Request to expand conditional marketing authorization of Nuvaxovid the COVID-19 vaccine in the European Union to adolescents (Ages 12-17),- Novavax
Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced submission of its request to expand the conditional marketing authorization (CMA) of Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) in the European Union (EU) to adolescents aged 12 through 17 years.
The submission includes clinical data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase III trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Novavax' COVID-19 vaccine.
The vaccine, also known as NVX-CoV2373, achieved its primary effectiveness endpoint in the trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S.
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