Louisville kids as young as six months old will soon be able to participate in a clinical trial for the Pfizer COVID-19 vaccine. The city is one of 100 sites around the world testing it in young children.
Norton Children’s Research Institute and University of Louisville School of Medicine will conduct the trial. Researchers are looking for 50 children from 6 months to five years old, and another 50 ages 6 to 11 years old, to participate in the study. Children must be generally healthy to participate.
The FDA has already authorized the Pfizer vaccine for people ages 12 and up.
“[It’s] the most exciting vaccine trial I’ve ever been involved with because of the magnitude of what COVID-19 has meant for us as a community, and for the country and for the world,” principal investigator and local pediatrician Dr. Gary Marshall said.
In a call with reporters Wednesday, Marshall said two-thirds of participants will receive the vaccine, and one third will receive a placebo.
After 6 months, the placebo recipients will also be given the opportunity to receive the vaccine.
Participants will be monitored over two years to judge the efficacy and safety of the vaccine in young children.
Marshall said the vaccine has already proven “incredibly safe” in people 12 and older.
“We have no reason to believe, just based on the biology, that the vaccines would be any less safe in children, but it is something that we have to study, and we have to study in a rigorous fashion,” he said.
As of May, nearly 140 million people in the U.S had received at least one dose of the Pfizer vaccine. Marshall said he believes short-term side effects, such as fever and arm soreness, will likely be the same for young children who receive the vaccine, based on preliminary studies.
“For children it might translate into fussiness, irritability, not feeding well for a day or two,” he said.
Participants’ families will log children’s symptoms and temperatures in an electronic diary for researchers.
Marshall said this trial is an important next step.
“I think that this is one way for us to get back to normal life, where our kids can go to school, and to summer camp, and to the park and to the swimming pool, and not have to worry about this,” he said.
His group is trying to recruit a diverse pool of participants. They’ll randomly select 100 patients from the pool of eligible applicants. The trial will begin as soon as the researchers in the phase 1 study determine the ideal dosage for young children.
The 100 Louisville children will be among 4,500 worldwide participating in the study.
Interested families can sign up to be considered for the trial at NortonChildrens.com/COVIDTrial.
