CLEVELAND, Ohio – University Hospitals has been selected as clinical site to test a possible COVID-19 vaccine.
UH joins about 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants, the hospital system said in a release on Monday. The trial is expected to start next week.
The phase 2/3 vaccine study is sponsored by biopharmaceutical company Pfizer Inc. and German biotech company BioNTech SE.
This vaccine is one of the most advanced candidates in the BNT162 program currently being evaluated in the United States and Germany. It recently received fast track designation from the U.S. Food and Drug Administration, UH said.
The Phase 2/3 trial will provide data on the vaccine’s safety, level of immune response it produces in the body and efficacy, or the ability to produce the desired result, UH said.
Clinical development is a three-phase process, according to the Centers for Disease Control and Prevention. In Phase 1, small groups of people receive a trial vaccine. In Phase 2, the trial vaccine is given to people who have characteristics similar to those for whom the new vaccine is intended. In Phase 3, the vaccine is given to thousands of people and tested for efficacy and safety.
“This is encouraging news for Ohioans,” UH President Dr. Daniel I. Simon said in a statement. “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.”
The new study will enroll adults 18 to 85 who are not pregnant. Because of the disproportional rate of COVID-19 among people of color, UH plans to ensure that people of color are well represented in this study, the hospital system said.
You can call 612-524-9091 to learn how to participate in the study.
The principal investigator for the trial is Dr. Robert Salata, chairman of the department of medicine and program director of the UH Roe Green Center for Travel Medicine & Global Health.
“The trials we are preparing to conduct are especially significant because if proven safe and effective, and the vaccine receives regulatory approval, Pfizer and BioNTech expect to be able to manufacture up to 100 million doses by the end of 2020,” Salata said in a statement.
Co-investigators are director of infection control Dr. Elie Saade, as well as Dr. Scott Fulton, and Dr. George Yendewa, both assistant professors of medicine at UH.
In July, Pfizer and BioNTech announced promising early findings from its Phase 1/2 trial of the vaccine.
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