1 00:00:01,720 --> 00:00:06,760 Speaker 1: Welcome the prognosis. I'm Laura Carlson. It's day one and 2 00:00:06,840 --> 00:00:12,400 Speaker 1: sixty six since coronavirus was declared a global pandemic. Today's 3 00:00:12,400 --> 00:00:17,200 Speaker 1: main story using the blood plasma of recovered COVID patients 4 00:00:17,440 --> 00:00:21,760 Speaker 1: to treat very sick ones. It's a promising experimental tool 5 00:00:22,160 --> 00:00:25,439 Speaker 1: in the fight against the disease. But what should we 6 00:00:25,520 --> 00:00:28,640 Speaker 1: make of today's decision by the White House to expand 7 00:00:28,800 --> 00:00:34,159 Speaker 1: access to the treatment even before researchers fully understand it. 8 00:00:34,760 --> 00:00:43,200 Speaker 1: But first, here's what happened in virus news today. After 9 00:00:43,240 --> 00:00:48,440 Speaker 1: suffering one of Europe's earliest and fiercest outbreaks, Italy emerged 10 00:00:48,720 --> 00:00:52,560 Speaker 1: as an unlikely role model for its handling of the pandemic. 11 00:00:53,840 --> 00:00:58,320 Speaker 1: The country managed to reduce infections and fatalities dramatically in 12 00:00:58,440 --> 00:01:03,440 Speaker 1: June and July after two months of strict lockdown, but 13 00:01:03,520 --> 00:01:07,360 Speaker 1: as cases flare in Europe, Italy's success may now be 14 00:01:07,480 --> 00:01:13,240 Speaker 1: in jeopardy. On Saturday, Italy recorded the most new cases 15 00:01:13,640 --> 00:01:18,720 Speaker 1: since mid May. The intensity and duration of Italy's lockdown 16 00:01:18,840 --> 00:01:22,560 Speaker 1: is widely seen as one of the reasons why cases 17 00:01:22,640 --> 00:01:27,560 Speaker 1: continue to fall. After curbs started to be gradually lifted 18 00:01:27,760 --> 00:01:32,600 Speaker 1: in early May, restrictions were maintained for a full six 19 00:01:32,720 --> 00:01:38,319 Speaker 1: weeks after new infections peaked, and schools never reopened. Unlike 20 00:01:38,360 --> 00:01:44,360 Speaker 1: in France or Germany, Hong Kong has confirmed the first 21 00:01:44,600 --> 00:01:49,720 Speaker 1: known case of a coronavirus reinfection. A man was infected 22 00:01:49,720 --> 00:01:53,680 Speaker 1: with the virus this month after recovering from an initial 23 00:01:53,720 --> 00:01:58,880 Speaker 1: bout in April. Scientists say they found the second infection 24 00:01:58,960 --> 00:02:01,680 Speaker 1: in the thirty three or old who had no symptoms 25 00:02:02,080 --> 00:02:05,600 Speaker 1: when he was screened at an airport after returning from Europe. 26 00:02:07,400 --> 00:02:10,760 Speaker 1: Researchers at the University of Hong Kong say they know 27 00:02:11,240 --> 00:02:15,680 Speaker 1: it is a reinfection because they used genomic sequence analysis 28 00:02:15,720 --> 00:02:20,360 Speaker 1: to prove that he had been reinfected by two different strains. 29 00:02:21,560 --> 00:02:25,120 Speaker 1: The findings suggests there may not be long lasting immunity 30 00:02:25,160 --> 00:02:29,960 Speaker 1: from the virus in those who recover. The South Korean 31 00:02:29,960 --> 00:02:34,160 Speaker 1: government is deciding whether to raise social distancing restrictions to 32 00:02:34,280 --> 00:02:38,320 Speaker 1: the highest level, as officials warn the country is at 33 00:02:38,320 --> 00:02:44,679 Speaker 1: the risk of a quote massive nationwide outbreak. An additional 34 00:02:44,720 --> 00:02:47,959 Speaker 1: three d and ninety seven new virus cases were reported 35 00:02:48,040 --> 00:02:54,040 Speaker 1: on Sunday, the highest number since March seven. Jung Un