WEBVTT - What Do We Really Know About Plasma? 0:00:01.720 --> 0:00:06.760 Welcome the prognosis. I'm Laura Carlson. It's day one and 0:00:06.840 --> 0:00:12.400 sixty six since coronavirus was declared a global pandemic. Today's 0:00:12.400 --> 0:00:17.200 main story using the blood plasma of recovered COVID patients 0:00:17.440 --> 0:00:21.760 to treat very sick ones. It's a promising experimental tool 0:00:22.160 --> 0:00:25.439 in the fight against the disease. But what should we 0:00:25.520 --> 0:00:28.640 make of today's decision by the White House to expand 0:00:28.800 --> 0:00:34.159 access to the treatment even before researchers fully understand it. 0:00:34.760 --> 0:00:43.200 But first, here's what happened in virus news today. After 0:00:43.240 --> 0:00:48.440 suffering one of Europe's earliest and fiercest outbreaks, Italy emerged 0:00:48.720 --> 0:00:52.560 as an unlikely role model for its handling of the pandemic. 0:00:53.840 --> 0:00:58.320 The country managed to reduce infections and fatalities dramatically in 0:00:58.440 --> 0:01:03.440 June and July after two months of strict lockdown, but 0:01:03.520 --> 0:01:07.360 as cases flare in Europe, Italy's success may now be 0:01:07.480 --> 0:01:13.240 in jeopardy. On Saturday, Italy recorded the most new cases 0:01:13.640 --> 0:01:18.720 since mid May. The intensity and duration of Italy's lockdown 0:01:18.840 --> 0:01:22.560 is widely seen as one of the reasons why cases 0:01:22.640 --> 0:01:27.560 continue to fall. After curbs started to be gradually lifted 0:01:27.760 --> 0:01:32.600 in early May, restrictions were maintained for a full six 0:01:32.720 --> 0:01:38.319 weeks after new infections peaked, and schools never reopened. Unlike 0:01:38.360 --> 0:01:44.360 in France or Germany, Hong Kong has confirmed the first 0:01:44.600 --> 0:01:49.720 known case of a coronavirus reinfection. A man was infected 0:01:49.720 --> 0:01:53.680 with the virus this month after recovering from an initial 0:01:53.720 --> 0:01:58.880 bout in April. Scientists say they found the second infection 0:01:58.960 --> 0:02:01.680 in the thirty three or old who had no symptoms 0:02:02.080 --> 0:02:05.600 when he was screened at an airport after returning from Europe. 0:02:07.400 --> 0:02:10.760 Researchers at the University of Hong Kong say they know 0:02:11.240 --> 0:02:15.680 it is a reinfection because they used genomic sequence analysis 0:02:15.720 --> 0:02:20.360 to prove that he had been reinfected by two different strains. 0:02:21.560 --> 0:02:25.120 The findings suggests there may not be long lasting immunity 0:02:25.160 --> 0:02:29.960 from the virus in those who recover. The South Korean 0:02:29.960 --> 0:02:34.160 government is deciding whether to raise social distancing restrictions to 0:02:34.280 --> 0:02:38.320 the highest level, as officials warn the country is at 0:02:38.320 --> 0:02:44.679 the risk of a quote massive nationwide outbreak. An additional 0:02:44.720 --> 0:02:47.959 three d and ninety seven new virus cases were reported 0:02:48.040 --> 0:02:54.040 on Sunday, the highest number since March seven. Jung Un Kyung, 0:02:54.480 --> 0:02:57.520 head of Korea's Centers for Disease Control and Preventions set 0:02:57.600 --> 0:03:00.880 at a briefing on Sunday that case is are rising 0:03:00.960 --> 0:03:12.760 in seventeen cities and provinces across the nation. And now 0:03:13.000 --> 0:03:18.280 for today's main story, President Donald Trump expanded access to 0:03:18.320 --> 0:03:23.600 a coronavirus treatment that involves blood plasma donated by people 0:03:23.639 --> 0:03:29.200 who have recovered from COVID nineteen. But while convalescent plasma 0:03:29.320 --> 0:03:34.080 as it's known, is a promising therapy, researchers don't yet 0:03:34.120 --> 0:03:38.880 fully understand how well it works. I spoke with Bloomberg's 0:03:38.880 --> 0:03:43.280 Michelle fake Cortez about what the announcement means and the 0:03:43.320 --> 0:03:47.440 concerns that agencies like the f d A are letting 0:03:47.480 --> 0:03:52.320 pressures from the White House rather than science guide their decisions. 0:03:54.840 --> 0:03:58.760 What is the promise of plasma as a treatment for 0:03:58.920 --> 0:04:04.480 COVID nineteen. Convalescent plasma is basically bringing in reinforcements to 0:04:04.560 --> 0:04:08.320 help someone who's newly infected with coronavirus fight it off. 0:04:08.640 --> 0:04:11.760 When you think about an infection, there is a pathogen 0:04:12.120 --> 0:04:15.240 that your body encounters and your immune system fights it 0:04:15.280 --> 0:04:20.080 off using antibodies. These antibodies remain in your blood and 0:04:20.160 --> 0:04:24.480 in your system for some extended period perhaps life long 0:04:24.960 --> 0:04:28.120 after you successfully fight off that infection. So think of 0:04:28.160 --> 0:04:32.760 these antibodies as your soldiers in your fight against the virus. 0:04:32.960 --> 0:04:39.000 What convalescent plasma does is it takes your blood, your antibodies, 0:04:39.120 --> 0:04:42.520 your fighters, and gives them to another person who's been 0:04:42.520 --> 0:04:45.640 newly infected, and it takes up the battle for them. 0:04:46.320 --> 0:04:49.600 So obviously there's all kinds of questions around it. What 0:04:49.720 --> 0:04:53.240 antibodies specifically do you need, Because the body makes a 0:04:53.240 --> 0:04:57.000 wide variety, at what point should you get the antibodies. 0:04:57.360 --> 0:04:59.640 If you've had the infection for a while, you've made 0:04:59.680 --> 0:05:02.719 your own antibodies, so maybe someone else's don't help, but 0:05:02.839 --> 0:05:06.719 perhaps early on in the infection they do. Has convalescent 0:05:06.760 --> 0:05:11.680 plasma been used before with other diseases. Convalescent plasma has 0:05:11.720 --> 0:05:14.440 been used for over a hundred years, and in fact, 0:05:14.520 --> 0:05:19.760 it won the first Nobel Prize for treatment of diphtheria. 0:05:19.920 --> 0:05:23.840 So it is a known quantity. That being said, because 0:05:23.920 --> 0:05:27.200 of the way viruses infections move, we don't yet have 0:05:27.279 --> 0:05:30.920 definitive proof that it works. There haven't been any clinical 0:05:30.960 --> 0:05:35.360 trials that have been completed that show that convalescent plasma 0:05:35.520 --> 0:05:39.919 actually does help you recover more quickly or lower mortality 0:05:40.440 --> 0:05:44.600 from any type of infection. Again, there's great hope that 0:05:44.680 --> 0:05:47.960 this does work, and we know that millions of people 0:05:48.080 --> 0:05:51.520 get blood transfusions all the time. So it's considered very 0:05:51.600 --> 0:05:54.440 very safe. Because it's safe, it doesn't have to be 0:05:54.520 --> 0:05:57.479 all that beneficial in order to make a difference in 0:05:57.920 --> 0:06:01.120 patients lives. Usually, when we're thinking about drugs, we have 0:06:01.200 --> 0:06:05.080 safety versus efficacy. In this case, we know there's not 0:06:05.120 --> 0:06:07.560 a safety risk. So even if it helps a little bit, 0:06:07.720 --> 0:06:10.960 if you're not hurting anybody, why not go forward. The 0:06:11.000 --> 0:06:13.839 bottom line is, though, we really want evidence, We really 0:06:13.839 --> 0:06:16.599 want proof that this product is going to benefit people. 0:06:17.600 --> 0:06:21.960 And what evidence is there that the use of convalescent 0:06:22.000 --> 0:06:26.440 plasma works with regard to COVID nineteen, The Mayo Clinic 0:06:26.480 --> 0:06:30.000 had a program that showed that people who received a 0:06:30.200 --> 0:06:34.160 high dose of convalescent plasma were thirty five percent less 0:06:34.200 --> 0:06:37.000 likely to die than those who received a lower dose 0:06:37.040 --> 0:06:40.920 of that plasma, but everyone in the trial received plasma. 0:06:41.480 --> 0:06:43.839 The way that it was talked about by the Trump 0:06:43.880 --> 0:06:48.880 administration and f d A Commissioner Han was that convalescent 0:06:48.880 --> 0:06:54.600 plasma itself reduced mortality by but because everybody did get 0:06:54.640 --> 0:06:58.000 the convalescent plasma. It wasn't the plasma itself that was 0:06:58.040 --> 0:07:01.279 making the difference. Likely it was the high dose antibodies 0:07:01.600 --> 0:07:04.400 versus the low dose antibodies. But again, there wasn't a 0:07:04.400 --> 0:07:07.680 clinical trial, so there are other things that could have 0:07:07.720 --> 0:07:11.240 been playing a role, other variables like how sick the 0:07:11.280 --> 0:07:14.760 patients were, how old the patients were, whether they got 0:07:14.800 --> 0:07:17.240 it early in their infection or late in their infection. 0:07:17.800 --> 0:07:21.240 So without those kind of controls, we really don't know 0:07:21.320 --> 0:07:24.080 how effective it was at all. And when you look 0:07:24.120 --> 0:07:27.200 at a thirty five percent reduction in mortality, that's a 0:07:27.240 --> 0:07:30.680 relative risk reduction. When you look at the actual numbers 0:07:30.760 --> 0:07:33.120 from the program that was done by the Mayo Clinic, 0:07:33.720 --> 0:07:35.920 we saw that people who had a high dose of 0:07:35.920 --> 0:07:40.160 antibodies were eight point nine percent likely to die. People 0:07:40.160 --> 0:07:43.320 who had a lower dose or thirteen point seven percent 0:07:43.360 --> 0:07:46.600 more likely to die. Now, while that is a thirty 0:07:46.600 --> 0:07:49.960 five percent decrease in depths, it doesn't mean that half 0:07:49.960 --> 0:07:52.760 of all the people didn't die. And it's those kind 0:07:52.760 --> 0:07:57.200 of nuances around statistical analysis and math that most people 0:07:57.240 --> 0:08:00.760 don't follow anyway, and so some of the details might 0:08:00.760 --> 0:08:04.960 get lost in translation. We've recently seen an emergency Use 0:08:05.040 --> 0:08:09.520 authorization issued with regard to convalescent plasma. Now, how does 0:08:09.560 --> 0:08:14.360 this exactly speed up the process of medical facilities and 0:08:14.360 --> 0:08:19.680 physicians acquiring and issuing this as a treatment for COVID nineteen? 0:08:20.320 --> 0:08:25.280 An expanded use authorization is essentially like an approval in 0:08:25.360 --> 0:08:30.240 that it allows hospitals and doctors to prescribe the therapy 0:08:30.320 --> 0:08:33.240 and to use it unilaterally. They don't have to enroll 0:08:33.320 --> 0:08:35.880 their patients in a clinical trial, they don't have to 0:08:35.920 --> 0:08:39.680 track their outcomes. They don't have to report any kind 0:08:39.760 --> 0:08:44.120 of an improvement or deceleration in their response to the therapy. 0:08:44.160 --> 0:08:45.920 They will have to tell the f d A if 0:08:45.920 --> 0:08:49.440 there's been any terrible side effects with it, but that's 0:08:49.480 --> 0:08:52.240 a generally pretty high bar. That's when you've had a 0:08:52.280 --> 0:08:55.520 serious adverse event. But these patients who are going to 0:08:55.559 --> 0:08:59.880 be getting plasma under the emergency Use authorization will get 0:08:59.880 --> 0:09:03.280 it just like people get any approved medicine. So how 0:09:03.320 --> 0:09:06.520 they ultimately do isn't going to be tracked by anyone, 0:09:07.000 --> 0:09:09.760 So we won't really know if they are better off 0:09:09.840 --> 0:09:13.440 than if they had just gotten standard of care. And 0:09:13.480 --> 0:09:19.280 will the emergency use authorization affected all the acquisition or say, 0:09:19.320 --> 0:09:23.600 the distribution of this convalescent plasma. It can be really 0:09:23.640 --> 0:09:27.480 tricky to get convalescent plasma. This isn't a product that's 0:09:27.520 --> 0:09:30.679 being made in a laboratory. You literally have to take 0:09:30.720 --> 0:09:33.280 it out of people's bodies, and there are a number 0:09:33.280 --> 0:09:36.400 of companies out there who do that. You've probably seen 0:09:36.440 --> 0:09:39.439 them on the side of the road in small little buildings, 0:09:39.520 --> 0:09:43.280 Biolife other places like that. Also, the American Red Cross 0:09:43.760 --> 0:09:47.120 and hospitals have set up their own plasma donation centers. 0:09:47.200 --> 0:09:53.080 So getting access to the plasma requires people to be 0:09:53.120 --> 0:09:56.199 willing to donate after they've already gone through an infection, 0:09:56.520 --> 0:09:58.800 So you have to know you've been infected, you have 0:09:58.880 --> 0:10:00.960 to be willing to donate, and you have to have 0:10:01.000 --> 0:10:04.360 a place to go to do the donation. But there's 0:10:04.440 --> 0:10:07.400 already a lot of demand for blood products in general, 0:10:07.480 --> 0:10:10.800 and donations have gone down, so the entire industry is 0:10:10.840 --> 0:10:15.680 actually already under pressure. Exactly how this emergency Use authorization 0:10:15.760 --> 0:10:19.520 is going to impact the industry isn't entirely clear. The 0:10:19.600 --> 0:10:22.360 hope is that it will make it easier for these 0:10:22.440 --> 0:10:26.520 organizations to gather the plasma and to distribute it widely 0:10:26.559 --> 0:10:31.240 across the country where it's needed. Is it likely that 0:10:31.280 --> 0:10:35.240 we are going to see more uses of the emergency 0:10:35.320 --> 0:10:39.400 use authorization in the future, for potentially, say the development 0:10:39.440 --> 0:10:45.240 of a COVID nineteen vaccine. Emergency use authorizations get products 0:10:45.240 --> 0:10:49.760 to patients markedly faster than any other kind of approach 0:10:50.240 --> 0:10:55.400 used by regulators. It's a critical tool during the pandemic 0:10:55.880 --> 0:10:58.040 because we don't really have time in a lot of 0:10:58.040 --> 0:11:01.120 cases to make sure we're dotting every eye and crossing 0:11:01.120 --> 0:11:04.480 every t so the standard is lower. It's just they 0:11:04.480 --> 0:11:06.640 want to make sure that it's safe and that it 0:11:06.679 --> 0:11:09.560 has some suggestion that there might be a benefit. But 0:11:09.679 --> 0:11:12.800 there is a broader issue here that is concerning a 0:11:12.840 --> 0:11:16.160 lot of people in the industry and in science and 0:11:16.200 --> 0:11:19.840 medicine in general. So the concern is that politics is 0:11:20.040 --> 0:11:26.280 entering into play here. Certainly, everyone is anxious, beyond measure 0:11:26.679 --> 0:11:31.040 to get new treatments and vaccines and testing tools out 0:11:31.320 --> 0:11:33.480 to the people, to the doctor so that we can 0:11:33.520 --> 0:11:37.960 get coronavirus under control. There are a lot of uncertainties ahead, 0:11:38.480 --> 0:11:41.680 and when we talk about something like a vaccine which 0:11:41.720 --> 0:11:44.960 will be given to people who are entirely healthy in 0:11:45.040 --> 0:11:48.040 hopes of averting an infection that they might not ever 0:11:48.160 --> 0:11:52.280 have anyway, the idea of giving something that is not 0:11:52.880 --> 0:11:56.679 truly vetted and truly safe is worrisome to a lot 0:11:56.679 --> 0:11:59.640 of people. And so the idea that maybe we're losing 0:11:59.679 --> 0:12:02.720 some of our confidence and some of our belief in 0:12:02.720 --> 0:12:05.960 our public health officials because they are racing to get 0:12:06.040 --> 0:12:10.360 new products two people quicker, so that perhaps they might 0:12:10.400 --> 0:12:16.120 be cutting some corners raises critical problems. Obviously, with the 0:12:16.120 --> 0:12:19.400 election coming up over the next couple of months, there 0:12:19.480 --> 0:12:22.760 has been perhaps an even increased pressure for the Trump 0:12:22.760 --> 0:12:27.440 administration to have a vaccine ready by that time. Is 0:12:27.480 --> 0:12:31.760 there an option or have we seen any likelihood that 0:12:31.840 --> 0:12:35.319 there may be a similar emergency use authorization or emergency 0:12:35.440 --> 0:12:41.120 order for a fast tract vaccine before November. There's almost 0:12:41.160 --> 0:12:44.720 no question that the first vaccines that become available for 0:12:44.760 --> 0:12:49.199 coronavirus will be made available through an emergency use authorization. 0:12:49.320 --> 0:12:53.200 Everyone expects that. Whether it's possible for that to happen 0:12:53.320 --> 0:12:57.160 before the election is still an open question. Almost all 0:12:57.200 --> 0:12:59.760 of the data we have so far suggests that the 0:13:00.040 --> 0:13:03.000 uncle trials will not be completed. Going back to the 0:13:03.040 --> 0:13:06.000 criteria of what regulators are going to act on when 0:13:06.040 --> 0:13:08.360 it comes to something like that. They don't have to 0:13:08.440 --> 0:13:11.800 have fully definitive proof, but they do need to have 0:13:11.880 --> 0:13:14.839 some guarantee that at least it's safe, and then a 0:13:14.920 --> 0:13:18.000 show's signs of promise. It is possible that there could 0:13:18.000 --> 0:13:21.880 be action before the election, but whether or not people 0:13:21.880 --> 0:13:25.280 are going to trust those findings and ultimately embrace the 0:13:25.360 --> 0:13:30.600 vaccine isn't known, and that's critically important for controlling coronavirus. 0:13:30.880 --> 0:13:33.600 If a vaccine works or it doesn't work, If people 0:13:33.600 --> 0:13:39.920 don't get it, it doesn't even matter. That was Michelle 0:13:39.920 --> 0:13:43.240 Fake Quartets, and that's it for our show today. For 0:13:43.360 --> 0:13:46.520 coverage of the outbreak from one twenty bears around the world, 0:13:46.880 --> 0:13:51.480 visit Bloomberg dot com slash coronavirus and if you like 0:13:51.559 --> 0:13:54.480 the show, please leave us a review and a radar 0:13:54.920 --> 0:13:58.520 on Apple Podcasts or Spotify. It's the best way to 0:13:58.559 --> 0:14:03.480 help more listeners fall our global reporting, The Prognosis Daily 0:14:03.600 --> 0:14:08.880 edition is produced by Topher Foreheads, Jordan Gaspure, Magnus Hendrickson 0:14:09.080 --> 0:14:13.520 and me Laura Carlson. Today's main story was reported by 0:14:13.520 --> 0:14:18.920 Michelle Fake Cortez. Original music by Leo Sidran. Our editors 0:14:18.960 --> 0:14:23.800 are Rick Shine and Francesca Levi. Francesco Levi is Bloomberg's 0:14:23.840 --> 0:14:26.360 head of podcasts. Thanks for listening.