Nashville News 2 (WKRN) recently reported on our contributions to COVID vaccine research and pediatric clinical studies. See the story below for an interview with our medical director, Dr. Stephan Sharp, about why more families are needed so that we can continue to help study vaccines.
NASHVILLE, Tenn. (WKRN) — A Pfizer vaccine for children under 5 has been stalled after the FDA decided there just wasn’t enough data to move forward.
That’s why Clinical Research Associates is pushing for more babies and toddlers to enter the clinical trial.
Like any COVID-19 vaccine, the FDA collects data on how well the vaccine works on actual
In this case, researchers say not enough kids enrolled in the program. They now need patients between 6 months and 5 years old to participate.
“[Children] are less likely to be symptomatic,” said Dr. Stephan Sharp, Medical Director for Clinical Research Associates. “The endpoint of the study is symptomatic illness. So you actually need a whole lot more folks in order to get statistically significant results. So because of that, they keep expanding the study.”
The clinical trial needs several thousand more children to enroll before the vaccine can be federally approved and released.
“The kids just don’t get sick as often. And if you don’t have enough events, you can’t tell the difference between the vaccine and the placebo,” said Dr. Sharp.
“If you have three illnesses and there’s two in one group and one in the other, that’s not a meaningful difference. So you have to have enough kids to actually have symptomatic COVID,” said Sharp.
Dr. Sharp says while there is always a potential risk for vaccine reactions, they are rare after about a week.
Every family is screened for pre-existing conditions and each patient is monitored through an electronic diary.
If you want to enroll your child, all you have to do is call Clinical Research Associates at 615.329.2222 or visit their website.
Link to original story: Children Needed For COVID Vaccine Research