Speaker 1: Welcome to prognosis. I'm Laura Carlson. As some states start
Speaker 1: to reopen and ease physical distancing, the message from most
Speaker 1: experts remains clear. The only true way back to normal
Speaker 1: is a vaccine. In hopes of getting that as soon
Speaker 1: as possible, people around the globe are volunteering to be
Speaker 1: human test subjects to be intentionally injected with the coronavirus.
Speaker 1: Now scientists, top health officials, and pharmaceutical executives are taking
Speaker 1: very seriously an option that would normally be unthinkable today.
Speaker 1: With the help of trade Offs. A podcast about our costly, complicated,
Speaker 1: and counterintuitive health care system, we explore how scientists could
Speaker 1: ethically and safely in fact people to speed up the
Speaker 1: fight against COVID nineteen. Dan Gornstein reports Hua Gray knows
Speaker 1: the risks of volunteering to be infected with stars covie
Speaker 1: to the virus that causes COVID nineteen. It is a
Speaker 1: disease that doesn't have a cure and is something that
Speaker 1: could possibly kill you me could possibly kill me. A
Speaker 1: friend shared a journal article describing what are called human
Speaker 1: challenge trials, where healthy, young, consenting adult volunteers are intentionally
Speaker 1: infected to speed up vaccine development. The article suggested this
Speaker 1: kind of study could shave three months off the time
Speaker 1: it would take to get a COVID nineteen vaccine. Three
Speaker 1: months would be huge, three months could save a lot
Speaker 1: of lives. The thirty two year old away the personal cost,
Speaker 1: she weighed the larger societal benefit, and she volunteered herself
Speaker 1: for science. Actually, Hua was among the first few thousand
Speaker 1: people to sign up through the online Adequacy Group One
Speaker 1: Day Sooner, back in April. As of thousand eighty six
Speaker 1: people have now signed up, with numbers growing every day.
Speaker 1: Seema Shaw is a bioethicist at Laurie Children's Hospital of
Speaker 1: Chicago and one of the world's top experts on when
Speaker 1: it's okay to put people at risk for the benefit
Speaker 1: of others. She says infecting volunteers for vaccine research is
Speaker 1: a common tool under certain conditions. They're typically used when
Speaker 1: either there's a treatment that you can give people, or
Speaker 1: it's a disease where we know a lot about the
Speaker 1: disease and how to manage it. Cholera, malaria, influenza. Researchers
Speaker 1: have five months of data on the coronavirus, meaning little
Speaker 1: is known about how to protect Lahua or any other
Speaker 1: human test subject. But Seema says the need for vaccine
Speaker 1: is so urgent. There's a growing camp of scientists and
Speaker 1: bioethicist who think this moment warrants a break from standard protocol.
Speaker 1: We're all looking for a way out of this pandemic,
Speaker 1: and the thought of a novel, innovative idea that even
Speaker 1: sounds a little bit crazy the first time you hear it,
Speaker 1: it sounds like it might be a way out. Not
Speaker 1: all scientists and ethicis are on board, but that hasn't
Speaker 1: stopped the idea from catching fire. In April thirty five,
Speaker 1: bipartisan members of Congress urged the FDA to consider challenge trials.
Speaker 1: Johnson and Johnson told The Financial Times the company would
Speaker 1: do challenge trous if okayed by ethicists, and working groups
Speaker 1: at the World Health Organization and the National Institutes of
Speaker 1: Health are now both exploring the issue. Simon, who's part
Speaker 1: of the w h O group, says much of the
Speaker 1: excitement has centered on one particular use of intentionally infecting people.
Speaker 1: You could use challenge studies to replace the step of
Speaker 1: efficacy testing for a vaccine. Here's the step she's talking
Speaker 1: about replacing Normally, researchers recruit thousands of people, give half
Speaker 1: of them the vaccine, and then let them live their
Speaker 1: regular lives to see if they're protected from the disease.
