Biotech Moderna announced that the first participants have 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. The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
The study will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. The biotech plans to to enroll approximately 6,750 kids in the U.S. and Canada from the ages of 6 months to 12 years old. The vaccine has already been authorized for emergency use in Americans who are aged 18 and older.
"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," said Stéphane Bancel, CEO of Moderna. "We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population."
In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 μg or 100 μg). Each participant ages six months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg). An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination.
Read the Moderna statement