Novavax Gets Expanded Authorization From European Commission For COVID-19 Vaccine

The European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Novavax’s NVAX Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) for adolescents aged between 12 and 17 years.

The conditional authorization was supported by the data readout from PREVENT-19 study, a pivotal Phase 3 clinical trial evaluating the safety and efficacy of Nuvaxovid in adolescents aged 12 through 17 years across 73 sites in the United States.

Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the United States.

Stanley C. Erck, President and Chief Executive Officer, said, ”With this authorization, we are extremely pleased to be able to offer our Nuvaxovid COVID-19 vaccine to adolescents in the EU. Our protein-based vaccine was developed using an innovative approach to traditional technology and has demonstrated efficacy and safety in both adolescents and adults.”

The European regulatory agency has granted conditional marketing authorization (CMA) for Nuvaxovid to prevent COVID-19 in individuals aged 18 and over in the month of Dec, 2021.

Price Action: Novavax shares are trading about 6 percent higher at $60.53 on Tuesday at the time of publication.