The clinical trial, called the KidCOVE study, will recruit approximately 6,750 children in the U.S. and Canada between the ages of 6 months and 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 6 months and 1 year of age will receive two doses of the vaccine spaced about 28 days apart at a level of 25 or 50 or 100 micrograms. Children between the ages of 2 and 11 will receive two doses of the vaccine about 28 days apart at a level of 50 or 100 micrograms.
The conclusions of the first part will be used to determine which dose will be used in the second part. For the second part, the trial will be expanded to include children who are given a saline placebo, which does nothing. Children will be followed for 12 months after their second injection.
According to the clinical trial patient information website, Moderna is testing to see if the vaccine protects children from getting sick if they come in contact with the coronavirus.
“We are pleased to begin this phase 2/3 study on mRNA-1273 in healthy children in the United States and Canada,” Stéphane Bancel, CEO of Moderna, said in a press release. “This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age 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 Biomedical Authority for Advanced Research and Development of the U.S. Department of Health and Human Services.
In December, the U.S. Food and Drug Administration authorized the emergency use of the Modern Covid-19 vaccine for adults and the Pfizer / BioNTech Covf-19 vaccine for people over 16. years.
In February, the FDA authorized the emergency use of the Johnson & Johnson vaccine for adults over 18 years of age.