Nuvaxovid COVID-19 vaccine conditionally authorized in the European Union for adolescents aged 12 through 17 years.
Novavax, Inc. announced that the European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17.
The approval follows the positive recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use on June 23, 2022.
The authorization was based on 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 Nuvaxovid. In the trial, 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 U.S. Preliminary safety data from the trial showed the vaccine to be generally well-tolerated.
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