1 00:00:15,396 --> 00:00:21,916 Speaker 1: Pushkin from Pushkin Industries. This is Deep Background, the show 2 00:00:21,956 --> 00:00:25,276 Speaker 1: where we explore the stories behind the stories in the news. 3 00:00:25,756 --> 00:00:30,756 Speaker 1: I'm Noah Feldman. Coronavirus cases are surging across the country. 4 00:00:31,396 --> 00:00:35,396 Speaker 1: Cities and states are responding with new regulations on social gatherings, 5 00:00:36,156 --> 00:00:39,876 Speaker 1: but another potential solution is at least on the horizon 6 00:00:40,196 --> 00:00:43,276 Speaker 1: and maybe a little closer than that. Last week, the 7 00:00:43,356 --> 00:00:46,676 Speaker 1: drug company Visor announced in a press release that it's 8 00:00:46,716 --> 00:00:51,756 Speaker 1: coronavirus vaccine seems to work. According to a preliminary analysis, 9 00:00:52,236 --> 00:00:57,756 Speaker 1: Visor's vaccine is ninety percent effective at preventing COVID nineteen. 10 00:00:58,476 --> 00:01:02,836 Speaker 1: Maderna's vaccine, which operates on similar principles, has produced similar 11 00:01:02,916 --> 00:01:06,116 Speaker 1: numbers reported by that company as well. To discuss the 12 00:01:06,156 --> 00:01:09,116 Speaker 1: science behind these developments and what's going to happen in practice, 13 00:01:09,436 --> 00:01:12,556 Speaker 1: we are joined by doctor Paul Offen. He's a professor 14 00:01:12,596 --> 00:01:16,636 Speaker 1: of vaccinology and pediatrics at the University of Pennsylvania. He's 15 00:01:16,636 --> 00:01:20,956 Speaker 1: also importantly a member of the FDA's Vaccine Advisory Panel. 16 00:01:21,596 --> 00:01:24,276 Speaker 1: Among his other distinctions, he is also the co inventor 17 00:01:24,476 --> 00:01:32,316 Speaker 1: of the rhodavirus vaccine. Paul, thank you so much for 18 00:01:32,396 --> 00:01:36,476 Speaker 1: joining me. The immediate impetus for our conversation is the 19 00:01:36,516 --> 00:01:41,796 Speaker 1: good news that mRNA vaccines like Visors and Maderna's shows 20 00:01:41,836 --> 00:01:46,196 Speaker 1: efficacy in trials. So let's just start with the very 21 00:01:46,196 --> 00:01:51,156 Speaker 1: basic question. The Visor vaccine is an RNA vaccine. There's 22 00:01:51,156 --> 00:01:54,156 Speaker 1: never been one of those that worked before. Why is 23 00:01:54,196 --> 00:01:57,996 Speaker 1: this appear to be working? So what we think we 24 00:01:58,116 --> 00:02:01,076 Speaker 1: know is we think we know that we want to 25 00:02:01,076 --> 00:02:03,636 Speaker 1: make antibodies to the protein that emanates from the surface 26 00:02:03,676 --> 00:02:06,516 Speaker 1: of the virus that is responsible for attaching the virus 27 00:02:06,556 --> 00:02:09,396 Speaker 1: to cells. If you can then make antibodies to that protein, 28 00:02:09,516 --> 00:02:11,836 Speaker 1: you can prevent the virus from attaching the cells. In 29 00:02:11,916 --> 00:02:14,596 Speaker 1: the past, when we've wanted to make an about it 30 00:02:14,636 --> 00:02:16,876 Speaker 1: to the spike protein, we would do things like give 31 00:02:17,356 --> 00:02:19,276 Speaker 1: sort of a whole killed form of the virus which 32 00:02:19,276 --> 00:02:21,036 Speaker 1: would have the spike protein on it, or we would 33 00:02:21,076 --> 00:02:22,836 Speaker 1: give a live we can form of the virus which 34 00:02:22,836 --> 00:02:24,876 Speaker 1: would have the spike protein on it, or we would 35 00:02:24,916 --> 00:02:27,636 Speaker 1: purify the spike protein, or we would use recomment at 36 00:02:27,676 --> 00:02:31,036 Speaker 1: DNA technology to make the spike protein. What we're doing 37 00:02:31,116 --> 00:02:32,916 Speaker 1: now is we're saying we're not going to do any 38 00:02:32,956 --> 00:02:35,836 Speaker 1: of that. We're going to take a small gene that 39 00:02:35,996 --> 00:02:39,476 Speaker 1: essentially codes for that spike protein, and then we'll inject 40 00:02:39,516 --> 00:02:42,276 Speaker 1: that and hope that it gets into muscle cells and 41 00:02:42,956 --> 00:02:45,356 Speaker 1: will then be translated to the spike protein. So, in 42 00:02:45,356 --> 00:02:47,876 Speaker 1: other words, the person makes the spike protein, then the 43 00:02:47,956 --> 00:02:50,276 Speaker 1: person makes in about it's the spectro protein. We've never 44 00:02:50,276 --> 00:02:52,436 Speaker 1: done that before. Just like you said, there's no commercial 45 00:02:52,436 --> 00:02:56,756 Speaker 1: equivalent for that for any vaccine. It should theoretically work, 46 00:02:56,876 --> 00:02:59,236 Speaker 1: we just never knew that it could. That was a 47 00:02:59,316 --> 00:03:03,156 Speaker 1: spectacularly clear explanation. I want to just dive into a 48 00:03:03,236 --> 00:03:05,276 Speaker 1: specific part of it. The part I want to dive 49 00:03:05,316 --> 00:03:08,276 Speaker 1: into is the idea that historically, the way we've done 50 00:03:08,316 --> 00:03:11,916 Speaker 1: vaccines and by Weime and you the scientific community, is 51 00:03:12,396 --> 00:03:15,716 Speaker 1: by introducing a version of the spike protein in this 52 00:03:15,756 --> 00:03:18,236 Speaker 1: case that we want to block, and then having the 53 00:03:18,236 --> 00:03:21,836 Speaker 1: body produce antibodies to it. And that what makes the 54 00:03:21,996 --> 00:03:25,196 Speaker 1: mRNA approach, which is characteristic of the Fiser approach and 55 00:03:25,276 --> 00:03:29,836 Speaker 1: of the Maderna approach, distinctive, is that it actually introduces 56 00:03:29,876 --> 00:03:34,196 Speaker 1: a genetic code to produce the spike protein, which the 57 00:03:34,196 --> 00:03:36,316 Speaker 1: body then produces, which we don't want in principle a 58 00:03:36,316 --> 00:03:39,476 Speaker 1: body to produce. But then the body produces antibodies to 59 00:03:39,516 --> 00:03:42,116 Speaker 1: the spike protein that the body has produced. So you're 60 00:03:42,156 --> 00:03:43,796 Speaker 1: saving a step, as it were, you don't have to 61 00:03:43,796 --> 00:03:46,316 Speaker 1: introduce the spike protein in some form from the outside. 62 00:03:46,716 --> 00:03:49,596 Speaker 1: First of all, am I getting that right? That's exactly right. 63 00:03:49,876 --> 00:03:53,036 Speaker 1: But if for example, you gave a live attenuated viral vaccine, 64 00:03:53,116 --> 00:03:55,916 Speaker 1: that virus would then enter the cell, reproduce itself, and 65 00:03:55,956 --> 00:03:58,556 Speaker 1: it would make the spike protein inside that cell. So 66 00:03:58,596 --> 00:04:01,276 Speaker 1: it's not like a complete long shot. And we certainly 67 00:04:01,756 --> 00:04:06,076 Speaker 1: have a wealth of experience using live weakened viruses to 68 00:04:06,116 --> 00:04:08,716 Speaker 1: induce immune response, starting in the mid nineteen thirties with 69 00:04:09,196 --> 00:04:12,396 Speaker 1: yellow fever vaccine. And is it a good thing that 70 00:04:12,836 --> 00:04:17,036 Speaker 1: by encoding for the spike protein without introducing the virus, 71 00:04:17,516 --> 00:04:20,116 Speaker 1: the virus actually doesn't in principle have a chance of 72 00:04:20,156 --> 00:04:23,196 Speaker 1: arising within the cell with this kind of vaccine, correct, 73 00:04:23,196 --> 00:04:25,276 Speaker 1: because we're not encoding for the virus, just encoding for 74 00:04:25,316 --> 00:04:28,036 Speaker 1: the spike protein. That's right. It's just you're being infected, 75 00:04:28,076 --> 00:04:31,196 Speaker 1: if you will, with one protein, so that's not the virus, 76 00:04:31,236 --> 00:04:34,916 Speaker 1: that's right. So when we think about potential negative side effects, 77 00:04:34,916 --> 00:04:38,396 Speaker 1: when we think about live attenuated viruses or killed viruses, 78 00:04:38,636 --> 00:04:41,756 Speaker 1: sometimes we worry that they might produce, at least in 79 00:04:41,796 --> 00:04:45,796 Speaker 1: some people, symptoms of the actual virus or the bad 80 00:04:45,796 --> 00:04:48,196 Speaker 1: consequence of the actual virus. Is it correct to say that, 81 00:04:48,236 --> 00:04:51,036 Speaker 1: at least in principle, the mRNA vaccine can't do that 82 00:04:51,236 --> 00:04:53,676 Speaker 1: because there is no virus introduced into the system. There's 83 00:04:53,716 --> 00:04:56,156 Speaker 1: just the genetic code for the spike protein, which is 84 00:04:56,156 --> 00:04:58,636 Speaker 1: not itself the virus. Yeah, this is not sours cob 85 00:04:58,716 --> 00:05:01,596 Speaker 1: two virus. This is just one protein from the virus 86 00:05:01,676 --> 00:05:04,876 Speaker 1: that you will make. Therefore, the signs and symptoms that 87 00:05:04,916 --> 00:05:08,396 Speaker 1: you develop will not resemble those of SARS cob two infection. 88 00:05:09,476 --> 00:05:12,356 Speaker 1: So one of the best things about an RNA vaccine, 89 00:05:12,396 --> 00:05:15,796 Speaker 1: if indeed it works, is that it avoids some of 90 00:05:15,836 --> 00:05:20,076 Speaker 1: the potential downsides of more traditional vaccination. That's correct. Yes, 91 00:05:20,756 --> 00:05:22,876 Speaker 1: Sometimes it's been said in the media and by the 92 00:05:22,916 --> 00:05:26,116 Speaker 1: companies that it's easier to produce large numbers of doses 93 00:05:26,396 --> 00:05:29,276 Speaker 1: of an mRNA vaccine than it is to produce large 94 00:05:29,316 --> 00:05:33,716 Speaker 1: numbers of doses of a traditional killed or attenuated virus vaccine. 