Under an expanded agreement with Moderna, Inc., the Biomedical Advanced Research and Development Authority (BARDA) announced this week that it will provide program management support and up to $144 million for the Phase 2/3 clinical trial of its COVID-19 vaccine on children.
Also known as KidCOVE, the trial will take on approximately 7,000 children between six months and 12 years old. They will be given doses of Moderna’s mRNA-1273 vaccine, which has already been approved for emergency use on adults by the U.S. Food and Drug Administration (FDA). Following positive results in May from a trial on adolescents between the ages of 12 and 17 years old, Moderna applied for emergency use authorization for the vaccine among adolescents.
mRNA-1273 was developed as part of a collaboration between Moderna and the National Institute of Allergy and Infectious Diseases (NIAID). BARDA began supporting the candidate back in April 2020 and has also included a Phase 2 adult dose confirmation study and the addition of a crossover arm for the adult Phase 3 efficacy study (COVE) to get the actual vaccine to trial participants who received a placebo the first time around.
All supporting funds will be drawn from those allotted under the Coronavirus Response and Relief Supplemental Appropriations Act.