Kyung, 36 00:02:54,480 --> 00:02:57,520 Speaker 1: head of Korea's Centers for Disease Control and Preventions set 37 00:02:57,600 --> 00:03:00,880 Speaker 1: at a briefing on Sunday that case is are rising 38 00:03:00,960 --> 00:03:12,760 Speaker 1: in seventeen cities and provinces across the nation. And now 39 00:03:13,000 --> 00:03:18,280 Speaker 1: for today's main story, President Donald Trump expanded access to 40 00:03:18,320 --> 00:03:23,600 Speaker 1: a coronavirus treatment that involves blood plasma donated by people 41 00:03:23,639 --> 00:03:29,200 Speaker 1: who have recovered from COVID nineteen. But while convalescent plasma 42 00:03:29,320 --> 00:03:34,080 Speaker 1: as it's known, is a promising therapy, researchers don't yet 43 00:03:34,120 --> 00:03:38,880 Speaker 1: fully understand how well it works. I spoke with Bloomberg's 44 00:03:38,880 --> 00:03:43,280 Speaker 1: Michelle fake Cortez about what the announcement means and the 45 00:03:43,320 --> 00:03:47,440 Speaker 1: concerns that agencies like the f d A are letting 46 00:03:47,480 --> 00:03:52,320 Speaker 1: pressures from the White House rather than science guide their decisions. 47 00:03:54,840 --> 00:03:58,760 Speaker 1: What is the promise of plasma as a treatment for 48 00:03:58,920 --> 00:04:04,480 Speaker 1: COVID nineteen. Convalescent plasma is basically bringing in reinforcements to 49 00:04:04,560 --> 00:04:08,320 Speaker 1: help someone who's newly infected with coronavirus fight it off. 50 00:04:08,640 --> 00:04:11,760 Speaker 1: When you think about an infection, there is a pathogen 51 00:04:12,120 --> 00:04:15,240 Speaker 1: that your body encounters and your immune system fights it 52 00:04:15,280 --> 00:04:20,080 Speaker 1: off using antibodies. These antibodies remain in your blood and 53 00:04:20,160 --> 00:04:24,480 Speaker 1: in your system for some extended period perhaps life long 54 00:04:24,960 --> 00:04:28,120 Speaker 1: after you successfully fight off that infection. So think of 55 00:04:28,160 --> 00:04:32,760 Speaker 1: these antibodies as your soldiers in your fight against the virus. 56 00:04:32,960 --> 00:04:39,000 Speaker 1: What convalescent plasma does is it takes your blood, your antibodies, 57 00:04:39,120 --> 00:04:42,520 Speaker 1: your fighters, and gives them to another person who's been 58 00:04:42,520 --> 00:04:45,640 Speaker 1: newly infected, and it takes up the battle for them. 59 00:04:46,320 --> 00:04:49,600 Speaker 1: So obviously there's all kinds of questions around it. What 60 00:04:49,720 --> 00:04:53,240 Speaker 1: antibodies specifically do you need, Because the body makes a 61 00:04:53,240 --> 00:04:57,000 Speaker 1: wide variety, at what point should you get the antibodies. 62 00:04:57,360 --> 00:04:59,640 Speaker 1: If you've had the infection for a while, you've made 63 00:04:59,680 --> 00:05:02,719 Speaker 1: your own antibodies, so maybe someone else's don't help, but 64 00:05:02,839 --> 00:05:06,719 Speaker 1: perhaps early on in the infection they do. Has convalescent 65 00:05:06,760 --> 00:05:11,680 Speaker 1: plasma been used before with other diseases. Convalescent plasma has 66 00:05:11,720 --> 00:05:14,440 Speaker 1: been used for over a hundred years, and in fact, 67 00:05:14,520 --> 00:05:19,760 Speaker 1: it won the first Nobel Prize for treatment of diphtheria. 68 00:05:19,920 --> 00:05:23,840 Speaker 1: So it is a known quantity. That being said, because 69 00:05:23,920 --> 00:05:27,200 Speaker 1: of the way viruses infections move, we don't yet have 70 00:05:27,279 --> 00:05:30,920 Speaker 1: definitive proof that it works. There haven't been any clinical 71 00:05:30,960 --> 00:05:35,360 Speaker 1: trials that have been completed that show that convalescent plasma 72 00:05:35,520 --> 00:05:39,919 Speaker 1: actually does help you recover more quickly or lower mortality 73 00:05:40,440 --> 00:05:44,600 Speaker 1: from any type of infection. Again, there's great hope that 74 00:05:44,680 --> 00:05:47,960 Speaker 1: this does work, and we know that millions of people 75 00:05:48,080 --> 00:05:51,520 Speaker 1: get blood transfusions all the time. So it's considered very 76 00:05:51,600 --> 00:05:54,440 Speaker 1: very safe. Because it's safe, it doesn't have to be 77 00:05:54,520 --> 00:05:57,479 Speaker 1: all that beneficial in order to make a difference in 78 00:05:57,920 --> 00:06:01,120 Speaker 1: patients lives. Usually, when we're thinking about drugs, we have 79 00:06:01,200 --> 00:06:05,080 Speaker 1: safety versus efficacy. In this case, we know there's not 80 00:06:05,120 --> 00:06:07,560 Speaker 1: a safety risk. So even if it helps a little bit, 81 00:06:07,720 --> 00:06:10,960 Speaker 1: if you're not hurting anybody, why not go forward. The 82 00:06:11,000 --> 00:06:13,839 Speaker 1: bottom line is, though, we really want evidence, We really 83 00:06:13,839 --> 00:06:16,599 Speaker 1: want proof that this product is going to benefit people. 84 00:06:17,600 --> 00:06:21,960 Speaker 1: And what evidence is there that the use of convalescent 85 00:06:22,000 --> 00:06:26,440 Speaker 1: plasma works with regard to COVID nineteen, The Mayo Clinic 86 00:06:26,480 --> 00:06:30,000 Speaker 1: had a program that showed that people who received a 87 00:06:30,200 --> 00:06:34,160 Speaker 1: high dose of convalescent plasma were thirty five percent less 88 00:06:34,200 --> 00:06:37,000 Speaker 1: likely to die than those who received a lower dose 89 00:06:37,040 --> 00:06:40,920 Speaker 1: of that plasma, but everyone in the trial received plasma. 90 00:06:41,480 --> 00:06:43,839 Speaker 1: The way that it was talked about by the Trump 91 00:06:43,880 --> 00:06:48,880 Speaker 1: administration and f d A Commissioner Han was that convalescent 92 00:06:48,880 --> 00:06:54,600 Speaker 1: plasma itself reduced mortality by but because everybody did get 93 00:06:54,640 --> 00:06:58,000 Speaker 1: the convalescent plasma. It wasn't the plasma itself that was 94 00:06:58,040 --> 00:07:01,279 Speaker 1: making the difference. Likely it was the high dose antibodies 95 00:07:01,600 --> 00:07:04,400 Speaker 1: versus the low dose antibodies. But again, there wasn't a 96 00:07:04,400 --> 00:07:07,680 Speaker 1: clinical trial, so there are other things that could have 97 00:07:07,720 --> 00:07:11,240 Speaker 1: been playing a role, other variables like how sick the 98 00:07:11,280 --> 00:07:14,760 Speaker 1: patients were, how old the patients were, whether they got 99 00:07:14,800 --> 00:07:17,240 Speaker 1: it early in their infection or late in their infection. 100 00:07:17,800 --> 00:07:21,240 Speaker 1: So without those kind of controls, we really don't know 101 00:07:21,320 --> 00:07:24,080 Speaker 1: how effective it was at all. And when you look 102 00:07:24,120 --> 00:07:27,200 Speaker 1: at a thirty five percent reduction in mortality, that's a 103 00:07:27,240 --> 00:07:30,680 Speaker 1: relative risk reduction. When you look at the actual numbers 104 00:07:30,760 --> 00:07:33,120 Speaker 1: from the program that was done by the Mayo Clinic, 105 00:07:33,720 --> 00:07:35,920 Speaker 1: we saw that people who had a high dose of 106 00:07:35,920 --> 00:07:40,160 Speaker 1: antibodies were eight point nine percent likely to die. People 107 00:07:40,160 --> 00:07:43,320 Speaker 1: who had a lower dose or thirteen point seven percent 108 00:07:43,360 --> 00:07:46,600 Speaker 1: more likely to die. Now, while that is a thirty 109 00:07:46,600 --> 00:07:49,960 Speaker 1: five percent decrease in depths, it doesn't mean that half 110 00:07:49,960 --> 00:07:52,760 Speaker 1: of all the people didn't die. And it's those kind 111 00:07:52,760 --> 00:07:57,200 Speaker 1: of nuances around statistical analysis and math that most people 112 00:07:57,240 --> 00:08:00,760 Speaker 1: don't follow anyway, and so some of the details might 113 00:08:00,760 --> 00:08:04,960 Speaker 1: get lost in translation. We've recently seen an emergency Use 114 00:08:05,040 --> 00:08:09,520 Speaker 1: authorization issued with regard to convalescent plasma. Now, how does 115 00:08:09,560 --> 00:08:14,360 Speaker 1: this exactly speed up the process of medical facilities and 116 00:08:14,360 --> 00:08:19,680 Speaker 1: physicians acquiring and issuing this as a treatment for COVID nineteen? 117 00:08:20,320 --> 00:08:25,280 Speaker 1: An expanded use authorization is essentially like an approval in 118 00:08:25,360 --> 00:08:30,240 Speaker 1: that it allows hospitals and doctors to prescribe the therapy 119 00:08:30,320 --> 00:08:33,240 Speaker 1: and to use it unilaterally. They don't have to enroll 120 00:08:33,320 --> 00:08:35,880 Speaker 1: their patients in a clinical trial, they don't have to 121 00:08:35,920 --> 00:08:39,680 Speaker 1: track their outcomes. They don't have to report any kind 122 00:08:39,760 --> 00:08:44,120 Speaker 1: of an improvement or deceleration in their response to the therapy. 123 00:08:44,160 --> 00:08:45,920 Speaker 1: They will have to tell the f d A if 124 00:08:45,920 --> 00:08:49,440 Speaker 1: there's been any terrible side effects with it, but that's 125 00:08:49,480 --> 00:08:52,240 Speaker 1: a generally pretty high bar. That's when you've had a 126 00:08:52,280 --> 00:08:55,520 Speaker 1: serious adverse event. But these patients who are going to 127 00:08:55,559 --> 00:08:59,880 Speaker 1: be getting plasma under the emergency Use authorization will get 128 00:08:59,880 --> 00:09:03,280 Speaker 1: it just like people get any approved medicine. So how 129 00:09:03,320 --> 00:09:06,520 Speaker 1: they ultimately do isn't going to be tracked by anyone, 130 00:09:07,000 --> 00:09:09,760 Speaker 1: So we won't really know if they are better off 131 00:09:09,840 --> 00:09:13,440 Speaker 1: than if they had just gotten standard of care. And 132 00:09:13,480 --> 00:09:19,280 Speaker 1: will the emergency use authorization affected all the acquisition or say, 133 00:09:19,320 --> 00:09:23,600 Speaker 1: the distribution of this convalescent plasma. It can be really 134 00:09:23,640 --> 00:09:27,480 Speaker 1: tricky to get convalescent plasma. This isn't a product that's 135 00:09:27,520 --> 00:09:30,679 Speaker 1: being made in a laboratory. You literally have to take 136 00:09:30,720 --> 00:09:33,280 Speaker 1: it out of people's bodies, and there are a number 137 00:09:33,280 --> 00:09:36,400 Speaker 1: of companies out there who do that. You've probably seen 138 00:09:36,440 --> 00:09:39,439 Speaker 1: them on the side of the road in small little buildings, 139 00:09:39,520 --> 00:09:43,280 Speaker 1: Biolife other places like that. Also, the American Red Cross 140 00:09:43,760 --> 00:09:47,120 Speaker 1: and hospitals have set up their own plasma donation centers. 141 00:09:47,200 --> 00:09:53,080 Speaker 1: So getting access to the plasma requires people to be 142 00:09:53,120 --> 00:09:56,199 Speaker 1: willing to donate after they've already gone through an infection, 143 00:09:56,520 --> 00:09:58,800 Speaker 1: So you have to know you've been infected, you have 144 00:09:58,880 --> 00:10:00,960 Speaker 1: to be willing to donate, and you have to have 145 00:10:01,000 --> 00:10:04,360 Speaker 1: a place to go to do the donation. But there's 146 00:10:04,440 --> 00:10:07,400 Speaker 1: already a lot of demand for blood products in general, 147 00:10:07,480 --> 00:10:10,800 Speaker 1: and donations have gone down, so the entire industry is 148 00:10:10,840 --> 00:10:15,680 Speaker 1: actually already under pressure. Exactly how this emergency Use authorization 149 00:10:15,760 --> 00:10:19,520 Speaker 1: is going to impact the industry isn't entirely clear. The 150 00:10:19,600 --> 00:10:22,360 Speaker 1: hope is that it will make it easier for these 151 00:10:22,440 --> 00:10:26,520 Speaker 1: organizations to gather the plasma and to distribute it widely 152 00:10:26,559 --> 00:10:31,240 Speaker 1: across the country where it's needed. Is it likely that 153 00:10:31,280 --> 00:10:35,240 Speaker 1: we are going to see more uses of the emergency 154 00:10:35,320 --> 00:10:39,400 Speaker 1: use authorization in the future, for potentially, say the development 155 00:10:39,440 --> 00:10:45,240 Speaker 1: of a COVID nineteen vaccine. Emergency use authorizations get products 156 00:10:45,240 --> 00:10:49,760 Speaker 1: to patients markedly faster than any other kind of approach 157 00:10:50,240 --> 00:10:55,400 Speaker 1: used by regulators. It's a critical tool during the pandemic 158 00:10:55,880 --> 00:10:58,040 Speaker 1: because we don't really have time in a lot of 159 00:10:58,040 --> 00:11:01,120 Speaker 1: cases to make sure we're dotting every eye and crossing 160 00:11:01,120 --> 00:11:04,480 Speaker 1: every t so the standard is lower. It's just they 161 00:11:04,480 --> 00:11:06,640 Speaker 1: want to make sure that it's safe and that it 162 00:11:06,679 --> 00:11:09,560 Speaker 1: has some suggestion that there might be a benefit. But 163 00:11:09,679 --> 00:11:12,800 Speaker 1: there is a broader issue here that is concerning a 164 00:11:12,840 --> 00:11:16,160 Speaker 1: lot of people in the industry and in science and 165 00:11:16,200 --> 00:11:19,840 Speaker 1: medicine in general. So the concern is that politics is 166 00:11:20,040 --> 00:11:26,280 Speaker 1: entering into play here. Certainly, everyone is anxious, beyond measure 167 00:11:26,679 --> 00:11:31,040 Speaker 1: to get new treatments and vaccines and testing tools out 168 00:11:31,320 --> 00:11:33,480 Speaker 1: to the people, to the doctor so that we can 169 00:11:33,520 --> 00:11:37,960 Speaker 1: get coronavirus under control. There are a lot of uncertainties ahead, 170 00:11:38,480 --> 00:11:41,680 Speaker 1: and when we talk about something like a vaccine which 171 00:11:41,720 --> 00:11:44,960 Speaker 1: will be given to people who are entirely healthy in 172 00:11:45,040 --> 00:11:48,040 Speaker 1: hopes of averting an infection that they might not ever 173 00:11:48,160 --> 00:11:52,280 Speaker 1: have anyway, the idea of giving something that is not 174 00:11:52,880 --> 00:11:56,679 Speaker 1: truly vetted and truly safe is worrisome to a lot 175 00:11:56,679 --> 00:11:59,640 Speaker 1: of people. And so the idea that maybe we're losing 176 00:11:59,679 --> 00:12:02,720 Speaker 1: some of our confidence and some of our belief in 177 00:12:02,720 --> 00:12:05,960 Speaker 1: our public health officials because they are racing