COLUMBUS (WCMH) – Ohio doctors are looking ahead to the next group of Americans who could be eligible for the COVID-19 vaccine.

Dr. Joseph Gastaldo, an infectious disease specialist with OhioHealth, expects children younger than 5 will likely have access to the Pfizer vaccine in early to mid-2022.

Dr. Gastaldo explained, “Of course that takes time, but more importantly, we really do not want to cut any corners and we really want to emphasize the safety of these vaccines.”

At Cincinnati Children’s Hospital, a team of researchers is currently conducting 11 clinical trials for Pfizer, Moderna and the CyanVac intranasal vaccines.

Dr. Robert Frenck, the director of the Vaccine Research Center at Cincinnati Children’s, explained the next vaccine phases will be split into several age groups: ages 2-4 and ages 6-23 months.

More than 1,500 volunteers are enrolled at Cincinnati Children’s, including more than 400 children. The participants range from 6 months to 85 years old. 44 have volunteered for Pfizer trials for children younger than 5. 28 are currently involved in a study of Moderna’s effectiveness in children ages 6-11 and 32 have signed up in the under 6 category for the Moderna vaccine.

“Parents are excited and interested,” Dr. Frenck said of the trials. “They see it as a way of having help in curing and ending this pandemic.”

In early November, the FDA and CDC granted emergency use authorization (EUA) for the Pfizer vaccine in ages 5-11. Doctors anticipate Pfizer’s EUA will next be extended to ages 2-4, followed by 6-23 months.

Like adults, vaccinations will be split up into 2 doses, several weeks apart. Unlike adults and older children, doses used for younger children are smaller.

“What is part of the science is figuring out what the lowest dose possible is that’s going to induce an appropriate immune response to children under the age of 5,” said Dr. Gastaldo.

Doctors say the studies in the younger age group have the benefit of nearly 2 years of medical research. Dr. Frenck said the data is promising for all age groups.

“I feel very comfortable to say the safety profile is good, the vaccine is safe, it’s immunogenic and the vaccine is protective,” he said.

When the clinical trials conclude, federal regulators require 2 months of safety data on the participants. The FDA and CDC will then review the research and make recommendations based on findings of the vaccine’s safety and effectiveness.

“It’s not something where people need to feel concerned and say, ‘I don’t know the safety of this vaccine.’ We know this vaccine has actually had a very good safety profile,” said Dr. Frenck, pointing to the thorough regulation protocol vaccines are subject to in the U.S.

He anticipates the Pfizer vaccine could receive EUA for ages 2-4 by spring 2022, followed by ages 6-23 months in the summer.
Cincinnati Children’s is still enrolling volunteers for the under 6-year-old group for the Moderna trial and other studies. You can enroll here: https://redcap.link/COVID-19Vaccine, email gambleprogram@cchmc.org or call (513) 636-7699.