1 00:00:02,560 --> 00:00:07,640 Speaker 1: Welcome to prognosis. I'm Laura Carlson. As some states start 2 00:00:07,680 --> 00:00:11,920 Speaker 1: to reopen and ease physical distancing, the message from most 3 00:00:11,960 --> 00:00:16,240 Speaker 1: experts remains clear. The only true way back to normal 4 00:00:16,880 --> 00:00:20,360 Speaker 1: is a vaccine. In hopes of getting that as soon 5 00:00:20,520 --> 00:00:24,720 Speaker 1: as possible, people around the globe are volunteering to be 6 00:00:24,880 --> 00:00:29,680 Speaker 1: human test subjects to be intentionally injected with the coronavirus. 7 00:00:31,320 --> 00:00:36,519 Speaker 1: Now scientists, top health officials, and pharmaceutical executives are taking 8 00:00:36,680 --> 00:00:42,120 Speaker 1: very seriously an option that would normally be unthinkable today. 9 00:00:42,360 --> 00:00:46,159 Speaker 1: With the help of trade Offs. A podcast about our costly, complicated, 10 00:00:46,240 --> 00:00:50,560 Speaker 1: and counterintuitive health care system, we explore how scientists could 11 00:00:50,600 --> 00:00:54,320 Speaker 1: ethically and safely in fact people to speed up the 12 00:00:54,360 --> 00:01:04,800 Speaker 1: fight against COVID nineteen. Dan Gornstein reports Hua Gray knows 13 00:01:04,840 --> 00:01:07,759 Speaker 1: the risks of volunteering to be infected with stars covie 14 00:01:07,920 --> 00:01:12,440 Speaker 1: to the virus that causes COVID nineteen. It is a 15 00:01:12,480 --> 00:01:16,000 Speaker 1: disease that doesn't have a cure and is something that 16 00:01:16,040 --> 00:01:21,319 Speaker 1: could possibly kill you me could possibly kill me. A 17 00:01:21,319 --> 00:01:24,600 Speaker 1: friend shared a journal article describing what are called human 18 00:01:24,720 --> 00:01:29,480 Speaker 1: challenge trials, where healthy, young, consenting adult volunteers are intentionally 19 00:01:29,520 --> 00:01:33,520 Speaker 1: infected to speed up vaccine development. The article suggested this 20 00:01:33,600 --> 00:01:36,080 Speaker 1: kind of study could shave three months off the time 21 00:01:36,120 --> 00:01:38,800 Speaker 1: it would take to get a COVID nineteen vaccine. Three 22 00:01:38,800 --> 00:01:42,319 Speaker 1: months would be huge, three months could save a lot 23 00:01:42,319 --> 00:01:47,520 Speaker 1: of lives. The thirty two year old away the personal cost, 24 00:01:47,800 --> 00:01:51,960 Speaker 1: she weighed the larger societal benefit, and she volunteered herself 25 00:01:51,960 --> 00:01:56,080 Speaker 1: for science. Actually, Hua was among the first few thousand 26 00:01:56,120 --> 00:01:59,200 Speaker 1: people to sign up through the online Adequacy Group One 27 00:01:59,280 --> 00:02:05,160 Speaker 1: Day Sooner, back in April. As of thousand eighty six 28 00:02:05,240 --> 00:02:08,640 Speaker 1: people have now signed up, with numbers growing every day. 29 00:02:11,520 --> 00:02:15,239 Speaker 1: Seema Shaw is a bioethicist at Laurie Children's Hospital of 30 00:02:15,320 --> 00:02:18,519 Speaker 1: Chicago and one of the world's top experts on when 31 00:02:18,560 --> 00:02:20,960 Speaker 1: it's okay to put people at risk for the benefit 32 00:02:21,000 --> 00:02:24,760 Speaker 1: of others. She says infecting volunteers for vaccine research is 33 00:02:24,800 --> 00:02:29,240 Speaker 1: a common tool under certain conditions. They're typically used when 34 00:02:29,400 --> 00:02:32,600 Speaker 1: either there's a treatment that you can give people, or 35 00:02:32,680 --> 00:02:35,280 Speaker 1: it's a disease where we know a lot about the 36 00:02:35,360 --> 00:02:40,519 Speaker 1: disease and how to manage it. Cholera, malaria, influenza. Researchers 37 00:02:40,639 --> 00:02:43,960 Speaker 1: have five months of data on the coronavirus, meaning little 38 00:02:44,080 --> 00:02:47,000 Speaker 1: is known about how to protect Lahua or any other 39 00:02:47,080 --> 00:02:50,880 Speaker 1: human test subject. But Seema says the need for vaccine 40 00:02:50,919 --> 00:02:53,360 Speaker 1: is so urgent. There's a growing camp of scientists and 41 00:02:53,400 --> 00:02:57,920 Speaker 1: bioethicist who think this moment warrants a break from standard protocol. 