95 00:05:33,876 --> 00:05:35,716 Speaker 1: Is that so, And if it is so, why is 96 00:05:35,716 --> 00:05:38,076 Speaker 1: it so? I think there's a couple advantages for these 97 00:05:38,116 --> 00:05:41,876 Speaker 1: genetic approaches. The so called genetic plug and play approaches 98 00:05:42,396 --> 00:05:45,836 Speaker 1: are fast because they're very easy to construct. You just 99 00:05:45,916 --> 00:05:48,196 Speaker 1: take the gene and in the case of mRNA, you 100 00:05:48,236 --> 00:05:49,676 Speaker 1: give the gene, or in the case of some of 101 00:05:49,676 --> 00:05:53,116 Speaker 1: these other so called viral vectors, you just insert the 102 00:05:53,156 --> 00:05:55,676 Speaker 1: gene into that viral vector. So it's really very fast 103 00:05:55,716 --> 00:05:58,436 Speaker 1: to be able to construct it, and then it's very 104 00:05:58,436 --> 00:06:02,596 Speaker 1: easy to scale up rapidly. So MESSERNA, it's essentially synthetic. 105 00:06:02,716 --> 00:06:05,356 Speaker 1: You're just manufacturing it, so it can be scaled up 106 00:06:05,396 --> 00:06:07,356 Speaker 1: very quickly. I mean, I think Visor said that they 107 00:06:07,356 --> 00:06:10,276 Speaker 1: would have fifty million doses by the end of twenty twenty, 108 00:06:10,276 --> 00:06:12,516 Speaker 1: that they would have one point three billion doses in 109 00:06:12,556 --> 00:06:15,996 Speaker 1: the year twenty twenty one. You mentioned the viral vector 110 00:06:16,076 --> 00:06:20,036 Speaker 1: vaccines also sometimes called trojan horse vaccines. The Astroxenica approach, 111 00:06:20,076 --> 00:06:23,356 Speaker 1: the Oxford approach is one of those. Could you describe 112 00:06:23,396 --> 00:06:27,276 Speaker 1: how that works in relationship to the mRNA approach, right, 113 00:06:27,276 --> 00:06:30,196 Speaker 1: So it's a little different. So the so called replication 114 00:06:30,356 --> 00:06:34,476 Speaker 1: defective adnovirus vectors, which is the approach that's being used 115 00:06:34,476 --> 00:06:37,276 Speaker 1: by Johnson Johnson, the approach that's being used by Astroxenica, 116 00:06:37,316 --> 00:06:39,956 Speaker 1: the approach is being used by Russia. The approach is 117 00:06:39,996 --> 00:06:42,996 Speaker 1: being used by Chin in part is the adnovirus is 118 00:06:42,996 --> 00:06:45,556 Speaker 1: a human virus that can cause a variety of diseases. 119 00:06:45,796 --> 00:06:48,716 Speaker 1: But by engineering the virus so that it's replication defective, 120 00:06:48,756 --> 00:06:50,876 Speaker 1: that means that it cannot reproduce itself, that means that 121 00:06:50,956 --> 00:06:53,996 Speaker 1: it cannot cause disease. But it's also genetically engineered so 122 00:06:54,036 --> 00:06:56,956 Speaker 1: it has the gene that codes for the spike protein. 123 00:06:57,396 --> 00:07:01,836 Speaker 1: So then you inoculate this replication defective viral vector into 124 00:07:01,876 --> 00:07:04,516 Speaker 1: the person. It's taken up into muscle cells, and then 125 00:07:04,596 --> 00:07:08,996 Speaker 1: that replication of vectivirus enters the cell nucleus, where then 126 00:07:09,236 --> 00:07:12,756 Speaker 1: that gene that codes for the spike protein is transcribed 127 00:07:12,916 --> 00:07:16,596 Speaker 1: into messenger rna, and then the messenger rna then enters 128 00:07:16,596 --> 00:07:19,476 Speaker 1: the cytoplasm and then makes the protein, and then you 129 00:07:19,556 --> 00:07:21,276 Speaker 1: make the protein. So it's sort of like a step 130 00:07:21,476 --> 00:07:24,596 Speaker 1: back from the messenger RNA strategy, but essentially it's the 131 00:07:24,596 --> 00:07:28,316 Speaker 1: same strategy. It's ultimately getting the cell to make sours 132 00:07:28,356 --> 00:07:31,796 Speaker 1: covie to spike protein. And the reason that it's sometimes 133 00:07:31,796 --> 00:07:35,676 Speaker 1: called the trojan horse vaccination approach is that the adnovirus 134 00:07:36,236 --> 00:07:39,556 Speaker 1: is another virus that does in fact, in effect the cell, 135 00:07:39,676 --> 00:07:42,516 Speaker 1: though not with the possibility of replication. And once it's 136 00:07:42,596 --> 00:07:46,396 Speaker 1: in there, it delivers the genetic code for the spike 137 00:07:46,436 --> 00:07:49,356 Speaker 1: protein exactly right, and then the human body makes the 138 00:07:49,356 --> 00:07:51,676 Speaker 1: spike protein and then develops the antibodies to it, and 139 00:07:51,716 --> 00:07:53,636 Speaker 1: we're off to the races, as it were, off to 140 00:07:53,676 --> 00:07:59,276 Speaker 1: the races. Are those viral vector vaccines just as easy 141 00:07:59,356 --> 00:08:03,156 Speaker 1: to produce in large numbers of doses as the mRNA 142 00:08:03,236 --> 00:08:06,116 Speaker 1: vaccine is. Well, the mRNA is synthetic at some level, 143 00:08:06,196 --> 00:08:08,156 Speaker 1: so it's in that sense easier to make, but it 144 00:08:08,156 --> 00:08:10,076 Speaker 1: can be rapidly killed up. And there's a lot of 145 00:08:10,156 --> 00:08:13,676 Speaker 1: experience actually with replication effective add and ofvirus vectors, which 146 00:08:13,756 --> 00:08:15,236 Speaker 1: was used actually as one of the e bowl of 147 00:08:15,316 --> 00:08:18,436 Speaker 1: vaccines by Johnson and Johnson, the so called replication effective 148 00:08:18,436 --> 00:08:22,196 Speaker 1: ad ofvirus twenty six, So millions of doses were administered 149 00:08:22,276 --> 00:08:25,556 Speaker 1: in West Africa associated with that outbreak. Plus, interestingly, I 150 00:08:25,596 --> 00:08:28,156 Speaker 1: think many people don't realize this that product who had 151 00:08:28,156 --> 00:08:31,396 Speaker 1: to be maintained on dry ice and it was successfully 152 00:08:31,396 --> 00:08:33,956 Speaker 1: maintained on dry ice in West Africa, because that's going 153 00:08:33,996 --> 00:08:36,196 Speaker 1: to be also the story with the Fiser vaccine. So 154 00:08:36,436 --> 00:08:38,196 Speaker 1: we'll see how this plays out, but there is at 155 00:08:38,276 --> 00:08:41,916 Speaker 1: least some experience, some commercial experience with this approach. I'm 156 00:08:41,956 --> 00:08:44,076 Speaker 1: glad you raised the temperature issue, which seems like it's 157 00:08:44,076 --> 00:08:46,836 Speaker 1: going to be an important one going forward. The Fiser 158 00:08:46,876 --> 00:08:49,476 Speaker 1: folks are saying that their vaccine needs to be kept 159 00:08:49,516 --> 00:08:52,956 Speaker 1: at negative seventy degrees centigrade, which is around ninety four 160 00:08:53,116 --> 00:08:57,356 Speaker 1: degrees below zero fahrenheit. Why does it have to be 161 00:08:57,436 --> 00:08:59,436 Speaker 1: kept at that cold temperature? So? People who work with 162 00:08:59,476 --> 00:09:02,836 Speaker 1: messenge drying in a laboratories usually stored in liquid nitrogen, 163 00:09:02,876 --> 00:09:05,676 Speaker 1: which is like minus seventy to minus eighty degrees centigrade 164 00:09:06,516 --> 00:09:09,596 Speaker 1: in order to be able to make sure that that 165 00:09:09,836 --> 00:09:12,796 Speaker 1: molecule doesn't break down at least the fives are construct. 166 00:09:13,356 --> 00:09:16,156 Speaker 1: You have to ship it and store it at minus seventy, 167 00:09:16,156 --> 00:09:18,356 Speaker 1: which means that for the people who are taking care 168 00:09:18,396 --> 00:09:21,596 Speaker 1: of it, they have to constantly replenish the dry ice, 169 00:09:21,676 --> 00:09:23,516 Speaker 1: which is a lot to ask. And it gets worse 170 00:09:23,556 --> 00:09:25,716 Speaker 1: than that. Then what happens is when you've thought it 171 00:09:25,756 --> 00:09:28,676 Speaker 1: out and you put it in the refrigerator, that concentrated 172 00:09:28,716 --> 00:09:31,996 Speaker 1: form of Messenger RNA can only stay in the refrigerator 173 00:09:32,036 --> 00:09:34,516 Speaker 1: for twenty four hours. After twenty four hours you have 174 00:09:34,556 --> 00:09:36,876 Speaker 1: to throw it out. Also, if you reconstitute it and 175 00:09:36,916 --> 00:09:40,076 Speaker 1: it's just reconstituted with just a normal as salt water solution, 176 00:09:40,836 --> 00:09:44,156 Speaker 1: after you reconstitute it, you have six hours to give it. 177 00:09:44,356 --> 00:09:46,396 Speaker 1: So that's a lot to ask and I think when 178 00:09:46,436 --> 00:09:49,156 Speaker 1: you do these trials, it's forty four thousand person trial, 179 00:09:49,556 --> 00:09:51,636 Speaker 1: you can be sure that the company was very good 180 00:09:51,676 --> 00:09:54,516 Speaker 1: about making that these study centers that were doing these 181 00:09:54,556 --> 00:09:57,396 Speaker 1: trials knew exactly how to do it, and we're good 182 00:09:57,396 --> 00:09:59,596 Speaker 1: at doing it. When a thing gets out into the 183 00:09:59,596 --> 00:10:01,996 Speaker 1: real world, you worry that people are going to be 184 00:10:02,036 --> 00:10:05,436 Speaker 1: as good at making sure they kept this ultra cold 185 00:10:05,516 --> 00:10:08,316 Speaker 1: chain going as we did into trials, and that the 186 00:10:08,356 --> 00:10:11,076 Speaker 1: efficacy may be a little less in a real world center. 187 00:10:11,116 --> 00:10:15,196 Speaker 1: Because messenger RNA breaks down very quickly. It decentegrates very quickly, 188 00:10:15,436 --> 00:10:17,196 Speaker 1: and although that would not be an issue, I think 189 00:10:17,236 --> 00:10:19,716 Speaker 1: in terms of safety, it would definitely be an issue 190 00:10:19,716 --> 00:10:23,236 Speaker 1: in terms of potency. Why does it break down so quickly? 