Emory, Children’s Healthcare of Atlanta start COVID-19 vax trial for childrenPediatric Nurse Practitioner Hannah Addis draws up a dose of Pfizer-BioNTech COVID-19 vaccine at DeKalb Pediatric Center on Thursday March 25, 2021. Photo by Dean Hesse.
Atlanta, GA — Doctors at Emory University and Children’s Healthcare of Atlanta will be taking part in a clinical trial of the Moderna COVID-19 vaccine in children ages six months to 12 years old, a press release announced.
“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 press release from Emory Healthcare says. “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 Infectious Diseases Clinical Research Consortium in collaboration with the National Institute of Allergy and Infectious Diseases is conducting the study.
“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,” said Evan Anderson, MD, attending physician at Children’s Healthcare of Atlanta and Emory and the study site principal investigator for the trial.
Anderson has advocated for the trials to begin in children. Anderson is a professor of pediatrics and medicine at Emory University School of Medicine. He was the site principal investigator for the phase 1 study of mRNA-1273 last year, according to the press release. That study 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, the press release says.
“We know, through careful clinical trials, that the Moderna mRNA-1273 vaccine is safe and very effective in preventing COVID-19 in adults,” he said. “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. The emergence of viral variants makes it even more imperative to help protect our children.”
Moderna will enroll 6,000 children ages six months to 12-year-old in the study. The study for children ages 12 to 17 began in December and is fully enrolled, the press release says.
The KidCOVE study has two parts, each with different participants.
“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,” the press release says. “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 may have previously gotten a COVID-19 vaccine can’t participate in the trial. Participants also must not have tested positive for the virus or have been in contact with anyone who has had COVID-19 within two weeks of getting the vaccine.
“The clinicaltrials.gov identifier is NCT04796896. For more information about the trial, including the process for enrolling participants, please visit the KidCOVE Study website,” the press release says. “Parents or guardians of interested parties can contact Emory Children’s Center.”
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