Thousands of Americans who volunteer for Covid-19 vaccine trials only to get a placebo should jump toward the front of the line when a shot is available, bioethicists said.
Front line health workers will likely get the vaccine first once one is ready, but parsing out who should go next for limited shots among 300 million Americans is something medical experts and policymakers are already wrestling with. One of the groups up for some extra consideration is volunteers who received a placebo during the medical trials.
Distributing the vaccine is a fraught proposition, and medical experts are juggling competing interests of need and racial and economic justice. Where trial volunteers land on that spectrum is still an open question.
“People who participate in vaccine trials are assuming risks for the benefits of all of us, and therefore warrant priority as vaccine becomes available,” Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics and a member of the World Health Organization’s Covid-19 vaccines working group, said. “How much priority, relative to other high priority groups, is a bit more complex.”
Both Pfizer Inc. and Moderna Inc. want to recruit 30,000 participants in their late stage studies with half getting a placebo.
At the inaugural meeting of the National Academies committee charged with developing an equitable vaccine distribution plan, National Institutes of Health Director Francis S. Collins said anyone who got a placebo probably should have “some special priority” for a vaccine. The draft plan is expected by late August or early September.
While the ethicists interviewed said giving trial volunteers extra consideration when distributing a vaccine is warranted, where volunteers rank compared to front line medical workers and other vulnerable populations is up for debate.
Protect Vulnerable First
While trial participation could be one consideration, study volunteers shouldn’t jump ahead of anyone who’s at highest risk, Aisha T. Langford, a population health researcher at New York University, said.
Lawrence O. Gostin, director of Georgetown University’s health law programs, agreed.
“What we want a vaccine to do is help society function and protect the vulnerable,” he said.
If companies compensate volunteers fairly for their time, it may not be ethically necessary to give them priority access, Govind Persad, a bioethicist at the University of Denver law school, said.
“But I think it could be reasonable to do that, and the exact form that takes would depend on a lot on what the epidemiology looks like,” he said.
If someone gets a placebo but there’s a major outbreak in another area, “then you have a big tradeoff between recognizing the contribution and looking backward and trying to deal with a hot spot going forward,” he said.
Ordinarily, there’s no ethical rule that somebody who enters a clinical trial gets first access to the intervention once it’s proven to be effective, Gostin said. “It’s a thumb on the scale. They’ve been a good citizen, but it doesn’t a priori give them priority for a vaccine.”
David Magnus, director of the Stanford Center for Biomedical Ethics, said it’s often the case in drug trials that volunteers who got a placebo have some level of priority for the approved medicine.
“But the reality of the political context of Covid has me concerned that a vaccine that is not proven to be safe or effective could wind up being approved for political reasons prior to the election,” he said. “If that happens, I’m not sure that there is an argument for any prioritization to anyone.”
Given the service volunteers are providing during a lethal outbreak, failure to offer an available vaccine to volunteers who got a placebo is “unethical at best and criminal at worst,” said Glenn Ellis, president of wellness education company Strategies for Well-Being, LLC who also has posts at Tuskegee University and Harvard University’s bioethics programs.
NYU bioethicist Alison Bateman-House and University of Pennsylvania bioethicist Harald Schmidt both said the principle of reciprocity demands prioritizing study volunteers.
“Without your participation, there would be no approved vaccine to distribute,” Bateman-House said.
Langford, who enrolled in an early stage Covid-19 vaccine trial, said she never expected special access as a result.
“Acknowledgment of my contribution to science is very nice, but those who are most at risk should have the opportunity to get the vaccine first once it is proven to be safe and effective.”