The past few weeks have seen encouraging reports on the development of COVID-19 vaccines, with biotech company Moderna reporting positive results with their attempt. The testing process promises to be long, as researchers wait and see how well test subjects fend off the virus over time. Now, some young people and experts are calling for a more aggressive type of COVID-19 vaccine test — known as a human challenge trial — to speed up results. Some are even volunteering themselves as subjects, willing to be purposefully infected to test out vaccines.
What Is a COVID-19 Human Challenge Trial?
Currently, researchers are testing COVID-19 vaccines with normal clinical trials, according to the Boston Globe. In a normal clinical trial, researchers only administer a vaccine to a patient, not the full-strength virus itself. They then follow-up with the subject as they go about their lives to determine how well the vaccine holds up under normal conditions.
A human challenge trial takes a more proactive approach. Not only do these trials give subjects the vaccine, but they’re also infected with the virus itself. This provides researchers with a more immediate idea of how well the vaccine works.
Government officials have pushed for human challenge trials as a way to speed up the battle against COVID-19. In April, thirty-five members of Congress signed a letter urging regulators to consider them to combat the disease.
“If done properly, live Coronavirus human challenge trials can be an important way to accelerate vaccine development and, ideally, to save the lives of millions around the world as well as help rescue global economies,” the letter said.
Some medical experts have also endorsed the idea.
“I think we need to prepare for human challenge trials and for the possibility that we will need to do them,” said Marc Lipsitch, epidemiology professor and director of the Chan School of Public Health’s Center for Communicable Disease Dynamics. “We should be preparing the plans, the protocols, the virus strains, the facilities, and other prerequisites to do them.”
Young People Volunteer Themselves
Now, young people are taking up the cause of human challenge trials — and offering themselves up as human subjects. One of these is 22-year-old college student Sophie Rose, who co-founded the 1DaySooner initiative advocating for challenge trials.
“If the last 6 months have taught us nothing else, the progression of this entire thing has been fairly uncertain,” Rose told Science magazine. “There is a world in which we have a vaccine by then and that would be great, but there’s also a world in which we don’t. I know I would much rather live in a world where we were ready to implement a human challenge study.”
An open letter on 1DaySooner’s website has been signed by 125 advocates, Nobel laureates, experts and academics. The letter calls for young, healthy applicants who are statistically less vulnerable to the disease.
Rose added that she felt compelled to personally volunteer because of “logistical reasoning” and looking at the data, the magazine said.
She isn’t alone. According to the 1DaySooner website, over 32 thousand volunteers from 140 countries have already signed up. Reasons given anonymously range from a desire to contribute in a meaningful way to just wanting the crisis to be over sooner.
A Misguided Effort?
However, not all medical professionals agree that human challenge trials are a good idea. Writing for Stat news, physician Michael Rosenblatt said that, while he admires the volunteers, “their sacrifice cannot be justified” in this situation.
He pointed out that while other diseases have “rescue” treatments that can be used if a subject takes a turn for the worse, no such backups exist for COVID-19.
“[T]here is no cure or treatment against the SARS-CoV-2 virus that can be deployed with confidence, making viral challenge particularly risky and ethically questionable,” he said.
Rosenblatt also warned against assuming younger test subjects would be safer, despite only 7% of all US COVID-19 deaths occurring in patients 25 to 54.
“[T]he example of fatal infections in health care workers in the prime of life makes clear that even healthy non-elderly adults may succumb to the novel coronavirus,” he said.
Should the scientific community decide to back human challenge trials full-force, it could still be a long wait for results. Fred Turner, founder of biotech startup and COVID diagnostic maker Curative Inc., told Science magazine that a challenge virus likely won’t be ready until September.
Meanwhile, the World Health Organization (WHO) estimates a 2-month wait between the creation of viral strains to use in human challenge trials and the actual start of testing.