Infecting volunteers with COVID-19 could save countless lives. But is it ethical? A Q&A

First dose of COVID-19 vaccine given in UK

You are far more likely to die from a kidney donation. (AP Photo | Frank Augstein, Pool)AP

Assume you are young and healthy, and would be almost sure to survive a Covid-19 infection. Would you agree to deliberately infect yourself to help speed the development of a vaccine, and possibly save countless lives?

Well, nearly 40,000 do-gooders from 166 countries have already signed up to join what is known as “human challenge trials.” But in the United States, the government won’t allow them to be deliberately infected. Does that make sense?

No, it does not, according to Dr. Nir Eyal, director of the newly established Rutgers Center for Population-Level Bioethics. He recently spoke to editorial writer Julie O’Connor. An edited transcript appears below.

Q. How is this different than a conventional clinical trial?

A. In a regular clinical trial, tens of thousands of volunteers get the vaccine, and some are randomly selected to get the control. Then they’re returned back to the community to go about their normal lives, and see if, by chance, they get infected with COVID. You hear back from them if they become symptomatic.

But in a human challenge trial, after people are given the vaccine or the control, all are deliberately exposed to COVID. They are then isolated in a quarantine facility. Experts can tell rapidly, and with great certainty, exactly what the vaccine does to them and if it protects them.

Q. Scientists finally expect to launch the first human challenge trial for COVID in London, in late Spring. Why did it take so long to set this up?

A. The U.K. decided it would be ethical only after having given it consideration for many months, and the U.S. hasn’t yet decided that it would be ethical.

Q. Why aren’t we doing this in the U.S.? Could it have sped up vaccine development here?

A. I believe it would. And it would also assure a speedy process, with greater certainty. The reason it did not happen is that there were ethical qualms, which in my view, were misguided. And there was a perception that the setup would take one and a half to two years, which is an unlikely figure that swayed the National Institutes of Health.

Q. What’s the backstory?

A. In March, I was the lead author of the first article that called for conducting human challenge trials for a COVID vaccine. That same month, there was an internal memo at the National Institutes of Health calling to conduct challenge trials.

What NIH could have started then was the preparations for these challenge trials, which do take a few months. The countdown could have begun last spring, and the challenge trials could have started in the summer.

We could still benefit from challenge trials, because there are a lot of things we don’t know about the vaccine. These things could be found out a lot more easily through challenge trials.

Q. Like what?

A. We don’t know if the high efficacy of the proven vaccines includes preventing infections. All we know is that people who take them tend to get sick less. We also don’t know how many of them infect others. And we don’t know how long their protection lasts.

Challenge trials are especially suitable for generating evidence on exactly these questions.

Q. I understand that human challenge trials could be crucial for the next generations of COVID vaccines, since rich countries are likely to outbid poor ones on the first batch. Can you explain?

A. Yes. We still need to develop further vaccines that might block infections better, be easier to store, require only a single dose, and be more affordable – or simply available for purchase by countries other than a few that have hoarded the global supply of proven vaccines. And again, we need volunteers willing to forgo the proven vaccine to do this.

Q. We have three vaccines now that work. Why can’t we just get those to everybody?

A. There are serious questions about the ability of the vaccines proven so far – and even some of the others tested – to avoid the need for freezing or deep freezing. The Associated Press recently reported that an estimated 3 billion people around the world could not get any vaccine that required deep freezing. And all of the vaccines proven so far require repeat injections, as opposed to a single jab that is far easier to secure.

Q. The advocacy group 1DaySooner has gathered the names of tens of thousands of low-risk people all over the globe who say they’d be interested in volunteering. Why would someone sign up to get infected with COVID-19?

A. I’ve actually teamed up with 1DaySooner to survey the first batch of their volunteers and ask about their motivations, as well as investigate their demographics, psychological profiles, and their understanding of the risks involved in challenge trials. We are still analyzing our data, but it is clear that the overwhelming motivation is wanting to do good. Certainly, it is not false hope that one would make a lot of money through these trials. A high percentage of the early volunteers we surveyed earned extremely high salaries.

Q. One volunteer wrote that he was in the Peace Corps in Mali and got malaria a couple times. He’s a young person who says he’s willing to take on a certain amount of risk in order to make a difference – in this case, to find a vaccine that could save many lives.

A. This is the kind of thing we’re hearing. On average, these people are far more altruistic than the control group. Anecdotally, many of them have done extremely altruistic things in the past.

Q. Unlike previous human challenge trials for influenza, malaria, typhoid, dengue or cholera, we don’t yet have a reliable cure for COVID. And we know little about its long-term impacts, like lung scarring and brain fog. Can people really give informed consent, if they have a youthful sense of invincibility?

A. What informed consent requires is simply communicating that uncertainty.

Q. Another volunteer for 1DaySooner compared this to young people who enlist in the military or serve as cops or firefighters, taking on risk to serve and protect their communities.

A. Right. For me, the best comparison is kidney donations. The risk of death from COVID has recently been estimated at about one tenth of the risk of death from a kidney donation. Why do we accept kidney donations? Because of the benefit to the dying recipient and the informed consent of the donor. We should not stand in the way of trials that would help millions and could be done with informed consent.

Q. If we had started human challenge trials early on for COVID, how many lives might have been saved?

A. It’s hard to say, exactly. With regular vaccine field trials, you need to wait for a natural infection to happen. It can take a short or a long time. Some have estimated a challenge trial would have saved anywhere between one month and 8 months of a vaccine rollout. My colleagues and I estimated that using challenge trials would have saved at least 720,000 years of life for each month of an earlier vaccine rollout, collectively around the world. And it would have averted 40 million years of dire poverty for each month. That’s 40 million years of lives shattered, even though these people are not dead.

Q. I read that the UK challenge trial might pay about $5,000, which could attract participants who are low income or unemployed. Is that exploitative?

A. I don’t have firm views on how much to pay participants. Paying them at high rates seems only fair – after all, we ask them to isolate themselves for many weeks. But if you think that you are exploitatively attracting poor people and would rather not just screen them out, or hurting the cause by being perceived to do so, then the solution is to pay them less. It is not a valid reason against conducting the trial.

Q. Where would you draw the line? Is a human challenge trial always ethical if it’s for the greater good?

A. No. If it exposes volunteers to extremely high risk and achieves only a little more good than harm, then it is not justified. But we are not in that ballpark here. These trials are extremely valuable for humanity and pose real potential, and they would be recruiting only people at low risk of severe COVID outcomes.

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