FDA Panel To Review Novavax COVID-19 Vaccine In June

(RTTNews) - The U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee or VRBPAC will review Novavax Inc.'s (NVAX) NVX-CoV2373 COVID-19 vaccine (recombinant, adjuvanted) for active immunization against SARS-CoV-2 at a meeting scheduled for June 7, 2022, the company said in a statement on Friday.

The company noted that NVX-CoV2373 would be the first protein-based COVID-19 vaccine to be reviewed by VRBPAC in the U.S.

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 for NVX-CoV2373 in January 2022 based on the totality of pre-clinical, clinical, and manufacturing-related data provided to the agency.