to get 178 00:12:06,040 --> 00:12:10,360 Speaker 1: new products two people quicker, so that perhaps they might 179 00:12:10,400 --> 00:12:16,120 Speaker 1: be cutting some corners raises critical problems. Obviously, with the 180 00:12:16,120 --> 00:12:19,400 Speaker 1: election coming up over the next couple of months, there 181 00:12:19,480 --> 00:12:22,760 Speaker 1: has been perhaps an even increased pressure for the Trump 182 00:12:22,760 --> 00:12:27,440 Speaker 1: administration to have a vaccine ready by that time. Is 183 00:12:27,480 --> 00:12:31,760 Speaker 1: there an option or have we seen any likelihood that 184 00:12:31,840 --> 00:12:35,319 Speaker 1: there may be a similar emergency use authorization or emergency 185 00:12:35,440 --> 00:12:41,120 Speaker 1: order for a fast tract vaccine before November. There's almost 186 00:12:41,160 --> 00:12:44,720 Speaker 1: no question that the first vaccines that become available for 187 00:12:44,760 --> 00:12:49,199 Speaker 1: coronavirus will be made available through an emergency use authorization. 188 00:12:49,320 --> 00:12:53,200 Speaker 1: Everyone expects that. Whether it's possible for that to happen 189 00:12:53,320 --> 00:12:57,160 Speaker 1: before the election is still an open question. Almost all 190 00:12:57,200 --> 00:12:59,760 Speaker 1: of the data we have so far suggests that the 191 00:13:00,040 --> 00:13:03,000 Speaker 1: uncle trials will not be completed. Going back to the 192 00:13:03,040 --> 00:13:06,000 Speaker 1: criteria of what regulators are going to act on when 193 00:13:06,040 --> 00:13:08,360 Speaker 1: it comes to something like that. They don't have to 194 00:13:08,440 --> 00:13:11,800 Speaker 1: have fully definitive proof, but they do need to have 195 00:13:11,880 --> 00:13:14,839 Speaker 1: some guarantee that at least it's safe, and then a 196 00:13:14,920 --> 00:13:18,000 Speaker 1: show's signs of promise. It is possible that there could 197 00:13:18,000 --> 00:13:21,880 Speaker 1: be action before the election, but whether or not people 198 00:13:21,880 --> 00:13:25,280 Speaker 1: are going to trust those findings and ultimately embrace the 199 00:13:25,360 --> 00:13:30,600 Speaker 1: vaccine isn't known, and that's critically important for controlling coronavirus. 200 00:13:30,880 --> 00:13:33,600 Speaker 1: If a vaccine works or it doesn't work, If people 201 00:13:33,600 --> 00:13:39,920 Speaker 1: don't get it, it doesn't even matter. That was Michelle 202 00:13:39,920 --> 00:13:43,240 Speaker 1: Fake Quartets, and that's it for our show today. For 203 00:13:43,360 --> 00:13:46,520 Speaker 1: coverage of the outbreak from one twenty bears around the world, 204 00:13:46,880 --> 00:13:51,480 Speaker 1: visit Bloomberg dot com slash coronavirus and if you like 205 00:13:51,559 --> 00:13:54,480 Speaker 1: the show, please leave us a review and a radar 206 00:13:54,920 --> 00:13:58,520 Speaker 1: on Apple Podcasts or Spotify. It's the best way to 207 00:13:58,559 --> 00:14:03,480 Speaker 1: help more listeners fall our global reporting, The Prognosis Daily 208 00:14:03,600 --> 00:14:08,880 Speaker 1: edition is produced by Topher Foreheads, Jordan Gaspure, Magnus Hendrickson 209 00:14:09,080 --> 00:14:13,520 Speaker 1: and me Laura Carlson. Today's main story was reported by 210 00:14:13,520 --> 00:14:18,920 Speaker 1: Michelle Fake Cortez. Original music by Leo Sidran. Our editors 211 00:14:18,960 --> 00:14:23,800 Speaker 1: are Rick Shine and Francesca Levi. Francesco Levi is Bloomberg's 212 00:14:23,840 --> 00:14:26,360 Speaker 1: head of podcasts. Thanks for listening.