WEBVTT - The Home Run Approach 0:00:02.560 --> 0:00:07.640 Welcome to prognosis. I'm Laura Carlson. As some states start 0:00:07.680 --> 0:00:11.920 to reopen and ease physical distancing, the message from most 0:00:11.960 --> 0:00:16.240 experts remains clear. The only true way back to normal 0:00:16.880 --> 0:00:20.360 is a vaccine. In hopes of getting that as soon 0:00:20.520 --> 0:00:24.720 as possible, people around the globe are volunteering to be 0:00:24.880 --> 0:00:29.680 human test subjects to be intentionally injected with the coronavirus. 0:00:31.320 --> 0:00:36.519 Now scientists, top health officials, and pharmaceutical executives are taking 0:00:36.680 --> 0:00:42.120 very seriously an option that would normally be unthinkable today. 0:00:42.360 --> 0:00:46.159 With the help of trade Offs. A podcast about our costly, complicated, 0:00:46.240 --> 0:00:50.560 and counterintuitive health care system, we explore how scientists could 0:00:50.600 --> 0:00:54.320 ethically and safely in fact people to speed up the 0:00:54.360 --> 0:01:04.800 fight against COVID nineteen. Dan Gornstein reports Hua Gray knows 0:01:04.840 --> 0:01:07.759 the risks of volunteering to be infected with stars covie 0:01:07.920 --> 0:01:12.440 to the virus that causes COVID nineteen. It is a 0:01:12.480 --> 0:01:16.000 disease that doesn't have a cure and is something that 0:01:16.040 --> 0:01:21.319 could possibly kill you me could possibly kill me. A 0:01:21.319 --> 0:01:24.600 friend shared a journal article describing what are called human 0:01:24.720 --> 0:01:29.480 challenge trials, where healthy, young, consenting adult volunteers are intentionally 0:01:29.520 --> 0:01:33.520 infected to speed up vaccine development. The article suggested this 0:01:33.600 --> 0:01:36.080 kind of study could shave three months off the time 0:01:36.120 --> 0:01:38.800 it would take to get a COVID nineteen vaccine. Three 0:01:38.800 --> 0:01:42.319 months would be huge, three months could save a lot 0:01:42.319 --> 0:01:47.520 of lives. The thirty two year old away the personal cost, 0:01:47.800 --> 0:01:51.960 she weighed the larger societal benefit, and she volunteered herself 0:01:51.960 --> 0:01:56.080 for science. Actually, Hua was among the first few thousand 0:01:56.120 --> 0:01:59.200 people to sign up through the online Adequacy Group One 0:01:59.280 --> 0:02:05.160 Day Sooner, back in April. As of thousand eighty six 0:02:05.240 --> 0:02:08.640 people have now signed up, with numbers growing every day. 0:02:11.520 --> 0:02:15.239 Seema Shaw is a bioethicist at Laurie Children's Hospital of 0:02:15.320 --> 0:02:18.519 Chicago and one of the world's top experts on when 0:02:18.560 --> 0:02:20.960 it's okay to put people at risk for the benefit 0:02:21.000 --> 0:02:24.760 of others. She says infecting volunteers for vaccine research is 0:02:24.800 --> 0:02:29.240 a common tool under certain conditions. They're typically used when 0:02:29.400 --> 0:02:32.600 either there's a treatment that you can give people, or 0:02:32.680 --> 0:02:35.280 it's a disease where we know a lot about the 0:02:35.360 --> 0:02:40.519 disease and how to manage it. Cholera, malaria, influenza. Researchers 0:02:40.639 --> 0:02:43.960 have five months of data on the coronavirus, meaning little 0:02:44.080 --> 0:02:47.000 is known about how to protect Lahua or any other 0:02:47.080 --> 0:02:50.880 human test subject. But Seema says the need for vaccine 0:02:50.919 --> 0:02:53.360 is so urgent. There's a growing camp of scientists and 0:02:53.400 --> 0:02:57.920 bioethicist who think this moment warrants a break from standard protocol. 0:02:58.360 --> 0:03:01.360 We're all looking for a way out of this pandemic, 0:03:02.000 --> 0:03:06.400 and the thought of a novel, innovative idea that even 0:03:06.400 --> 0:03:09.040 sounds a little bit crazy the first time you hear it, 0:03:09.040 --> 0:03:12.359 it sounds like it might be a way out. Not 0:03:12.480 --> 0:03:16.120 all scientists and ethicis are on board, but that hasn't 0:03:16.120 --> 0:03:19.359 stopped the idea from catching fire. In April thirty five, 0:03:19.360 --> 0:03:23.200 bipartisan members of Congress urged the FDA to consider challenge trials. 