191 00:10:23,276 --> 00:10:27,556 Speaker 1: If in the human body, mRNA is tremendously necessary, and 192 00:10:27,596 --> 00:10:31,276 Speaker 1: of course the human body is not negative seventy degrees centigrade, right, 193 00:10:31,476 --> 00:10:33,516 Speaker 1: it does break down quickly in the human body, but 194 00:10:33,516 --> 00:10:36,836 Speaker 1: you're constantly making messenger RNA and it's constantly breaking down. 195 00:10:36,996 --> 00:10:38,996 Speaker 1: I mean, one thing, it's interesting just from a nerdy 196 00:10:39,076 --> 00:10:43,116 Speaker 1: virologious standpoint, when you're infected with this virus, you usually 197 00:10:43,156 --> 00:10:47,556 Speaker 1: shed infectious virus for about a week, meaning live virus 198 00:10:47,596 --> 00:10:50,356 Speaker 1: for about a week, but you can be PCR positive 199 00:10:50,396 --> 00:10:52,836 Speaker 1: for three months. Which interesting about that is when you're 200 00:10:52,876 --> 00:10:56,676 Speaker 1: PCR positive, what that means is is that the virus 201 00:10:56,796 --> 00:10:59,036 Speaker 1: gene is being detected in the back of your throw, 202 00:10:59,076 --> 00:11:01,476 Speaker 1: so it's not the live virus necessarily, it's just the 203 00:11:01,556 --> 00:11:04,916 Speaker 1: virus genome. Well, if messenger RNA breaks down so quickly, 204 00:11:04,916 --> 00:11:07,716 Speaker 1: and it does, why is it that you're positive for 205 00:11:07,756 --> 00:11:10,596 Speaker 1: three months after you're no longer making effect as virus. 206 00:11:10,676 --> 00:11:13,396 Speaker 1: I mean, shouldn't the mRNA breakdown very quickly? And the 207 00:11:13,396 --> 00:11:16,036 Speaker 1: answer as it does. So the only explanation for this 208 00:11:16,236 --> 00:11:19,196 Speaker 1: is that the virus continues to make messenger rna, continues 209 00:11:19,236 --> 00:11:22,236 Speaker 1: to make its genome, but doesn't make whole virus particles, 210 00:11:22,276 --> 00:11:24,436 Speaker 1: which would be the first virus at least that I 211 00:11:24,476 --> 00:11:26,596 Speaker 1: know about, has ever done something like that. It's just 212 00:11:26,636 --> 00:11:30,516 Speaker 1: a very strange virus, this bad coronavirus. Can you think 213 00:11:30,556 --> 00:11:35,116 Speaker 1: of any adaptive advantage genetically for an organism to continue 214 00:11:35,116 --> 00:11:37,836 Speaker 1: to make its genome, maybe if it's not making the 215 00:11:37,836 --> 00:11:40,116 Speaker 1: thing that enables it to spread in the population. That 216 00:11:40,156 --> 00:11:43,236 Speaker 1: doesn't sound super efficient from a sort of classic evolutionary 217 00:11:43,276 --> 00:11:46,076 Speaker 1: advantage standpoint. I know, I can't think of a reason, 218 00:11:46,156 --> 00:11:47,796 Speaker 1: but you know what, I'm going to assume the virus 219 00:11:47,836 --> 00:11:49,836 Speaker 1: is smarter than I am, and it's doing it for 220 00:11:49,836 --> 00:11:52,236 Speaker 1: a reason, because why would it expand the energy that's 221 00:11:52,276 --> 00:11:55,996 Speaker 1: needed to make message RNA unless there was some advantage 222 00:11:55,996 --> 00:12:02,596 Speaker 1: to its survivability. Fascinating of the viral vector vaccines, the 223 00:12:02,596 --> 00:12:06,076 Speaker 1: ones that Johnson and Johnson and Astra Zeneca are producing, 224 00:12:06,956 --> 00:12:10,116 Speaker 1: will those also have to be kept at a comparable 225 00:12:10,236 --> 00:12:12,276 Speaker 1: level of coldness. You mentioned that the vaccine that was 226 00:12:12,356 --> 00:12:14,716 Speaker 1: used in Africa was stored on dry eye, so that's 227 00:12:14,716 --> 00:12:17,596 Speaker 1: at the same kinds of low temperatures. My understanding is 228 00:12:17,756 --> 00:12:20,636 Speaker 1: it's they'll be either kept at freezer or refrigerator temperatures, 229 00:12:20,636 --> 00:12:22,596 Speaker 1: so they're not going to nearly require the kind of 230 00:12:23,036 --> 00:12:24,676 Speaker 1: issues that are going to be required at least with 231 00:12:24,716 --> 00:12:27,236 Speaker 1: the Fiser vaccine. Which interesting is that the modernist vaccine 232 00:12:27,276 --> 00:12:29,796 Speaker 1: is also an mr anda vaccine, but it doesn't have 233 00:12:29,796 --> 00:12:31,876 Speaker 1: to be shipped in stored at minus seventy to Minusa. 234 00:12:31,876 --> 00:12:34,036 Speaker 1: It can be shipped in stored at minus twenty degrees centigrade, 235 00:12:34,036 --> 00:12:37,516 Speaker 1: which is basically freezer temperature. They're both mr Anda vaccines. 236 00:12:37,516 --> 00:12:41,116 Speaker 1: The gene sequence that determines the so called receptor binding 237 00:12:41,156 --> 00:12:44,716 Speaker 1: domain on the Saurus CoV two spy protein is identical, 238 00:12:45,156 --> 00:12:47,836 Speaker 1: but they are different. I mean, Fiser's vaccine is given 239 00:12:47,876 --> 00:12:51,676 Speaker 1: at thirty micrograms per dose in two successive doses. Madernas 240 00:12:51,716 --> 00:12:54,596 Speaker 1: is a hundred micrograms and two successive doses, And they 241 00:12:54,636 --> 00:12:57,196 Speaker 1: don't have the same so called ducleoside analog, so they're 242 00:12:57,236 --> 00:13:00,916 Speaker 1: not the same molecule. Obviously, there's there's stability differences, physical 243 00:13:00,996 --> 00:13:03,556 Speaker 1: chemical differences between those two products, and I'm not sure 244 00:13:03,556 --> 00:13:06,316 Speaker 1: exactly why, because obviously I'm sure if Fizer could ship 245 00:13:06,396 --> 00:13:08,516 Speaker 1: in store at freezer temperature, which is much more doable, 246 00:13:08,756 --> 00:13:12,076 Speaker 1: they would, so will that potentially turn out to be 247 00:13:12,116 --> 00:13:16,916 Speaker 1: a determinative factor for governments that are making specific orders 248 00:13:16,956 --> 00:13:19,836 Speaker 1: or for healthcare systems that are making specific orders. I mean, 249 00:13:19,876 --> 00:13:22,956 Speaker 1: I'm sitting in I don't know, the Massachusetts Department of 250 00:13:23,276 --> 00:13:25,236 Speaker 1: Health and Human Services, and I'm trying to figure out 251 00:13:25,276 --> 00:13:27,836 Speaker 1: which one should I buy? Would that be ir relevant 252 00:13:27,836 --> 00:13:30,556 Speaker 1: consideration for me? I'd rather buy the one, for example, 253 00:13:31,076 --> 00:13:34,276 Speaker 1: that can be shipped at a slightly higher temperature or 254 00:13:34,276 --> 00:13:36,996 Speaker 1: stored at us slightly higher temperature. You would think that 255 00:13:37,076 --> 00:13:39,916 Speaker 1: the degree of ease, the degree to which administration and 256 00:13:40,036 --> 00:13:42,836 Speaker 1: storage is idiot proof, it would be attractive what is 257 00:13:43,036 --> 00:13:45,676 Speaker 1: currently required for the Fiser vaccine, which is, you know 258 00:13:45,716 --> 00:13:48,076 Speaker 1: that you can't keep in the refrigerator from more than 259 00:13:48,116 --> 00:13:50,196 Speaker 1: a day once we constuted, can't be kept for more 260 00:13:50,236 --> 00:13:52,916 Speaker 1: than six hours, that you constantly have to replace with 261 00:13:52,996 --> 00:13:55,356 Speaker 1: dry ice. I can't imagine how that is going to 262 00:13:55,436 --> 00:13:58,316 Speaker 1: be done in a large retail pharmacy. I can't. I 263 00:13:58,316 --> 00:14:01,916 Speaker 1: can't imagine how it's going to be done at our hospital, frankly, so, 264 00:14:01,916 --> 00:14:03,956 Speaker 1: so then how would it be done? One way would 265 00:14:03,996 --> 00:14:06,876 Speaker 1: be to have a series of centers that are distributed 266 00:14:06,876 --> 00:14:09,396 Speaker 1: throughout a city that are like a testing center sept 267 00:14:09,436 --> 00:14:12,756 Speaker 1: here that are specifically devoted to giving the vaccine. That 268 00:14:12,796 --> 00:14:14,196 Speaker 1: would be one way to do it, and that may 269 00:14:14,236 --> 00:14:15,676 Speaker 1: be the way it's going to be done. So yes, 270 00:14:15,716 --> 00:14:19,156 Speaker 1: I think you're exactly right. How operationally or we get 271 00:14:19,156 --> 00:14:21,476 Speaker 1: a vaccine that has these kinds of requirements out there. 272 00:14:23,036 --> 00:14:25,556 Speaker 1: When you just described that you're not even sure your hospital, 273 00:14:25,596 --> 00:14:27,676 Speaker 1: which is one of the best hospitals in the country 274 00:14:27,676 --> 00:14:29,996 Speaker 1: and indeed in the world, could do it, that actually 275 00:14:30,036 --> 00:14:33,996 Speaker 1: makes me wonder about viability altogether. I mean, you describe 276 00:14:34,036 --> 00:14:36,436 Speaker 1: setting up these centers in different cities. That might be 277 00:14:36,476 --> 00:14:39,196 Speaker 1: all well and good in big cities that have lots 278 00:14:39,196 --> 00:14:41,516 Speaker 1: of resources, but it sounds like it would be hard 279 00:14:41,556 --> 00:14:43,516 Speaker 1: to do in lots of parts of the United States, 280 00:14:43,596 --> 00:14:46,596 Speaker 1: and definitely very hard to do in lots of parts 281 00:14:46,636 --> 00:14:48,676 Speaker 1: of the world where such centers don't exist, and would 282 00:14:48,676 --> 00:14:51,036 Speaker 1: then have to be built from scratch. From the way 283 00:14:51,036 --> 00:14:53,476 Speaker 1: you formulated it there, I almost thought you were hinting 284 00:14:54,156 --> 00:14:57,556 Speaker 1: that unless there is no other choice, the Fiser approach 285 00:14:57,636 --> 00:14:59,836 Speaker 1: doesn't sound like it's going to be doable at scale. 286 00:15:00,836 --> 00:15:03,276 Speaker 1: I think it's doable, and I think it's doable at scale. 287 00:15:03,436 --> 00:15:05,436 Speaker 1: I just think it's going to require an enormous effort, 288 00:15:05,476 --> 00:15:07,996 Speaker 1: which means an enormous expenditure as well as time. Yes, 289 00:15:08,076 --> 00:15:10,396 Speaker 1: I think that's right, And understandings in the United States 290 00:15:10,516 --> 00:15:13,396 Speaker 1: has contracted to by one hundred million doses of the 291 00:15:13,396 --> 00:15:17,396 Speaker 1: Fiser vaccine, which means that they could vaccinate fifty million people. 292 00:15:17,436 --> 00:15:19,916 Speaker 1: Now that the number of people that have been considered 293 00:15:19,956 --> 00:15:24,196 Speaker 1: sort of first tier responders meaning essential workers like healthcare workers, 294 00:15:24,196 --> 00:15:28,036 Speaker 1: people in transportation, law enforcement, etc. People over sixty five, 295 00:15:28,076 --> 00:15:30,676 Speaker 1: people who have certain high risk medical conditions, added up 296 00:15:30,676 --> 00:15:33,996 Speaker 1: to about one hundred and fifty million American adults, which 297 00:15:34,036 --> 00:15:38,036 Speaker 1: is roughly half the adult population. This vaccine to be 298 00:15:38,036 --> 00:15:41,436 Speaker 1: given exclusively at least for that hundred million, doses to 299 00:15:41,516 --> 00:15:44,116 Speaker 1: the United States would be about a third of that. 300 00:15:44,236 --> 00:15:46,396 Speaker 1: So the only way we're going to vaccinate the American 301 00:15:46,396 --> 00:15:48,516 Speaker 1: population is if there's more than one vaccine. That's going 302 00:15:48,516 --> 00:16:01,716 Speaker 1: to have to be true. We'll be right back. When 303 00:16:01,756 --> 00:16:04,596 Speaker 1: I try to picture a center, a newly created center 304 00:16:04,636 --> 00:16:07,676 Speaker 1: that becomes the vaccination center in a city, I guess 305 00:16:08,236 --> 00:16:09,916 Speaker 1: we're down at getting into the nitty gritty, But I 306 00:16:09,916 --> 00:16:12,236 Speaker 1: guess you have to set up appointments for people. You 307 00:16:12,236 --> 00:16:15,436 Speaker 1: can have fifty million people lining up and waiting for vaccines, 308 00:16:15,436 --> 00:16:17,596 Speaker 1: among other things, they would probably be too proximate to 309 00:16:17,596 --> 00:16:20,236 Speaker 1: one another and that might spread the virus, right, and 310 00:16:20,396 --> 00:16:23,076 Speaker 1: you have to identify whether or not these people really 311 00:16:23,076 --> 00:16:26,076 Speaker 1: are the first tier for whom the vaccine is recommended. 312 00:16:26,076 --> 00:16:27,236 Speaker 1: Because I think there are a lot of people who 313 00:16:27,276 --> 00:16:29,116 Speaker 1: were going to get it who are not necessarily in 314 00:16:29,156 --> 00:16:31,956 Speaker 1: that first tier group. So how do you identify who 315 00:16:31,956 --> 00:16:33,516 Speaker 1: they are? How do you make sure they come back 316 00:16:33,556 --> 00:16:35,996 Speaker 1: twenty one or twenty eight days letter depending on the vaccine, 317 00:16:36,036 --> 00:16:38,196 Speaker 1: so to make sure they got their second dose. If 318 00:16:38,196 --> 00:16:39,916 Speaker 1: you look at shing ricks, which is probably the best 319 00:16:39,916 --> 00:16:42,556 Speaker 1: equivalent for this, which is an adult vaccine that's given 320 00:16:42,556 --> 00:16:45,676 Speaker 1: in two doses roughly separated by a month, what percentage 321 00:16:45,716 --> 00:16:47,716 Speaker 1: of people come back for that second dose. The answer 322 00:16:47,756 --> 00:16:50,116 Speaker 1: is it's pretty high. It's about eighty five percent or 323 00:16:50,156 --> 00:16:52,036 Speaker 1: so ninety percent. But still, you know, one out of 324 00:16:52,036 --> 00:16:54,316 Speaker 1: ten or more people don't come back for that second 325 00:16:54,356 --> 00:16:56,796 Speaker 1: dose because, first of all, the first dose of a 326 00:16:56,836 --> 00:16:59,836 Speaker 1: shingles vaccine does cause side effect, as these vaccines will 327 00:17:00,036 --> 00:17:03,076 Speaker 1: for different reasons. Mess Darna is an adgement. By adgement, 328 00:17:03,156 --> 00:17:05,636 Speaker 1: I mean it stimulates the immune system so that you 329 00:17:05,636 --> 00:17:08,396 Speaker 1: can give a lesser quantity of the active ingredient. And 330 00:17:08,436 --> 00:17:10,276 Speaker 1: so you may get a first US and think, yeah, hey, 331 00:17:10,316 --> 00:17:12,956 Speaker 1: this wasn't fun. I had fever, including high fever, I 332 00:17:13,036 --> 00:17:16,476 Speaker 1: had headaches, chills, muscle eggs. I'm not signing up for that. Seconds, 333 00:17:16,556 --> 00:17:18,716 Speaker 1: which really is the shingle story. I mean, it's certainly 334 00:17:18,836 --> 00:17:21,356 Speaker 1: nothing compared to what the benefit is, which is preventing 335 00:17:21,356 --> 00:17:24,436 Speaker 1: a disease that could kill you. So it's certainly worth it. 336 00:17:24,476 --> 00:17:26,436 Speaker 1: But you know, for some people, they may think, you know, 337 00:17:26,596 --> 00:17:28,636 Speaker 1: I'm young and healthy, I'm probably not going to die 338 00:17:28,636 --> 00:17:30,356 Speaker 1: from this, so I really have to go back for 339 00:17:30,436 --> 00:17:34,876 Speaker 1: that second dose. This wasn't much fun. The fact that 340 00:17:35,156 --> 00:17:38,596 Speaker 1: mRNA it can be used as an adjument, namely something 341 00:17:38,596 --> 00:17:41,596 Speaker 1: that stimulates your immune system, does that mean that a 342 00:17:41,716 --> 00:17:44,836 Speaker 1: high percentage of the population who takes the vaccine will 343 00:17:44,876 --> 00:17:48,516 Speaker 1: have those kinds of quasi flu leg symptoms in response 344 00:17:48,556 --> 00:17:50,956 Speaker 1: to taking the vaccine. Yes, I think that's right. I 345 00:17:50,996 --> 00:17:53,356 Speaker 1: think probably as much as half of people will have fever, 346 00:17:53,396 --> 00:17:56,596 Speaker 1: including high fever, and then the symptoms associated with fever, headache, chills, 347 00:17:56,676 --> 00:17:58,996 Speaker 1: muscle as I think that's likely. And how long do 348 00:17:59,036 --> 00:18:02,316 Speaker 1: those symptoms typically last When you've administered just an agement 349 00:18:02,516 --> 00:18:05,356 Speaker 1: a day or two. I mean, it'll go away again. 350 00:18:05,396 --> 00:18:08,556 Speaker 1: So people will know they don't have COVID because they've 351 00:18:08,596 --> 00:18:10,316 Speaker 1: just taken the vaccine, but they may be a little 352 00:18:10,316 --> 00:18:12,556 Speaker 1: nervous about it. Well, the same thing actually applies for 353 00:18:12,636 --> 00:18:15,396 Speaker 1: the vaccine trials. In theory, the participant doesn't know whether 354 00:18:15,396 --> 00:18:18,356 Speaker 1: they're getting vaccine or placebo. But because the mRNA vaccines, 355 00:18:18,356 --> 00:18:21,516 Speaker 1: and actually also true for the replication effect of adenovirus 356 00:18:21,556 --> 00:18:23,916 Speaker 1: vaccines for a different reason, that too had a fairly 357 00:18:23,996 --> 00:18:26,516 Speaker 1: high side effect profile. So if you didn't have side effects, 358 00:18:26,516 --> 00:18:28,396 Speaker 1: you probably did have a placebo, and if you did 359 00:18:28,476 --> 00:18:30,916 Speaker 1: have side effects, you probably did have the vaccine. So 360 00:18:31,156 --> 00:18:34,556 Speaker 1: most people probably do know which they got. Interesting. Interesting. 361 00:18:34,636 --> 00:18:37,556 Speaker 1: The second question I wanted to ask about that scenario 362 00:18:37,876 --> 00:18:40,196 Speaker 1: is if one hundred and fifty million people aren't being 363 00:18:40,236 --> 00:18:43,476 Speaker 1: described as first responders, and as you say, that's half 364 00:18:43,516 --> 00:18:46,556 Speaker 1: of the US adult population, that on some level that 365 00:18:46,676 --> 00:18:50,196 Speaker 1: first responder categorization isn't that meaningful, and it's going to 366 00:18:50,276 --> 00:18:52,316 Speaker 1: have to be more narrowed down, especially if let's say 367 00:18:52,316 --> 00:18:54,076 Speaker 1: we have fifteen million doses to begin with, and even 368 00:18:54,076 --> 00:18:55,676 Speaker 1: among that there's the question of the order in which 369 00:18:55,676 --> 00:18:58,396 Speaker 1: it will be given. Do you have a view about 370 00:18:58,436 --> 00:19:01,636 Speaker 1: what would be plausible ways to narrow it down beyond that, 371 00:19:02,116 --> 00:19:04,636 Speaker 1: or do you think that the governments involved are just 372 00:19:04,676 --> 00:19:08,036 Speaker 1: going to duck the issue because it's so difficult to 373 00:19:08,116 --> 00:19:11,116 Speaker 1: do allocation processes like this in a way that seems 374 00:19:11,156 --> 00:19:14,476 Speaker 1: fair to people. I think you're exactly right. I think 375 00:19:14,476 --> 00:19:16,436 Speaker 1: it is going to be difficult to do that, But 376 00:19:16,476 --> 00:19:18,116 Speaker 1: I don't think they're going to duck the issue. I 377 00:19:18,156 --> 00:19:20,676 Speaker 1: think both the Advisor Community for Communization Practice to the 378 00:19:20,716 --> 00:19:23,276 Speaker 1: CDC and the National Category Medicine, which have been charged 379 00:19:23,316 --> 00:19:26,716 Speaker 1: with trying to figure out exactly how these tiers are 380 00:19:26,716 --> 00:19:28,716 Speaker 1: going to work out who's in the top top tier, 381 00:19:28,756 --> 00:19:31,636 Speaker 1: who's just below that top tier, they won't duck it. 382 00:19:31,836 --> 00:19:33,396 Speaker 1: The question is how it then is going to play 383 00:19:33,396 --> 00:19:35,836 Speaker 1: out in the real world when the rubber