University Hospitals Ready Initiation of BNT162b2 Phase 2/3 COVID-19 Vaccine Trial Next Week: Seeking Minority Participation

University Hospitals Ready Initiation of BNT162b2 Phase 23 COVID-19 Vaccine Trial Next Week Seeking Minority Participation

The Cleveland area will be contributing to the battle against COVID-19 as University Hospitals was selected by Pfizer and BioNTech SE to participate in the Phase 2/3 global clinical program evaluating the mRNA-based BNT162 program (actually represents now five therapies for which BNT162b2 will now be tested in up to 30,000 participants for safety and efficacy. The experimental vaccine was recently assigned Fast Track designation by the U.S. FDA. TrialSite recently wrote the Pfizer BNT 162 program represents a top candidate for the COVID-19 vaccine race. Experimental vaccine is on its way and the University Hospitals, including UH Cleveland Medical Center, should initiate the study by next week.

One of 120 trial site organizations, Dr. Daniel I Simon, chief clinical and scientific officer and president UH Cleveland Medical Center, reported that the Cleveland based medical center was one of the first to test remdesivir, which, of course, went on to be approved by the FDA as part of an emergency use authorization (EUA).

Simon reports that “The trial has been approved by the FDA and our Institutional Review Board.” He continued that the research center should receive the experimental vaccine shipment by next week hence they can then initiate the trial, reports Chad Felton of the Morning Journal.

The Investigators

The actual study will occur at UH Cleveland Medical Center, and Robert Salat, chairman of the Department of Medicine at UH Cleveland Medical Center, will serve the study as Principal Investigator while Co-Investigators include Dr. Elie Saade, UH Director of infection control; and Dr. Scott Fulton and Dr. George Yendewa, assistant professors of medicine at UH Cleveland Medical Center.

Minority Groups Sought

COVID-19 has disproportionately impacted communities of color—e.g. African Americans, Hispanics, certain Asian groups, Native Americans, etc. Cleveland has a large Black population, nearly 50% of the city’s total.  

The COVID-19 vaccine study teams also seek other at-risk groups such as healthcare workers, first responders, etc.

Call to Action: If you live in the Cleveland area, consider participation; this is one of the most advanced experimental vaccine products in the world. Contact 612-524-9091.