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Support Grows for "Human Challenge" Trials for COVID-19 Cure

This is the current number of volunteers who have signed up for human challenge studies as part of COVID-19 vaccine trials through the nonprofit 1 Day Sooner. (1 Day Sooner)
This is the current number of volunteers who have signed up for human challenge studies as part of COVID-19 vaccine trials through the nonprofit 1 Day Sooner. (1 Day Sooner)
May 22, 2020

CAMBRIDGE, Mass. - At least three possible COVID-19 vaccines, including from Cambridge biotech firm Moderna, have seen promising results in Phase One trials. And some experts think infecting volunteers with the virus that causes COVID-19 may be worthwhile to speed vaccine development.

They believe so-called "human challenge trials" on a small number of young, healthy participants could partially replace a later phase of vaccine trials.

Dr. Zeb Jamrozik is a bioethicist at Monash University in Australia and member of the World Health Organization's working group on human challenge studies in COVID-19. He thinks if no current vaccine candidate passes a Phase Three trial in the next six to 12 months, this approach could be considered.

"If we don't have one that's been shown to be efficacious, then I think it's extremely likely that challenge studies are going to be on the table," says Jamrozik. "And that they might even be the best way to test the remaining candidates as efficiently as possible."

But human challenge trials are controversial - infecting participants in this case with the new coronavirus, which has limited treatments and can be fatal. Still, 35 members of Congress - including Massachusetts Rep. Seth Moulton (D - Salem) and Rep. Stephen Lynch (D - Boston) - support the idea for COVID-19.

A new nonprofit known as "1 Day Sooner" has quickly signed up close to 25,000 people willing to participate in human challenge trials for a COVID-19 vaccine. The group's founder, attorney Josh Morrison, says many might think of him and other volunteers as selfless - but he disagrees.

"It makes my life quite a bit better to be doing this than what I was doing before, of just like sitting in my apartment in Brooklyn, not having a lot of work to do," says Morrison. "Feeling just miserable and scared, especially for my parents' health. Trying to be part of the solution, that's made my life a lot better."

Morrison explains that, for young, healthy volunteers, the risk is comparable to donating a kidney - something he did close to a decade ago. He thinks if it shaves months off the COVID-19 vaccine trials, the risk would be worth it.

Beyond the ethical considerations and regulatory approvals, cost is another big barrier. Jamrozik says this type of research can only be conducted at a small number of bio-secure facilities, and volunteers need to be isolated and under observation for months.

"There's significant set-up costs that are larger than a Phase Three field trial, in the sense that you need to build a strain," says Jamrozik.

In other words, they must also create a dose of the coronavirus to infect the volunteers with, which isn't cheap. However, if it ends up helping shorten the time to market, Jamrozik says it could save time and money.

Laura Rosbrow-Telem, Public News Service - MA