WEBVTT - What We Can't Know About a Vaccine 0:00:03.880 --> 0:00:08.680 Welcome to Prognosis. I'm Laura Carlson. It's day two d 0:00:08.880 --> 0:00:13.960 and one since coronavirus was declared a global pandemic. Today's 0:00:14.000 --> 0:00:19.400 main story headlines about new vaccine candidates drop nearly every day, 0:00:20.400 --> 0:00:25.200 But because the development process is moving at superspeed, there's 0:00:25.320 --> 0:00:28.280 a lot we just can't know about the new crop 0:00:28.600 --> 0:00:34.680 of potential inoculations. But first, here's what happened in virus 0:00:34.720 --> 0:00:48.040 news today. German Chancellor Angela Merkel is warning that the 0:00:48.080 --> 0:00:52.960 country may see a coronavirus surge by Christmas. Merkel said 0:00:53.000 --> 0:00:57.360 today that Germany will face more than nineteen thousand new 0:00:57.440 --> 0:01:01.280 COVID nineteen cases a day by the end of December 0:01:01.680 --> 0:01:05.760 if the current trend in infections isn't halted. The country 0:01:05.800 --> 0:01:10.720 recorded about eleven thousand cases last week. Merkel told leaders 0:01:10.720 --> 0:01:13.920 of her party that the country must act quickly to 0:01:14.000 --> 0:01:17.959 avoid the same rapid rise in cases as neighboring countries 0:01:18.200 --> 0:01:21.440 such as France, which has been reporting an average of 0:01:21.480 --> 0:01:26.600 about twelve thousand cases each day. Moscow has started to 0:01:26.640 --> 0:01:31.440 reopen temporary hospital wards after daily coronavirus infections in the 0:01:31.520 --> 0:01:35.840 Russian capital Sword. The capital is the epicenter of the 0:01:35.959 --> 0:01:40.520 virus in Russia. City Hall ordered eight Moscow hospitals to 0:01:40.600 --> 0:01:44.080 re equip themselves to handle patients by early next week. 0:01:44.520 --> 0:01:49.720 According to the inter Facts news service, Moscow began demobilizing 0:01:49.760 --> 0:01:55.560 its temporary wards in late May. Finally, Hong Kong's latest 0:01:55.600 --> 0:02:00.160 coronavirus wave is showing signs of subsiding after months of 0:02:00.240 --> 0:02:05.320 social distancing measures. The country posted single digit increases in 0:02:05.400 --> 0:02:09.680 cases for seven of the last eight days. That has 0:02:09.720 --> 0:02:13.960 pushed the rolling seven day average daily infection rate down 0:02:14.000 --> 0:02:17.959 to about five the lowest since the end of June. 0:02:24.480 --> 0:02:28.880 And now for today's main story, the race for a 0:02:28.919 --> 0:02:33.720 COVID nineteen vaccine entered a new phase. Recently, four different 0:02:33.800 --> 0:02:38.280 vaccine candidates developed by Moderna, Fiser, bio ent Tech, and 0:02:38.360 --> 0:02:42.919 Johnson and Johnson entered final stage trials, with two others 0:02:42.919 --> 0:02:47.040 close behind. But we won't know exactly how these four 0:02:47.160 --> 0:02:52.000 vaccines work for months. I spoke to reporter Robert Langrath 0:02:52.320 --> 0:02:56.360 about what we can and more importantly, what we can't 0:02:56.440 --> 0:03:09.600 know about a vaccine developed at breakneckt speed give us 0:03:09.639 --> 0:03:13.519 a broad overview of some of the major differences among 0:03:13.680 --> 0:03:16.560 the front runners right now in the race to develop 0:03:16.600 --> 0:03:19.800 a COVID nineteen vaccine. Yeah, so there are a variety 0:03:19.840 --> 0:03:22.359 of different vaccines that are now in the final state 0:03:22.480 --> 0:03:26.120 trials in the United States for COVID nineteen. Two of 0:03:26.120 --> 0:03:29.960 the vaccine front runners are so called a messenger RNA vaccines. 