ATLANTA – Physicians from Children’s Healthcare of Atlanta and Emory University are participating in a clinical trial testing the Moderna COVID-19 vaccine in children ages 6 months to less than 12 years.
This is the same Moderna mRNA-1273 vaccine that is being distributed nationwide for adults ages 18 and older following an emergency use authorization from the U.S. Food and Drug Administration in December for that age group. The initial phase of the KidCOVE study will test different doses of the vaccine to evaluate safety in a younger population. Children are expected to begin enrolling in the trial at the Emory Children’s Center (ECC) in the coming days.
The study is being conducted by the Infectious Diseases Clinical Research Consortium in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority.
“This is a critical step for children which could make it possible for them to receive the same type of immune protection now provided to adults,” says Evan Anderson, MD, attending physician at Children’s Healthcare of Atlanta and Emory and the study site principal investigator for the trial.
Anderson, who has advocated for COVID-19 vaccine clinical trials to begin in children, is professor of pediatrics and medicine at Emory University School of Medicine. He was site principal investigator for the phase 1 study of mRNA-1273 last year, which showed that the vaccine was safe and generated an immune response in adults. He also was a site principal investigator for the phase 3 study in adults.
“We know, through careful clinical trials, that the Moderna mRNA-1273 vaccine is safe and very effective in preventing COVID-19 in adults. This study can help provide critical information about the safety, reactogenicity and immune responses observed with the vaccine in children and could ultimately allow the vaccine to be approved for children. This is crucial in getting children back to their usual pre-2020 activities,” Anderson says. “The emergence of viral variants makes it even more imperative to help protect our children.”
For its children’s vaccine study, Moderna intends to enroll more than 6,000 pediatric participants aged 6 months to less than 12 years old in the United States and Canada. Moderna’s TeenCOVE study, for children ages 12 to 17, began in December 2020 and is fully enrolled.
KidCOVE is composed of two parts, with different participants in each.
In part one, all participants receive two doses of the vaccine. The objective is to evaluate and determine the best dose for each age group. An interim analysis will be conducted to assess safety and determine which dose will be used moving forward.
Part two of the study will further evaluate safety and immune responses, measuring how well two doses of the vaccine work. It is placebo-controlled.
Children who have previously received a COVID-19 vaccine are not eligible for the trial. Additionally, participants should not have tested positive for SARS-CoV-2 or been in contact with anyone diagnosed with COVID-19 within two weeks of vaccine administration.
The clinicaltrials.gov identifier is NCT04796896. For more information about the trial, including the process for enrolling participants, please visit the KidCOVE Study website.
Parents or guardians of interested parties can contact Emory Children’s Center.