42 00:02:58,360 --> 00:03:01,360 Speaker 1: We're all looking for a way out of this pandemic, 43 00:03:02,000 --> 00:03:06,400 Speaker 1: and the thought of a novel, innovative idea that even 44 00:03:06,400 --> 00:03:09,040 Speaker 1: sounds a little bit crazy the first time you hear it, 45 00:03:09,040 --> 00:03:12,359 Speaker 1: it sounds like it might be a way out. Not 46 00:03:12,480 --> 00:03:16,120 Speaker 1: all scientists and ethicis are on board, but that hasn't 47 00:03:16,120 --> 00:03:19,359 Speaker 1: stopped the idea from catching fire. In April thirty five, 48 00:03:19,360 --> 00:03:23,200 Speaker 1: bipartisan members of Congress urged the FDA to consider challenge trials. 49 00:03:23,360 --> 00:03:26,639 Speaker 1: Johnson and Johnson told The Financial Times the company would 50 00:03:26,720 --> 00:03:30,920 Speaker 1: do challenge trous if okayed by ethicists, and working groups 51 00:03:30,960 --> 00:03:33,840 Speaker 1: at the World Health Organization and the National Institutes of 52 00:03:33,880 --> 00:03:37,839 Speaker 1: Health are now both exploring the issue. Simon, who's part 53 00:03:37,880 --> 00:03:40,360 Speaker 1: of the w h O group, says much of the 54 00:03:40,400 --> 00:03:44,360 Speaker 1: excitement has centered on one particular use of intentionally infecting people. 55 00:03:44,760 --> 00:03:48,000 Speaker 1: You could use challenge studies to replace the step of 56 00:03:48,200 --> 00:03:51,800 Speaker 1: efficacy testing for a vaccine. Here's the step she's talking 57 00:03:51,800 --> 00:03:58,360 Speaker 1: about replacing Normally, researchers recruit thousands of people, give half 58 00:03:58,400 --> 00:04:00,840 Speaker 1: of them the vaccine, and then let them live their 59 00:04:00,840 --> 00:04:03,640 Speaker 1: regular lives to see if they're protected from the disease. 60 00:04:04,000 --> 00:04:07,960 Speaker 1: This can take years. Advocates of challenge trials say you 61 00:04:07,960 --> 00:04:11,040 Speaker 1: can save three to six months by infecting a few 62 00:04:11,080 --> 00:04:13,720 Speaker 1: dozen volunteers with the virus, giving half of them the 63 00:04:13,800 --> 00:04:17,520 Speaker 1: vaccine and not giving it to the other half, then 64 00:04:17,680 --> 00:04:21,560 Speaker 1: seeing what happens. If the vaccine works and the researchers 65 00:04:21,640 --> 00:04:24,279 Speaker 1: are confident it's safe, then it's off to the f 66 00:04:24,360 --> 00:04:30,760 Speaker 1: d A. This is the home run approach, or maybe 67 00:04:30,800 --> 00:04:33,919 Speaker 1: the inside the park home run approach, instead of the 68 00:04:34,000 --> 00:04:37,400 Speaker 1: usual deliberate trot around the basis of vaccine development, and 69 00:04:37,360 --> 00:04:40,760 Speaker 1: the scientists could sprint home, growing from a promising candidate 70 00:04:40,839 --> 00:04:45,880 Speaker 1: to a widely distributed vaccine. But before even stepping into 71 00:04:45,880 --> 00:04:49,240 Speaker 1: the batter's box, federal regulators have to sign off. In 72 00:04:49,279 --> 00:04:52,640 Speaker 1: the US, the FDA must approve any vaccine, and Seama 73 00:04:52,720 --> 00:04:55,800 Speaker 1: says they rarely do that without evidence from the big, 74 00:04:55,839 --> 00:05:00,480 Speaker 1: time consuming field trials. They're often concerned about what