0:03:30.040 --> 0:03:32.440 And those two vaccines that use that very new technology 0:03:32.480 --> 0:03:37.160 messenger RNA are the ones from maderna US biotech company 0:03:37.280 --> 0:03:40.040 and from the big drug giant Fightser, and they are 0:03:40.080 --> 0:03:45.320 both very far along and testing and could have results 0:03:45.440 --> 0:03:49.240 early results from a phase three trial trials plural in 0:03:49.480 --> 0:03:53.480 a month or so. They're both two shot vaccines. Most 0:03:53.480 --> 0:03:56.680 of the first vaccines are two shot vaccines, meaning you'll 0:03:56.720 --> 0:03:59.160 get you'll need to take two shots of the vaccine 0:03:59.160 --> 0:04:02.120 spread out over three or four weeks in order to 0:04:02.160 --> 0:04:07.120 potentially have some protection from the virus. And then the 0:04:07.200 --> 0:04:10.880 third vaccine that's in final stage trial now in the 0:04:11.000 --> 0:04:14.280 US is a vaccine that's based on a cold virus 0:04:14.360 --> 0:04:19.200 called adnovirus that is from astro Zenica and University of Oxford, 0:04:19.240 --> 0:04:23.080 and that that cold virus based vaccine. It's based on 0:04:23.080 --> 0:04:25.800 a monkey cold virus that basically can't replicate in the 0:04:25.839 --> 0:04:29.240 body but helps bring in the coronavirus spike protein in 0:04:29.680 --> 0:04:32.359 and in the fourth vaccine in final stage trials in 0:04:32.400 --> 0:04:37.320 the US that is also based on adnovirus, a type 0:04:37.320 --> 0:04:39.920 of common cold virus. And again, UH, this is one 0:04:39.960 --> 0:04:42.560 that's been altered so it cannot replicate in the body. 0:04:42.800 --> 0:04:44.920 And that's the J and J vaccine, and that just 0:04:45.120 --> 0:04:49.000 began final stage trial in the United States and other 0:04:49.040 --> 0:04:52.440 countries on sixty people. And the big difference with this 0:04:52.560 --> 0:04:55.320 vaccine is that J and J says and may be 0:04:55.480 --> 0:04:57.840 able to have efficacy with just one shot. So this 0:04:57.880 --> 0:05:00.799 is gonna be the first attempt at a single vaccine 0:05:01.240 --> 0:05:03.880 UH in the United States. And the advantages of a 0:05:03.920 --> 0:05:08.040 single shot vaccine is of course just practical distribution and 0:05:08.320 --> 0:05:14.039 immunization mass immunization advantages. Okay, So among these four front runners, 0:05:14.120 --> 0:05:18.479 obviously everyone is keen for the same goal that their 0:05:18.600 --> 0:05:22.480 vaccine is effective. But in terms of the trials that 0:05:22.520 --> 0:05:26.679 are going on right now, how exactly does one prove 0:05:27.320 --> 0:05:32.080 that a vaccine is effective. So all these trials are 0:05:32.160 --> 0:05:37.000 a placebo controlled trials where a participants healthy volunteers in 0:05:37.040 --> 0:05:41.000 the trials are randomly assigned to either get the vaccine 0:05:41.360 --> 0:05:45.720 or a placebo shot, and then they're basically followed after 0:05:45.760 --> 0:05:49.520 they get their shots for weeks and months to see 0:05:49.600 --> 0:05:53.800 how many patients that got the real vaccine got the 0:05:53.839 --> 0:05:57.039 coronavirus COVID nineteen versus how many patients they got the 0:05:57.040 --> 0:06:01.080 bacebo vaccine at the coronavir IRUs. And the hope is 0:06:01.600 --> 0:06:06.080 UH that these vaccines will reduce the incidents of symptomatic 0:06:06.120 --> 0:06:08.720 COVID nineteen by at least half. That's the hope. That's 0:06:08.720 --> 0:06:10.320 the goal of the trials are hoping to do more 0:06:10.360 --> 0:06:11.880 than half, but the kind of half is sort of 0:06:11.880 --> 0:06:15.440 the minimum, the bare minimum that the Food and Recondministration 0:06:15.480 --> 0:06:18.440 has said it would accept. There's some controversy over whether 0:06:19.200 --> 0:06:21.600 the trials, in a rush to get results, in a 0:06:21.680 --> 0:06:24.720 race to get sooner, are including UH and counting in 0:06:24.760 --> 0:06:28.040 the trials, you know, patients with you know, relatively mild 0:06:28.120 --> 0:06:30.480 or moderate cases and not focusing enough on the more 0:06:30.520 --> 0:06:32.839 severe cases and the kinds we all want to prevent, 0:06:32.880 --> 0:06:37.680 the hospitalizations and I see you visits and the deaths UH, 0:06:37.720 --> 0:06:39.919 and that kind of data will take much longer to collect. 