Vaccine

As the COVID-19 pandemic continues worldwide, scientists are working to develop a vaccine that can be distributed widely to prevent the disease. The COVID-19 virus has caused millions of infections and hundreds of thousands of deaths worldwide.

In the U.S., a government initiative known as Operation Warp Speed aims to produce and distribute a vaccine with 300 million doses. Operation Warp Speed is a partnership between the Department of Health and Human Services and the Department of Defense.

Vaccines often take many years to develop, but Operation Warp Speed aims to have the first doses of vaccine ready to distribute by January 2021.

The project has identified five potential candidate vaccines ready for widespread human testing after showing promise in animal testing and early stages of human testing.

UPMC has established the Pittsburgh Vaccine Trial Unit to help test COVID-19 vaccine candidates. Soon, UPMC will begin enrolling participants in a human trial of a COVID-19 vaccine candidate developed by Moderna and the National Institutes of Health (NIH).

“We need a COVID-19 vaccine now more than ever,” says Terence Dermody, MD, physician in chief and scientific director at UPMC Children’s Hospital of Pittsburgh. “And it’s clear that worldwide need has engendered a tremendous interest in the development of vaccines and testing.”

UPMC is seeking 250 volunteers for the trial of the Moderna/NIH vaccine candidate. The Pittsburgh Vaccine Trial Unit also may test other potential vaccines in the coming months. You can register for the Pittsburgh Vaccine Trial Unit on the UPMC Children’s Hospital of Pittsburgh website. Though the trial program is through UPMC Children’s Hospital, it is open for adults.

Dr. Dermody says the hope is that one of the vaccines will be safe and effective against COVID-19, allowing for large-scale manufacture and distribution.

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Who Is a Candidate for COVID-19 Vaccine Trials at UPMC?

The Pittsburgh Vaccine Trial Unit is seeking people across all demographics, from older adolescents to older adults. That includes people of different ages, races, ethnicities, and genders, as well as people in higher-risk groups for COVID-19.

“We are including in the registry truly anybody who would like to register,” Dr. Dermody says. “We’ll contact you if you’re interested in participating in the Moderna trial or one of the trials to come later this year or the early part of next. We’re interested in all comers.”

The unit is looking ideally for participants who have had no exposure to or infection from COVID-19. Previous COVID-19 exposure or illness may provide people with some level of protection against the disease.

“The trial will give us the strongest signal of protection if no one we enroll has been exposed to COVID-19 virus prior to immunization,” Dr. Dermody says.

How Will The COVID-19 Vaccine Trials at UPMC Work?

Typical vaccine trials consist of three broad phases: laboratory work, where a disease-causing microbe is studied and a potential vaccine is engineered; animal trials; and human trials.

Human trials also include three phases, where the vaccine is tested for safety and effectiveness in increasing numbers of people.

The Operation Warp Speed studies taking place at UPMC are part of the third phase. The Moderna/NIH vaccine candidate will be tested in tens of thousands of people nationwide.

Trial participants will either receive the Moderna/NIH vaccine candidate or a placebo. Afterward, they will be monitored over the next several months to see if the vaccine is safe, promotes an immune response, and is effective in preventing COVID-19.

In some clinical trials, scientists expose participants to the disease directly. That is not the case for this trial, Dr. Dermody says.

“Right now in Allegheny County, there’s plenty of COVID-19 virus circulating,” he says. “And we expect that even in practicing careful COVID-19 precautions, that some of our immunized study subjects will be exposed to the virus. And then in following those study subjects over several months, we can determine whether those exposures have resulted in infection or disease caused by the virus.”

What Is the Goal of COVID-19 Vaccine Trials?

UPMC’s trial of the Moderna/NIH vaccine and other potential COVID-19 vaccines will take place at the same time as similar trials nationwide. If vaccines show safety and effectiveness over several months, it’s possible they will be approved for widespread manufacture and distribution.

The Food and Drug Administration (FDA) monitors vaccine trials, studying the vaccines for safety and effectiveness.

If a vaccine is safe, promotes immune response, and is effective, the FDA will approve it for wide use. Vaccines are not approved unless their benefits outweigh the risks.

“We think it is absolutely essential that COVID-19 vaccines are safe,” Dr. Dermody says. “These vaccines will be used in people who are healthy, they have no health problems, they’re well. We’re trying to prevent disease in these folks. We’re certainly not trying to cause any kinds of symptoms in these individuals, so vaccines need to be safe.”

Vaccines are safe, effective against disease, and have been used for more than 200 years to eradicate diseases worldwide. The World Health Organization estimates vaccines save the lives of between 2 million and 3 million people each year.

In the 1950s, Jonas Salk, a doctor working at UPMC Children’s Hospital of Pittsburgh, developed the first vaccine against the polio virus in the United States. His research helped to eradicate polio.

It is hoped that a COVID-19 vaccine can help stop the ongoing pandemic worldwide.

“We need to put COVID-19 in the rear view mirror, and the way we’re going to do it is with a vaccine,” Dr. Dermody says.

For more information on the Vaccine Trial Unit Registry, visit UPMC Children’s Hospital of Pittsburgh online.

Sources

U.S. Department of Health and Human Services, Fact Sheet: Explaining Operation Warp Speed. https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

World Health Organization, Vaccines and Immunization. https://www.who.int/health-topics/vaccines-and-immunization#tab=tab_1

About UPMC

Based in Pittsburgh, UPMC is a world-renowned health care provider and insurer. We operate 40 hospitals and more than 700 doctor’s offices and outpatient centers. Our expert physicians are among the leaders in their fields, and we are leaders in groundbreaking research and treatment breakthroughs. UPMC Presbyterian Shadyside ranks as “One of America’s Best Hospitals” and No. 1 in Pennsylvania in U.S. News & World Report’s listings.