Hundreds sign up for youth COVID-19 vaccine trial at Upstate

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When Amanda Alnutt-Hauptfleisch’s two sons saw an opportunity to enroll in clinical trials of the COVID-19 vaccine for children under 14, they were eager to participate. 

Alnutt-Hauptfleisch’s sons aren’t the only ones interested in participating — they’re among hundreds in central New York on the lengthy enrollment list for the trial at Upstate University Hospital. 

Upstate announced April 1 that it was seeking participants for a clinical trial of the Pfizer COVID-19 vaccine in children under 12. After 48 hours, Upstate had a total of 1,200 children on a list of volunteers for the trial, said Kathleen Froio, the assistant director of public and media relations at Upstate. 

The trial at Upstate is part of an international study sponsored by Pfizer that will involve roughly 50 hospitals and 4,500 children around the world, said Joseph Domachowske, the principal investigator in the trial at Upstate. But Upstate is one of just four sites in the world that will include children under 5 in its trials.

“Children make up 17% of our population in the United States. If we don’t include them in our vaccine efforts, we won’t have enough community immunity to really reduce transmission of this virus across the entire U.S.,” Domachowske said.

This trial, which began on April 5, will measure the efficacy and safety of Pfizer’s COVID-19 vaccine in children between 6 months and 11 years old. The trial is currently in its first of three phases, Domachowske said. 

The first phase, which is set to conclude by the end of May, is designed to determine the optimal dosage of the vaccine for children in different age groups.

“Enrollment (for phases two and three) will probably only take four to six weeks for each age group because there’s so much community interest in this,” Domachowkse said. “And for the 50 or so sites that are doing it, we all have very long lists of people that are really interested in being involved.”

Baylor College of Medicine in Houston, Texas is one of the other sites involved in establishing the optimal vaccine doses for children. There, the trial is being led by Dr. Flor Munoz, an associate professor of pediatrics and infectious disease. Over the past few weeks, she has received a similar flurry of phone calls and emails from parents volunteering their children for the Baylor study, she said. 

“Right now, everybody knows that the studies are happening for COVID vaccines … so even if you don’t advertise, people want to have their children join and are contacting the sites,” she said.

Both Munoz’ and Domachowske’s teams are currently finalizing their determination of the optimal vaccine dose — one that causes minimal side effects but results in a sufficient antibody response — for children between 5 and 11. 

The trials will differ from those involving adult participants, Munoz said, as children don’t experience as many COVID-19 symptoms as adults and are rarely ill enough to be hospitalized. Measuring the vaccine’s efficacy in children will require conducting blood tests to measure their antibody levels and comparing them to the levels present in adults who have been vaccinated, she said. 

Though children often don’t experience COVID-19 symptoms, they are uniquely prone to developing an inflammatory syndrome called MIS-C in response to being infected with COVID-19, Domachowske said. 

MIS-C is still being studied, but it appears to be caused by a delayed response by children’s immune systems to COVID-19, he said. If children are vaccinated against the virus, they will be protected against MIS-C, as the antibodies developed in response to the vaccine don’t cause the same dangerous response as the one that results in MIS-C, he said.

Phase two and three of these trials are expected to be carried out throughout the summer and results will likely be available by the fall, Munoz said. 

Upstate is also part of a Pfizer-sponsored trial of the vaccine’s efficacy in children between the ages of 12 and 15 that began in December. In March, Pfizer announced that the vaccine has been shown to be 100% effective in preventing COVID-19 infection for children in this age group and recently urged the FDA to authorize its vaccine for children 12 and older. 

JD Hauptfleisch, 14, is one of the participants in Upstate’s trial of 12- to 15-year-old children. He received his first dose in December and his second in January, and returns for antibody testing every few months, he said. He is also required to keep track of any potential COVID-19 symptoms over the next two years through a smartphone application. 

Though Hauptfleisch received financial compensation for his involvement, he chose to donate the money to Upstate Golisano Children’s Hospital to help fund more research into infectious diseases like COVID-19. He said he’s grateful for the opportunity to help protect more children against the virus. 

“I know that I’m not just helping the hospital, but I’m helping every kid possible get the vaccine,” he said. “It feels good to know that everyone will be getting healthy, and the faster that everyone gets healthy, the faster things get back to normal.”