Four Rochester residents were among the first in the country to receive the new coronavirus (COVID-19) vaccine at Rochester General Hospital (RGH) as part of the clinical trial's third and final phase. RGH is one of four sites nationwide participating in the study, alongside the University of Rochester Medical Center, developed by Pfizer and BioNTech.
The four individuals range in age from 26 to 74 and have a variety of occupations, confirmed 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.
Phase three will be the final stage of vaccine development before it goes to the FDA for approval, production, and distribution. 30,000 volunteers are being recruited at more than 120 sites around the world for the study, including up to 200 volunteers in Rochester.
Eligible individuals include:
*Immunocompromised persons or pregnant women are not eligible at this time.
If you are interested in participating, please email [email protected], or call the vaccine study line at (585) 922-5944.
Becky Timmons was one of 40 initial volunteers of the phase 1 trial to take her first dose of the vaccine at Rochester General Hospital.
Timmons said one of the reasons she volunteered for the trial is because of her grandfather. "I have a 96-year-old grandfather and I have not been able to hug him in three months, nor has anyone else," Timmons said. "I think it would be really amazing if it works."
The study consists of multiple visits for volunteers over a two-year period and focuses on how participants’ immune systems respond to proteins being used in other vaccines to prevent flu spread.
“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 Dr. Walsh.
“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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