The University of Rochester Medical Center (URMC) and Rochester Regional Health (RRH) are investigating a new 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, M.D., a professor in the URMC Department of Medicine (infectious diseases) 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 R. Falsey, M.D., co-director of the URMC Vaccine and Treatment Evaluation Unit and a member of the Infectious Disease at Rochester General Hospital, 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 of up to four variations of the vaccine. Pfizer 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 study is the only active COVID-19 vaccine clinical trial in upstate New York.
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 approximately 100 potential COVID-19 vaccines in various stages of development, the Pfizer/BioNTech experimental vaccine is one of only seven that have advanced to human clinical trials worldwide. Rochester is one of four sites in the U.S. that will be conducting early stage studies of the vaccine, which began 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 (mRNA), 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, there are currently no approved RNA vaccines for humans.
Individuals interested in learning more about volunteering for the study should call 585 922-5944 or email firstname.lastname@example.org