On Nov. 9, 2021, Moderna announced that it has submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a 50 ﾵg two-dose series of mRNA-12731 in children ages 6-11 years.

The Phase 2 “KidCOVE” study of mRNA-1273 in pediatric population ages 6 months to under 12 years was ongoing. Moderna recently shared new data from the KidCOVE study of mRNA-1273 in children ages 6 years to under 12 years. Vaccine efficacy of 100% using the P301 primary case definition for COVID-19 was observed two weeks after the first dose of mRNA-1273 at the 50 µg dose level. Additionally, for asymptomatic infection two weeks after the first dose, vaccine efficacy was 65%. For SARS-CoV-2 infection regardless of symptoms,​ vaccine efficacy was 80% two weeks after the first dose.

On October 24, the Company announced positive top line top line data from the Phase 2/3 study of mRNA-1273 in children 6 to under 12 years of age. Geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 μg doses of mRNA-1273 were generally well tolerated.