They are volunteering for what’s called a “human challenge trial,” an ethically controversial way to test vaccines that would deliberately infect people with a virus that has killed over 270,000 people worldwide and has no cure.
“It’s not every day we give a healthy individual an exposure to a pathogen — the very same thing doctors are trying to protect people from,” said Dr. Nir Eyal, director of the Center for Population-Level Bioethics at Rutgers University. “But it becomes increasingly clear [that] the only sustainable exit from the current health and societal crisis is a vaccine, and there are ways to conduct such a trial that are perfectly ethical.”
A vaccine is society’s ticket back to normalcy — to crowded sports stadiums, birthday parties and visits to elderly loved ones, as well to some of the over 33 million jobs lost. But a solution is likely still a year to 18 months away at best, spurring warnings of social distancing until 2022 and a worse second wave this winter.
The problem is that vaccines take time to develop and test — often, upwards of a decade. The final phase of vaccine testing usually requires tracking up to tens of thousands of people to see who becomes infected in their daily lives, sometimes over several years.
But leading epidemiologists, philosophers and vaccinologists have recently advocated human challenge studies to accelerate the process. With careful design and informed consent, Eyal and his co-authors predict it could bring a vaccine months earlier and save thousands of lives.
There are no public plans for such a study in the U.S., but politicians and volunteers are pushing for one. More than 14,000 willing study participants have organized an advocacy group, and 35 members of Congress recently asked regulators to consider human challenge trials. Across the Atlantic, London-based hVIVO and Switzerland-based SGS are working to launch challenge studies, and the WHO recently released a working document outlining criteria for an ethically acceptable design.
The Food and Drug Administration has never allowed a human challenge trial for such a novel disease without a cure, but it is not ruling one out.
“I definitely think it’s going to be pursued,” said Dr. Matthew Memoli, director of the Clinical Studies Unit at the National Institute of Health’s Laboratory of Infectious Diseases. “So many things could change, but I think it’s likely we could see one at some point in the future.”
But not everyone is happy about the momentum. The concept of human challenge studies will forever be tainted by non-consensual experiments on captive or disabled populations, including Nazi concentration camp research. Though the coronavirus version would be consensual, it would present new risks and unknowns. There is little consensus on treatment, mortality rate or long-term effects — let alone exactly who and how it kills.
Final decisions would fall largely to the FDA. So far, three U.S. companies — Pfizer, Inovio and Moderna— have reached at least phase one in clinical trials, and the FDA did not comment on whether human challenge studies had yet been proposed for down the line in statements to NBC News. But more than half a dozen experts tell NBC News that they expect these proposals to come.
“Challenge trials may end up pushing the envelope when it comes to reasonable research risks,” said Dr. David Magnus, director of the Stanford Center for Biomedical Ethics. “I don’t know how far that will be pushed before people say no.”
READ MORE AT NBC NEWS | Why have 14,000 people volunteered to be infected with coronavirus?
