Novavax Inc. said Tuesday that the European Commission has approved the expanded conditional marketing authorization of Nuvaxovid NVX-CoV2373 Covid-19 vaccine in the EU for adolescents aged 12 through 17.
The approval follows the positive recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use on June 23.
The authorization was based on data from the ongoing pediatric expansion of a Phase 3 trial of Nuvaxovid in the U.S. Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy at a time when the Delta variant was the predominant strain in the U.S., the company said.
NVX-CoV2373 hasn't been authorized for use in the U.S., and the trade name Nuvaxovid hasn't been approved by the U.S. Food and Drug Administration.
Novavax shares rose 6% to $60.67 after finishing Friday's session up 11%.
