BARDA expands collaboration with Moderna on COVID-19 vaccine trials for children

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.