Moderna has asked the EMA for the green light for its anti-Covid vaccine in the 12-17 age range. This was announced by the same company, which explains that it has already filed the application for the conditional authorization for the marketing in the EU of its vaccine for adolescents between 12 and under 18 years of age.
The request is based on the phase 2/3 study of the mRna-1273 vaccine conducted in adolescents in the USA. In the nearly 2,500 who received shield injection in the trial, “100% effectiveness was observed when using the same case definition from the Phase 3 Cove study in adults,” recalls the American society in a note.
A 93% vaccine efficacy was also observed in seronegative participants starting 14 days after the first dose, using the secondary case definition of Covid-19 used by the Centers for Disease Control and Prevention ( Cdc), who tested a milder disease “. Moderna’s vaccine was generally “well tolerated, with a safety and tolerability profile generally consistent with the Phase 3 Cove study in adults.”
“We have also applied for authorization from Health Canada and will apply for emergency clearance from the US FDA and regulatory agencies around the world for this important segment of the population,” said Stéphane Bancel, CEO of Modern American, whose mRna Covid vaccine is currently approved for ages 18 and up. “We are also pleased to announce” that we have submitted to the European Medicines Agency Ema the request for the conditional marketing approval of our Covid-19 vaccine for use in adolescents “under 18.” We are encouraged that our vaccine is highly effective in preventing Covid-19 and Sars-CoV-2 infection in adolescents, “he added. “We remain committed to doing our part to help end the pandemic.”