1 00:00:15,396 --> 00:00:24,236 Speaker 1: Pushkin from Pushkin Industries. This is Deep Background, the show 2 00:00:24,276 --> 00:00:27,276 Speaker 1: where we explore at the stories behind the stories in 3 00:00:27,276 --> 00:00:32,076 Speaker 1: the news. I'm Noah Feldman. Regular listeners of this podcast 4 00:00:32,196 --> 00:00:35,196 Speaker 1: know that we view one of our chief jobs as 5 00:00:35,356 --> 00:00:39,116 Speaker 1: keeping you updated on the twists and turns of developments 6 00:00:39,156 --> 00:00:42,876 Speaker 1: relating to COVID, in particular when we seem to be 7 00:00:42,956 --> 00:00:47,796 Speaker 1: at a confusing or complex juncture point in the process. 8 00:00:48,436 --> 00:00:52,476 Speaker 1: We are at one of those points now, particularly with 9 00:00:52,516 --> 00:00:56,756 Speaker 1: respect to the question of boosters. Back in August, the 10 00:00:56,796 --> 00:01:00,196 Speaker 1: Biden administration announced that by September twentieth they plan to 11 00:01:00,236 --> 00:01:02,516 Speaker 1: be giving out boosters on a broad scale in the 12 00:01:02,596 --> 00:01:08,036 Speaker 1: United States. Almost immediately, this announcement met with pushback from 13 00:01:08,156 --> 00:01:13,076 Speaker 1: senior career scientists, and then from scientists outside the government, 14 00:01:13,396 --> 00:01:17,276 Speaker 1: and then ultimately from the politically appointed leaders of Scientific 15 00:01:17,396 --> 00:01:21,076 Speaker 1: Agencias events seem to come to a head in the 16 00:01:21,156 --> 00:01:24,996 Speaker 1: last week or so, they were dueling articles in different 17 00:01:25,036 --> 00:01:27,956 Speaker 1: medical journals, the Lancet out of the United Kingdom and 18 00:01:27,996 --> 00:01:31,476 Speaker 1: the New England Journal of Medicine advising, roughly speaking, different 19 00:01:31,516 --> 00:01:35,556 Speaker 1: approaches or paths on the booster question. Then an advisory 20 00:01:35,596 --> 00:01:40,916 Speaker 1: committee of scientists and physicians to the FDA focusing on vaccines, 21 00:01:41,156 --> 00:01:44,716 Speaker 1: had a public meeting last week to discuss these matters. Meanwhile, 22 00:01:44,876 --> 00:01:49,156 Speaker 1: this week, a separate advisory committee, also of independent scientists 23 00:01:49,156 --> 00:01:53,476 Speaker 1: and physicians, that advises the CDC is also expected to 24 00:01:53,516 --> 00:01:58,476 Speaker 1: weigh in. The upshot is a lot of confusion, certainly 25 00:01:58,516 --> 00:02:01,276 Speaker 1: for me, but I think also for many people who 26 00:02:01,396 --> 00:02:03,796 Speaker 1: like me, have been trying to figure out what's going on. 27 00:02:04,556 --> 00:02:07,396 Speaker 1: To help us walk through this confusion and give us 28 00:02:07,476 --> 00:02:11,716 Speaker 1: some clear understanding the process and of the opinions, we're 29 00:02:11,716 --> 00:02:15,316 Speaker 1: turning today to doctor Genevieve Cantor, who is a Research 30 00:02:15,356 --> 00:02:18,836 Speaker 1: Assistant Professor at the Perilman School of Medicine at the 31 00:02:18,916 --> 00:02:22,836 Speaker 1: University of Pennsylvania. Doctor Cantor is trained as an economist, 32 00:02:22,836 --> 00:02:26,396 Speaker 1: which means her central expertise is on the modeling and 33 00:02:26,436 --> 00:02:32,236 Speaker 1: the measuring of causation, precisely the issues at hand today. Furthermore, 34 00:02:32,356 --> 00:02:36,996 Speaker 1: her substantive area of expertise includes regulatory policy and the 35 00:02:37,116 --> 00:02:44,516 Speaker 1: regulation of biomedical technologies, including vaccines, and the relationship between industry, government, politicians, 36 00:02:44,516 --> 00:02:48,036 Speaker 1: and regulators. In short, doctor Cantor is the perfect person 37 00:02:48,236 --> 00:02:52,116 Speaker 1: with whom to get some clarity in these very complex waters. 