CLEVELAND — The beginning of the clinical trial to test Pfizer and BioNTech’s COVID-19 vaccine is expected to begin next week at University Hospitals Cleveland Medical Center, according to news release from the hospital.
UH Medical center is the first hospital system in Northeast Ohio and one of approximately 120 sites around the world that will collectively enroll up to 30,000 participants for the Phase 2/3 clinical trial.
“This is encouraging news for Ohioans,” said Daniel I. Simon, MD, Chief Clinical & Scientific Officer and President, UH Cleveland Medical Center, in a news release. “We were among the first in the nation to test Remdesivir, the promising drug in the treatment of COVID-19, which enabled our community to benefit from our participation in the clinical trial program. And now once again, we are bringing our community another potential defense mechanism in our fight against the coronavirus – a vaccine candidate. The trial has been approved by the FDA and our Institutional Review Board. We are expecting shipment of the experimental vaccine and initiation of the trial in the next week.”
The Phase 2/3 study is designed to obtain the safety, immune response and efficacy data needed for regulatory review for this vaccine's development approach, which used mRNA packaged with coronavirus genes to generate the spike protein which is believed to generate protective antibodies, according to the release.
Researchers are looking to enroll non-pregnant adults from 18 to 85 years old. UH said because of the disproportionate occurrence of COVID-19 among people of color and the severity of the disease and the higher death rate, it plans to have diverse representation included in this study.
Those who are interested in participating in the study at UH Medical Center should call 612-524-9091.
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