The study, called "KidCOVE," will test the vaccine in children 6 months to less than 12 years. The company hopes to enroll 6,750 children in the U.S. and Canada.
Right now, no vaccine currently approved for emergency use are able to be used on kids under age 16.
"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, Chief Executive Officer of Moderna. “It is humbling to know that 17.8 million adults in the U.S. have received the Moderna COVID-19 Vaccine to date. 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.”
Children in the study are given two shots, 28 days apart.
In the first part of the study, kids ages 2 years to less than 12 years may receive one of two dose levels, 50 or 100 micrograms. Also in Part 1, kids 6 months to less than 2 years may receive one of three dose levels 25, 50 or 100 micrograms.
In part two, an interim analysis will be conducted to determine which dose will be used. This is the placebo-controlled expansion portion of the study.
Children will be followed for a year after being vaccinated, to look for side effects and antibodies.
Meanwhile, Pfizer is underway in its vaccine trial for kids ages 12 to 15.