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Monday, January 31, 2022

Novavax Requests Emergency Use Authorization for COVID-19 Vaccine

  Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.

https://finance.yahoo.com/news/novavax-submits-request-u-fda-184200011.html

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