0:06:40.200 --> 0:06:43.720 But what they may get early on in the trials, 0:06:43.720 --> 0:06:45.320 they may get a sense of, you know, how it 0:06:45.360 --> 0:06:49.640 prevents UH somewhat milder cases and mild moderate cases and 0:06:49.720 --> 0:06:52.000 may not know as much about what it does in 0:06:52.160 --> 0:06:55.279 terms of preventing hospitalizations or I SeeU visits, because those, 0:06:55.320 --> 0:06:57.880 of course are very severe events we want to prevent, 0:06:57.880 --> 0:07:01.839 but they're much rarer. And how about how these studies 0:07:01.839 --> 0:07:05.920 can account for, say, diverse populations that a vaccine will 0:07:05.920 --> 0:07:09.600 be effective, and say the elderly or communities of color, 0:07:09.680 --> 0:07:13.760 how is that taken into account. Maderna actually slowed down 0:07:13.760 --> 0:07:16.520 one of the company's Maderna actually said it slowed down 0:07:16.720 --> 0:07:19.440 enrollment of its trials a little bit in order to 0:07:19.480 --> 0:07:23.080 make sure, you know, increased minority representation. I made an 0:07:23.080 --> 0:07:25.600 effort to do that now. Of course, another issue is 0:07:25.640 --> 0:07:27.840 that the coronavirus, as everyone knows now, is you know, 0:07:27.880 --> 0:07:29.920 most severe in the elderly, and that's where you know, 0:07:30.000 --> 0:07:32.400 most of the deaths are occurring. Is what I don't 0:07:32.400 --> 0:07:34.640 think anyone wants is a vaccine that does a great 0:07:34.680 --> 0:07:37.800 job offending mild cases and young people, but you still 0:07:37.840 --> 0:07:39.840 have the deaths and elderly people. That's, you know, a 0:07:39.960 --> 0:07:42.800 nightmare scenario. I don't think anyone wants. So they're trying 0:07:42.800 --> 0:07:46.120 to enroll those people, and we don't just won't know 0:07:46.240 --> 0:07:48.560 yet when the early results come out, you know, how 0:07:48.680 --> 0:07:52.119 much we'll have in terms of detailed results in older people, 0:07:52.200 --> 0:07:54.680 we may you know, not have all that information because 0:07:54.760 --> 0:07:57.320 if the trials, you know, are stocked based on kind 0:07:57.320 --> 0:08:00.200 of early results and symptomatic cases in the large your 0:08:00.240 --> 0:08:02.720 population the trial, it may not have those kind of 0:08:02.800 --> 0:08:07.280 all important subsets to how well does the vaccine do 0:08:07.400 --> 0:08:12.560 an elderly population. Let's talk about accountability. You mentioned the 0:08:12.640 --> 0:08:15.680 requirements of the FDA has put out. What kind of 0:08:15.800 --> 0:08:19.360 data do these drug makers have to provide to say 0:08:19.440 --> 0:08:22.400 that their vaccine is reliable and safe and ready to 0:08:22.440 --> 0:08:25.000 be used. Yeah, well, they certainly have to provide a 0:08:25.120 --> 0:08:27.880 data to the FDA, and there's sort of there's sort 0:08:27.880 --> 0:08:32.040 of a basic minimum requirement that the vaccines be at 0:08:32.120 --> 0:08:36.560 least you know, effective and preventing symptomatic COVID. But how 0:08:36.559 --> 0:08:38.840 do you define the symptoms and how mild a case 0:08:38.920 --> 0:08:41.000 do you kind of include for a point of counting. 