The study will evaluate safety, tolerability and immune response in this age group. It is the only site in Louisville offering the trial and among 100 participating sites around the world.
The Norton Children’s Research Institute, affiliated with the UofL School of Medicine, will participate in a phase 2/3 clinical trial of the Pfizer-BioNTech COVID-19 investigational vaccine for healthy children ages 6 months to 11 years. The study will evaluate safety, tolerability and immune response in this age group. It is the only site in Louisville offering the trial and among 100 participating sites around the world.
“As of now, we do not have a vaccine that is authorized for use in children under age 12,” said Gary S. Marshall, M.D., chief of pediatric infectious diseases at Norton Children’s and the UofL School of Medicine, and principal investigator for the Louisville trial. “Having a safe and effective vaccine for children will not only keep them healthy but also would facilitate a return to normal in terms of school and other activities.”
In the randomized clinical trial, two children will be assigned to receive the vaccine for every one child who receives a placebo. The study is blinded, meaning that no one initially will know which injection they receive. Parents and caregivers will be asked to track changes to the child’s health in an electronic diary, and children will have at least six in-person visits over a two-year period, some to include blood draws.
Children who are randomly assigned to receive the placebo will be given the chance to receive the active vaccine after six months; therefore, all children in the study ultimately will have the opportunity to receive the active vaccine.
The vaccine being studied is the same one that has been authorized for people ages 12 and older. In adults, this vaccine demonstrated 95% efficacy against COVID-19, and as of May 11, 2021, nearly 140 million people in the U.S. had received at least one dose. Preliminary data show the vaccine to be safe in children as well as able to generate a strong immune response.
The research team plans to enroll about 100 local volunteers for the trial; the overall enrollment will be about 4,500. Children ages 6 months to 11 years who are generally healthy are eligible to be included.
“The Pfizer-BioNTech vaccine has been shown to be very safe and effective in adults and adolescents,” said Kimberly A. Boland, M.D., chief of staff, Norton Children’s Hospital, and department chair, UofL School of Medicine Department of Pediatrics. “We have every reason to believe this study will show the vaccine to be safe and effective in children and an important step forward for children’s health and for protecting our communities.”
Dr. Marshall is known for his work in vaccine development, advocacy and education. In fact, he has worked on many of the vaccines that children routinely receive today.
The clinical trial team has responded to the pandemic, treating children with COVID-19 and its consequences.
“This is the most exciting vaccine trial I have ever been involved with, and I’ve been doing this for over 30 years,” Dr. Marshall said.
Parents and caregivers can sign children up to be considered for the trial by going to NortonChildrens.com/COVIDTrial.