While bourbon may have put Bardstown on the map, the rural Kentucky town is helping bring to market the most coveted vaccine in modern history. Kentucky Pediatric\Adult Research, or KPAR, is one of 150 sites worldwide and the only in the state conducting human clinical trials on Pfizer's COVID-19 vaccine.
The Bardstown facility had a hand in getting the vaccine approved for adults, as well as 16 and 17-year-olds. Now, KPAR is studying the vaccine in children ages 12-15. Isabella Stiles was 15 when she began participating in the trials. The student at Thomas Nelson High School has mostly kept her contribution to science under wraps.
"A few know, but not many," Stiles told WKU Public Radio. "Some people are interested and want to know what it’s all about, but some people are like, 'Why would you do this?'"
She did it because testing the vaccine is a family affair. Her parents and older siblings went first in the adult trials at KPAR. Isabella’s father, Dr. Matthew Stiles, practices family medicine in Bardstown.
"We had confidence and we had our personal experience. By the time she joined the trial, the results of the adult trial were already published," Stiles explained. "We knew it was important to find out for that age group too so they could expand the universe of who was eligible.”
Isabella received her first injection last November and her second in December. She doesn’t know whether she received the vaccine or a placebo and won’t find out until her age group becomes eligible to receive the vaccine. Isabella says she felt no side effects and continues to be monitored. Dr. Dan Finn is a pediatrician and principal investigator for the Pfizer study at KPAR.
"She’s now doing nasal swabs every ten to 18 days when she doesn’t have symptoms. There’s a group of patients doing that to see if the vaccine helps prevent a-symptomatic transmission," explained Finn. "If you don’t have symptoms, could you still have the virus? We’re still collecting that information.”
For the next two years, adolescents in the study will be monitored for COVID infections and routinely have their blood drawn to assess their levels of antibodies. Dr. Finn says while results on children have not been released, initial studies indicate the same short-term side effects seen in adults.
"Fever, aches and pains, chills, headaches, muscle aches. We’ve definitely had folks get some side effects like that," stated Finn. "Knock on wood, no long-lasting serious problems that we’ve had with any patients in our trial.”
While children are less likely than adults to become seriously ill or die from Covid-19, Dr. Finn says getting the vaccine approved for youth will help prevent the spread of the virus and achieve herd immunity.
"Just getting that approval will help get more kids vaccinated, and the more people vaccinated, the less transmissibility, and hopefully the less disease overall," commented Finn. "Even though it may not be huge for them, it could be huge for the adults they’re around so that they’re not transmitting it to them.”
Seventy to 80 percent of Americans need to get immunized to reach herd immunity. In Kentucky, that amounts to more than three-million residents. So far, more than 1.3 million Kentuckians had received at least one injection of the vaccine.
Sixteen-year-old Isabella Stiles says she understands that her role as a young COVID vaccine volunteer is helping the U.S. get a handle on the disease that’s taken the lives of 545,000 Americans, and an estimated 2.75 million people worldwide.
"Yeah, I’m glad I can do this because it makes me feel like I’m doing something to help," Stiles said. "I feel it’s the least we can do after all our doctors and everyone has been through.”
The FDA could grant emergency approval of the vaccine for 12 to 15-year-olds as early as this summer. Kentucky Pediatric\Adult Research is slated to begin trials on five to 11-year-olds in June.