meets the road, 384 00:19:36,356 --> 00:19:39,156 Speaker 1: and we'll see I'm sure that the healthcare workers will 385 00:19:39,196 --> 00:19:41,316 Speaker 1: be right up at the top, as will people who 386 00:19:41,316 --> 00:19:43,396 Speaker 1: are older. For in terms of people who are over 387 00:19:43,436 --> 00:19:45,596 Speaker 1: sixty five, we do need data to prove that the 388 00:19:45,676 --> 00:19:49,316 Speaker 1: vaccine is effective in that age group. Hopefully we'll have 389 00:19:49,436 --> 00:19:51,916 Speaker 1: enough people in these fisor trials, and we're during the trials, 390 00:19:51,956 --> 00:19:53,516 Speaker 1: which are going to be the first ones to go 391 00:19:53,596 --> 00:19:56,036 Speaker 1: through the FDA, we'll have enough data to be able 392 00:19:56,076 --> 00:19:58,556 Speaker 1: to make that statement. Because although you know, obviously you 393 00:19:58,636 --> 00:20:00,796 Speaker 1: want to make sure that both genders weekly represented, you 394 00:20:00,796 --> 00:20:02,916 Speaker 1: want to make sure that there's an adequate representation of 395 00:20:03,036 --> 00:20:05,316 Speaker 1: racial and ethnic minorities. There's no reason to believe that 396 00:20:05,356 --> 00:20:08,276 Speaker 1: there would be really differences in the ability to respond 397 00:20:08,516 --> 00:20:10,756 Speaker 1: with the accept for someone older and people who have 398 00:20:10,836 --> 00:20:14,636 Speaker 1: various medical conditions, like you know, say obesity or diabetes. 399 00:20:14,756 --> 00:20:17,516 Speaker 1: So that needs to be clear or as we do this. 400 00:20:18,596 --> 00:20:21,036 Speaker 1: I thought of that specifically because I heard an interview 401 00:20:21,076 --> 00:20:24,076 Speaker 1: on the radio with one of the fiser's spokespeople who 402 00:20:24,156 --> 00:20:27,236 Speaker 1: was asked, of your forty four thousand people in your trial, 403 00:20:27,596 --> 00:20:31,556 Speaker 1: were their elderly people? And the spokesperson responded by saying 404 00:20:31,956 --> 00:20:36,316 Speaker 1: the trial group was demographically broad, which was not a 405 00:20:36,316 --> 00:20:38,676 Speaker 1: direct answer, and of course it didn't say anything about 406 00:20:38,716 --> 00:20:41,996 Speaker 1: whether the ninety percent efficacy level is you know, nearly 407 00:20:41,996 --> 00:20:44,076 Speaker 1: one hundred percent of young people are finding it working 408 00:20:44,316 --> 00:20:46,916 Speaker 1: and a very substantial number of older people are not 409 00:20:47,036 --> 00:20:49,956 Speaker 1: discovering that it works. Do you have an instinct about that? 410 00:20:49,996 --> 00:20:52,516 Speaker 1: I mean, would it be ordinarily the case that if 411 00:20:52,516 --> 00:20:55,596 Speaker 1: you looked at a natural variation across a population, that 412 00:20:55,836 --> 00:20:58,836 Speaker 1: older people would have a much harder time having the 413 00:20:58,916 --> 00:21:03,076 Speaker 1: vaccine effectively generate successful protections for them, just because their 414 00:21:03,076 --> 00:21:05,676 Speaker 1: immune systems are less responsive as they get older. Yes, 415 00:21:05,756 --> 00:21:08,556 Speaker 1: and that's the flu story. I mean, influenza vaccine works. 416 00:21:09,156 --> 00:21:11,516 Speaker 1: It's about sixty to sixty five percent effective to say, 417 00:21:11,556 --> 00:21:14,916 Speaker 1: people less than eighteen years of age, but it's barely 418 00:21:14,916 --> 00:21:17,236 Speaker 1: effective in people over sixty five. On the other hand, 419 00:21:17,236 --> 00:21:20,836 Speaker 1: is shingles vaccine in those over seventy eighty years old 420 00:21:20,916 --> 00:21:24,436 Speaker 1: works extremely well. So there are horses for courses. As 421 00:21:24,516 --> 00:21:26,196 Speaker 1: they say at the track, I think we'll find that 422 00:21:26,236 --> 00:21:28,556 Speaker 1: there are vaccines that may work well in one group 423 00:21:28,596 --> 00:21:30,836 Speaker 1: but not another. And I thought, of you. I thought 424 00:21:30,836 --> 00:21:32,756 Speaker 1: that the press release was pretty cajry. I think it 425 00:21:32,836 --> 00:21:34,476 Speaker 1: made a statement that they had X number of people 426 00:21:34,476 --> 00:21:36,756 Speaker 1: over fifty five, but it's really over sixty five that 427 00:21:36,796 --> 00:21:38,556 Speaker 1: you care about. And I'm not just saying that because 428 00:21:38,596 --> 00:21:40,676 Speaker 1: I'm over sixty five. Okay, I am saying that because 429 00:21:40,676 --> 00:21:43,196 Speaker 1: I'm over sixty five. But you know you can't forget 430 00:21:43,236 --> 00:21:46,156 Speaker 1: about us. Well, I don't think anyone is going to 431 00:21:46,196 --> 00:21:48,516 Speaker 1: forget about people over sixty five. In the context of 432 00:21:48,556 --> 00:21:51,036 Speaker 1: responding to a disease where most of the people whom 433 00:21:51,036 --> 00:21:53,836 Speaker 1: it has killed were not just over sixty five, but 434 00:21:54,116 --> 00:21:56,396 Speaker 1: over seventy or over seventy five, I think people are 435 00:21:56,396 --> 00:21:58,796 Speaker 1: going to be extremely concerned about this. I guess there's 436 00:21:58,836 --> 00:22:00,836 Speaker 1: the answer. Then we just have because of your horses 437 00:22:00,836 --> 00:22:02,996 Speaker 1: for courses point, there's just no way we're going to 438 00:22:03,076 --> 00:22:06,036 Speaker 1: know anything about this until we see the data. We 439 00:22:06,076 --> 00:22:08,836 Speaker 1: can't assume what it's going to look like. The challenges here. 440 00:22:08,836 --> 00:22:10,876 Speaker 1: If you look at that forty four thousand person trial 441 00:22:11,076 --> 00:22:13,516 Speaker 1: and then you look at the instance of infection, it's 442 00:22:13,556 --> 00:22:16,636 Speaker 1: actually much less than you would have predicted based on 443 00:22:16,756 --> 00:22:22,036 Speaker 1: what the instances of outbreaks were as these trials were progressing. 444 00:22:22,396 --> 00:22:25,316 Speaker 1: Which makes you wonder whether the people who were participants, 445 00:22:25,356 --> 00:22:28,276 Speaker 1: because they may be more attentive to their health, were 446 00:22:28,316 --> 00:22:30,796 Speaker 1: more likely to wear a mask, more likely to social distance, 447 00:22:30,836 --> 00:22:33,876 Speaker 1: and therefore less likely to have been infected than an 448 00:22:33,876 --> 00:22:36,396 Speaker 1: otherwise group. In other words, as compared to if they say, 449 00:22:36,476 --> 00:22:39,516 Speaker 1: did the trials with bikers in Sturge of South Dakota 450 00:22:39,556 --> 00:22:41,836 Speaker 1: who didn't wear masks, or you know, people who go 451 00:22:41,876 --> 00:22:45,036 Speaker 1: to the Trump rallies or go to Rose Garden ceremonies, 452 00:22:45,156 --> 00:22:47,476 Speaker 1: you know that you'd be more likely to have a 453 00:22:47,556 --> 00:22:51,116 Speaker 1: higher rate of infections. And that matters because masks aren't 454 00:22:51,116 --> 00:22:53,516 Speaker 1: one hundred percent effective, and so it may be that 455 00:22:53,556 --> 00:22:56,756 Speaker 1: you were exposed to a lesser inoculum than someone who 456 00:22:56,836 --> 00:22:59,716 Speaker 1: was less careful about their care. And you know, there's 457 00:22:59,756 --> 00:23:02,276 Speaker 1: definitely an anoculum effect. The greater the enocuum, the more 458 00:23:02,476 --> 00:23:04,676 Speaker 1: likely to have some modern secure disease. So there's a 459 00:23:04,676 --> 00:23:06,516 Speaker 1: lot to work out. I don't think we're going to 460 00:23:06,596 --> 00:23:08,836 Speaker 1: work a lot of it out before these vaccines are 461 00:23:08,836 --> 00:23:12,316 Speaker 1: already introduced, because we have two hundred and forty thousand 462 00:23:12,316 --> 00:23:14,636 Speaker 1: people that died of this virus this year. You're not 463 00:23:14,676 --> 00:23:17,716 Speaker 1: going to do huge long term trials. You're not, and 464 00:23:17,716 --> 00:23:20,596 Speaker 1: there's going to be whenever you do subsets, there's always 465 00:23:20,636 --> 00:23:23,636 Speaker 1: going to be a loss of statistical strength, and so 466 00:23:23,796 --> 00:23:25,436 Speaker 1: you're just going to take your best guests. I'm on 467 00:23:25,476 --> 00:23:27,716 Speaker 1: the FDAs Vaccine Advisor Committee. These are the questions that 468 00:23:27,756 --> 00:23:29,716 Speaker 1: are going to come before us, probably in the next 469 00:23:29,756 --> 00:23:33,116 Speaker 1: few weeks when we're asked to approve these products through EUA, 470 00:23:33,156 --> 00:23:34,756 Speaker 1: and I think we're going to be looking to approve 471 00:23:34,796 --> 00:23:37,396 Speaker 1: both fisor in Maderna soon. And the other thing is 472 00:23:37,436 --> 00:23:40,316 Speaker 1: I think although ninety four cases was reported by fives 473 00:23:40,316 --> 00:23:42,356 Speaker 1: are in this press release, my sense was they're going 474 00:23:42,396 --> 00:23:43,876 Speaker 1: to have at least one hundred and sixty by the 475 00:23:43,916 --> 00:23:45,996 Speaker 1: time that our committee looks at this and it may 476 00:23:46,036 --> 00:23:49,956 Speaker 1: be also drew from Maderna. So just to clarify the 477 00:23:49,956 --> 00:23:52,876 Speaker 1: EUA as the emergency use authorization, your committee is a 478 00:23:52,876 --> 00:23:55,716 Speaker 1: crucial step because the head of the FDA has said 479 00:23:55,716 --> 00:23:57,876 Speaker 1: they're not going to issue an emergency use authorization unless 480 00:23:57,916 --> 00:24:00,476 Speaker 1: your committee says go for it. So you're an important 481 00:24:00,556 --> 00:24:03,076 Speaker 1: choke point in that structure. When you talk about the 482 00:24:03,116 --> 00:24:05,156 Speaker 1: number ninety four or the number one hundred and sixty, 483 00:24:05,436 --> 00:24:07,956 Speaker 1: clarify what that number refers to for us, Right, So 484 00:24:08,036 --> 00:24:10,756 Speaker 1: what fives are said press releases that they had ninety 485 00:24:10,756 --> 00:24:14,116 Speaker 1: four illnesses among participants and that the vaccine was ninety 486 00:24:14,156 --> 00:24:16,556 Speaker 1: percent effective roughly, So we don't really know the numbers, yeah, 487 00:24:16,596 --> 00:24:18,796 Speaker 1: but let's make them up. Let's assume then that there 488 00:24:18,796 --> 00:24:21,396 Speaker 1: were eighty six cases in the placebo group in eight 489 00:24:21,436 --> 00:24:24,716 Speaker 1: cases in the vaccine group, so that would be ninety 490 00:24:24,756 --> 00:24:28,196 Speaker 1: percent protection. And just to clarify, that's out of forty 491 00:24:28,316 --> 00:24:32,236 Speaker 1: four thousand people, twenty two thousand of whom got the vaccine, 492 00:24:32,276 --> 00:24:33,996 Speaker 1: twenty two thousand of whom did not get the vaccine. 