Fauci’s ideal universal vaccine … would provide lifelong immunity against all coronaviruses, preferably in one dose. Development of such a vaccine will require greater knowledge of the human immune system and its response to coronaviruses. And that, as Fauci acknowledges, will likely require the use of (ethically controversial) “human challenge” trials.*
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Peter McKnight: Universal vaccine only way to put coronavirus pandemics behind us for good
Opinion: Prospect of intentionally exposing volunteer subjects to potentially lethal virus in studies is highly controversial but given the potential benefits, is worth addressing the ethical concerns
That dim prognosis was offered by none other than Dr. Anthony Fauci and his colleagues at the U.S. National Institute of Allergies and Infectious Diseases.
Real killjoys, aren’t they? Just when it looked like the most infectious COVID variant was in decline, when we thought this might finally be over, Fauci tells us COVID is forever. Or worse, that other coronavirus pandemics might well be on the way.
A brief look at the history of fatal coronavirus pandemics reveals, however, that Fauci’s depressing prognostication is more likely than not to come to fruition. COVID is the fourth such pandemic in just the last 20 years, following the dual outbreaks of severe acute respiratory syndrome (SARS) in 2002 and 2003, and Middle East respiratory syndrome (MERS) in 2012.
So Fauci’s prediction isn’t meant to scare us, but rather to prepare us. Forewarned is forearmed, as they say. To that end, Fauci recommends that we work toward developing a universal vaccine, one that will prove effective against all coronaviruses.
That’s a tall order, to be sure, but a necessary one to fill if we are to put coronavirus pandemics behind us for good. Fauci notes that while current vaccines continue to play a crucial role in addressing the pandemic, they’re clearly inadequate given that their effectiveness wanes over time, they fail to prevent reinfection and, perhaps most importantly, they fail to forestall the emergence of variants.
Fauci’s ideal universal vaccine, on the other hand, would provide lifelong immunity against all coronaviruses, preferably in one dose. Development of such a vaccine will require greater knowledge of the human immune system and its response to coronaviruses. And that, as Fauci acknowledges, will likely require the use of (ethically controversial) “human challenge“ trials.
Vaccines are normally tested by giving thousands of people throughout the world the vaccine or a placebo, and then waiting to see if those who received the vaccine are protected from infection or illness. This is an unwieldy and time-consuming procedure, as scientists can’t control variables, notably the fact that many study participants do their best to avoid infection.Human challenge trials, in contrast, involve intentionally exposing participants to the virus. This allows for easier study of immune response to viruses and vaccines, and dramatically reduces both the number of people studied as well as the time it takes to determine if the vaccine is effective. And that, in turn, could translate to saving millions of lives around the world.
For these reasons, human challenge studies have been conducted on vaccines for a wide range of diseases, including influenza, malaria and cholera. And the COVID pandemic led to the formation of 1Day Sooner , a group of scientists and ethicists dedicated to promoting the use of human challenge trials for COVID vaccines.Challenge studies are, in fact, now being conducted in the United Kingdom, but the prospect of intentionally exposing individuals to a potentially lethal virus remains highly controversial, especially since there remains a lack of effective treatments for the disease.
Nonetheless, given the potential benefits, it’s worth addressing the ethical concerns. To begin with, while you might not risk being exposed to a dangerous virus, many people are willing to do so. Writing in the Journal of Infectious Diseases early in the pandemic, Rutgers University bioethicist Nir Eyal notes that health-care workers have repeatedly placed themselves in positions where exposure was virtually guaranteed.
This doesn’t, however, address the moral obligations of the researchers, who will, after all, be infecting participants. As is the case with human subjects of all medical research, researchers will be obligated to fully inform participants of the risks of the trial. Beyond that, study design can help to keep those risks to a minimum.
Eyal argues that risks can be minimized by choosing only young, healthy people — those not likely to become severely ill from infection — as participants. Furthermore, participants ought to be drawn from those at high risk of being infected in their daily lives even without experimental exposure.Finally, participants should receive daily monitoring for any signs of infection, and state-of-the-art care should they become ill. In this sense, they would arguably receive better and more intensive care than if they had been infected naturally, which provides a non-altruistic reason to take part in the trials. To these recommendations, 1Day Sooner adds that participants ought to be involved in study design to ensure that they’re comfortable with the risks.
The risks remain, of course, even if they’re minimized. And challenge trials will always present a challenge, morally and ethically. But given the potential payoff, it’s a challenge we ought to consider.