Novavax today announced that the US Food and Drug Administration (FDA) has approved full licensure for its COVID-19 vaccine, Nuvaxovid, which had been used since July 2022 under an emergency use authorization. 

The FDA, however, provided a narrowed approval, 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. In its approval letter, the FDA did not specify the underlying conditions.

The FDA 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 said the request is in addition to earlier agreed-upon postmarketing study requirements that are routinely required for COVID vaccine makers. The company said it is working closely with Sanofi to assess funding and execution of the new trial. 

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. Drug regulators in several other countries have already fully approved the vaccine, including the European Union, United Kingdom, Japan, Canada, Australia, Taiwan, and Singapore, without the FDA’s restrictions.

Delays, extra steps cloud future of COVID vaccines

When Novavax submitted its application for full licensure, the FDA set an April 2025 approval date. In early April, an FDA deputy commissioner asked for more data on the vaccine, 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, narrowed approval, and extra study steps raise concerns about the status of and potential added requirements for other COVID vaccines, with the FDA’s vaccine advisory group set to meet on May 22 to discuss the vaccine strains for versions that manufacturers will produce for the US market for the fall and winter season.

Novavax said it expects to be ready for the commercial delivery of the 2025-26 vaccine in the fall through its partnership with Sanofi and pending the strain recommendation by the FDA Vaccines and Related Biological Products Advisory Committee later this week.

In a related development, the World Health Organization (WHO) COVID vaccine advisory group last week announced its recommendation, that current vaccine strains, such as JN.1 or KP.2, are still appropriate for monovalent vaccines, but LP.8.1 is a suitable alternative.