Moderna said,"We are pleased to announce that we have submitted for conditional marketing approval of our COVID-19 vaccine with the European Medicines Agency for use in adolescents in the European Union,"“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
We have filed for authorization with Health Canada and we will file for an Emergency Use Authorization with the U.S. FDA and regulatory agencies around the world for this important younger age population.
We remain committed to doing our part to help end the COVID-19 pandemic."In May, the Company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary.