The clinical trial, called the KidCOVE study, will enroll approximately 6,750 children in the United States and Canada aged 6 months to 11 years.
The trial is divided into two parts. In the first part, different doses of the vaccine are being tested in children. Children between the ages of 6 months and 1 year old will receive two doses of the vaccine about 28 days apart at a level of 25 or 50 or 100 micrograms. Children between 2 and 11 years of age will receive two doses of the vaccine approximately 28 days apart, at a level of 50 or 100 micrograms.
The results from part one will be used to determine which dose will be used in part two. For the second part, the trial will be expanded to include children who receive a saline placebo, which does nothing. Children will be followed for 12 months after the second injection.
Moderna is running the tests to see if the vaccine protects children from falling ill if they come into contact with the coronavirus, according to the clinical trial’s patient information website.
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the United States and Canada,” Moderna’s CEO, Stéphane Bancel, said in a press release. “This pediatric study will help us assess the potential safety and immunogenicity of our candidate vaccine COVID-19 in this important young population.”
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and the United States Department of Health and Human Services Advanced Biomedical Research and Development Authority.
In December, the Food and Drug Administration authorized the emergency use of Moderna’s Covid-19 vaccine for adults and the Pfizer / BioNTech Covid-19 vaccine for people aged 16 and over.
In February, the FDA authorized the emergency use of the Johnson & Johnson vaccine for adults 18 years and older.