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Results are the first from pivotal study in children aged six years to under 12 years
Two 50 μg doses of mRNA-1273 were generally well tolerated and showed robust neutralizing antibody titers; primary immunogenicity endpoints were met
Moderna plans to submit results to the U.S. FDA, EMA and regulatory agencies around the world soon
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today 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 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 U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the near term.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
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
