Is it worth risking lives to speed up a coronavirus vaccine?


“The 360” shows you diverse perspectives on the day’s top stories and debates.

What’s happening

The Trump administration last week announced a program to dramatically speed up the process of creating a vaccine for the coronavirus through a project called “Operation Warp Speed.” Containment efforts like social distancing and a robust testing regime can help limit virus spread, but experts agree the pandemic won’t be truly behind us until the broader population is given immunity through a vaccine.

Despite the urgency, creating a vaccine is a slow, painstaking process. There are as many as 90 vaccines in development around the world, though only a handful are in the earliest stages of human trials. The most optimistic predictions suggest it will be at least a year to 18 months before a vaccine is widely available. That may seem slow, but it would actually shatter the record for fastest vaccine ever developed, which currently stands at four years.

Some scientists have proposed a controversial step they say could shave months from that time line: deliberately exposing people to the coronavirus to test vaccines more quickly.

Vaccines are typically tested by giving subjects a dose, then letting them go back to their everyday lives with the expectation that a certain number of them will come in contact with the virus. This process could take a long time for the coronavirus, especially given the steps to avoid infection that are part of our typical daily routines. Exposing subjects to the virus — what’s known as a “human challenge trial” — would eliminate that wait time.

Why there’s debate

Human challenge trials are rare because they are seen by many as violating the core principle of medicine: “First, do no harm.” Exposing people to the virus would inevitably mean some of them would get sick or even die.

Proponents of using challenge trials to develop a coronavirus vaccine say the current pandemic challenges that logic. A delay of several months to getting a vaccine on the market would likely lead to thousands of deaths, a far worse outcome than any potential drawbacks of a challenge trial, they argue.

Advocates say the health risks to subjects could be dramatically reduced by exposing them to a less potent version of the virus and selecting volunteers from less vulnerable groups, like young adults. A key element is the consent of the people involved in the trial. If individuals are willing to take on the risk of exposure to help save the lives of potentially thousands of people, they should be allowed to do that, supporters say. A website set up to collect names of those willing to participate in a challenge trial has received more than 10,000 volunteers as of Monday.

The idea has also received significant pushback from scientists who argue it’s impossible to gauge how much risk participants are being subjected to because so much is unknown about the virus and how it behaves. There is also skepticism that the results of a challenge trial made up of young, healthy subjects could be applied to the broader population.

Others worry about the logistics of carrying out such trials, especially if several vaccines are tested at the same time. Some of those vaccines will inevitably fail, meaning all subjects will be put at risk without any protection. Challenge trials also face unique hurdles — like determining the correct form and amount of the virus to expose subjects to — that some experts say could make them take even longer than traditional methods.

What’s next

No challenge trials in the U.S. can be started without the approval of the Food and Drug Administration. A group of 35 lawmakers recently sent a letter to the FDA asking for the agency to acknowledge the urgency of the pandemic and allow future trials to go forward. With only a few vaccines in the early stages of human testing, it will likely be several months before any of them are ready for large-scale trials of any kind.



The sooner a vaccine is ready, the more lives will be saved

“Covid-19 is currently killing thousands of people a day. The vast majority of the world’s population has no acquired immunity to the disease. And the economy is grinding to a halt to curb its spread. Given the dire situation, the value of even marginally speeding the widespread availability of a vaccine is incredibly high and warrants much more attention and more extreme measures.” — Matthew Yglesias, Vox

We shouldn’t stand in the way of people willing to take on risk for the greater good

“If healthy volunteers, fully informed about the risks, are willing to help fight the pandemic by aiding promising research, there are strong moral reasons to gratefully accept their help. To refuse it would implicitly subject others to still graver risks.” — Peter Singer and Richard Yetter Chappell, Washington Post

It may actually be safer to be part of a challenge trial

“By the time vaccine candidates are tried, there may be some treatments that are proven to work. And surely, the brave volunteers we recruit should be assured ready access to those. The dramatic-sounding exposure of healthy volunteers to the virus is therefore adding less net risk than you might think. It might even be curiously safer for some to join the study than to await probable infection and then try to rely on the general health-care system.” — Bioethicist Nir Eyal to Nature

There’s a moral imperative to pursue every possible course to develop a vaccine

“Especially as the government impedes liberty on an emergency basis to arrest the spread of COVID-19, it would be perverse for it to simultaneously restrict the ability of willing heroes to help save lives and hasten the return of normalcy and prosperity. Paternalistically preventing altruists from volunteering to do good may even be evil.” — Conor Friedersdorf, Atlantic

The trials would be carried out ethically

“I think people worry, ‘Well are they going to go do this to prisoners or poor people?’ No. We’re not arguing for any suspension of the ethical rules on how to do experiments. We may be arguing that the risk/benefit facing the world justifies offering the opportunity, but no one would be forced coerced, tricked, exploited.” — Bioethicist Arthur Caplan to Vice


We don’t know enough about the virus to ensure safety

“Where you’re going to give somebody a virus on purpose, you really want to understand the disease so that you know that what you’re doing is a reasonable risk,” — Immunologist Matthew Memoli to Science

The results may not be applicable to the broader population

“You would only know that that works in healthy young adults, probably a very narrow age. … And that may or may not be extrapolatable information to the population with the mortality, which is, you know, 60s and 70s, and 80s.” — Infectious disease expert Myron Levine to STAT

Intensive trials may use up too many resources

“With the number of vaccine candidates increasing at a rapid pace, such challenge trials would not be possible for all proposed drugs. Having to isolate hundreds of people for weeks for each vaccine challenge trial would also rob hospitals of resources that could be used to treat regular COVID-19 patients.” — Chris Smith, New York Post

Challenge trials would run counter to core medical principles

“It would be a sharp break from precedent to do a challenge trial for a virus with no known cure that is as deadly as the coronavirus. Even if the volunteers were all young and healthy, that would not entirely reduce the risk of serious illness.” — Peter Sullivan, The Hill

Challenge trials may not be faster

“While I’m sure these timelines can be accelerated, it still won’t be easy to do this very quickly. It doesn’t mean we shouldn’t do it, it would certainly help down the line, but I don’t see how it happens very fast.” — Vaccine expert Peter Hotez to BuzzFeed News

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Photo illustration: Yahoo News; photos: Getty images

Originally published