step given that FDA staff typically reviews and manages the massive amounts of data that support product reviews, a process designed to shield the deliberations from political interference.”

The delay, in addition to the “narrowed approval and extra study steps,” have raised “concerns about the status of and potential added requirements for other COVID vaccines.”