University of Rochester Medical Center Commences Project Lightspeed Trial Dosing First Participants with Pfizer/BioNTech BNT162

Jul 29, 2020 | BioNTech, BNT162, COVID-19, Leading Sites, News, Pfizer, Site Success, Site Watch

University of Rochester Medical Center Commences Project Lightspeed Trial Dosing First Participants with PfizerBioNTech BNT162

The University of Rochester Medical Center (URMC) and Rochester Regional Health have commenced the Phase 3 clinical trial of the Pfizer and BioNTech mRNA-based vaccine known as BNT162. The local branch of the study seeks to enroll 200 volunteers between 18 and 85 for this critical final stage of the study. URMC and Rochester Regional Health join “Project Lightspeed.”

Previous BNT162 Involvement

Rochester-based investigators have experience with the investigational vaccine known as BNT162. For example Dr. Edward Walsh, URMC Department of Medicine professor and Dr. Ann Falsey, co-director URMC’s Vaccine Treatment Evaluation Unit both lead the effort. Both investigators are also physicians with the Rochester General Hospital Infectious Unit, reports 13 ABC WHAM.

The Study

This Phase 1/2/3 study evaluates the safety, tolerability, immunogenicity, and efficacy of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19. For more details, see study # NCT04368728

Study Focus

This trial site is focusing on those who are at a high-risk for the virus, such as health care and other essential workers. Moreover due to the fact that the virus disproportionately impact African American and Latinx community members the center will pay particular attention to those participants.

Principal Investigator Comments

Dr. Falsey summarized her feelings in regards to the opportunity to participate in these historical trials, commenting, “We feel very privileged to be at the forefront here. I think it’s a great benefit for our community to participate in these trials.” Dr. Falsey continued, “I think its helpful for people to have some control and feel like they can move the science along, and so by participating in a trial, they’re doing just that.  We hear from some of our older volunteers that the polio pioneers came before them, so this is their way to give back and to get everybody out of their houses sooner than later.”

Study Site

University of Rochester Medical Center, also known as UR Medicine, is located in Rochester, New York and is one of the main campuses of the University of Rochester and comprises the university’s primary medical education, research and patient care facilities. The UR Health Research Department manages all of the clinical trials at the center.

Operation Warp Speed

UR Medicine reports to 13 ABC WHAM that they will also be selected as part of a forthcoming Operation Warp Speed clinical trial.

Lead Research/Investigator

Dr. Edward Walsh, URMC Department of Medicine professor

Dr. Ann Falsey, co-director URMC’s Vaccine Treatment Evaluation Unit

Call to Action: Based in this part of New York State and interested in participating? Contact 585-276-5212

Source: 13WHAM