0:03:23.360 --> 0:03:26.639 Johnson and Johnson told The Financial Times the company would 0:03:26.720 --> 0:03:30.920 do challenge trous if okayed by ethicists, and working groups 0:03:30.960 --> 0:03:33.840 at the World Health Organization and the National Institutes of 0:03:33.880 --> 0:03:37.839 Health are now both exploring the issue. Simon, who's part 0:03:37.880 --> 0:03:40.360 of the w h O group, says much of the 0:03:40.400 --> 0:03:44.360 excitement has centered on one particular use of intentionally infecting people. 0:03:44.760 --> 0:03:48.000 You could use challenge studies to replace the step of 0:03:48.200 --> 0:03:51.800 efficacy testing for a vaccine. Here's the step she's talking 0:03:51.800 --> 0:03:58.360 about replacing Normally, researchers recruit thousands of people, give half 0:03:58.400 --> 0:04:00.840 of them the vaccine, and then let them live their 0:04:00.840 --> 0:04:03.640 regular lives to see if they're protected from the disease. 0:04:04.000 --> 0:04:07.960 This can take years. Advocates of challenge trials say you 0:04:07.960 --> 0:04:11.040 can save three to six months by infecting a few 0:04:11.080 --> 0:04:13.720 dozen volunteers with the virus, giving half of them the 0:04:13.800 --> 0:04:17.520 vaccine and not giving it to the other half, then 0:04:17.680 --> 0:04:21.560 seeing what happens. If the vaccine works and the researchers 0:04:21.640 --> 0:04:24.279 are confident it's safe, then it's off to the f 0:04:24.360 --> 0:04:30.760 d A. This is the home run approach, or maybe 0:04:30.800 --> 0:04:33.919 the inside the park home run approach, instead of the 0:04:34.000 --> 0:04:37.400 usual deliberate trot around the basis of vaccine development, and 0:04:37.360 --> 0:04:40.760 the scientists could sprint home, growing from a promising candidate 0:04:40.839 --> 0:04:45.880 to a widely distributed vaccine. But before even stepping into 0:04:45.880 --> 0:04:49.240 the batter's box, federal regulators have to sign off. In 0:04:49.279 --> 0:04:52.640 the US, the FDA must approve any vaccine, and Seama 0:04:52.720 --> 0:04:55.800 says they rarely do that without evidence from the big, 0:04:55.839 --> 0:05:00.480 time consuming field trials. They're often concerned about what are 0:05:00.480 --> 0:05:04.600 giving someone a virus in a non natural way. Um 0:05:04.640 --> 0:05:07.719 who's young, healthy volunteer is going to tell you enough 0:05:07.920 --> 0:05:11.719 about how well the vaccine works to then feel confident 0:05:11.760 --> 0:05:15.040 it's actually going to work in the general population. There 0:05:15.080 --> 0:05:18.680 are other concerns too. Scientists would be infecting people with 0:05:18.760 --> 0:05:21.240 the deadly virus that we don't have a sure fire 0:05:21.279 --> 0:05:24.400 way to treat, and some even question how much time 0:05:24.440 --> 0:05:27.320 this would say With some vaccines expected to start normal 0:05:27.400 --> 0:05:31.640 field trials this summer, and FDA spokesperson said any decisions 0:05:31.680 --> 0:05:34.480 about using challenge trials will be made on a case 0:05:34.600 --> 0:05:41.080 by case basis. Most of the conversation over the first 0:05:41.120 --> 0:05:43.640 few months of the pandemic has focused on this home 0:05:43.720 --> 0:05:46.520 run approach, but if people are going to be intentionally 0:05:46.600 --> 0:05:49.400 infected for research, there are a few other uses that 0:05:49.480 --> 0:05:53.440 experts think are more likely. Sticking with the baseball metaphor 0:05:53.480 --> 0:05:56.520 here for a second. If replacing field trials with challenge 0:05:56.520 --> 0:05:59.640 trials is a home run, figuring out how to prioritize 0:05:59.640 --> 0:06:02.960 the hundred plus vaccine candidates is more like hitting a 0:06:03.040 --> 0:06:06.599 double that sharply hit ball down the third base line. 0:06:07.240 --> 0:06:10.279 Having a hundred potential vaccine candidates is great, but it 0:06:10.360 --> 0:06:14.400 also creates difficulties. Zab m Erosic is a physician and 0:06:14.480 --> 0:06:18.599 bioethicist at the man Ash Bioethics Center in Melbourne, Australia. 