CLEVELAND — University Hospitals announced plans Monday to participate in an investigative trial as a research site for phase 2/3 for a possible COVID-19 vaccine.
The hospital chain will be one of nearly 120 sites worldwide to take part in the trial of BNT162b2, the investigational vaccine being tested, run by Pfizer and BioNTech SE. Around the world, more than 30,000 participants will help to test the drug in an effort to quickly find a solution to the ongoing Coronavirus pandemic.
The vaccine has been recognized as one of the most promising trials in the current race to end COVID-19 and was recently fast-tracked by the U.S. Food and Drug Administration (FDA) after early studies in the U.S. and Germany.
“This is encouraging news for Ohioans,” said Daniel I. Simon, MD, Chief Clinical & Scientific Officer and President, UH Cleveland Medical Center. “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 trial will take place at the UH Cleveland Medical Center on a 1:1 ratio of candidates receiving the vaccine and candidates receiving a placebo.
Phase 2/3 will be spearheaded by Robert Salata, MD, Chairman of the Department of Medicine at UH Cleveland Medical Center, Program Director of the UH Roe Green Center for Travel Medicine & Global Health and Professor of Medicine, Epidemiology and International Health at Case Western Reserve University.
“The need for an effective vaccine is critical in the fight against the COVID-19 pandemic,” said Dr. Salata. “There is presently no cure for the highly contagious novel coronavirus that causes COVID-19 and our best plan of attack is to find a vaccine that can help protect people from getting it in the first place. 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.”
The study is looking to enroll a diverse group of adults between the ages of 18-85.
Researchers say that the goals of the trial are to prevent COVID-19 in those who have not been infected and to stop COVID-19 even in the case of individuals who have been exposed.