Novavax Seeks CMA of COVID-19 Vax in Adolescents

Novavax, Inc. submitted a request to expand the conditional marketing authorization (CMA) of Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) in the EU for 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, 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.
 
Preliminary safety data from the pediatric expansion of PREVENT-19 showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. 
 
The European Commission granted CMA for Nuvaxovid to prevent COVID-19 in people 18 years of age and older in December 2021. Doses of Nuvaxovid began shipping to EU member states shortly thereafter.