FDA Advisory Committee recommends Novavax COVID-19 vaccine gain Emergency Use Authorization for adults

After considering data from a Phase 3 clinical trial of approximately 30,000 participants, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend the Novavax COVID-19 vaccine gain Emergency Use Authorization (EUA).

The Novavax COVID-19 vaccine, or NVX-CoV2373, is meant for use on individuals 18 years and older. It survived numerous clinical tests, with the most recent results pulled from participants in both the United States and Mexico participating in the PREVENT-19 Phase 3 trial. By the numbers published in the New England Journal of Medicine, the vaccine demonstrated 90.4 percent efficacy among adults and a solid safety profile. Serious and adverse side effects were low, and most of these were restricted to headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

“The advisory committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” Stanley Erck, president and CEO of Novavax, said. “In today’s VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision.”

The EUA recommendation was made by 21 VRBPAC members. One member abstained. These recommendations are weighed as the FDA makes its final decision. If authorized, this would make the Novavax COVID-19 vaccine the first protein-based COVID-19 vaccine available to the United States. However, it has already been authorized for use in individuals 18 years and older in more than 40 countries and has an Emergency Use Listing from the World Health Organization.