“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 Dr. Evan Anderson, a professor of pediatrics and medicine at Emory University School of Medicine and the study site principal investigator for the trial.
At present, adults ages 18 and up are eligible to receive the Moderna and Johnson & Johnson vaccines under emergency use authorization granted by the FDA, while the Pfizer-BioNTech vaccine before Monday had been authorized for ages 16 and up.
Moderna intends to enroll more than 6,000 pediatric participants in the United States and Canada in its KidCOVE clinical trials.
Children are expected to begin enrolling at Emory Children’s Center in coming days, the university said.
The study contains two parts. In part one, all participants receive two doses of the vaccine to evaluate the best dose for each age group. In the second part, a placebo-controlled study will determine safety and efficacy. The research is anticipated to last several months.
The company also is expected to seek authorization for its vaccine to be used with ages 12 to 17.
Its TeenCOVE study for that age group began in December 2020 and is fully enrolled. An initial analysis found the vaccine had a 96% efficacy rate, the company said in a business update last week.
Anderson was principal investigator for the phase 1 study of Moderna’s vaccine last year.
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