The University of Rochester Medical Center and Rochester Regional Health are investigating a potential coronavirus vaccine developed by Pfizer and BioNTech.

“COVID-19 is a highly infectious and deadly disease, and there is a tremendous urgency to develop a vaccine that will help us fight this global pandemic,” said Edward Walsh, a professor in the URMC Department of Medicine and member of the Infectious Diseases Unit at Rochester General Hospital. “While the scientific and medical community are moving at an unprecedented speed to advance vaccine candidates, it is critical that this effort be conducted in a rigorous manner that evaluates the safety and efficacy of potential vaccines. This new clinical trial is the first step in that process.”

Walsh and Ann Falsey, co-director of the URMC Vaccine Trials and Evaluation Unit and IDU member, are leading the Rochester arm of the study.

The randomized placebo-controlled clinical trial will recruit 90 individuals in the Rochester area ages 18-85 who have not been infected with COVID-19, and will evaluate the safety, tolerability and immunogenicity of up to four variations of the vaccine.

Pfizer contracted with URMC to conduct the clinical trial in Rochester. Recruitment of study volunteers and testing of the vaccine will occur at RGH. The study is the only active COVID-19 vaccine clinical trial in upstate New York.

Pfizer partnered with BioNTech, a German biotech company that created a platform to rapidly develop vaccines for coronavirus and other emerging viral diseases. While there are approximately 100 potential COVID-19 vaccines in various stages of development, the Pfizer/BioNTech experimental vaccine is one of seven that advanced to human clinical trials worldwide. Rochester is one of four sites in the U.S. that will conduct early-stage studies of the vaccine, which started in clinical trials in Germany in late April.

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 provide protection from infection.

The Pfizer/BioNTech vaccines 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, which provide precise instructions to the recipients’ own cells to produce the virus antigens. While experimental vaccines against cancer and bird flu have used a similar mRNA strategy, currently there are no approved RNA vaccines for humans.

Individuals interested in learning more about volunteering for the study can email rghcovidvaccinetrial@rochesterregional.org or call (585) 922-5944 for information.

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