The U.S. Food and Drug Administration (FDA) grants emergency use authorization (EUA) to Novavax’s NVAX lead candidate Adjuvanted (NVX-CoV2373) COVID-19 Vaccine for individuals 18 years of age and over.
The adjuvanted (NVX-CoV2373) vaccine is tested to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and over.
The FDA grant was supported by the data readout from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and over in the U.S. and Mexico.
Stanley C. Erck, President and Chief Executive Officer, said, “Today’s FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine, This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”
The company underscored that its Covid-19 vaccine is the first protein-based COVID-19 vaccine authorized in the United States.
Price Action : Novavax shares are trading down around 2 percent at $68.78 on Wednesday after-hours session.