The University of Rochester Medical Center (URMC) and Rochester Regional Health (RRH) are joining a phase 3 clinical trial for a potential coronavirus vaccine developed by Pfizer and BioNTech. The companies received approval from the Food and Drug Administration (FDA) to proceed to phase 3 on Monday, immediately after which four volunteers in Rochester were among the first in the nation to receive the experimental vaccine.
Phase 3 marks the final stage of vaccine development prior to FDA approval, mass production, and distribution. A total of 30,000 volunteers will be recruited at more than 120 sites across the globe for the study, including up to 200 in Rochester.
In May, URMC and RRH began participating in phase 1 trials of the Pfizer/BioNTech vaccine candidates. Rochester was one of only four sites in the U.S. involved in this early stage study. That study evaluated four variations of the vaccine and one of these candidates, named BNT162b2, was given the green light by the FDA yesterday to move to phase 3 clinical trials. The first volunteers to receive the vaccine in the U.S. were dosed in Rochester later that same afternoon.
The phase 1 and now the new study are led by Edward Walsh, M.D., a professor in the URMC Department of Medicine (Infectious Diseases) and member of the Infectious Diseases Unit at Rochester General Hospital and Ann R. Falsey, M.D., co-director of the URMC Vaccine and Treatment Evaluation Unit and a member 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 Hospital.
“The speed at which the scientific community is moving to develop a vaccine for COVID-19 is unprecedented in modern medical history,” said Walsh. “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 randomized placebo-controlled clinical trial will recruit up to 200 individuals in the Rochester area ages 18 to 85 with a focus on individuals who are at high risk for coronavirus infection, such as health care workers, first responders, teachers, and people who work in restaurants or retail. Researchers will work with community partners to invite Black and Latinx families to participate in vaccine trials, which will help to address the disproportionate impact COVID-19 has had on people of color.
In addition to this study, it is anticipated that URMC will soon launch a second phase 3 COVID-19 vaccine study in Rochester that will involve a different vaccine being developed under the federal Operation Warp Speed initiative. Recruitment for that study began earlier this month.
“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,” said Falsey. “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.”
In March, Pfizer partnered with BioNTech, a German biotech company that has created a platform to rapidly develop vaccines for coronavirus and other emerging viral diseases. While there are more than 100 potential COVID-19 vaccines in various stages of development, the Pfizer/BioNTech vaccine is one of only five that have advanced to human phase 3 clinical trials worldwide and only the second in the U.S. On July 22, the federal government awarded the companies a contract for 100 million doses of the vaccine to be delivered by December and the option to acquire 500 million more doses.
The Pfizer/BioNTech vaccine utilizes a relatively new genetic engineering method to stimulate the immune system to produce a protective response to the new coronavirus. The vaccines are composed of short sequences of the virus RNA, known as messenger RNA (mRNA), which provide precise instructions to the recipients own cells to produce the virus antigens that activate an immune response that can fight off the infection.
Individuals interested in learning more about volunteering for the study should call 585 276-5212 or visit covidresearch.urmc.edu.