are 75 00:05:00,480 --> 00:05:04,600 Speaker 1: giving someone a virus in a non natural way. Um 76 00:05:04,640 --> 00:05:07,719 Speaker 1: who's young, healthy volunteer is going to tell you enough 77 00:05:07,920 --> 00:05:11,719 Speaker 1: about how well the vaccine works to then feel confident 78 00:05:11,760 --> 00:05:15,040 Speaker 1: it's actually going to work in the general population. There 79 00:05:15,080 --> 00:05:18,680 Speaker 1: are other concerns too. Scientists would be infecting people with 80 00:05:18,760 --> 00:05:21,240 Speaker 1: the deadly virus that we don't have a sure fire 81 00:05:21,279 --> 00:05:24,400 Speaker 1: way to treat, and some even question how much time 82 00:05:24,440 --> 00:05:27,320 Speaker 1: this would say With some vaccines expected to start normal 83 00:05:27,400 --> 00:05:31,640 Speaker 1: field trials this summer, and FDA spokesperson said any decisions 84 00:05:31,680 --> 00:05:34,480 Speaker 1: about using challenge trials will be made on a case 85 00:05:34,600 --> 00:05:41,080 Speaker 1: by case basis. Most of the conversation over the first 86 00:05:41,120 --> 00:05:43,640 Speaker 1: few months of the pandemic has focused on this home 87 00:05:43,720 --> 00:05:46,520 Speaker 1: run approach, but if people are going to be intentionally 88 00:05:46,600 --> 00:05:49,400 Speaker 1: infected for research, there are a few other uses that 89 00:05:49,480 --> 00:05:53,440 Speaker 1: experts think are more likely. Sticking with the baseball metaphor 90 00:05:53,480 --> 00:05:56,520 Speaker 1: here for a second. If replacing field trials with challenge 91 00:05:56,520 --> 00:05:59,640 Speaker 1: trials is a home run, figuring out how to prioritize 92 00:05:59,640 --> 00:06:02,960 Speaker 1: the hundred plus vaccine candidates is more like hitting a 93 00:06:03,040 --> 00:06:06,599 Speaker 1: double that sharply hit ball down the third base line. 94 00:06:07,240 --> 00:06:10,279 Speaker 1: Having a hundred potential vaccine candidates is great, but it 95 00:06:10,360 --> 00:06:14,400 Speaker 1: also creates difficulties. Zab m Erosic is a physician and 96 00:06:14,480 --> 00:06:18,599 Speaker 1: bioethicist at the man Ash Bioethics Center in Melbourne, Australia. 97 00:06:18,839 --> 00:06:21,359 Speaker 1: We spoke to him via zoom. If the first of 98 00:06:21,400 --> 00:06:23,880 Speaker 1: a second vaccine don't turn out to work, then we 99 00:06:23,920 --> 00:06:27,279 Speaker 1: need to select among the next ten vaccines or twenty 100 00:06:27,360 --> 00:06:30,760 Speaker 1: vaccines that are ready for human testing. Doing each trial 101 00:06:30,960 --> 00:06:33,560 Speaker 1: one after another or even all at once would be 102 00:06:33,600 --> 00:06:36,880 Speaker 1: really difficult and require tens of thousands of people across 103 00:06:36,880 --> 00:06:39,839 Speaker 1: the world. We could test ten or twenty vaccines in 104 00:06:39,839 --> 00:06:41,960 Speaker 1: a challenge study in a short space of time and 105 00:06:42,040 --> 00:06:45,080 Speaker 1: decide which three of those vaccines look the most promising, 106 00:06:45,240 --> 00:06:47,640 Speaker 1: and then to just as those ones well. This still 107 00:06:47,640 --> 00:06:51,720 Speaker 1: saves sometime regulators would get their traditional big field trial 108 00:06:51,800 --> 00:06:54,200 Speaker 1: to look at before green lighting of vaccine for the 109 00:06:54,240 --> 00:06:58,320 Speaker 1: general public. Then there are reasons we might infect volunteers 110 00:06:58,320 --> 00:07:02,160 Speaker 1: that feel even further away for finding a vaccine approaches 111 00:07:02,200 --> 00:07:05,600 Speaker 1: where scientists are just trying to get on base. JOHNS 112 00:07:05,600 --> 00:07:09,200 Speaker 1: Hopkins vaccine researcher and A. Durban has developed challenge models 113 00:07:09,400 --> 00:07:12,520 Speaker 1: for Dana vaccine and is working on one for Zica. 114 00:07:12,640 --> 00:07:15,640 Speaker 1: She says challenge trials could help us learn more about 115 00:07:15,680 --> 00:07:19,520 Speaker 1: how immunity works. Can you develop antibodies to COVID nineteen 116 00:07:20,160 --> 00:07:24,360 Speaker 1: that would protect you from another infection with COVID nineteen. 