COVID-19 vaccine trial underway at Cincinnati Children’s

Coronavirus vaccine trial moving to Phase 2 at Cincinnati Children's

CINCINNATI (FOX19) - The first set of patients is being vaccinated for COVID-19 as part of a trial at Cincinnati Children’s Hospital Medical Center.

The hospital is one of four sites in the U.S. participating in the clinical trial for the BNT162 vaccine.

Cincinnati Children’s is continuing to enroll participants in the first stage of the study and is working to diversify the patient pool by recruiting underrepresented populations.

Tracy Shirley is one of the 50 participants in the first phase of the trial. She says the future health of her family was a big motivation for participating.

“I don’t live just for myself, and I wanted to be a part of it,” she told FOX19 NOW. “I wanted to be a part of the solution.”

After she got the shot, she says she had soreness at the injection site and noticed after she made an entry in her trial diary that she felt some fatigue.

Because of how the trial works, neither Shirley nor the doctors doing the trial know if she got the vaccine or a placebo.

The study arm at Cincinnati Children’s is led by Robert Frenck, MD, Director of the NIH-funded Vaccine and Treatment Evaluation Unit (VTEU) and Vaccine Research Center.

Out of the 50 participants Frenck said the most common symptoms from the shot are: “A little bit of arm pains, sometimes a mild headache, but we have not seen anything more significant than that.”

The results of phase 1 are good enough to move into phase 2 of the trial. Around 500 people will participate in that phase.

Right now, one of the biggest challenges facing the team at Cincinnati Children’s is having enough diversity represented in the next phase. That includes racial, economic and underlying health conditions.

“We have to get folks with all types of backgrounds in the trials to really understand who this vaccine works for and who it may not,” said Lori Crosby, PsyD, Behavioral Medicine and Clinical Psychologist at Cincinnati Children’s.

The leaders of the trial are also fighting against misinformation about the vaccine. Frenck says the vaccine does not give participants the coronavirus.

Shirley will be encouraging people in the community to participate in the 2nd phase of the trial.

“It’s not going to get better just with you and I just thinking about it and putting our mask on,” she said. “It’s only going to get better by us showing up and saying ‘yes.‘”

Frenck says phase 2 of the trial will begin in July. If it goes well they will move into phase 3. If the Food and Drug Administration is satisfied with the results Frenck says they could allow emergency use of the vaccine in the fall.

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