The University of Kentucky is beginning a new clinical trial to test the safety and effectiveness of the Moderna vaccine in children as young as 6-months-old, university officials said Wednesday.
UK is one of 90 sites across the country selected to participate in KidCOVE, which will study how effective the two-shot Moderna vaccine is at protecting kids 6-months- to 11-years-old from COVID-19. At least 200 children are needed for UK’s part in the trial, the university said in a news release.
“With all other age groups currently eligible for vaccination, it’s vital that we extend this to young children, which is critical to their own protection and to facilitate herd immunity in order to help bring an end to this pandemic,” said Dr. George J. Fuchs III, who’s leading the study for UK HealthCare. Fuchs is chief of pediatric gastroenterology and vice chair of clinical affairs in the Department of Pediatrics at the Kentucky Children’s Hospital.
This isn’t the first clinical vaccine trial UK has conducted during the pandemic. In November, UK recruited close to 900 adults for a single-dose Johnson & Johnson trial, and in February, the university began a separate arm of that study to gauge whether two doses of the Jonhson & Johnson were more effective than one. In early May, researchers began recruiting college-age students to study how effective vaccines were at reducing transmission rates.
Three vaccines have so far received emergency approval from the U.S. Food and Drug Administration: the Johnson & Johnson vaccine and two-dose Moderna vaccine, accessible only to adults, and the two-dose Pfizer-BioNTech vaccine, accessible to adults and kids as young as 12.
Clinical trials to test efficacy of vaccines in young children have just begun across the country. More than 7,000 children are being sought for the KidCOVE trial, which will stagger participants into three different age groups: the first will enroll kids between ages 6 and 12; the second will enroll children between ages 2 and 6; and the third will study monitor the vaccine in children 6-months-old to age 2.
UK will enroll as many as 200 kids to receive either both Moderna doses or a placebo, 28 days apart, starting in July. They will be monitored for up to two years. As with other clinical trials, participants will be paid. The trial will require occasional telemedicine visits and up to seven in-person visits to UK’s outpatient Turfland clinic off Harrodsburg Road.
Parents or guardians interested in learning more can visit www.StopCOVIDKy.com.