FDA Confirms Vaccines and Related Biological Products Advisory Committee Review of Novavax’ COVID-19 Vaccine on June 7, 2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has confirmed it will review the Novavax COVID-19 vaccine (NVX-CoV2373) for active immunization against SARS-CoV-2 in individuals 18 years of age and over at a meeting scheduled for June 7, 2022. VRBPAC reviews and evaluates data regarding the safety and efficacy of vaccines and related biological products that are intended for use in the prevention, treatment, or diagnosis of human diseases.
Novavax submitted a request to the FDA for Emergency Use Authorization in January 2022.
Authorization in the U.S.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid™ has not yet been approved by the U.S. FDA.