Novavax, Inc. (NVAX) announced submission of the company's request to expand the conditional marketing authorization of Nuvaxovid COVID-19 Vaccine 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 phase 3 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S.
Novavax expects to begin rolling submissions of regulatory filings in this age group to additional regulatory authorities worldwide.
The European Commission granted CMA for Nuvaxovid in people 18 years of age and older in December 2021.
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