Children Can Participate in mRNA Vaccine Study
Massachusetts-based Moderna Inc. announced that the first participants had been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the Company’s vaccine candidate against COVID-19, in children ages 6 months to less than 12 years.
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada, and we thank NIAID and BARDA for their collaboration,” stated Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.
This Phase 2/3 two-part, open-label, dose-escalation, age de-escalation (Part 1), and randomized, observer-blind, placebo-controlled expansion study (Part 2) will evaluate the safety, tolerability, reactogenicity, and effectiveness of two doses of mRNA-1273 given 28 days apart. The Company intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada, ages 6 months to less than 12 years.
The study is being conducted in collaboration with the US National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
Currently, the experimental Moderna COVID-19 Vaccine is authorized under an Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. Moderna COVID-19 Vaccine is investigational and not approved by the U.S. FDA.
According to the US Centers for Disease Control and Prevention(CDC), very few children have been impacted by COVID-19. At the end of 2020, the CDC reported (888) hospitalization by children less than five years of age related to COVID-19.