117 00:07:24,400 --> 00:07:27,920 Speaker 1: In the future, scientists could infect people who have already 118 00:07:27,960 --> 00:07:30,800 Speaker 1: recovered from COVID nineteen to see if they get sick again, 119 00:07:31,120 --> 00:07:33,840 Speaker 1: and if they don't, they could try and figure out 120 00:07:33,920 --> 00:07:37,239 Speaker 1: what in the body is protecting them. Or they could 121 00:07:37,240 --> 00:07:40,680 Speaker 1: try to learn more about how the virus spreads. Challenge 122 00:07:40,760 --> 00:07:44,040 Speaker 1: one person and then you have an unchallenged person in 123 00:07:44,040 --> 00:07:47,320 Speaker 1: there and and see if that virus is able to 124 00:07:47,360 --> 00:07:50,080 Speaker 1: be transmitted, and if so, then you know, is it 125 00:07:50,200 --> 00:07:54,200 Speaker 1: just touching surfaces? Um you know, how close do you 126 00:07:54,200 --> 00:07:55,880 Speaker 1: have to be, how long do you have to be 127 00:07:55,880 --> 00:07:59,400 Speaker 1: in contact risking your life to study how disease spreads 128 00:07:59,440 --> 00:08:04,640 Speaker 1: may feel glamorous, more like a walk than a home run. Scientists, regulators, 129 00:08:04,680 --> 00:08:07,560 Speaker 1: and especially the people volunteering to be infected would have 130 00:08:07,600 --> 00:08:10,840 Speaker 1: to decide whether the possible benefit to society was worth 131 00:08:10,880 --> 00:08:14,360 Speaker 1: the personal risk. Hu Gray says she needs to see 132 00:08:14,360 --> 00:08:16,840 Speaker 1: a direct line between her role and some kind of 133 00:08:16,920 --> 00:08:20,440 Speaker 1: game changing breakthrough. Whatever I was volunteering for, I would 134 00:08:20,520 --> 00:08:23,560 Speaker 1: want to have some confidence that it was reducing risk 135 00:08:23,680 --> 00:08:27,320 Speaker 1: to everyone else, even scientists and ethicis who are a 136 00:08:27,320 --> 00:08:30,320 Speaker 1: way of challenge trials. I think we should start preparing 137 00:08:30,360 --> 00:08:32,840 Speaker 1: for them now so that when the time comes to 138 00:08:32,880 --> 00:08:36,400 Speaker 1: actually decide if it's worth infecting people like Lahua will 139 00:08:36,440 --> 00:08:51,360 Speaker 1: be ready. I'm Dan Gornstein. This is trade Offs. That 140 00:08:51,720 --> 00:08:54,480 Speaker 1: was Dan Gornstein on a segment brought to us by 141 00:08:54,480 --> 00:08:59,680 Speaker 1: the podcast trade Offs. It was produced by Ryan Levy. 142 00:09:00,120 --> 00:09:04,880 Speaker 1: Music by Tai Sidderman, Blue Dot Sessions and Bacon. Additional 143 00:09:04,920 --> 00:09:09,200 Speaker 1: thanks to Tom Darton, Josh Morrison, Peter Niels, and Peter Smi. 144 00:09:09,960 --> 00:09:13,720 Speaker 1: If you enjoyed today's story, subscribe to the Tradeoffs podcast 145 00:09:14,200 --> 00:09:18,960 Speaker 1: or check them out at tradeoffs dot org. The Prognosis 146 00:09:19,000 --> 00:09:23,480 Speaker 1: Daily edition is produced by Tophur foreheads Jordan Gospure, Magnus 147 00:09:23,480 --> 00:09:28,559 Speaker 1: Hendrickson and me Laura Carlson. Original music by Leo Sidran. 148 00:09:29,280 --> 00:09:33,760 Speaker 1: Our editors are Francesco Levi and Rick Shy. Francesco Levi 149 00:09:34,160 --> 00:09:37,320 Speaker 1: is Bloomberg's head of Podcasts. Thanks for listening.