Novavax on Thursday filed an application to extend approval of its coronavirus vaccine to adolescents in the EU.
The vaccine, which was approved for use in adults in the EU in December, was the first protein-based COVID-19 vaccine to be approved in the EU. In a statement Thursday, Novavax said it had submitted an application to the European Medicines Agency to extend conditional marketing authorization of its vaccine, called Nuvaxovid, to young people between the ages of 12 and 17.
“We continue to see spikes in COVID-19 across Europe and recognize the need to improve immunization rates, particularly among children,” said Stanley C. Erck, CEO of Novavax. “We look forward to a decision from the European Medicines Agency and strongly believe in the value of diversified vaccine options.”
The request contains data from an ongoing study of the vaccine in teenagers in the United States, which the drugmaker says showed 80 percent effectiveness at a time when the Delta variant was the dominant strain in the United States
Novavax said in December that its vaccine was effective in both adults and adolescents against the Omicron variant. The US company, which had never marketed a vaccine before, now has approvals for its coronavirus shot from regulators in multiple regions. However, it has yet to give the green light in the US
https://www.politico.eu/article/novavax-eu-approve-coronavirus-vaccine-adolescents/?utm_source=RSS_Feed&utm_medium=RSS&utm_campaign=RSS_Syndication Novavax asks EU to approve youth coronavirus vaccine - POLITICO