New front against variants studied here

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Rochester Regional Health and the University of Rochester Medical Center are helping to develop a defense against new and possibly troublesome variants of the virus that causes COVID-19. 

Mutated versions of the SARS-CoV-2 virus could be more transmissible and more capable of evading the immunological defenses that COVID vaccines trigger, experts fear. Variants so far have cropped up in Britain, South Africa, South America and California. One case of the U.K. variant, called B.1.1.7, was reported in Ontario County last week. The infected individual recovered.

RRH and URMC are among only four institutions nationally conducting a new clinical trial of the Pfizer-BioNTech COVID-19 vaccine that aims to see if an additional shot of the vaccine could be key to defeating such variants. The vaccine is currently recommended for a two-injection course with shots spaced at least three weeks apart.

“This study will help us understand important questions about the safety and immunogenicity of multiple doses of an mRNA vaccine, information that could ultimately enable us to extend the protection of vaccines and develop tailor-made, variant-specific boosters,” says Ed Walsh, M.D. an infectious disease specialist and professor in the URMC Department of Medicine.

Walsh and Anne Falsey M.D., led Phase I, II and III trials of the Pfizer-BioNTech vaccine in Rochester and are leading the new trial as well. Falsey is a member of the URMC and RRH infectious disease units. 

Pfizer contracted with URMC to conduct the clinical trial in Rochester. RRH will recruit volunteers and test the vaccine at Rochester General Hospital. 

Phase I trials of the Pfizer-BioNTech vaccine began in May 2020, with Rochester among the first sites to conduct double-blind tests of the COVID vaccine. 

The new trial is open only to individuals who got shots of the vaccine at least six months ago as early participants in the vaccine’s first round of trials. A total of 144 individuals who fit that profile—including 35 in Rochester—will be subjects of the study. Unlike the earlier trials of the vaccine, all participants will get the vaccine; none will receive a placebo. 

With research starting from scratch only months earlier, the Pfizer-BioNTech vaccine was granted emergency U.S. Food and Drug Administration approval in mid-December. Area residents and individuals across the country are currently being vaccinated with it. Developed in record time, the Pfizer-BioNTech vaccine has been found to be 57 percent effective after one dose and 94 percent effective after a second shot. Not yet certain is how long that protection lasts.

second mRNA vaccine, developed by Moderna, also received emergency approval in December. On Saturday, a third—Johnson & Johnson’s single-dose vaccine, developed using viral vectors instead of mRNA technology—also was approved by the FDA.

Pfizer and BioNTech last week announced they had kicked off talks with regulatory agencies on studies to evaluate a modified version of their already approved vaccine. 

“This booster study is critical to understanding the safety of a third dose and immunity against circulating strains,” says Pfizer CEO Albert Bourla. “While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine.” 

Will Astor is Rochester Beacon senior writer.

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