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Moderna announces positive top line data from phase II/III study of COVID-19 vaccine in children 6 to 11

Written by | 31 Oct 2021 | COVID-19

-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to under 12 years of age. This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile. Moderna plans to submit these data to the FDA, European Medicines Agency (EMA) and other global regulators in the near term.

KidCOVE 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). Moderna reports on the 6 to under 12 years of age cohort. This cohort enrolled 4,753 participants who were 6 to less than 12 years of age. In the trial, the SARS-Cov-2-neutralizing antibody geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase III COVE study was 1.5 (95% Cl: 1.3, 1.8), with a seroresponse rate of 99.3%, representing a difference of 0.6% (95% CI: -2.8%, 2.8%) to the Phase III benchmark. These results demonstrate strong immune response in this cohort of children one month after the second dose and met the co-primary immunogenicity endpoints for 6 to less than 12 years olds in KidCOVE.

mRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the Phase III COVE study in adolescents and adults. The majority of adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever, and injection site pain.

The enrollment for the 6 years to under 12 years is complete, but the Phase II/III study continues to enroll children ages 6 months to under 6 years of age. The Company has enrolled approximately 5,700 pediatric participants in the U.S. and Canada in the trial as a whole.

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