The European Commission has approved the extended Conditional Marketing Authorization (CMA) for Nuvaxovid, the Covid-19 vaccine, for adolescents in Europe between the ages of 12 and 17. Novavax announced it.
The decision comes after the positive opinion of 23 June last expressed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
"We are extremely pleased that Nuvaxovid, our Covid vaccine, is now also available for adolescents in Europe - comments Stanley C. Erck, president and CEO of Novavax - Our protein-based vaccine - developed using an innovative approach to traditional technology - it has shown efficacy and safety in both adolescents and adults ".
The authorization is based on data from the pediatric extension of PREVENT-19, an ongoing pivotal phase III study of 2,247 adolescents aged 12 to 17 years at 73 US sites, aimed at evaluating safety, immunogenicity and Nuvaxovid efficacy that met its primary efficacy endpoint and demonstrated an overall clinical efficacy of 80% at a time when the Delta variant was the predominant SARS-CoV-2 strain in the United States.
The vaccine, based on preliminary safety data from the study, is generally well tolerated. Serious adverse events were few and balanced between the vaccine arm and the placebo arm, and were not considered vaccine related. Local and systemic reactogenicity was generally less than or similar to that in adults after the first and second doses. The most common adverse reactions observed were injection site tenderness / pain, headache, myalgia, fatigue and malaise.
(Unioneonline / ss)
