Moderna will soon begin coronavirus vaccine trials in babies and children.
The drugmaker’s study, called KidCOVE, will test the vaccine in children ages six months to 11 years old, with the hope of enrolling 6,750 children in the U.S. and Canada, the company announced Tuesday.
“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 [National Institute of Infectious Diseases] and BARDA [Biomedical Advanced Research and Development Authority] for their collaboration,” said Stephane Bancel, CEO of Moderna said. “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 to be given two doses, 28 days apart. In the study’s first part, children ages two years to younger than 12 may get one of two dose levels, 50 or 100 micrograms and in addition, children six months to less than two years may receive one of three dose levels 25, 50 or 100 micrograms. In the second part, a short-term analysis will take place to determine which dose will be used.
The study participants will be monitored for a year after inoculation for signs of side effects and antibodies.
Presently, none of the three vaccines authorized by the Food and Drug Administration for emergency use — Pfizer/BioNTech, Moderna and Johnson & Johnson — are approved for anyone younger than 16.