493 00:24:34,036 --> 00:24:36,476 Speaker 1: Because it has to have been evenly divided, right, at least, 494 00:24:36,476 --> 00:24:40,276 Speaker 1: that's a normal practice, that's right, so of forty four 495 00:24:40,276 --> 00:24:43,876 Speaker 1: thousand people, twenty two thousand get the vaccine, eight of 496 00:24:43,916 --> 00:24:49,436 Speaker 1: them get sick roughly on this reconstruction, and only eighty 497 00:24:49,516 --> 00:24:54,556 Speaker 1: six people get the virus of twenty two thousand people 498 00:24:54,596 --> 00:24:57,636 Speaker 1: who are not vaccinated. I mean that is stunningly small 499 00:24:57,676 --> 00:25:00,396 Speaker 1: degree of the number of people, isn't it weirdly small? 500 00:25:00,516 --> 00:25:02,436 Speaker 1: That's why I sort of had mentioned before that they 501 00:25:02,516 --> 00:25:05,316 Speaker 1: may be much more likely to protect themselves by it. It 502 00:25:05,236 --> 00:25:07,316 Speaker 1: It means because we're not helpless here, I mean hygienic 503 00:25:07,316 --> 00:25:10,436 Speaker 1: measures who work, so that maybe that's what's going on. 504 00:25:11,116 --> 00:25:13,676 Speaker 1: If that were true, if your hypothesis were correct, then 505 00:25:13,716 --> 00:25:17,596 Speaker 1: maybe this vaccine is a lot less than effective. That's 506 00:25:17,916 --> 00:25:19,356 Speaker 1: a good point. I think it was your point. I 507 00:25:19,356 --> 00:25:21,836 Speaker 1: didn't mean it to you my point. Then I agree 508 00:25:21,876 --> 00:25:24,076 Speaker 1: with my point. Let's assume, just theoretically, that there were 509 00:25:24,076 --> 00:25:26,036 Speaker 1: eight people in the vaccine group who got sick. Those 510 00:25:26,076 --> 00:25:27,956 Speaker 1: are the people you learn the most from, because you'll 511 00:25:27,956 --> 00:25:29,956 Speaker 1: know whether or not they had an immune response what 512 00:25:30,036 --> 00:25:31,916 Speaker 1: you thought was going to be an adequate immune response 513 00:25:31,956 --> 00:25:34,636 Speaker 1: to the vaccine, if they didn't, if they had didn't 514 00:25:34,636 --> 00:25:36,916 Speaker 1: have a very good neutralizing handibody response I e. And 515 00:25:36,916 --> 00:25:40,356 Speaker 1: antibody response that neutralized virus and effectivity. Then you may 516 00:25:40,396 --> 00:25:43,396 Speaker 1: have an immunological marker. You can say that, look, if 517 00:25:43,436 --> 00:25:45,676 Speaker 1: you don't have this sort of level of immunity in 518 00:25:45,756 --> 00:25:48,076 Speaker 1: response to the vaccine, you may not be protected. On 519 00:25:48,116 --> 00:25:50,276 Speaker 1: the other hand, they may have had an a perfectly 520 00:25:50,276 --> 00:25:53,276 Speaker 1: adequate neutralizing antibode response, in which case you can say, 521 00:25:53,716 --> 00:25:55,996 Speaker 1: maybe the immune response that we thought was associated with 522 00:25:56,036 --> 00:25:59,036 Speaker 1: protection isn't clearly associated with protection. And then it's a 523 00:25:59,036 --> 00:26:01,076 Speaker 1: matter of looking at who those people were the god sick. 524 00:26:01,156 --> 00:26:03,756 Speaker 1: Were they more likely to be over sixty five, did 525 00:26:03,756 --> 00:26:06,316 Speaker 1: they have other healthcare problems, were they of a particular 526 00:26:06,596 --> 00:26:08,876 Speaker 1: racial or ethnic background. That's where you learn the most 527 00:26:09,156 --> 00:26:12,356 Speaker 1: people that got the vaccine still got sick. Should we, 528 00:26:12,516 --> 00:26:15,716 Speaker 1: on the more positive front, have a pretty good indication 529 00:26:16,116 --> 00:26:19,156 Speaker 1: of the lack of bad side effects if twenty two 530 00:26:19,156 --> 00:26:22,436 Speaker 1: thousand people have gotten the vaccine, because presumably if there 531 00:26:22,436 --> 00:26:25,356 Speaker 1: were any really meaningfully bad side effects, we would have 532 00:26:25,396 --> 00:26:27,676 Speaker 1: seen them in this population. That's right. And if you 533 00:26:27,716 --> 00:26:31,076 Speaker 1: look historically at the side effects that have been associated 534 00:26:31,076 --> 00:26:33,556 Speaker 1: with vaccines, whether it's sort of polio from the ro 535 00:26:33,636 --> 00:26:36,956 Speaker 1: polio vaccine or so called vicerotropic disease, which is to say, 536 00:26:37,036 --> 00:26:41,036 Speaker 1: yellow fever following the yellow fever vaccine, or Gambera syndrome, 537 00:26:41,036 --> 00:26:43,916 Speaker 1: which is the ascending paralysis that occurs very rarely after 538 00:26:43,956 --> 00:26:46,556 Speaker 1: flu vaccine, and all of which are extremely rare, and 539 00:26:46,636 --> 00:26:48,956 Speaker 1: they all occur really within six weeks of getting a dose. 540 00:26:48,996 --> 00:26:50,796 Speaker 1: So and the way these trials are now being set 541 00:26:50,876 --> 00:26:53,476 Speaker 1: up is that you can't get in EUA unless you 542 00:26:53,516 --> 00:26:55,876 Speaker 1: follow at least half of the population who was vaccinated 543 00:26:55,916 --> 00:26:59,116 Speaker 1: at least two months after dose two. So what that'll 544 00:26:59,156 --> 00:27:00,756 Speaker 1: tell you is that at least as far as you 545 00:27:00,836 --> 00:27:04,876 Speaker 1: know that you don't have a relatively uncommon severe side effect. 546 00:27:05,076 --> 00:27:08,036 Speaker 1: But twenty thousand people isn't twenty million people. I once 547 00:27:08,076 --> 00:27:10,436 Speaker 1: you put the vaccine out there in twenty million people, 548 00:27:10,556 --> 00:27:12,476 Speaker 1: there may be a very rare side effect that the 549 00:27:12,556 --> 00:27:14,396 Speaker 1: cursent say one in a million people or one in 550 00:27:14,396 --> 00:27:16,516 Speaker 1: five hundred thousand people, that you're not going to pick 551 00:27:16,596 --> 00:27:19,036 Speaker 1: up pre approval. But the good news is there are 552 00:27:19,076 --> 00:27:22,076 Speaker 1: systems in place, like the Vaccine Adverse Events Reporting System, 553 00:27:22,196 --> 00:27:24,596 Speaker 1: or like the Vaccine Safety Data Link, which will pick 554 00:27:24,636 --> 00:27:26,596 Speaker 1: that up and have picked that up in the past. 555 00:27:26,596 --> 00:27:28,356 Speaker 1: So I think people can be reassured that you're looking 556 00:27:28,356 --> 00:27:30,556 Speaker 1: to remember a choice not to get a vaccine. It's 557 00:27:30,556 --> 00:27:32,636 Speaker 1: not a risk free choice. It's just a choice to 558 00:27:32,676 --> 00:27:34,956 Speaker 1: take a different risk. And the question is when do 559 00:27:34,956 --> 00:27:37,236 Speaker 1: you know enough to say that I think that we 560 00:27:37,356 --> 00:27:41,036 Speaker 1: have mitigated a critical amount of risk associated with this vaccine. 561 00:27:41,036 --> 00:27:43,636 Speaker 1: Should I feel better say, as an over sixty five 562 00:27:43,716 --> 00:27:46,916 Speaker 1: year old that ten thousand people are five thousand people 563 00:27:46,916 --> 00:27:48,836 Speaker 1: who are three thousand people who've been vaccinated with the 564 00:27:48,916 --> 00:27:52,196 Speaker 1: vaccine safely knowing that if I get infected with this virus, 565 00:27:52,236 --> 00:27:54,836 Speaker 1: I have a higher chance of dying. It's always a 566 00:27:54,836 --> 00:27:56,516 Speaker 1: matter of risk benefit, and I don't think people see 567 00:27:56,516 --> 00:27:58,076 Speaker 1: it that way. They think that I'm just going to 568 00:27:58,156 --> 00:28:00,556 Speaker 1: take the conservative thing and I'm just going to wait, 569 00:28:00,836 --> 00:28:03,836 Speaker 1: And you know, while you're waiting, you may get infected. Now, 570 00:28:03,876 --> 00:28:06,276 Speaker 1: as you wait, more and more people will get vaccinated, 571 00:28:06,476 --> 00:28:08,716 Speaker 1: and then you have a much bigger platform in which 572 00:28:08,756 --> 00:28:11,756 Speaker 1: to say, I think there really isn't a safety issue here, 573 00:28:11,996 --> 00:28:15,636 Speaker 1: but while you wait, you might suffer the consequences. You've 574 00:28:15,636 --> 00:28:18,996 Speaker 1: just replicated the conversation I have had with my parents recently, 575 00:28:19,276 --> 00:28:22,196 Speaker 1: who are definitely over sixty five. And so I want 576 00:28:22,236 --> 00:28:24,356 Speaker 1: to ask you if you're willing to share what your 577 00:28:24,436 --> 00:28:27,596 Speaker 1: view is of the cost benefit here. I mean, my takeaway, 578 00:28:27,876 --> 00:28:29,956 Speaker 1: and this is what I said to my parents, is 579 00:28:29,956 --> 00:28:32,956 Speaker 1: that because you're in an age group, and they also 580 00:28:33,036 --> 00:28:36,396 Speaker 1: live in New York where if you were to become infected, 581 00:28:36,756 --> 00:28:40,236 Speaker 1: your health outcomes are not great, even with the new 582 00:28:40,276 --> 00:28:42,316 Speaker 1: treatments that are available. I mean, I said it more 583 00:28:42,316 --> 00:28:44,316 Speaker 1: bluntly like that. I said, you know, if you're infected 584 00:28:44,316 --> 00:28:47,036 Speaker 1: and you're over this age, the danger that you could 585 00:28:47,076 --> 00:28:50,516 Speaker 1: become sick and even die is really very high. Therefore, 586 00:28:50,916 --> 00:28:55,276 Speaker 1: I argued, being conservative and waiting in this instance would 587 00:28:55,276 --> 00:28:58,556 Speaker 1: make no sense at all measured by cost benefit, because 588 00:28:58,556 --> 00:29:00,956 Speaker 1: although it's nice in general to be cautious about healthcare, 589 00:29:01,196 --> 00:29:03,916 Speaker 1: in this instance, the side effects have not been shown 590 00:29:03,956 --> 00:29:06,236 Speaker 1: to be particularly bad, and if they were in existence, 591 00:29:06,236 --> 00:29:08,916 Speaker 1: they would be of tiny probability, and it would be 592 00:29:08,996 --> 00:29:11,716 Speaker 1: of very very very minuscule probability that you could be 593 00:29:11,996 --> 00:29:14,476 Speaker 1: so ill as to die from those side effects, whereas 594 00:29:14,476 --> 00:29:17,316 Speaker 1: if you get the virus the possibilities are much greater. 595 00:29:17,756 --> 00:29:21,196 Speaker 1: So that was my argument. I'm wondering was I right? 596 00:29:21,316 --> 00:29:22,916 Speaker 1: I mean, I hope I was right, But if I wasn't, 597 00:29:23,076 --> 00:29:24,556 Speaker 1: I want to know that. So I can take it back. 598 00:29:25,356 --> 00:29:27,196 Speaker 1: What would you say to someone in that situation. No, 599 00:29:27,276 --> 00:29:29,836 Speaker 1: I agree with you completely. I think that's exactly the argument. 600 00:29:29,956 --> 00:29:32,156 Speaker 1: You know, when you do vaccine trials and you go 601 00:29:32,236 --> 00:29:34,356 Speaker 1: from phase one trials of twenty two hundred people to 602 00:29:34,396 --> 00:29:36,556 Speaker 1: face through trials of several hundred people, to face three 603 00:29:36,556 --> 00:29:38,756 Speaker 1: trials of tens of thousands of peach people. Every time 604 00:29:38,796 --> 00:29:40,996 Speaker 1: you do that, you mitigate risk, you lessen the risk. 605 00:29:41,796 --> 00:29:44,956 Speaker 1: You never eliminate the risk, you never know everything. I mean, 606 00:29:44,996 --> 00:29:47,156 Speaker 1: one of the real dangers here is that we could 607 00:29:47,236 --> 00:29:49,596 Speaker 1: have a scenario where we have a pretty darn good 608 00:29:49,676 --> 00:29:54,476 Speaker 1: vaccine that's pretty darn safe, and yet there's some significant 609 00:29:54,516 --> 00:29:57,476 Speaker 1: part of the population that refuses to take it. I 610 00:29:57,516 --> 00:29:59,316 Speaker 1: think what's going to happen Because this vaccine, it's not 611 00:29:59,316 --> 00:30:01,636 Speaker 1: going to be recommended for the general population. Initially, it'll 612 00:30:01,636 --> 00:30:06,156 Speaker 1: be recommended for certain groups like healthcare workers and transportation workers, etc. 613 00:30:06,516 --> 00:30:08,636 Speaker 1: Those groups will start to get that vaccine, and then 614 00:30:08,636 --> 00:30:11,196 Speaker 1: you'll see millions of people have been vaccinated, and then 615 00:30:11,196 --> 00:30:13,796 Speaker 1: you'll see that they're happy they've been vaccinated, that there's 616 00:30:13,796 --> 00:30:16,156 Speaker 1: no serious side effect. You may start to see an 617 00:30:16,196 --> 00:30:19,516 Speaker 1: instance of cases and hospitalizations and deaths start to decrease, 618 00:30:19,676 --> 00:30:21,476 Speaker 1: and people will see that the vaccine is having a 619 00:30:21,516 --> 00:30:24,956 Speaker 1: positive effect, and that, I think, which assure people that 620 00:30:25,156 --> 00:30:27,236 Speaker 1: there doesn't seem to be a problem, and there'll be 621 00:30:27,276 --> 00:30:30,636 Speaker 1: more and more confident in getting the vaccine overtime. So 622 00:30:30,676 --> 00:30:33,476 Speaker 1: that's the happy story, and I desperately hope that you're right. 623 00:30:34,156 --> 00:30:37,236 Speaker 1: One of the reasons I always think that anti vaccination 624 00:30:37,516 --> 00:30:40,796 Speaker 1: people manage to have the effect that they do have 625 00:30:41,116 --> 00:30:43,836 Speaker 1: is that they're often free riding. You know that, in effect, 626 00:30:43,876 --> 00:30:46,476 Speaker 1: there are some diseases that are the prevalences which is 627 00:30:46,516 --> 00:30:49,156 Speaker 1: so low as a result or broad vaccination that some 628 00:30:49,196 --> 00:30:50,996 Speaker 1: people say, well, I'm not going to get the vaccine 629 00:30:51,036 --> 00:30:52,276 Speaker 1: and watch, I'm not going to get sick, And they 630 00:30:52,356 --> 00:30:55,356 Speaker 1: might not get sick because the vaccine has effectively reduced 631 00:30:55,356 --> 00:30:56,996 Speaker 1: the prevalence of the disease such that they're not very 632 00:30:56,996 --> 00:30:59,836 Speaker 1: likely to be exposed. Is there a danger of that 633 00:30:59,956 --> 00:31:02,876 Speaker 1: kind of a perceived free rider effect if the first 634 00:31:02,916 --> 00:31:06,036 Speaker 1: responders and others and healthcare workers get the vaccine, if 635 00:31:06,116 --> 00:31:09,396 Speaker 1: numbers start to go down, and then some people say, well, 636 00:31:09,476 --> 00:31:11,316 Speaker 1: now that it's going down, I don't need to be vaccinated. 637 00:31:11,836 --> 00:31:15,316 Speaker 1: I mean, we eliminated measles in the United States. By 638 00:31:15,356 --> 00:31:18,236 Speaker 1: the year two thousand, it's come back because a critical 639 00:31:18,316 --> 00:31:20,596 Speaker 1: number of parents have chosen not to vaccinate their children 640 00:31:20,636 --> 00:31:22,556 Speaker 1: for just that reason. I think they figure, what the 641 00:31:22,596 --> 00:31:25,396 Speaker 1: hell everybody around me is being vaccinated, Why should I 642 00:31:25,396 --> 00:31:28,276 Speaker 1: take the risk and I'll still be protected. When enough 643 00:31:28,316 --> 00:31:31,716 Speaker 1: people make that decision, then the virus thrives. And you 644 00:31:31,796 --> 00:31:33,636 Speaker 1: had a handful of children who were in the Intensive 645 00:31:33,636 --> 00:31:37,996 Speaker 1: care Union in New York hospitals because of severe measles, 646 00:31:38,036 --> 00:31:40,636 Speaker 1: because the parents had made the decision to frankly put 647 00:31:40,636 --> 00:31:42,996 Speaker 1: their children unnecessary risk. And you know, you are a 648 00:31:43,036 --> 00:31:45,596 Speaker 1: member of society. I don't think it's your right to 649 00:31:45,636 --> 00:31:48,156 Speaker 1: catch and transmitted potentially fatal infection. I think you owe 650 00:31:48,196 --> 00:31:50,356 Speaker 1: it not only to yourself or to your children eventually, 651 00:31:50,356 --> 00:31:51,996 Speaker 1: but to the people with whom you come in contact. 652 00:31:51,996 --> 00:31:54,196 Speaker 1: We're remembering that there's five hundred thousand people in this 653 00:31:54,236 --> 00:31:57,076 Speaker 1: country who can't be vaccinated. There can't be vaccinated because 654 00:31:57,116 --> 00:31:59,956 Speaker 1: they're getting cancer chemotherapy, and then some instances now they're 655 00:31:59,996 --> 00:32:02,196 Speaker 1: not going to be vaccinated because they're too young. They 656 00:32:02,236 --> 00:32:05,796 Speaker 1: can't be vaccinated because they're getting biologicals for their chronic diseases. 657 00:32:05,876 --> 00:32:08,916 Speaker 1: So do you have a responsibility to them the answer 658 00:32:08,956 --> 00:32:12,036 Speaker 1: to I mean, in our hospital Children's Hospital of Philadelphia, 659 00:32:12,156 --> 00:32:14,676 Speaker 1: every year we ask our healthcare workers to get a 660 00:32:14,676 --> 00:32:17,076 Speaker 1: flu vaccine. Not just healthcare workers, anybody who could walk 661 00:32:17,076 --> 00:32:20,956 Speaker 1: in the room, dietary, environmental services, anybody. Because you are 662 00:32:21,116 --> 00:32:24,156 Speaker 1: working in a hospital of vulnerable children and it is 663 00:32:24,196 --> 00:32:27,636 Speaker 1: therefore your responsibility to make sure that you protect them. Well, 664 00:32:27,636 --> 00:32:30,156 Speaker 1: you could make the same argument in society. As a 665 00:32:30,196 --> 00:32:32,956 Speaker 1: member of society, it's your obligation to protect those around. 