Cleveland, Ohio-based University Hospitals will serve as one of 120 global clinical investigational sites to test Pfizer and BioNTech’s COVID-19 vaccine.
The clinical trial would be initiated at UH Cleveland Medical Center. Dr. Robert Salata, chairman of the Department of Medicine at UH Cleveland Medical Center, will serve as principal investigator.
“This is encouraging news for Ohioans,” said Dr. Daniel I. Simon, 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 effort is slated to enroll up to 30,000 participants. The vaccine is one of the most advanced candidates currently being evaluated in the United States and Germany. It recently received Fast Track designation from the U.S. Food and Drug Administration (FDA).
“The need for an effective vaccine is critical in the fight against the COVID-19 pandemic,” Salata said. “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.”
Salata said the trials are 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.