Clinical trials testing the COVID vaccine in children are recruiting kids in the Nashville area. Vanderbilt University Medical Center is specifically experimenting with dosages of the Moderna vaccine to determine the amount that works best for different age groups.
The first phase of Vanderbilt’s pediatric study will look at children ages 6 to 11, then 2 to 5, finishing up with toddlers and babies as young as 6 months. Researchers will begin with 100 kids, trying doses that are a quarter and half of the adult dosage.
“We know that children aren’t just little adults,” says Dr. Buddy Creech, director of the Vanderbilt Vaccine Research Program. “If children don’t need as high a dose as adults do, then we don’t want to give it to them. We want to give them just enough to make the type of immune response that we see in adults that we know are effective.”
The concern is that the possible side effects of fever and fatigue, which are relatively severe for a vaccine, could be dangerous in the youngest children.
Vanderbilt will also participate in Moderna’s phase 3 randomized trial, which will test the smaller dosage against patients who receive a placebo.
In Nashville, Clinical Research Associates will also be enrolling children for phase 3 of the Pfizer vaccine pediatric trial starting in June. A spokesperson says interest has been very high, with the families of 300 kids already trying to participate.
Both the Moderna and Pfizer pediatric trials will be much smaller than the adult trials, which involved more than 30,000 adults in the U.S. Timelines remain fluid, but Creech says he expects emergency authorization in children under 12 could come by the end of the year or soon after.
Clinical trials in teenagers are already wrapping up, and Creech says the Food and Drug Administration could authorize the vaccine for children over 12 before next school year.
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