Despite the urgency of beating COVID-19, health officials may delay the development of an effective vaccine.
Authorities in the U.S. and elsewhere have yet to authorize an ethical charge investigation procedure called “trials with human challenge.” Challenge tests deliberately involve volunteers with the disease – which explains the official retention – but they were able to substantially accelerate the development of a vaccine.
The debate over trials with human challenge has raged for months among health professionals and academics. But only now – about eight months after the pandemic – US authorities are beginning to consider a bid to speed up the vaccine development process.
Sitting and waiting
A fax must go through multiple stages before it can be unrolled. After determining its ability to trigger an immune response and its safety, developers need to test it for effectiveness. Ineffective vaccines can reduce the small risk that even in safe vaccines does not justify, can be extremely frustrating, can divert resources from better alternatives, and can damage immunization rates.
There are two main ways to measure effectiveness. Under the conventional method, researchers vaccinate tens of thousands of volunteers and then passively wait for some of them to become infected. The frequency of infection is then compared to a non-vaccinated control group.
In the second method, trials with human challenge, a much smaller group of volunteers is intentionally infected after receiving the experimental vaccine as a placebo. This enables a much faster and more efficient determination of vaccine efficiency.
To date, more than 33,000 people from 151 countries have volunteered to take part in such a procedure. But there is no official authorization for human challenge testing for COVID-19 in the US like other western countries. This means that vaccine developers are forced to vaccinate many more volunteers – typically about 30,000 are involved for each candidate vaccine – and then release them into the general population, hoping that enough data would be collected soon.
This is where we are currently in the US: waiting for enough participating volunteers to catch the virus through happenstance.
Paradoxically, these gigantic and costly studies – US taxpayers have already spent billions of dollars on vaccine development – are being slowed down by government efforts to minimize infection rates through quarantines, locks, mask use or social distance. Back in May, leading developers of potential COVID-19 vaccines, including the biotechnology company Moderna and Oxford University, issued a warning that low-level infections among their volunteers could delay the development of their vaccines.
It is, of course, possible that conventional studies will provide the required data. But there is a distinct possibility that tearing challenges can speed things up.
Medical ethics
Opposition to human challenge studies for COVID-19 is primarily based on ethical considerations. Since there is currently no cure for COVID-19, intentional infection may result in death or serious limitation. It is therefore argued by people like Michael Rosenblatt, a former dean of the Tufts University School of Medicine and a current advisor to Moderna, that the risks are too high, and that volunteers cannot give valid ‘informed consent’ for intentional infection.
The argument that willing adults cannot agree to risk their health for the greater good is, we believe, at odds with how society views other acts of volunteering. Volunteer firefighters, for example, also have unknown dangers. Moreover, few countries remember not to risk the health and lives of their young citizens on the battlefields of the world, if they think it generally requires such a sacrifice. And while COVID-19 human challenge tests would only include volunteers, most battlefields also include people who are forced into service.
Delaying a fax can also put health care volunteers at risk. Current estimates put the death toll of COVID-19 U.S. health workers at about 1,000. Healthcare volunteers risk continuing their lives as long as vaccine development is delayed.
The opposition to trials with human challenge stems from a justifiable sensitivity to medical experiments on humans, and the appalling history of such experiments – which often ignore the interests and rights of their subjects. These included the experiments that were carried out by the Nazis on prisoners such as the infamous Tuskegee study of untreated syphilis, which was carried out on unsuspecting African Americans. And of course, even medical experiments involving subjects can go horribly wrong.
Lives on the track
But rapid development of an effective vaccine could save hundreds of thousands of lives worldwide. At present, more than 5,000 people die from COVID-19 every day. At that rate, every month of delay in fax availability costs 150,000 lives.
The indirect costs are also enormous. For example, the United Nations recently announced that pandemic-linked hunger is linked to 10,000 child deaths each month. From these perspectives, the arguments against trials with human challenge seem much less convincing.
We believe that the decision to allow human challenge testing for COVID-19 should not only be examined through the narrow lens of medical ethics – with its cardinal protagonist to do no harm to the individual patient or the volunteer. The COVID-19 epidemic is a global disaster, and decisions about it need to be made with the broader perspectives of public health and general morality.
In other words, the decision may be more appropriate for high-level policymakers than for medical ethics committees.
In April, some U.S. lawmakers waited in line: 35 members of the U.S. House of Representatives sent a letter to the heads of the U.S. Food and Drug Administration and the Department of Public Health and Human Services, providing support for trials with human challenge. So far, however, this effort has had no effect.
There is no doubt that trials with human challenge carry significant risks for volunteers; but they also have the potential for significant benefits to humanity. Instead of considering these volunteers as uninformed, society can do better to value their altruism and heroism.
We believe that, given current circumstances, human challenge tests for COVID-19 are not morally wrong: on the contrary, they express the most noble human values.
Now read: This Seattle man volunteered to inject with an experimental COVID-19 vaccine: ‘It was kind of my duty as a healthy individual to step up’
Ofer Raban is a professor of constitutional law at the University of Oregon in Eugene. Yuval Dor is a Biology Professor at the Hebrew University of Jerusalem. This was first published by The Conversation – “The ethical issue for allowing medical trials that deliberately infect people with COVID-19”.
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