Moderna has started clinical trials of the COVID-19 vaccine in children
US-based Moderna has announced the start of phase 2/3 trials of its mRNA-1273 coronavirus vaccine on children aged 6 months to 12 years, according to a company press release.
The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, as well as with the Office of Advanced Biomedical Research and Development of the U.S. Department of Health and Human Services (BARDA).
“We are pleased to launch a phase 2/3 trial of mRNA-1273 in healthy children in the United States and Canada, and we thank NIAID and BARDA for their collaboration,” said Stefan Bansel, CEO of Moderna.
The study is intended to evaluate the safety, tolerability, reactogenicity, and efficacy of two doses of mRNA-1273 vaccine administered at 28-day intervals. It is planned that about 6,750 children in the United States and Canada aged 6 months to 12 years will participate in the study.
During the first phase, participants aged two to 12 years will receive one of two dosages (50 or 100 mcg), participants aged six months to two years will receive the drug in three dosages (25, 50 and 100 mcg). An interim analysis will then be performed to determine what dosage will be used in the second phase of the placebo-controlled trial. After the second vaccination, the study participants will be monitored for 12 months.
In December, Moderna began testing the COVID-19 vaccine in the United States among adolescents between the ages of 12 and 17. The information is planned to be collected in the spring of 2021.