On Jun. 7, 2021, Moderna announced announced that it had submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a 50 μg 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 is 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% (95% CI: .16, .85). For SARS-CoV-2 infection regardless of symptoms, vaccine efficacy was 80% (95% CI: .62, .90) 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.

The KidCOVE study is a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and effectiveness of two 50 μg doses of mRNA-1273 given to healthy children 28 days apart. The study population is divided into 3 age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years). The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). On July 23, 2021, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.