MOSCOW, March 16 – RIA Novosti. American Moderna announced the beginning of phase 2/3 trials of its mRNA-1273 coronavirus vaccine in children aged 6 months to 12 years, according to a press release from the company.
The KidCOVE study is being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, and the Advanced Biomedical Research and Development Administration of the United States Department of Health and Human Services (BARDA).
“We are delighted to begin Phase 2/3 of the mRNA-1273 study in healthy children in the US and Canada, and we thank NIAID and BARDA for their collaboration,” said Moderna CEO Stephen Bansel.
The study aims to evaluate the safety, tolerability, reactogenicity and efficacy of two doses of mRNA-1273 vaccine administered 28 days apart. It is planned that the study will involve about 6,750 children in the United States and Canada, aged 6 months to 12 years.
During the first phase, study 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 done to determine which dosage will be used in the second phase of the placebo-controlled study. After the second vaccination, study participants will be monitored for 12 months.
In December, Moderna began trials of a COVID-19 vaccine in the United States among teens aged 12 to 17. The information is planned to be collected in the spring of 2021.