Rochester Regional Health is investigating a new potential coronavirus vaccine in collaboration with the University of Rochester Medical Center (URMC). Rochester General Hospital is one of only four sites in the country chosen to test the vaccine for coronavirus. The experimental vaccine has been developed by pharmaceutical company Pfizer and biotech company, BioNTech.
“COVID-19 is a highly infectious and deadly disease, and there is tremendous urgency to develop a vaccine that will help us fight this global pandemic,” said Edward Walsh, MD, member of the Infectious Diseases Unit at Rochester General Hospital and a professor in the Department of Medicine (Infectious Diseases) at URMC.
“While the scientific and medical community are moving at unprecedented speed to advance vaccine candidates, it is critical that this effort is conducted in a rigorous manner that evaluates the safety and efficacy of potential vaccines. This new clinical trial, the only active coronavirus vaccine study in Rochester, is the first step in that process.”
Dr. Walsh and Ann R. Falsey, MD, an Infectious Disease specialist at Rochester Regional Health and co-director of the URMC Vaccine Trials and Evaluation Unit, are leading the Rochester arm of the study.
The randomized placebo-controlled clinical trial will recruit 90 individuals in the Rochester area ages 18 to 85 who have not been infected with COVID-19 and will evaluate the safety, tolerability, and immunogenicity (ability to induce an immune response) of up to four variations of the vaccine.
The recruitment of study volunteers and testing of the vaccine will occur at Rochester General Hospital. Rochester General Hospital is the only non-teaching hospital in the country to participate in the study, and Rochester is one of four sites in the U.S. that will be conducting early-stage studies of the vaccine, which began clinical trials in Germany in April.
“Our number one priority during this entire coronavirus outbreak has been the health and safety of our community,” said Robert Mayo, MD, Chief Medical Officer at Rochester Regional Health. “Now through this coronavirus vaccine trial, we can expand our radius of care to the entire world, and that is something we are very proud of.”
Traditionally, effective vaccines against viruses like hepatitis A and B and influenza contain protein components of the virus called antigens to stimulate the immune system to produce antibodies and immune cells that protect from infection. The Pfizer/BioNTech vaccine will utilize 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. While experimental vaccines against cancer and the bird flu have used a similar mRNA strategy, there are currently no FDA-approved RNA vaccines for humans.
While there are approximately 100 potential COVID-19 vaccines in various stages of development, the Pfizer/BioNTech experimental vaccine is one of only seven to have advanced to human clinical trials worldwide.
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