The Home Run Approach

Now scientists, top health officials, and pharmaceutical executives are taking very seriously an option that would normally be unthinkable today. With the help of trade Offs. A podcast about our costly, complicated, and counterintuitive health care system, we explore how scientists could ethically and safely in fact people to speed up the fight against COVID nineteen. Dan Gornstein reports Hua Gray knows the risks of volunteering to be infected with stars covie

to the virus that causes COVID nineteen. It is a disease that doesn't have a cure and is something that could possibly kill you me could possibly kill me. A friend shared a journal article describing what are called human challenge trials, where healthy, young, consenting adult volunteers are intentionally infected to speed up vaccine development. The article suggested this kind of study could shave three months off the time

it would take to get a COVID nineteen vaccine. Three months would be huge, three months could save a lot of lives. The thirty two year old away the personal cost, she weighed the larger societal benefit, and she volunteered herself for science. Actually, Hua was among the first few thousand people to sign up through the online Adequacy Group One Day Sooner, back in April. As of thousand eighty six people have now signed up, with numbers growing every day.

Seema Shaw is a bioethicist at Laurie Children's Hospital of Chicago and one of the world's top experts on when it's okay to put people at risk for the benefit of others. She says infecting volunteers for vaccine research is a common tool under certain conditions. They're typically used when either there's a treatment that you can give people, or it's a disease where we know a lot about the

disease and how to manage it. Cholera, malaria, influenza. Researchers have five months of data on the coronavirus, meaning little is known about how to protect Lahua or any other human test subject. But Seema says the need for vaccine is so urgent. There's a growing camp of scientists and bioethicist who think this moment warrants a break from standard protocol.

We're all looking for a way out of this pandemic, and the thought of a novel, innovative idea that even sounds a little bit crazy the first time you hear it, it sounds like it might be a way out. Not all scientists and ethicis are on board, but that hasn't stopped the idea from catching fire. In April thirty five, bipartisan members of Congress urged the FDA to consider challenge trials.

Johnson and Johnson told The Financial Times the company would do challenge trous if okayed by ethicists, and working groups at the World Health Organization and the National Institutes of Health are now both exploring the issue. Simon, who's part of the w h O group, says much of the excitement has centered on one particular use of intentionally infecting people. You could use challenge studies to replace the step of

efficacy testing for a vaccine. Here's the step she's talking about replacing Normally, researchers recruit thousands of people, give half of them the vaccine, and then let them live their regular lives to see if they're protected from the disease. This can take years. Advocates of challenge trials say you can save three to six months by infecting a few dozen volunteers with the virus, giving half of them the vaccine and not giving it to the other half, then

seeing what happens. If the vaccine works and the researchers are confident it's safe, then it's off to the f d A. This is the home run approach, or maybe the inside the park home run approach, instead of the usual deliberate trot around the basis of vaccine development, and the scientists could sprint home, growing from a promising candidate to a widely distributed vaccine. But before even stepping into

the batter's box, federal regulators have to sign off. In the US, the FDA must approve any vaccine, and Seama says they rarely do that without evidence from the big, time consuming field trials. They're often concerned about what are giving someone a virus in a non natural way. Um who's young, healthy volunteer is going to tell you enough about how well the vaccine works to then feel confident it's actually going to work in the general population. There

are other concerns too. Scientists would be infecting people with the deadly virus that we don't have a sure fire way to treat, and some even question how much time this would say With some vaccines expected to start normal field trials this summer, and FDA spokesperson said any decisions about using challenge trials will be made on a case

by case basis. Most of the conversation over the first few months of the pandemic has focused on this home run approach, but if people are going to be intentionally infected for research, there are a few other uses that experts think are more likely. Sticking with the baseball metaphor

here for a second. If replacing field trials with challenge trials is a home run, figuring out how to prioritize the hundred plus vaccine candidates is more like hitting a double that sharply hit ball down the third base line. Having a hundred potential vaccine candidates is great, but it also creates difficulties. Zab m Erosic is a physician and bioethicist at the man Ash Bioethics Center in Melbourne, Australia.

We spoke to him via zoom. If the first of a second vaccine don't turn out to work, then we need to select among the next ten vaccines or twenty vaccines that are ready for human testing. Doing each trial one after another or even all at once would be really difficult and require tens of thousands of people across the world. We could test ten or twenty vaccines in a challenge study in a short space of time and decide which three of those vaccines look the most promising,

and then to just as those ones well. This still saves sometime regulators would get their traditional big field trial to look at before green lighting of vaccine for the general public. Then there are reasons we might infect volunteers that feel even further away for finding a vaccine approaches where scientists are just trying to get on base. JOHNS Hopkins vaccine researcher and A. Durban has developed challenge models for Dana vaccine and is working on one for Zica.

She says challenge trials could help us learn more about how immunity works. Can you develop antibodies to COVID nineteen that would protect you from another infection with COVID nineteen. In the future, scientists could infect people who have already recovered from COVID nineteen to see if they get sick again, and if they don't, they could try and figure out what in the body is protecting them. Or they could

try to learn more about how the virus spreads. Challenge one person and then you have an unchallenged person in there and and see if that virus is able to be transmitted, and if so, then you know, is it just touching surfaces? Um you know, how close do you have to be, how long do you have to be in contact risking your life to study how disease spreads

may feel glamorous, more like a walk than a home run. Scientists, regulators, and especially the people volunteering to be infected would have to decide whether the possible benefit to society was worth the personal risk. Hu Gray says she needs to see a direct line between her role and some kind of game changing breakthrough. Whatever I was volunteering for, I would want to have some confidence that it was reducing risk to everyone else, even scientists and ethicis who are a

way of challenge trials. I think we should start preparing for them now so that when the time comes to actually decide if it's worth infecting people like Lahua will be ready. I'm Dan Gornstein. This is trade Offs. That was Dan Gornstein on a segment brought to us by the podcast trade Offs. It was produced by Ryan Levy. Music by Tai Sidderman, Blue Dot Sessions and Bacon. Additional thanks to Tom Darton, Josh Morrison, Peter Niels, and Peter Smi.

If you enjoyed today's story, subscribe to the Tradeoffs podcast or check them out at tradeoffs dot org. The Prognosis Daily edition is produced by Tophur foreheads Jordan Gospure, Magnus Hendrickson and me Laura Carlson. Original music by Leo Sidran. Our editors are Francesco Levi and Rick Shy. Francesco Levi is Bloomberg's head of Podcasts. Thanks for listening.