Phase 2 vaccine testing in young children begins at Cincinnati Children’s as school year nears

ajc.com

The second research phase to determine the efficacy of Pfizer’s COVID-19 vaccine for children 11 and under is starting at Cincinnati Children’s Hospital Medical Center, the closest facility in the region to participate.

The first phase of testing established how much of the vaccine is needed by different age groups, and now researchers will work to establish how much immunity from the virus each dose provides. A process called “immunobridging” will be used by researchers to compare immune responses among children to the responses seen in adults and teenagers.

Dr. Robert Frenk, director of the Vaccine Research Center at Cincinnati Children’s, said if young kids have the same level of an immune response as adults, they will hypothesize that the level of protection in children will be about the same. He said this next phase comes as the number of COVID-19 cases in children is rising.

“A little more than a year ago, only about 2% of the cases in the US were in children,” he told WCPO-TV in Cincinnati. “As of last week, 24% of the cases are in children. Children only make up about 17% of our population, so what that means now is that we’re having a disproportionately higher percentage of children are getting infected.”

The Ohio Department of Health deferred questions on the Phase 2 Cincinnati Children’s trials of the COVID-19 vaccine on children 11 and under to the U.S. Food and Drug Administration, the agency that gives the thumbs up or down to pharmaceutical company’s seeking Emergency Use Authorization.

“When COVID-19 vaccines are authorized by the FDA for a younger audience, even more people will be able to be protected from the virus. Until then, those currently eligible making the choice to be vaccinated will help us protect those 11 and younger,” said Alicia Shoults, ODH spokesperson. “Quite simply, when there are more people who are vaccinated, there are fewer people who can carry COVID-19 on to those who aren’t protected by vaccines.”

Through Wednesday, more than 1.1 million Ohioans have had the novel coronavirus since March 2020, and over that same timeline, nearly 61,000 Ohioans have been hospitalized, and more than 20,300 have died. Since the COVID-19 vaccine has been authorized for emergency use in the country, nearly half of Ohioans have started the inoculation process (47.95%), and 44.8% are fully vaccinated.

Officials from The Health Collaborative in Cincinnati say every vaccinated person, whether it’s a child or adult, helps improve the overall vaccination rate and protects the community.

“Right now, roughly a third of children ages 12 to 19 in the region have received at least one dose of the vaccine,” according to The Health Collaborative. “This is not surprising as this younger age group became eligible most recently ― but it does underscore the importance of reaching children and young adults as this group has the most room for growth.”

There are fewer mass vaccination clinics around the region as the demand for the COVID-19 vaccine shots has dropped, but many pediatric offices now offer the vaccine, and Health Collaborative officials “are encouraging parents to reach out to their pediatricians with any questions about getting the vaccine for their children.”

Even as testing moves forward, Frenk said he would guess the vaccine would be available to children before the end of 2021.

“My original thought was it was going to be more around November or December of this year,” Frenk said. “Pfizer has stated that they think that they will have sufficient data available by the end of August or September, so it’s possible.”

The Health Collaborative said as any COVID-19 vaccine timeline for children 11 and under is dependent on safety and efficacy data, officials also hope it’s available by the end of the year. And like with current trends of vaccine demand, Collaborative officials said “there tends to be high immediate demand once an age group becomes eligible and then demand levels off to a more steady state.”

Incentives to get the vaccine could be offered by the state again, but Gov. Mike DeWine spokesman Dan Tierney said there’s nothing to announce at this time.

“The governor’s talked about how he’s looking at additional incentives,” he said.

STUDY PARTICIPANTS

Cincinnati Children’s is looking for children to be a part of the next trial phase of the COVID-19 vaccine for those under 12 years old. If interested, register your child at redcap.research.cchmc.org/surveys/index.php?s=FTW4CTWRCR

VACCINATION RATES

Here are how many have started the vaccination process and completed it by county in southwest Ohio and the Miami Valley area:

Butler County: 45.4% started, 42.25% completed

Champaign County: 36.35% started, 33.81% completed

Clark County: 43.32% started, 40.9% completed

Darke County: 31.36% started, 29.77% completed

Greene County: 46.41% started, 43.64% completed

Mercer County: 31.62% started, 30.39% completed

Miami County: 39.18% started, 36.69% completed

Montgomery County: 45.94% started, 42.58% completed

Preble County: 32.81% started, 31.13% completed

Warren County: 52.38% started, 49.6% completed