Rochester Regional Health is participating in a new clinical trial that will evaluate the safety and efficacy of a third dose of the Pfizer/BioNTech COVID-19 vaccine.
In developing long-term vaccination strategies, studying booster doses that target coronavirus variants is an important step.
“While widespread vaccination is the key to moving past the current health crisis, COVID-19 has the potential to become a seasonal and mutating virus,” said Ed Walsh, MD, an infectious disease specialist at Rochester Regional Health.
The study will help experts further understand the way that mRNA vaccines invoke an immune response; information that could lead to the development of booster shots that target specific variants of COVID-19.
The study, which is being conducted in Rochester and three other sites in the U.S. will include participants of the phase 1 Pfizer/BioNTech trial last spring, all of who were fully vaccinated more than 6 months ago. Over the next several weeks, researchers will provide a booster dose of the Pfizer/BioNTech vaccine to 144 volunteers, including 35 people in Rochester.
Locally, Ed Walsh, MD, and Ann Falsey, MD, both infectious disease specialists at Rochester Regional Health and University of Rochester Medical Center, are leading the study. Testing of the vaccine and observation of volunteers will be conducted at Rochester General Hospital.
The duration of protection provided by the Pfizer/BioNTech COVID-19 vaccine is unknown. Since it’s assumed that immunity wanes over time, the trial will measure the boost to the immune system and evaluate whether antibodies and other immune cells generated after the third dose will provide protection against coronavirus variants.
The study will examine how well a third dose of the vaccine is tolerated in healthy volunteers. Researchers will closely monitor participants for side effects and other responses.
Researchers have turned their focus to the development of vaccines that can be tailored to meet the threat of emerging strains of coronavirus.
While there is no current evidence that the current vaccine cannot protect against new variants of the vaccine, researchers are taking proactive steps to be ready in case this becomes true. Recently, Pfizer and BioNTech announced that the two companies have begun discussions with regulatory agencies regarding an early-stage clinical study to evaluate a modified version of the currently approved vaccine.
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