0:06:18.839 --> 0:06:21.359 We spoke to him via zoom. If the first of 0:06:21.400 --> 0:06:23.880 a second vaccine don't turn out to work, then we 0:06:23.920 --> 0:06:27.279 need to select among the next ten vaccines or twenty 0:06:27.360 --> 0:06:30.760 vaccines that are ready for human testing. Doing each trial 0:06:30.960 --> 0:06:33.560 one after another or even all at once would be 0:06:33.600 --> 0:06:36.880 really difficult and require tens of thousands of people across 0:06:36.880 --> 0:06:39.839 the world. We could test ten or twenty vaccines in 0:06:39.839 --> 0:06:41.960 a challenge study in a short space of time and 0:06:42.040 --> 0:06:45.080 decide which three of those vaccines look the most promising, 0:06:45.240 --> 0:06:47.640 and then to just as those ones well. This still 0:06:47.640 --> 0:06:51.720 saves sometime regulators would get their traditional big field trial 0:06:51.800 --> 0:06:54.200 to look at before green lighting of vaccine for the 0:06:54.240 --> 0:06:58.320 general public. Then there are reasons we might infect volunteers 0:06:58.320 --> 0:07:02.160 that feel even further away for finding a vaccine approaches 0:07:02.200 --> 0:07:05.600 where scientists are just trying to get on base. JOHNS 0:07:05.600 --> 0:07:09.200 Hopkins vaccine researcher and A. Durban has developed challenge models 0:07:09.400 --> 0:07:12.520 for Dana vaccine and is working on one for Zica. 0:07:12.640 --> 0:07:15.640 She says challenge trials could help us learn more about 0:07:15.680 --> 0:07:19.520 how immunity works. Can you develop antibodies to COVID nineteen 0:07:20.160 --> 0:07:24.360 that would protect you from another infection with COVID nineteen. 0:07:24.400 --> 0:07:27.920 In the future, scientists could infect people who have already 0:07:27.960 --> 0:07:30.800 recovered from COVID nineteen to see if they get sick again, 0:07:31.120 --> 0:07:33.840 and if they don't, they could try and figure out 0:07:33.920 --> 0:07:37.239 what in the body is protecting them. Or they could 0:07:37.240 --> 0:07:40.680 try to learn more about how the virus spreads. Challenge 0:07:40.760 --> 0:07:44.040 one person and then you have an unchallenged person in 0:07:44.040 --> 0:07:47.320 there and and see if that virus is able to 0:07:47.360 --> 0:07:50.080 be transmitted, and if so, then you know, is it 0:07:50.200 --> 0:07:54.200 just touching surfaces? Um you know, how close do you 0:07:54.200 --> 0:07:55.880 have to be, how long do you have to be 0:07:55.880 --> 0:07:59.400 in contact risking your life to study how disease spreads 0:07:59.440 --> 0:08:04.640 may feel glamorous, more like a walk than a home run. Scientists, regulators, 0:08:04.680 --> 0:08:07.560 and especially the people volunteering to be infected would have 0:08:07.600 --> 0:08:10.840 to decide whether the possible benefit to society was worth 0:08:10.880 --> 0:08:14.360 the personal risk. Hu Gray says she needs to see 0:08:14.360 --> 0:08:16.840 a direct line between her role and some kind of 0:08:16.920 --> 0:08:20.440 game changing breakthrough. Whatever I was volunteering for, I would 0:08:20.520 --> 0:08:23.560 want to have some confidence that it was reducing risk 0:08:23.680 --> 0:08:27.320 to everyone else, even scientists and ethicis who are a 0:08:27.320 --> 0:08:30.320 way of challenge trials. I think we should start preparing 0:08:30.360 --> 0:08:32.840 for them now so that when the time comes to 0:08:32.880 --> 0:08:36.400 actually decide if it's worth infecting people like Lahua will 0:08:36.440 --> 0:08:51.360 be ready. I'm Dan Gornstein. This is trade Offs. That 0:08:51.720 --> 0:08:54.480 was Dan Gornstein on a segment brought to us by 0:08:54.480 --> 0:08:59.680 the podcast trade Offs. It was produced by Ryan Levy. 0:09:00.120 --> 0:09:04.880 Music by Tai Sidderman, Blue Dot Sessions and Bacon. Additional 0:09:04.920 --> 0:09:09.200 thanks to Tom Darton, Josh Morrison, Peter Niels, and Peter Smi. 0:09:09.960 --> 0:09:13.720 If you enjoyed today's story, subscribe to the Tradeoffs podcast 0:09:14.200 --> 0:09:18.960 or check them out at tradeoffs dot org. The Prognosis 0:09:19.000 --> 0:09:23.480 Daily edition is produced by Tophur foreheads Jordan Gospure, Magnus 0:09:23.480 --> 0:09:28.559 Hendrickson and me Laura Carlson. Original music by Leo Sidran. 0:09:29.280 --> 0:09:33.760 Our editors are Francesco Levi and Rick Shy. Francesco Levi 0:09:34.160 --> 0:09:37.320 is Bloomberg's head of Podcasts. Thanks for listening.