Vaccine for children 6-11 years, Moderna asks for ok EU

Moderna asks for the green light in the EU for its anti-Covid vaccine for the 6-11 age group. The American company announced today that it has submitted an application to obtain the variation of the conditional marketing authorization from the European Medicines Agency EMA. Evaluation is for a 2-dose 50 microgram regimen (half the dose for later age groups) of the mRna-12731 vaccine in 6-11 year olds. Read also “We are pleased to announce the submission of this variation to EMA for the use of our Covid vaccine in children aged 6-11 in the European Union. This marks our first application for the use of the vaccine. in this age group “, says Stéphane Bancel, CEO of Moderna. “We are encouraged that the Moderna vaccine at the dose level of 50 µg has helped prevent Sars-CoV-2 infection in children – recalls – We plan to send this data to other regulatory agencies around the world. to protect this important younger population “. The Phase 2 ‘KidCove’ study of mRna-1273 is ongoing in the pediatric population aged 6 months to less than 12 years. And Moderna recently shared new data for the 6-11 age group. A vaccine efficacy of 100% was observed (using the primary case definition P301 for Covid-19) 2 weeks after the first dose of mRna-1273, the company recalls. Furthermore, for asymptomatic infection the vaccine efficacy 2 weeks after the first dose was 65%; for Sars-CoV-2 infection regardless of symptoms it was 80%. On October 24, the company also announced positive first-line data from the phase 2/3 study of the mRna-1273 vaccine in children aged 6 to 12 years: the ratio of geometric means (Gmr) of neutralizing anti-SARS antibody titers. CoV-2, which compared the response in children to the response in young adults from the Phase 3 Cove study, was 1.5, with a 99.3% seroresponse rate. The two 50 µg doses were generally well tolerated. The KidCove study is a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and efficacy of the two doses administered to healthy children 28 days apart. The study population is divided into 3 age groups (6 to less than 12 years, 2 to less than 6 years and 6 months to less than 2 years).