New York – The notion of testing COVID-19 vaccines by deliberately infecting volunteers with the novel coronavirus — something that’s now on the table — isn’t necessarily crazy or unethical. It’s smart, and has benefits that far outweigh the risks.
Challenge trials, as scientists call them, vastly speed up the process of vaccine testing and might also help us understand natural immunity of people who have already been infected.
This doesn’t mean abandoning the framework of medical ethics that protects human research subjects from abuse. It means recognizing that there are risks and benefits unique to this situation.
In The Washington Post recently, philosopher Richard Yetter Chappell and bioethics professor Peter Singer wrote a piece called "The Case for Experiments on Human Volunteers.” A chorus of commenters fretted that this would exploit poor people, drawn by the few dollars the researchers will hand them as compensation. Some suggested that the authors go first.
That’s not a bad idea, though older males are not the right people to go first (Singer is 73). I should go first. I’m exactly the kind of person who should be part of this experiment. In fact, I just signed up for one.
I found out about the prospect of human challenge studies in late March, when I interviewed Rutgers University ethicist Nir Eyal for a column on rationing ventilators. Later, he gave an interview to the journal Nature on the ethics of human challenge trials.
The problem with ordinary vaccine efficacy trials is that they’re very slow. This is what led Anthony Fauci to warn that it could take 18 months or more to identify a safe vaccine. (The fastest vaccine developed so far — the one for mumps — took four years.) Researchers typically have to test the vaccine on large groups of people and compare them to large groups of unvaccinated people, waiting weeks or months until an appreciable number of both the vaccinated test subjects and the unvaccinated control group to become exposed to the illness in the course of their regular daily lives. Challenge trials short-circuit that process by exposing people deliberately to the virus.
So that I could learn more about volunteering for such a study, Eyal put me in touch with Josh Morrison, who started a foundation called 1daysooner. The website has a place where I was able to add my name to a list of volunteers willing to be COVID-19 vaccine study subjects. Morrison, a former lawyer, told me he started the organization after becoming interested in advocacy and health issues. He’s gathered signatures of more than 3,000 people.
Before COVID-19, his organization facilitated living organ donations. He donated one of his kidneys to a stranger. But vaccine studies, even if risky, don’t require such hyper-altruists. What they do require is subjects with the ability to acquire and understand technical information.
Informed consent is a cornerstone of medical ethics. I’ve spent decades interviewing scientists, doing research, understanding new ideas and putting them into a readable format. Since February I’ve been on a steady stream of phone calls with virologists, immunologists, epidemiologists, pulmonologists, hematologists and risk communication experts. I’ve digested and understood what they’ve said. I know other vaccines have caused side effects. If anyone could give fully informed consent, I could.
Other volunteers could be selected from the ranks of scientists, medical students, medical ethicists and others who have the relevant skills to become knowledgeable enough to give genuinely informed consent.
Stanley Plotkin of the University of Pennsylvania, who invented the rubella vaccine, the R in the standard MMR vaccines, told me they really want volunteers in their 20s, which rules a lot of people out, including me. But others have proposed a more diverse range of ages. While people over 65 would be at too high a risk to be deliberately infected, there’s growing evidence that the risks have more to do with comorbidities — existing health problems — than age.
Volunteers could be screened for the most high-risk comorbidities, and older volunteers should be female, since we’re at lower risk than males. Older volunteers should be thinner and fitter and have lower cholesterol and blood pressure than the average 20-something.
Eyal had originally suggested that whether or not the vaccine worked, volunteers would leave these studies with protective antibodies and the gift of immunity — something that’s become much-coveted in the age of COVID-19. But immunity to this new disease is not well-understood, so the dream of "immunity passports” won’t become a reality any time soon. At the very least, volunteers could test the protective value of these natural antibodies.
That’s something I learned from Plotkin. He said that even before vaccine trials began, human volunteers who tested positive for antibodies could participate in experiments where they got exposed to small doses of the virus to find out if these antibodies were indeed protective.
Since the amount of virus you are exposed to might affect the course of the disease, the doctors would want to use the minimum amount needed to develop symptoms in order to minimize risk.
I’ve already canvassed some experts who say a challenge wouldn’t necessarily be riskier than getting the virus out in the world, as most of us probably will without a vaccine. It might even be safer, since volunteers would likely be supervised and treated early with the best standard of care. There is a slight risk of something called antibody-dependent enhancement, in which the vaccine actually helps the virus get into cells. Something like that happened with a Dengue vaccine, but you would have to be extremely unlucky for it to happen in this case without showing up in animal studies.
Though some ethicists have debated paying volunteers, this would be a mistake. It would lead to the perception that the scientists were preying on those who need money. Nobody should participate in this kind of trial for the money.
But we should also recognize that, unlike a kidney donation, participation in COVID-19 vaccine trials wouldn’t be purely altruistic either. Unlike kidney donors, volunteers would benefit from being perhaps the first to feel safe from the disease. They’ll also share in the collective benefit accrued from a broader return to a normal life when more of us have the freedom to move about, do our jobs, and find love and companionship.
There’s always the possibility that something unpredictable could go wrong — and that could lead to a public relations nightmare that could derail vaccine research. But the bad PR might be worse if something happened to an innocent young person than to a considerably older, wiser, more informed person who knew what she was walking into.
Little about America’s approach to the pandemic has been ethical to date. We weren’t given informed consent about the lockdowns — many people don’t understand their purpose, or their limitations. There’s also been little informed consent on lifting them — it’s not clear whether people understand that the risk of contracting COVID-19 remains as large as ever in the United States.
The lockdowns only delay deaths from the virus. A vaccine would end them. Surely that’s a reward for which some of us are willing to risk ourselves.
Science writer Faye Flam is a Bloomberg Opinion columnist.
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