Volunteers Step Up to Be Patients in Tests for COVID-19 Vaccine – NBC Southern California

Nancy Alvarado worries about the deep toll COVID-19 is taking across the globe, and within her Atwater Village community.

"It's wreaking so much havoc here," she said. "I'm not a very good cook, so we eat out a lot. Just knowing all these little restaurants that we love so much and how much they're suffering."

But most of all, she worries about her parents.

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"My parents are in their mid-60s," she said. "My mom has sensitive lungs. She gets asthma and is so prone to bronchitis."

More than half a million people around the world have died from COVID-19 since January. A vaccine is essential, but developing vaccines usually takes years. Wanting to be helpful in anyway she could, Alvarez volunteered for a clinical trial that speeds up the process by giving volunteers a vaccine. But these "human challenge trials" also give participants the virus.

Josh Morrison, the executive director of a website that advocates on behalf of trial volunteers called "1 Day Sooner," describes these challenge studies as ways to learn about a disease by deliberately exposing people to infection.

In traditional trials, people get a vaccine and go back to their communities, where they may or may not be exposed. Challenge trials accelerate the process by making it certain that the vaccine will face off with the virus.

"In a traditional trial to test the effectiveness of a vaccine, you might test 10,000 or even more people," Morrison said. "For example, the Malaria vaccine that is being developed tested 15,000 over five years. Challenge studies test normally about 100 people and might take a couple of months."

Since launching "1 Day Sooner," Morrison's seen more than 31,000 volunteers from around the world sign up. This includes over 1,600 from California.

"That has been absolutely inspiring," he said.

While human challenge studies have been done before for diseases like Malaria and Influenza, scientists say COVID is more complicated. As bioethicist Dr. Ruth Macklin recently said, "... a rush to begin human challenge studies for grave disease lacking an effective treatment is ethically unjustifiable."

But with more than 50,000 new cases each day in the U.S., Dr. Stanley Korenman, associate dean of ethics at UCLA School of Medicine, disagrees.

"We can't afford to wait till we have something curative, that is why we are so determined to get a vaccine," he said. "Because the expectation is there won't be anything curative for a few years."

The World Health Organization requires participants to be fully informed of risks, but critics say that can't happen because so little is known about this new virus.

"You can understand the risks without understanding the disease at all, because the risks have been explained to us by what has happened to patients," Korenman said.

The idea of a few good people potentially having to sacrifice for the greater good is one ethical challenge. In a letter of support to the Food and Drug Administration, 35 members of Congress make the comparison to war.

"There is a long tradition of volunteers risking their health and lives on dangerous missions for which they understand the risks and are willing to do so in order to help save the lives of others."

Human challenge trials require approval from the FDA. In a statement to NBCLA, the FDA says these trials are currently under consideration.

As for Alvarez, she remains committed to the trial, even though her husband has some concerns.

"To be honest he hopes I change my mind," she said.

But like many volunteers, Alvarez wants to be part of the solution. Advocates argue the time for a challenge trial is now because, until a reliable vaccine is developed, people will continue to suffer and die.

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Volunteers Step Up to Be Patients in Tests for COVID-19 Vaccine - NBC Southern California