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The University of Rochester Medical Center is participating in a new clinical trial that will mix-and-match the initial regime of an approved vaccine with a booster dose from a different manufacturer. The research will help inform public health decisions around re-vaccination schedules and the deployment of boosters that target COVID variants. The study is being led by Ann Regina Falsey, MD, Angela Branche, MD, co-directors of the URMC Vaccine and Treatment Evaluation Unit (VTEU), and David M Dobrzynski, MD, an assistant professor of Medicine, Infectious Diseases.

Read more: New Study Mismatches Vaccine Doses to Boost Immunity to COVID and Variants

Our faculty will test the Pfizer/BioNTech SE vaccine on 200 to 300 children ages six months to 11 years. URMC previously announced its participation in pediatric trials for the Moderna vaccine (March 18). Jennifer Nayak, M.D., associate professor in the Department of Pediatrics and the Division of Infectious Diseases and Microbiology and Immunology, and Mary Caserta, M.D., professor in the Department of Pediatrics, Division of Infectious Diseases, will be monitoring progress of the study.

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Angela Branche, MD, Assistant Professor of Medicine in Infectious Diseases and Co-Director of the UR Vaccine Treatment and Evaluation Unit, was one of three URMC faculty members recognized for their contributions to improving health in the Greater Rochester region at the 12th annual Dr. David Satcher Community Health Improvement Awards, presented by the Center for Community Health & Prevention of URMC. The awards reflect the mission of the Center for Community Health & Prevention and the URMC to develop and expand community-university partnerships that support community-engaged research and interventions that reduce health inequities and improve the community's health. Dr. Branche has played an integral role in COVID-19 research, not only through her work on vaccine trials, but is also by being a trusted face in the Rochester community, participating in door-to-door outreach to the Black community to increase vaccine trial participation.

Paul Graman, M.D., Professor of Medicine, Clinical Director of the Infectious Disease Division, and Hospital Epidemiologist for Strong Memorial and Golisano Children's Hospitals, spoke with Spectrum News (April 22) about URMC's participation in a CDC study regarding vaccinated individuals who test positive for COVID. "No vaccine is 100 percent effective, but in the rare case a vaccinated person contracts COVID-19, the illness will be less severe," he said.

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You may be among the more than 95 million people in the United States who have taken at least one dose of a coronavirus vaccine. Or you may still be awaiting your turn. Regardless, there's a crucial question on most of our minds: How long will the vaccine really protect us?

As with most aspects of the virus, the answer is not completely clear. Why? Because although we have been battling the pandemic for more than a year, the vaccines were granted emergency use authorization relatively recently. So experts have not had time to observe their long-term effectiveness.

However, that research is underway, and in the meantime, experts say we can make an educated guess.

Can we extrapolate from what we know about natural immunity?

In fact, much of this hypothesizing comes from extrapolating data examining immune responses in people who have had covid-19 and illnesses from other coronaviruses, rather than in people who have been vaccinated, said Dbeibo, who is director of vaccine initiatives for Indiana University.

"But vaccine responses should not be less reliable than in natural infection," she added.

Current research shows that people who have been infected with covid-19, the illness caused by the coronavirus, retained immunity that was robust after eight months. That gives researchers a starting point in predicting how long immunity may last after vaccination, Dbeibo explained.

But research also shows people who had more severe cases developed a stronger immune reaction than those with milder forms of the disease. And because vaccine-induced immunity appears to be more similar to natural immunity that is derived from severe covid-19 infections, researchers say they believe people who take a coronavirus vaccine will be protected better than most people with natural immunity, said David Topham, a professor of microbiology and immunology at the University of Rochester.

All of that said, antibodies will wane. And although it is a gradual process, once antibodies decline to a level that is no longer protective, reinfection is possible. Still, the infection is likely to be milder, experts said.

Topham, founding director of the Translational Immunology and Infectious Disease Institute at the University of Rochester, has been studying the coronavirus and the role of memory B cells — immune cells that persist for a lifetime and produce antibodies when re-exposed to a pathogen that they have been programmed to fight. He said some people who were hospitalized with severe covid-19 infections still had high frequencies of memory B cells, as well as antibodies, up to nine months after infection.

He said memory B cells can even adapt quickly to a new variant, usually within days.

Ann Falsey, M.D., Professor of Medicine and Co-Director of the Vaccine Trials and Evaluation Unit (VTEU), hopes the results of a Phase 3 clinical trial of the AstraZeneca vaccine completed in the VTEU in January will clarify some of the confusion generated by the earlier UK-based study. "It was large, it was rigorously designed, ahead of time, and there were no changes that happened during the study," she says. Still, Falsey says "there is no reason to panic. To judge the outcome now would be very premature," she adds. "I do think the bulk of data shows the vaccine is very safe."

Her comments appeared in the March 16th issue of Time.

The University of Rochester Medical Center (URMC) and Rochester Regional Health (RRH) have begun a new clinical trial that will evaluate the safety and efficacy of a third dose of the Pfizer/BioNTech COVID-19 vaccine. The vaccine is currently approved for a two dose regimen. This study represents an important step in the development of long-term vaccination strategies, including the creation of booster doses that target coronavirus variants.

"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, M.D., and infectious disease specialist at URMC. "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."

URMC and RRH have been involved in the development of the Pfizer/BioNTech vaccine since the launch of phase 1 clinical trials in May 2020 when volunteers in Rochester were among the first in the nation to receive the then experimental vaccine. Rochester was also a site for the phase 2/3 clinical trials that ultimately led to the vaccine's emergency use authorization (EUA) by the U.S. Food and Drug Administration last December. Since then, tens of millions of people across the globe have received at least one dose of the Pfizer/BioNTech vaccine.

The new study will involve individuals who participated in the phase 1 trials last spring, all of whom were fully vaccinated more than 6 months ago. Over the next several weeks, researchers will dose 144 volunteers, including 35 in Rochester, with a booster dose of the EUA-approved Pfizer/BioNTech vaccine. Rochester is one of four sites in the U.S. involved in the study.

The local studies are led by Walsh and Ann Falsey, M.D.; both hold faculty appointments in the URMC Department of Medicine, Infectious Diseases and are members of the Infectious Disease Unit at RRH. 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.

While the duration of protection provided by the Pfizer/BioNTech vaccine is unknown, it is assumed that immunity wanes over time, a phenomenon common in vaccines for other infectious diseases. The trial will measure the boost to the immune system and evaluate in the lab whether antibodies and other immune cells generated after the third dose provide protection against coronavirus variants. The study will also seek to answer is how well a third dose of the vaccine is tolerated in healthy volunteers and researchers will closely monitor participants for side effects.

The findings of the study will also be important as vaccine developers have turned their focus to the development of vaccines that can be tailored to meet the threat of emerging strains of the virus. Pfizer and BioNTech announced today that the companies had begun discussions with regulatory agencies regarding an early stage clinical study to evaluate a modified version of approved vaccine.

"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. This booster study is critical to understanding the safety of a third dose and efficacy against circulating strains," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorization for an updated mRNA vaccine or booster if needed."

Angela Branche, M.D., Assistant Professor of Medicine (Infectious Diseases), knocked on doors in Rochester neighborhoods to talk about coronavirus and her research to ensure diverse participation in COVID-19 vaccine trials. Her efforts to combat mistrust in the Black community were highlighted in Reuters.