An idea that might seem outlandish at first is gaining some ground as a way to speed development of a coronavirus vaccine: intentionally infecting people with the virus as part of a trial.
The idea, known as a “challenge trial,” would deliberately infect a few hundred young, healthy volunteers, who were first given either the potential vaccine or a placebo. Those picked would be well informed about the risks.
That would allow the effectiveness of a vaccine to be determined faster than a traditional clinical trial, which would require that researchers wait for some of the participants to become infected in the course of their daily lives.
Supporters say the challenge trial could save several months in the search for a vaccine, which is widely seen as critical for people to feel confident again with social gatherings.
A group of 35 House lawmakers, led by Reps. Bill Foster (D-Ill.) and Donna Shalala (D-Fla.), a former secretary of Health and Human Services, wrote to the Food and Drug Administration this week lending their support to the idea.
“Our situation in this pandemic is analogous to war, in which 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,” they wrote in the letter.
Stanley Plotkin, a renowned vaccinologist who helped invent the rubella vaccine, also endorsed the idea in an article in the journal Vaccine, along with Arthur Caplan, a bioethicist at New York University.
They wrote that the vaccine trial process “normally takes months to years, during which [coronavirus] will infect and possibly kill millions. Acceleration of that standard process is necessary.”
Older people have been among the biggest casualties of the coronavirus globally, while younger people have generally shown a higher chance of recovery.
Still, the idea of purposefully infecting people with a potentially deadly virus raises some obvious ethical objections.
In a statement to The Hill on Thursday, FDA spokesman Michael Felberbaum said the agency is “exploring all possible options” to advance a coronavirus vaccine, but also raised a note of skepticism about human challenge trials, pointing to testing in animals as a possible alternative.
“The FDA is exploring all possible options to most efficiently advance the development of safe and effective vaccines that will prevent COVID-19,” Felberbaum said, while adding that “human challenge studies used to develop a COVID-19 vaccine may present ethical and feasibility issues that can be avoided with the use of animal models.”
Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics, said he did not see how an institutional review board that oversees research would approve a human challenge trial for coronavirus.
“Consent can only do so much work,” he said, raising the hypothetical of whether it would be ethical to take out someone’s heart and replace it with an experimental device simply because the person consented.
Challenge trials have been conducted in the past, but they are usually done to test vaccines for diseases that can be cured, like malaria.
It would be a sharp break from precedent to do a challenge trial for a virus with no known cure that is as deadly as the coronavirus. Even if the volunteers were all young and healthy, that would not entirely reduce the risk of serious illness.
Despite the risks, experts in support of the idea said they had already heard from people willing to volunteer.
A website set up to recruit volunteers, called 1 Day Sooner, says it has already had over 2,000 people sign up.
“People volunteer for the military, they volunteer to become emergency medical technicians,” said Marc Lipsitch, a professor of epidemiology at Harvard University who co-wrote an article in The Journal of Infectious Diseases in support of the idea. “All of those carry medical risks for the benefit of someone else and people do it.”
Foster, the lawmaker who helped lead the supportive letter, said in an interview on Tuesday that he hoped the message from lawmakers would help the FDA realize that there is “understanding from Congress” that somewhat more risks need to be taken to develop a vaccine faster.
“We should move the risk benefit optimization a little in favor of more rapid and riskier vaccine approval,” he said.
If a vaccine can be ready “even a month earlier,” he added, “then there will be tens of thousands of people whose lives have been saved.”