Speaker 1: This can take years. Advocates of challenge trials say you
Speaker 1: can save three to six months by infecting a few
Speaker 1: dozen volunteers with the virus, giving half of them the
Speaker 1: vaccine and not giving it to the other half, then
Speaker 1: seeing what happens. If the vaccine works and the researchers
Speaker 1: are confident it's safe, then it's off to the f
Speaker 1: d A. This is the home run approach, or maybe
Speaker 1: the inside the park home run approach, instead of the
Speaker 1: usual deliberate trot around the basis of vaccine development, and
Speaker 1: the scientists could sprint home, growing from a promising candidate
Speaker 1: to a widely distributed vaccine. But before even stepping into
Speaker 1: the batter's box, federal regulators have to sign off. In
Speaker 1: the US, the FDA must approve any vaccine, and Seama
Speaker 1: says they rarely do that without evidence from the big,
Speaker 1: time consuming field trials. They're often concerned about what are
Speaker 1: giving someone a virus in a non natural way. Um
Speaker 1: who's young, healthy volunteer is going to tell you enough
Speaker 1: about how well the vaccine works to then feel confident
Speaker 1: it's actually going to work in the general population. There
Speaker 1: are other concerns too. Scientists would be infecting people with
Speaker 1: the deadly virus that we don't have a sure fire
Speaker 1: way to treat, and some even question how much time
Speaker 1: this would say With some vaccines expected to start normal
Speaker 1: field trials this summer, and FDA spokesperson said any decisions
Speaker 1: about using challenge trials will be made on a case
Speaker 1: by case basis. Most of the conversation over the first
Speaker 1: few months of the pandemic has focused on this home
Speaker 1: run approach, but if people are going to be intentionally
Speaker 1: infected for research, there are a few other uses that
Speaker 1: experts think are more likely. Sticking with the baseball metaphor
Speaker 1: here for a second. If replacing field trials with challenge
Speaker 1: trials is a home run, figuring out how to prioritize
Speaker 1: the hundred plus vaccine candidates is more like hitting a
Speaker 1: double that sharply hit ball down the third base line.
Speaker 1: Having a hundred potential vaccine candidates is great, but it
Speaker 1: also creates difficulties. Zab m Erosic is a physician and
Speaker 1: bioethicist at the man Ash Bioethics Center in Melbourne, Australia.
Speaker 1: We spoke to him via zoom. If the first of
Speaker 1: a second vaccine don't turn out to work, then we
Speaker 1: need to select among the next ten vaccines or twenty
Speaker 1: vaccines that are ready for human testing. Doing each trial
Speaker 1: one after another or even all at once would be
Speaker 1: really difficult and require tens of thousands of people across
Speaker 1: the world. We could test ten or twenty vaccines in
Speaker 1: a challenge study in a short space of time and
Speaker 1: decide which three of those vaccines look the most promising,
Speaker 1: and then to just as those ones well. This still
Speaker 1: saves sometime regulators would get their traditional big field trial
Speaker 1: to look at before green lighting of vaccine for the
Speaker 1: general public. Then there are reasons we might infect volunteers
Speaker 1: that feel even further away for finding a vaccine approaches
Speaker 1: where scientists are just trying to get on base. JOHNS
Speaker 1: Hopkins vaccine researcher and A. Durban has developed challenge models
Speaker 1: for Dana vaccine and is working on one for Zica.
Speaker 1: She says challenge trials could help us learn more about
Speaker 1: how immunity works. Can you develop antibodies to COVID nineteen
Speaker 1: that would protect you from another infection with COVID nineteen.
Speaker 1: In the future, scientists could infect people who have already
Speaker 1: recovered from COVID nineteen to see if they get sick again,
Speaker 1: and if they don't, they could try and figure out
Speaker 1: what in the body is protecting them. Or they could
Speaker 1: try to learn more about how the virus spreads. Challenge
Speaker 1: one person and then you have an unchallenged person in
Speaker 1: there and and see if that virus is able to
Speaker 1: be transmitted, and if so, then you know, is it
Speaker 1: just touching surfaces? Um you know, how close do you
Speaker 1: have to be, how long do you have to be
Speaker 1: in contact risking your life to study how disease spreads
Speaker 1: may feel glamorous, more like a walk than a home run. Scientists, regulators,
Speaker 1: and especially the people volunteering to be infected would have
Speaker 1: to decide whether the possible benefit to society was worth
Speaker 1: the personal risk. Hu Gray says she needs to see
Speaker 1: a direct line between her role and some kind of
Speaker 1: game changing breakthrough. Whatever I was volunteering for, I would
Speaker 1: want to have some confidence that it was reducing risk
Speaker 1: to everyone else, even scientists and ethicis who are a
Speaker 1: way of challenge trials. I think we should start preparing
Speaker 1: for them now so that when the time comes to
Speaker 1: actually decide if it's worth infecting people like Lahua will
Speaker 1: be ready. I'm Dan Gornstein. This is trade Offs. That
Speaker 1: was Dan Gornstein on a segment brought to us by
Speaker 1: the podcast trade Offs. It was produced by Ryan Levy.
Speaker 1: Music by Tai Sidderman, Blue Dot Sessions and Bacon. Additional
Speaker 1: thanks to Tom Darton, Josh Morrison, Peter Niels, and Peter Smi.
Speaker 1: If you enjoyed today's story, subscribe to the Tradeoffs podcast
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Speaker 1: Daily edition is produced by Tophur foreheads Jordan Gospure, Magnus
Speaker 1: Hendrickson and me Laura Carlson. Original music by Leo Sidran.
Speaker 1: Our editors are Francesco Levi and Rick Shy. Francesco Levi
Speaker 1: is Bloomberg's head of Podcasts. Thanks for listening.