Moderna Announces Positive Interim Data From Phase 2/3 Study Of COVID-19 Vaccine In Young Children

(RTTNews) - Moderna Inc. (MRNA) announced positive interim data from the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the company's vaccine candidate against COVID-19, in children 6 to 11 years of Age.

The company noted that the 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.

The company plans to submit the data to the U.S. Food and Drug Administration, European Medicines Agency 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). Today Moderna reports on the 6 to under 12 years of age cohort.

According to the company, mRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 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.