0:08:41.640 --> 0:08:44.199 The FISER trials is I would say the most controversial 0:08:44.240 --> 0:08:48.400 among researchers because it includes for the purposes of counting 0:08:48.400 --> 0:08:53.080 coronavirus cases for its primary goal cases and with patients 0:08:53.120 --> 0:08:56.120 have a positive test and just one symptom, so that 0:08:56.200 --> 0:08:58.240 could include you know, a lot of my potentially a 0:08:58.280 --> 0:09:01.080 lot of milder cases, and they could declare a success 0:09:01.160 --> 0:09:04.439 based on that. And then some top researchers are worried 0:09:04.480 --> 0:09:07.280 they might declare success based on you know, mostly milder 0:09:07.360 --> 0:09:10.080 moderate cases and not have many cases that are severe, 0:09:10.120 --> 0:09:11.959 and we won't know how well it works in the 0:09:12.000 --> 0:09:15.040 all important severe cases. So there's a great worry about that. 0:09:15.840 --> 0:09:19.240 But one of the consultants we talked to estimated that 0:09:19.280 --> 0:09:22.000 neither FISER number DIRTA would be likely to have results 0:09:22.000 --> 0:09:25.600 in the more severe kind of hospitalization type cases. Really 0:09:25.640 --> 0:09:28.400 until February, they won't have you know, data, clear cut 0:09:28.480 --> 0:09:31.960 data on that. And it looks like other early results 0:09:32.000 --> 0:09:33.959 may come out as soon potentially as soon as the 0:09:34.040 --> 0:09:36.559 end of October for FISER and probably more like November 0:09:36.640 --> 0:09:39.240 sometime for MODERNA, So you know, it looks like there 0:09:39.240 --> 0:09:42.760 could be decision made on an emergency authorization of vaccine 0:09:42.800 --> 0:09:44.679 based on some of the kind of early results in 0:09:44.720 --> 0:09:47.360 the trial. And it's not really clear how much we're 0:09:47.400 --> 0:09:50.559 gonna know about whether the vaccine early on really prevents 0:09:50.600 --> 0:09:53.760 the severe cases severe complications. It's just it's really unclear 0:09:53.760 --> 0:09:57.120 at this point. So what are the risks of pushing 0:09:57.120 --> 0:10:00.920 through an experimental treatment too fast? Yeah. One one big 0:10:00.960 --> 0:10:04.120 issue with any vaccine UH as safety, right, because there's 0:10:04.160 --> 0:10:06.960 a big, big difference between a vaccine that might be 0:10:07.000 --> 0:10:10.560 given to millions of healthy people, including younger people who 0:10:10.720 --> 0:10:14.200 aren't at severe resee complications. So there's a big difference 0:10:14.200 --> 0:10:16.560 between a vaccine like that's given to very healthy people 0:10:16.880 --> 0:10:20.760 and a drug that's given to coronavirus patients already in 0:10:20.760 --> 0:10:24.840 the ICU. UH. And so in terms of side effects, UH, generally, 0:10:25.360 --> 0:10:28.040 you know, researchers want a lot a lot of data 0:10:28.440 --> 0:10:33.199 on safety. The question is, you know, how much is enough? Uh. 0:10:33.400 --> 0:10:37.240 These trials are large. You know, there are thirty thousand 0:10:37.320 --> 0:10:39.600 people or more, and so that means at least, say 0:10:39.640 --> 0:10:43.479 fifteen thousand people get the vaccine, fifteen thousands get the placebo. 0:10:43.679 --> 0:10:46.640 But in the past, vaccines have been felled, are even 0:10:46.679 --> 0:10:49.560 recalled for pretty rare side effects. These things can pop 0:10:49.679 --> 0:10:51.920 up and then you know, they may be you know, 0:10:52.000 --> 0:10:54.320 things that could occur, even severe events that could occur, 0:10:54.400 --> 0:10:57.079 even like one in ten thousand and so the researchers 0:10:57.120 --> 0:10:59.600 I talked to said that you know, based on a 0:10:59.640 --> 0:11:03.640 trial with thirty patients, we may know about things that 0:11:03.760 --> 0:11:06.559 happen you know, one in a few thousand, we may 0:11:06.600 --> 0:11:09.559 not know about you know, rarer events, a rarer adverse 0:11:09.600 --> 0:11:13.120 events that could happen because of vaccine, you know, until 0:11:13.679 --> 0:11:15.880 later on to more and more people start using it. 