FDA Advisory Committee Recommends Emergency Use Authorization For Novavax COVID-19 Vaccine

(RTTNews) - Novavax Inc. (NVAX) said that the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee or VRBPAC voted 21 to 0, with one abstention, to recommend that the FDA grant emergency use authorization for the company's COVID-19 vaccine, NVX-CoV2373, for individuals aged 18 years and over.

The advisory committee's recommendation is based on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico. In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.

The FDA considers the recommendations of the Committee when making decisions on Emergency Use Authorization.

If emergency use authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S.

The Novavax COVID-19 vaccine has received authorization for use in individuals aged 18 and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization.