The University of Rochester Medical Center and Rochester Regional Health are among the institutions partnering with the drug company Pfizer and the immunotherapy company BioNTech to test a group of COVID-19 vaccine candidates.
Rochester is one of four sites in the United States conducting early-stage clinical trials of the vaccine, according to a news release from URMC. Other American sites include the New York University Grossman School of Medicine and the University of Maryland School of Medicine, which have already started administering doses to participants, as well as Cincinnati Children’s Hospital Medical Center. Like URMC and Rochester Regional, Cincinnati Children’s Hospital will begin enrolling participants soon.
Researchers with the two health systems, which have extensive experience in vaccine development and trials, will recruit 90 participants who have not been infected by the virus and are otherwise healthy. Anyone interested in signing up can call (585) 922-5944 or email rghcovidvaccinetrial@rochesterregional.org.
Pfizer and BioNTech have also begun a trial of the vaccine in Germany, and participants there received their first doses of the vaccine last week, according to a statement from Pfizer. The vaccine is one of seven currently in clinical trials worldwide, according to URMC.
The study is designed to determine the safety, ability to invoke an immune response in recipients, and optimal dosage of four formulations of the BNT162 vaccine, which will be “evaluated in a single, continuous study,” according to Pfizer.
By running trials on four different vaccine formulations at the same time, researchers will be able to “identify the safest and potentially most efficacious candidate in a greater number of volunteers,” Pfizer’s statement read. The data will be shared with regulatory authorities in “real time.”
The U.S. trial will enroll up to 360 healthy participants, split into two age groups: 18-55 and 65-85, according to Pfizer.
Participants in the 18 to 55 age group will receive the vaccine doses first and participants in the 65 to 85 group will receive the same doses later, after researchers see initial evidence that the levels given to younger participants are
