Monroe Carell Jr. Children’s Hospital at Vanderbilt is part of a phase 2/3 clinical trial to study the safety and efficacy of the Moderna COVID-19 vaccine in children.
Researchers in the Vanderbilt Vaccine Research Program enrolled at least 100 healthy children, ages 6 months to 11 years, over the course of one to two months. The trials will follow an age de-escalation, dose escalation approach, where small doses of the vaccine are evaluated in older children first, followed by younger children. This allows the researchers to decide the best dose to use in different age groups. In this case, the study will first look at children 6 to 11 years old; then 2- to 5-year-olds; and finally, ages 6 months to up to 2 years.
“If our children are going to be in school, and grandparents are going to enjoy extended visits with grandchildren, we may have to vaccinate our children. Therefore, we need to evaluate the vaccine in children in order to optimize the use of COVID-19 vaccines,” said C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and associate professor of Pediatric Infectious Diseases.
Creech said age de-escalation is used to ensure the appropriate vaccine dose and effectiveness for each age group, especially since immune system behavior varies among different ages.