666 00:32:33,756 --> 00:32:35,276 Speaker 1: Could you just say a word about the half a 667 00:32:35,276 --> 00:32:37,916 Speaker 1: million people who we can't vaccinate and what the reasons are, 668 00:32:38,076 --> 00:32:40,716 Speaker 1: what's not safe for them to have their vaccine. Five 669 00:32:40,836 --> 00:32:44,076 Speaker 1: hundred thousand people in this country are receiving biologicals, you know, 670 00:32:44,196 --> 00:32:47,716 Speaker 1: things like monoclonal antibodies, because they have chronic disease, because 671 00:32:47,756 --> 00:32:50,716 Speaker 1: they have psoriasis or arthritis or whatever. And a lot 672 00:32:50,716 --> 00:32:53,036 Speaker 1: of people who are on chemotherapy for cancer, they too 673 00:32:53,076 --> 00:32:55,276 Speaker 1: can't get vaccines because it wouldn't work in them because 674 00:32:55,276 --> 00:32:57,636 Speaker 1: their immune systems are suppressed. Some people are born with 675 00:32:57,676 --> 00:33:00,796 Speaker 1: immune systems that don't work. So that involves about five 676 00:33:00,876 --> 00:33:04,196 Speaker 1: hundred thousand people in this population. Roughly three hundred and 677 00:33:04,196 --> 00:33:07,396 Speaker 1: thirty million, And they depend on the herd. They depend 678 00:33:07,436 --> 00:33:09,556 Speaker 1: on those around them to protect them. And when the 679 00:33:09,596 --> 00:33:12,316 Speaker 1: herd says I don't care about you, they're the ones 680 00:33:12,356 --> 00:33:15,236 Speaker 1: who are often the first to suffer these diseases. Last, 681 00:33:15,236 --> 00:33:17,316 Speaker 1: but not least. What's it kind of feel like in 682 00:33:17,356 --> 00:33:19,716 Speaker 1: the room when your committee meets? What does it usually 683 00:33:19,716 --> 00:33:21,276 Speaker 1: feel like when you're committee meets. I guess it'll be 684 00:33:21,356 --> 00:33:24,836 Speaker 1: virtual because of COVID. Well, we've never had a meeting 685 00:33:24,876 --> 00:33:26,476 Speaker 1: like this, I mean normally, what does it feel like 686 00:33:26,476 --> 00:33:28,596 Speaker 1: in the room. Normally it's it's a group of sort 687 00:33:28,636 --> 00:33:31,996 Speaker 1: of you know, nerdy virologists like myself sitting around talking 688 00:33:31,996 --> 00:33:34,076 Speaker 1: about what flu strange we're going to pick for the 689 00:33:34,196 --> 00:33:36,596 Speaker 1: vaccines for next year. So we haven't at least in 690 00:33:36,596 --> 00:33:39,636 Speaker 1: the last couple of years, licensed a new vaccine that's 691 00:33:39,636 --> 00:33:41,556 Speaker 1: going to be what's happening here, and it's opened to 692 00:33:41,596 --> 00:33:43,836 Speaker 1: the public. Anybody can come to those meetings. But if 693 00:33:43,876 --> 00:33:46,356 Speaker 1: you went to our flu meeting, you'd be bored to death. 694 00:33:46,436 --> 00:33:49,116 Speaker 1: Most likely. We don't have big crowds there. On the 695 00:33:49,116 --> 00:33:51,476 Speaker 1: other hand, when we had our first meeting of the 696 00:33:51,516 --> 00:33:54,156 Speaker 1: FDA's Vaccine Advisor committee regarding these vaccines. It was on 697 00:33:54,196 --> 00:33:57,476 Speaker 1: October twenty second, just to see what criteria we would 698 00:33:57,516 --> 00:34:01,356 Speaker 1: be happy with for approving a vaccine under emergency use authorization, 699 00:34:01,396 --> 00:34:04,236 Speaker 1: and that was televised. I mean, that was on c 700 00:34:04,396 --> 00:34:06,436 Speaker 1: SPAN because there was a lot of interest in seeing it. 701 00:34:06,556 --> 00:34:08,836 Speaker 1: And here again, when we meet, and I suspect we're 702 00:34:08,836 --> 00:34:10,516 Speaker 1: going to be in December, and I suspect we're going 703 00:34:10,596 --> 00:34:12,596 Speaker 1: to be meeting more than once in December and January, 704 00:34:12,916 --> 00:34:16,396 Speaker 1: that too will be televised and people can have public comment, 705 00:34:16,476 --> 00:34:20,036 Speaker 1: because that's true of any federal advisory committee meeting. Those 706 00:34:20,116 --> 00:34:21,876 Speaker 1: have to be open to the public, which is great 707 00:34:21,916 --> 00:34:24,076 Speaker 1: because I think then the public will see the data 708 00:34:24,116 --> 00:34:25,596 Speaker 1: in the same way we see the data, so it 709 00:34:25,636 --> 00:34:28,796 Speaker 1: shouldn't be an issue of transparency. Paul, I just want 710 00:34:28,796 --> 00:34:31,156 Speaker 1: to thank you for your important work with you luck 711 00:34:31,196 --> 00:34:33,876 Speaker 1: in these meetings, and really I just deeply appreciate the 712 00:34:33,876 --> 00:34:36,756 Speaker 1: clarification and the listeners do too, so thank you. Thank 713 00:34:36,796 --> 00:34:45,036 Speaker 1: you very much. That was fun. I appreciate it. I 714 00:34:45,196 --> 00:34:47,676 Speaker 1: learned many fascinating things in the course of my conversation 715 00:34:47,796 --> 00:34:50,156 Speaker 1: with doctor Offitt. The first had to do with the 716 00:34:50,196 --> 00:34:53,036 Speaker 1: basic science, which we've talked about before on this podcast. 717 00:34:53,436 --> 00:34:56,556 Speaker 1: To me, they takeaway here is that mRNA vaccines like 718 00:34:56,756 --> 00:35:00,236 Speaker 1: visors and madernas do not pose the traditional risk of 719 00:35:00,276 --> 00:35:03,436 Speaker 1: actually infecting people with the virus because they're not introducing 720 00:35:03,476 --> 00:35:07,316 Speaker 1: the virus at all into the human system. That seems 721 00:35:07,356 --> 00:35:11,356 Speaker 1: like a very positive fact. Simultaneously, it is true that 722 00:35:11,396 --> 00:35:14,156 Speaker 1: these vaccines may have the side effect on many people 723 00:35:14,236 --> 00:35:17,596 Speaker 1: of giving them twenty four hours of fever and chills, 724 00:35:17,716 --> 00:35:19,796 Speaker 1: and we need to be aware of that and recognize 725 00:35:19,836 --> 00:35:22,676 Speaker 1: that will not be a symptom of COVID. To the contrary, 726 00:35:22,716 --> 00:35:26,076 Speaker 1: it's a symptom that the vaccine is actually doing its work. 727 00:35:26,796 --> 00:35:30,196 Speaker 1: Another crucial takeaway is that the difficulty of delivering at 728 00:35:30,276 --> 00:35:33,076 Speaker 1: least the Fiser vaccine, which has to be stored at 729 00:35:33,076 --> 00:35:38,516 Speaker 1: seventy degrees below zero centigrade, will be very significant. The 730 00:35:38,556 --> 00:35:41,716 Speaker 1: practical difficulty of administering a vaccine that has to be 731 00:35:41,796 --> 00:35:44,756 Speaker 1: kept so cold is going to require, according to doctor Offit, 732 00:35:44,836 --> 00:35:48,556 Speaker 1: the development of new delivery systems and potentially even new 733 00:35:48,596 --> 00:35:52,916 Speaker 1: facilities for doing this. Mr Anda vaccines can be produced 734 00:35:52,916 --> 00:35:55,996 Speaker 1: extremely fast, but their distribution is going to be a 735 00:35:56,036 --> 00:36:00,236 Speaker 1: more subtle matter. A further consequence of my conversation with 736 00:36:00,316 --> 00:36:02,796 Speaker 1: Doctor offit is that I learned that there are half 737 00:36:02,836 --> 00:36:05,036 Speaker 1: a million people in the United States. I didn't know 738 00:36:05,116 --> 00:36:08,196 Speaker 1: that number who are not able to take a vaccine 739 00:36:08,236 --> 00:36:11,236 Speaker 1: of any kind, and therefore are dependent on the rest 740 00:36:11,276 --> 00:36:13,716 Speaker 1: of us to make sure that we take the vaccine, 741 00:36:13,916 --> 00:36:16,636 Speaker 1: to reduce the prevalence of the virus, and to protect 742 00:36:16,636 --> 00:36:21,316 Speaker 1: them via protection of the herd. Last, but by no 743 00:36:21,436 --> 00:36:24,956 Speaker 1: means least, is Doctor Office assessment that if the data 744 00:36:25,036 --> 00:36:27,956 Speaker 1: turn out to be what we've heard from the press release, 745 00:36:28,356 --> 00:36:31,876 Speaker 1: the cost benefit analysis will indicate clearly that people should 746 00:36:32,116 --> 00:36:35,276 Speaker 1: take the vaccine, and that that will be especially true 747 00:36:35,356 --> 00:36:38,956 Speaker 1: of older people who would be very vulnerable to serious, 748 00:36:39,036 --> 00:36:42,516 Speaker 1: serious illness and even death should they catch the stars 749 00:36:42,556 --> 00:36:46,116 Speaker 1: Cove two virus. For me and from my family, that 750 00:36:46,196 --> 00:36:50,276 Speaker 1: takeaway is hugely significant, and I intend to repeat it 751 00:36:50,396 --> 00:36:54,716 Speaker 1: to anyone who will listen. We at Deep Background will 752 00:36:54,756 --> 00:36:57,396 Speaker 1: be taking a Thanksgiving break, so we won't have an 753 00:36:57,396 --> 00:37:00,156 Speaker 1: episode for you next week, but we will be back 754 00:37:00,396 --> 00:37:03,836 Speaker 1: after Thanksgiving. Until the next time I speak to you, 755 00:37:04,396 --> 00:37:09,356 Speaker 1: be careful, be safe, and be well. Deep back Ground 756 00:37:09,396 --> 00:37:11,996 Speaker 1: is brought to you by Pushkin Industries. Our producer is 757 00:37:12,036 --> 00:37:15,836 Speaker 1: Lydia Gencott. Our engineer is Martin Gonzalez, and our showrunner 758 00:37:15,956 --> 00:37:19,756 Speaker 1: is Sophie Crane mckibbon. Theme music by Luis Gera at Pushkin. 759 00:37:19,996 --> 00:37:23,436 Speaker 1: Thanks to Mia Lobell, Julia Barton, Heather Faine, Carlie mcgliori, 760 00:37:23,556 --> 00:37:26,996 Speaker 1: Maggie Taylor, Eric Sandler, and Jacob Weisberg. You can find 761 00:37:26,996 --> 00:37:29,596 Speaker 1: me on Twitter at Noah Arfeld. I also write a 762 00:37:29,596 --> 00:37:32,316 Speaker 1: column for Bloomberg Opinion, which you can find at bloomberg 763 00:37:32,356 --> 00:37:36,596 Speaker 1: dot com slash Feldman. To discover Bloomberg's original slate of podcasts, 764 00:37:36,756 --> 00:37:40,036 Speaker 1: go to Bloomberg dot com slash podcasts, and if you 765 00:37:40,116 --> 00:37:42,476 Speaker 1: liked what you heard today, please write a review or 766 00:37:42,516 --> 00:37:44,796 Speaker 1: tell a friend. This is deep background