CINCINNATI (FOX19) - Cincinnati Children’s Hospital is one of just five COVID-19 vaccine testing sites in the country enrolling children and adolescents in its clinical trial, hospital officials said Thursday.
Children’s began a phase 3 trial of the Pfizer/BioNTech vaccine, dubbed BNT162, in August.
Hospitalization demographics indicate COVID-19 doesn’t affect the young as severely as it does the elderly.
Vaccine clinical trials need to include the young, officials say, both because the long-term affects of the virus are still unknown and because they can still pass the virus to more vulnerable people — their parents or grandparents, for example.
Kate Evans was the first adolescent patient to receive a dose in the clinical trial — whether vaccine or placebo, she doesn’t know.
“I think we should do whatever we’re able to do to help other people right now,” Evans said. “If any information they can get from me can help get a vaccine out sooner and help everyone out there, I feel like I can do it.”
As with the other adolescent participants, Evans will receive one dose on the first day and another dose three weeks later, according to Robert Frenck, MD, medical director in the Division of Infectious Diseases at Children’s.
A blood sample will be taken in two weeks to see how Evans’s body is reacting to the vaccine, and doctors will follow up at intervals over the next two years to check its safety.
“My daughter will keep a diary, and then they’re going to give us a card with a number we can call 24/7 for a nurse in case anything should happen to crop up,” Laurie Evans, Kate’s mom, said. “But it doesn’t sound like anything is happening. Everything is going very smoothly today.”
Frenck says early data about the vaccine’s efficacy is promising.
“[It] has a good safety profile and is getting a good immune response,” he said.
An mRNA vaccine, BNT162 doesn’t contain any live virus. Rather, it instructs the body’s cells to produce a protein that simulates the coronavirus, hence priming the immune system for the real thing.
Fewer than 17 percent of people enrolled in the phase 3 trial underway at Children’s have experienced side effects from the vaccine, Frenck says. He adds the side effects were mild in those who did experience them.
If it passes out of the clinical trial and receives FDA approval, Frenck expects the vaccine to be available by next spring.
UC Health is currently in phase 3 trials of a separate mRNA vaccine from Moderna. Both vaccines are considered front-running candidates in the race to develop a safe, working COVID-19 vaccine.