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Coronavirus vaccine enters final phase of testing at URMC, Rochester Regional Health

Jul 29, 2020

Four people in the Rochester area became the first in the country to receive an experimental novel coronavirus vaccine this week.

The vaccine, developed by the pharmaceutical companies Pfizer and BioNTech, is now in the final phase of the federal approval process after limited trials showed no major risks. Local researchers are now recruiting hundreds of participants to test the vaccine’s effectiveness.

Dr. Ann Falsey, a co-director of the University of Rochester Medical Center’s Vaccine and Treatment Evaluation Unit, said participants have told her that they’re excited to be a part of developing a new vaccine.

“It’s helpful for people to have some control and to feel like they can move the science along,” she said.

A volunteer gets a shot of an experimental novel coronavirus vaccine in Rochester.
Credit University of Rochester Medical Center / Rochester Regional Health

Vaccine researchers are looking for thousands of volunteers to join the trial nationwide. Falsey said they are looking in particular for people who are at high risk of exposure to the virus.

Essential workers in public-facing jobs are among those whom URMC is aiming to enroll in the study. More information about how to participate is on the medical center’s website.

Dr. Ed Walsh, another member of the medical center’s vaccine research team, said the injection works by giving the body a blueprint of one of the virus’s proteins so it can mount a defense without being infected.

“This is basically an instruction manual” for the immune system, he said.

Even though the body will respond to the vaccine by building more of the injected viral protein, it won’t have the ability to build an infectious virus, which is made of many different proteins, Walsh said.

Even if phase 3 of the trial is completely successful, the researchers said the timeline for a finished vaccine is still unclear and is likely several months away.

Dr. Anthony Fauci, the country’s top infectious disease official, said rising rates of virus transmission in other parts of the U.S., while unfortunate, could speed vaccine development by offering researchers a better view into how well the drug blocks the progression of COVID-19.

Half of the volunteers in the Rochester arm of the study will receive real doses of the vaccine. Half will receive saltwater injections as a placebo, Walsh said. Neither the patients nor the researchers tracking their infection status will know who got which dose.

No vaccine against the novel coronavirus is approved for use in the general population in the United States. Six, including the one under study in Rochester, are in the final phase of the federal approval process. Dozens are in earlier stages of development.

“This is an unprecedented situation where a single disease has so many ... trials all attempting to achieve the same goal,” said Walsh.

If one vaccine proves effective, others probably will, too, he said. That will be important when it comes time to distribute vaccines, as millions of people will need doses, and each company’s production capacity is finite, Walsh said.