Novavax submitted request to expand conditional Marketing Authorization of COVID-19 vaccine in the EU to adolescents
On Mar. 31, 2022, Novavax announced submission of its request to expand the conditional marketing authorization (CMA) of Nuvaxovidル COVID-19 Vaccine (recombinant, adjuvanted) in the European Union to adolescents aged 12 through 17 years.
The submission includes clinical data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 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.
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Source: Novavax
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