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Novavax has submitted a request Thursday to expand the authorization 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 jab to be authorized in the bloc. In a statement Thursday, Novavax said it had submitted a request to the European Medicines Agency to expand the conditional marketing authorization of their vaccine, called Nuvaxovid, to young people aged between 12 and 17.
“We are continuing to see spikes in COVID-19 across Europe and recognize the need to improve vaccination rates, particularly in the pediatric population,” said Stanley C. Erck, Novavax’s CEO. “We look forward to a decision from the European Medicines Agency and firmly believe in the benefit of diversified vaccine options.”
The request includes data from an ongoing trial of the jab in teenagers in the U.S., which the drugmaker said demonstrated 80 percent efficacy at a time when the Delta variant was the dominant strain in the U.S.
Novavax said in December that its jab was effective against the Omicron variant in both adults and teenagers. The U.S. company, which had previously never launched a vaccine, now has approvals for its coronavirus jab from regulators in multiple regions. However, it’s yet to get the green light in the U.S.
Source: Politico
