LOUISVILLE, Ky. — Norton Children’s Research Institute, affiliated with the UofL School of Medicine, is one of about 100 sites around the world participating in the clinical trial of the Pfizer-BioNTech COVID-19 vaccine for healthy children ages 6 months to 11 years old.
So far, 5 to 11-year-olds have received their first shot. Next up, are 2 to 4-year-olds, followed by infants 6 months up to toddlers two years old.
“Everyone that had passed away from COVID early on didn’t get a chance to even get the vaccine. So I wanted her to have a chance to help other kids that will eventually get the vaccine,” said Sydney Spencer, regarding one of the reasons why her daughter Symari Bruck is enrolled in the clinical trial.
“And I follow the science, I’m a health care worker so that was mainly what ultimately decided it for us,” said Spencer, who works as a medical assistant at UofL Health, which is not affiliated with the UofL School of Medicine.
On June 15 Spencer’s 5-year-old daughter got her first injection.
“I was like, ‘OK, so we are going to give you the COVID shot potentially, is that OK,’ and she was like, ‘Yeah, that’s fine mommy,” Spencer told Spectrum News 1.
Spencer also said the decision to have her daughter participate in the study was personal.
“We were affected by COVID-19, some of my family members, and some of them eventually passed away from it. So it’s something I always try to instill in her, to give back and help other people,” Spencer said.
The study is a randomized clinical trial. For every child who gets a placebo vaccine, two children are assigned the COVID-19 vaccine. It’s also a blind study, meaning no one knows which shot the enrolled participants received, not even the clinical research team.
Dr. Gary Marshall, Chief of Pediatric Infectious Diseases at Norton Children’s and UofL School of Medicine, is leading the study, which is a Phase 2/3 clinical trial. Phase 1 of the study, which Norton and UofL School of Medicine weren’t a part of, determined which dose to give children, depending on their age.
“What that basically means is, it’s beyond the preliminary studies where you’re determining exactly what the dose should be, and you are determining if the basic safety and immunogenicity is there. This is beyond that, and it involves many more children,” Dr. Marshall said.
The Pfizer vaccine given to assigned participants is the same one people 12 and older. However, the doses vary depending on age.
“They are smaller, and so they don’t need as high of a dose, and it’s always balancing the efficacy of the vaccine or the immunogenicity, which is the ability of the vaccine to make an immune response and protect you, balancing that with the potential side effects, like a sore arm or fever or chills, and we have to just strike the balance between those two things,” Dr. Marshall explained.
Currently, Dr. Marshall explained that those 12 and up currently receive 30 mg of the Pfizer vaccine. During this study, children 5 to 11 years old get 10 mg and those under 5 years old get 3 mg.
The children are followed for two years with at least six in-person visits, to check on their health and see if they have or have not contracted COVID-19. However, Dr. Marshall explained the most active part of this trial is for the first six months.
“So in those six months, you get two shots. You have a blood draw at the beginning; you have blood draw at the end. At the end of the first six months, the kids who got the placebo are given the opportunity to get the actual vaccine,” Dr. Marshall said.
The children are monitored closely after they get the shot. For example, parents are required to keep an electronic diary to track temperatures and any symptoms their child may have. So far, Dr. Marshall said there have been no serious side effects.
“There are parents who are reporting low-grade fevers and soar arms. The thing is, this is a blinded clinical trial and so we are not privy to which kids got the vaccine and which kids got the placebo. So it’s very hard to interpret that information. That will be interpreted ultimately when all of the data is collected from the whole study, and then the data are “unblinded,” which is that the analysts can now see if there’s differences between the vaccine recipients, and the placebo recipients,” Dr. Marshall said.
Spencer said her daughter had a sore arm after her first injection, but she didn’t have any redness.
“And when she got home and was telling my mom about it [getting the injection], she was like, ‘I get to help other kids,” Spencer said. “You know that just kind of made me feel good that she understood that she was helping other kids be able to get the vaccine.”
While Norton Children’s Research Institute already has its selected participants for its current clinical trial, Dr. Marshall told Spectrum News 1 it will probably not be the last COVID-19 vaccine trial that Norton will do with children. So if you’re interested in having your kids participate in upcoming trails or would like more information, you can register here.