Four Rochester volunteers were among the first in the nation to receive an experimental vaccine against COVID-19.
The University of Rochester Medical Center and Rochester Regional Health are joining a Phase III clinical trial for a vaccine candidate developed by Pfizer and BioNTech, URMC officials say. The firms received approval from the U.S. Food and Drug Administration on Monday to proceed to the next phase of clinical trials.
Some 30,000 volunteers will be recruited at more than 120 sites worldwide. Two hundred of them will be Rochesterians, URMC says. Phase III is the final stage of vaccine development before regulatory approval, production and distribution.
On July 22, Pfizer and BioNTech said the U.S. government placed an initial order of 100 million doses for $1.95 billion. The companies expect to seek regulatory review as early as October and manufacture up to 100 million doses by the end of the year.
A couple of weeks ago, two of the companies’ four investigational vaccine candidates from its BNT162 mRNA-based vaccine program had received FDA Fast Track designation. The vaccines use Germany-based BioNTech’s know-how to prompt the human immune system to protect itself against COVID-19. Pfizer and BioNTech’s alliance dates to a multimillion-dollar agreement in 2018 to develop mRNA vaccines for influenza. The collaborators pivoted to work on the coronavirus amid the pandemic.
URMC and RRH began participating in these trials in May, when Rochester was one of four sites participating in the early stage study. That study evaluated four variations of the vaccine and one of these candidates—BNT162b2—is moving to Phase III.
The local effort is led by Edward Walsh, M.D., a professor in URMC’s Department of Medicine, and Ann Falsey, M.D., co-director of the URMC Vaccine and Treatment Evaluation Unit. Both are members of the Infectious Disease Unit at Rochester General Hospital. Pfizer has contracted with URMC to conduct the clinical trial in Rochester, and the recruitment of study volunteers and testing of the vaccine will occur at Rochester General, URMC says.
“The speed at which the scientific community is moving to develop a vaccine for COVID-19 is unprecedented in modern medical history,” Walsh says. “We were pleased to be a part of the early stage studies of the Pfizer and BioNTech vaccine and look forward to participating in these new critical clinical trials.
“While there is a tremendous urgency to develop a coronavirus vaccine and this study represents the final stage of human research, it is equally essential that we continue to rigorously evaluate the safety and efficacy of every potential vaccine candidate.”
The trial will recruit local individuals ages 18 to 85, focusing on high-risk candidates such as health care workers, first responders, retail and restaurant workers and teachers. In an effort to address the unequal impact of the outbreak on people of color, researchers will work with community partners to invite Black and Latinx families to participate in the trial.
URMC is expected to launch a second Phase III study locally with another vaccine developed under the federal Operation Warp Speed Initiative, officials say. The initiative is a partnership of components of the Department of Health and Human Services, including the Centers for Disease Control and Prevention, the FDA, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority as well as the Department of Defense. It aims to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 2021.
“Rochester has a long history of national leadership in vaccine development, the study of emerging infectious diseases, and understanding how the human immune system reacts to infection,” Falsey says. “This recognition is due not only to the efforts of our scientific and medical community, but also because the people of Rochester have been critical partners in the process of advancing medical research. The possibility that our community could play an important role in the development of two potential coronavirus vaccines is a testament to that partnership.”
Recruitment for the second Phase III study began this month.
Smriti Jacob is Rochester Beacon managing editor. All coronavirus articles are collected here.