0:11:16.240 --> 0:11:18.280 Uh So, you know, safety is something that really needs 0:11:18.320 --> 0:11:21.880 to be looked at, you very carefully. And already there's 0:11:21.920 --> 0:11:25.480 has been this controversy with the Astrosennica vaccine over a 0:11:25.640 --> 0:11:30.600 possible neurologic adverse effects that we're seen in one patient 0:11:31.200 --> 0:11:35.160 in the UK that Assnica says in University Oxfors says 0:11:35.240 --> 0:11:37.320 aren't related to the vaccine. But that's led to the 0:11:37.320 --> 0:11:40.280 trial being on hold in the US while the US 0:11:40.320 --> 0:11:42.680 authorities trying to get more information about what happened in 0:11:42.679 --> 0:11:46.040 this case. What will we be able to know about 0:11:46.040 --> 0:11:50.360 how effective that vaccine is and perhaps more importantly, what 0:11:50.760 --> 0:11:54.400 won't we know? These trials are basically essentially going to show, 0:11:54.440 --> 0:11:58.840 you know, short term efficacy, because that's that's all we're 0:11:58.880 --> 0:12:01.160 gonna have. We're not going to have much information on 0:12:01.480 --> 0:12:03.600 how long does the protection last, and of course that's 0:12:03.600 --> 0:12:06.240 a really key factor. To now is you know, how 0:12:06.600 --> 0:12:08.920 how how long are these vaccines gonna work? And we're 0:12:08.960 --> 0:12:11.200 just not going to have that information early on. And 0:12:11.240 --> 0:12:15.280 of course, the history of coronavirus is the cold, common 0:12:15.320 --> 0:12:18.840 cold coronavirus and other ones, is that the immunity to 0:12:18.880 --> 0:12:21.360 them is your fades over time, over you know, months 0:12:21.360 --> 0:12:23.719 to a year or more, a fade. That's why you 0:12:23.800 --> 0:12:26.600 keep getting common colds again and again and again. Uh 0:12:26.640 --> 0:12:29.160 So there is a precedent for coronavirus is an immunity 0:12:29.320 --> 0:12:31.600 you know, not lasting a long period of time. And 0:12:31.640 --> 0:12:33.680 that's a really key question. It's like, are you gonna 0:12:33.679 --> 0:12:36.120 need to be reimmunized like a once every six months, 0:12:36.120 --> 0:12:38.040 once a year and nobody knows that and we're not 0:12:38.080 --> 0:12:39.840 going to know that when the vaccine comes out. All 0:12:39.880 --> 0:12:42.400 we're really going to have is relatively short term ethicsly 0:12:42.480 --> 0:12:44.800 data that hey, so far, for a couple of months, 0:12:44.800 --> 0:12:46.800 this thing, you know, seems to work or at least partially. 0:12:46.800 --> 0:12:48.760 So that's a really key question that we just there's 0:12:48.800 --> 0:12:50.719 no way we're gonna be able to know that what 0:12:50.840 --> 0:12:53.200 a vaccine has brought out, especially if it's brought out 0:12:53.200 --> 0:12:55.679 early on this fall, based on pretty short term follow 0:12:55.760 --> 0:13:03.200 up that was Robert Langrath, and that's it for our 0:13:03.200 --> 0:13:05.959 show today. For coverage of the outbreak from one hundred 0:13:06.000 --> 0:13:09.600 and twenty bureaus around the world, visit bloomberg dot com 0:13:09.760 --> 0:13:13.679 slash Coronavirus and if you like the show, please leave 0:13:13.760 --> 0:13:17.199 us a review and a rating on Apple Podcasts or Spotify. 0:13:17.640 --> 0:13:20.320 It's the best way to help more listeners find our 0:13:20.360 --> 0:13:25.160 global reporting. The Prognosis Daily Edition is produced by Topher 0:13:25.240 --> 0:13:31.320 foreheads Jordan Gaspure, Magnus Henrickson and me Laura Carlson. Today's 0:13:31.360 --> 0:13:35.400 main story was reported by Robert Langreth. Original music by 0:13:35.480 --> 0:13:39.440 Leo Sidrin. Our editors are Rick Shine and Francesco Levi. 0:13:39.920 --> 0:13:44.720 Francesca Levi is Bloomberg's head of podcasts. Thanks for listening.