University to hold clinical study on COVID vaccine in children

The University of South Florida’s college of medicine is looking for volunteers for a clinical study on the effectiveness of Moderna’s COVID-19 vaccine on children under 11 years of age.

The university is part of a phase 2/3 clinical study on how the vaccine will work in children between six months and 11 years old. The study, called KidCOVE Study, is designed “to evaluate safety and immune responses” in children, according to a statement.

The research comes as schools begin to reopen in the midst of a surge in infections and hospitalizations due to the delta variant and as the Academy of American Pediatrics reports that infections in children are growing. The U.S. Food and Drug Administration has thus far approved three COVID vaccines, but only one, Pfizer, is approved for the use in children. And even that is only for children 12 and older.

The dean of USF’s medical school, Charles Lockwood, says in the statement that “widespread vaccination is the best defense against COVID-19, and this rigorous scientific study may go a long way toward increasing vaccine access in this younger demographic.”

Moderna plans to enroll 12,000 children in the U.S. and Canada in the study and USF is looking for volunteers in the area.

Three out of four children who participate will receive two vaccine injections four weeks apart. The others, about a quarter of the volunteers, will get a placebo made from a saline solution.

The vaccine does not inject COVID into a person, instead, USF says, it sends an mRNA molecule that tells cells how to make proteins to help boost the body’s immune system in order to fight off the virus. The process has been used to treat various viruses, including influenza and Zika, and has shown promising results when used in studies of immunotherapy treatments for cancer patients.

 USF Health’s department of pediatrics will oversee the study and patients will be tracked for a year.  

The university says enrollment will begin in a few days and those who are interested can text or call (813) 853-1149 or email [email protected].