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Pfizer COVID-19 vaccine trial for children 11 and under generates massive interest

Published: Jun. 8, 2021 at 4:46 PM EDT|Updated: Jun. 8, 2021 at 6:10 PM EDT
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LOUISVILLE, Ky. (WAVE) - Parents have been signing up for the COVID vaccine trial since it was announced that children younger than 11 are eligible.

Norton Children’s Research Institute, affiliated with the University of Louisville School of Medicine, announced on June 2 that it will participate in a phase 2/3 clinical trial for the Pfizer-BioNTech COVID-19 vaccine, aimed at healthy children. The study is aiming to test the safety, tolerability, and immune response in participants aged six months old to 11 years old. It is one of only 100 participating sites worldwide and the only one in Louisville.

Norton Children’s Research Institute was only looking to enroll 100 local volunteers for the trial, but more than 800 have expressed interest.

“It has really been heartening to me to see this outpouring of interest from the community and the youngest members of our community,” Dr. Gary Marshall, the chief of pediatric infectious diseases at Norton Children’s and the UofL School of Medicine.

Marshall is also the principal investigator for the Louisville Pfizer-BioNTech COVID-19 vaccine trial for children.

“(Families) have seen their relatives get sick,” he said. “They have seen their grandparents, in some cases, die from the disease. They have now seen the adults get vaccinated and look what that has done for the community and getting our lives back to normal.”

In Marshall’s opinion, the large interest in the trial proves that people believe in science.

The vaccine being studied is the same one that has been authorized for people ages 12 and older. In adults, this vaccine demonstrated 95% efficacy against COVID-19. Preliminary data shows the vaccine is safe for children and generates a strong immune response.

In the randomized clinical trial, two children will be assigned to receive the vaccine for every one child who receives a placebo. The study is blinded, meaning that no one initially will know which injection they receive. Parents and caregivers will be asked to track changes to the child’s health in an electronic diary, and children will have at least six in-person visits over a two-year period, some to include blood draws.

To end this pandemic, Marshall said, trials like these must be conducted. Like those who doubted the polio vaccine when it was tested on children in the ’50s, there are those who doubt the COVID vaccine now.

“They got a shot and they got a lollipop and a little button that said ‘polio pioneer,’” Marshall said. “These kids are no different than those kids ... If those million children hadn’t volunteered in the ’50s to be in that study we would have never had known the polio vaccine worked.”

Marshall said those children in the ’50s were medical trailblazers and the children taking part in this trial in 2021 are too.

Children who are randomly assigned to receive the placebo will be given the chance to receive the active vaccine after six months; therefore, all children in the study will ultimately have the opportunity to receive the active vaccine.

Kym Williams is a mother to 11-year-old triplets. Williams told WAVE 3 News that she studied the vaccine and wanted her children to take part. Her children were also excited and rolled up their sleeves for the shot on Tuesday.

“Vaccinations are something I’m pretty passionate about,” Williams said. “Their risks associated with children are very small. I still think it’s important that you try to protect children.”

Williams said it’s about the bigger picture and what this trial means to children across the country.

“I hope for them to be protected, empowered, and to feel like they are part of something big,” Williams said.

Sign-ups are still being accepted for the trial. To learn more about the vaccine study or to register a child, click here.

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