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07 June 2021 The company Moderna has applied to the European Medicines Agency EMA for the authorization of use for adolescents for its COVID-19 vaccine, the company said, noting that the request is based on the phase study 2/3 of the vaccine (mRNA-1273) in adolescents aged 12 to less than 18 years in the United States. In the nearly 2,500 adolescents who received it, Moderna recalls, "vaccine efficacy equal to 100% was observed when the same case definition from the Phase 3 COVE study in adults was used."
Moderna therefore announces that it has filed the request for the conditional commercialization in the European Union of its COVID-19 Vaccine for adolescents. The company also recalls that a 93% vaccine efficacy was observed in seronegative participants starting 14 days after the first dose. Moderna's COVID-19 vaccine was generally well tolerated with a safety and tolerability profile consistent with the COVE phase 3 study in adults.
The company has also filed its application for authorization in Canada and will submit its emergency use authorization application to the United States FDA.
"We are pleased to announce that we have submitted to the European Medicines Agency (EMA) the request for approval of the conditional marketing of our COVID-19 Vaccine for use in adolescents," said Stéphane Bancel, Moderna's Chief Executive Officer. encouraged that Moderna's COVID-19 Vaccine is highly effective in preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have also applied for clearance from Health Canada and will be applying for emergency clearance from US FDA and regulatory agencies around the world for this important population group. We remain committed to doing our part to help end the COVID-19 pandemic. "