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Novavax Reports FDA's Vaccines, Related Biological Products Advisory Committee Will Review Co.'s COVID-19 Vaccine At A Meeting Scheduled For Jun. 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

Benzinga · 04/29/2022 11:09

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) will review NVX-CoV2373 COVID-19 Vaccine (recombinant, adjuvanted) for active immunization against SARS-CoV-2 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.

"We continue to hear from physicians, healthcare organizations, and consumers who are anxiously awaiting another vaccine option. We believe our vaccine, built on a well-understood protein-based vaccine platform, can play a part in fulfilling this need," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We look forward to a productive VRBPAC meeting and will continue to work with the FDA throughout the review process."

Novavax submitted a request to the FDA for Emergency Use Authorization (EUA) for NVX-CoV2373 in January 2022 based on the totality of pre-clinical, clinical, and manufacturing-related data provided to the agency.