38 00:02:52,556 --> 00:02:57,676 Speaker 1: Doctor Cantor thank you so much for joining me. Let's 39 00:02:57,756 --> 00:03:02,796 Speaker 1: start with the underlying fascinating challenge of the science here. 40 00:03:02,956 --> 00:03:06,556 Speaker 1: Just in the last week, two studies in highly respected 41 00:03:06,796 --> 00:03:11,076 Speaker 1: places with roughly speaking at least in Layman's terms, contradictory 42 00:03:11,116 --> 00:03:15,876 Speaker 1: messages about boosters, with the Lancet article suggesting that it's 43 00:03:15,876 --> 00:03:19,476 Speaker 1: too soon to recommend boosters for people other than the 44 00:03:19,516 --> 00:03:22,476 Speaker 1: oldest and the most infirm, and then the new England 45 00:03:22,556 --> 00:03:26,436 Speaker 1: Journal study relying on Israel data suggesting that boosters had 46 00:03:26,436 --> 00:03:29,796 Speaker 1: a substantially helpful effect for the part of the population 47 00:03:29,796 --> 00:03:36,076 Speaker 1: that was studied. There. What is a reasonable person to think, right, So, 48 00:03:36,516 --> 00:03:39,796 Speaker 1: the way it would interpret these two new papers is 49 00:03:39,836 --> 00:03:45,076 Speaker 1: that the Journal article reports on one particular case, which 50 00:03:45,156 --> 00:03:49,516 Speaker 1: certainly compelling case in Israel, where Israel launched its third 51 00:03:49,676 --> 00:03:56,356 Speaker 1: vaccination campaign involving boosters, and in that study they staggered 52 00:03:56,356 --> 00:04:01,676 Speaker 1: their role out, initially targeting the sixty plus population, eventually 53 00:04:02,036 --> 00:04:07,796 Speaker 1: reaching the younger population. They found that administering boosters to 54 00:04:08,436 --> 00:04:13,836 Speaker 1: the oldest population did reduce infections as well as severe 55 00:04:14,316 --> 00:04:19,596 Speaker 1: disease and hospitalizations. That's pretty compelling evidence. And although there 56 00:04:19,636 --> 00:04:22,156 Speaker 1: are some critiques that can be made of that study, 57 00:04:22,156 --> 00:04:25,036 Speaker 1: which I'm happy to go into in general. This was 58 00:04:25,036 --> 00:04:27,236 Speaker 1: a study that was presented, as you may know, during 59 00:04:27,396 --> 00:04:31,556 Speaker 1: last week's Friday's f Day Advisory Committee meeting, and on 60 00:04:31,556 --> 00:04:34,476 Speaker 1: the whole, that committee found that study to be compelling. 61 00:04:34,916 --> 00:04:39,756 Speaker 1: The Lancet paper, I would say it doesn't present new information, 62 00:04:39,796 --> 00:04:41,596 Speaker 1: As you said, it's sort of a study of studies. 63 00:04:41,756 --> 00:04:44,756 Speaker 1: I might actually even just say that it's more of 64 00:04:44,796 --> 00:04:48,396 Speaker 1: a framework, a holistic framework how we might consider the 65 00:04:48,476 --> 00:04:52,276 Speaker 1: various pieces of data that we're seeing to justify boosters. 66 00:04:52,476 --> 00:04:55,236 Speaker 1: It addresses do we know whether there's a need at all, 67 00:04:55,556 --> 00:04:59,236 Speaker 1: is it greater among certain populations? How can we interpret 68 00:04:59,396 --> 00:05:03,236 Speaker 1: some of that observational data. It also talks about considerations 69 00:05:03,236 --> 00:05:07,396 Speaker 1: in terms of what impact that booster shot would have 70 00:05:07,556 --> 00:05:10,996 Speaker 1: on either severe disease and hospit realizations or on infections. 71 00:05:11,036 --> 00:05:13,916 Speaker 1: Those are two very distinct and important things. So I 72 00:05:13,956 --> 00:05:17,316 Speaker 1: would consider that less a summary of the existing knowledge, 73 00:05:17,396 --> 00:05:19,836 Speaker 1: but more of here the considerations we need to take 74 00:05:19,876 --> 00:05:24,116 Speaker 1: into account. And perhaps there are also some political purposes 75 00:05:24,156 --> 00:05:27,596 Speaker 1: behind that article, which I'm happy to also get into. Well, 76 00:05:27,636 --> 00:05:29,956 Speaker 1: we need to talk about the political purposes, but again 77 00:05:29,996 --> 00:05:31,876 Speaker 1: I'm trying to the extent we can and it's always 78 00:05:31,916 --> 00:05:33,556 Speaker 1: hard here, and that's one of the reasons this topic 79 00:05:33,636 --> 00:05:38,716 Speaker 1: is so fascinating to differentiate the policy, the regulatory component, 80 00:05:38,836 --> 00:05:42,356 Speaker 1: and the scientific component, and they're intertwined. In my reading 81 00:05:42,436 --> 00:05:45,116 Speaker 1: of the Lancet it sounded to me as though they 82 00:05:45,156 --> 00:05:50,396 Speaker 1: were making a pretty substantive policy point, namely, do not 83 00:05:50,716 --> 00:05:54,436 Speaker 1: jump from the Israeli data, which they had seen preliminary 84 00:05:54,516 --> 00:05:59,116 Speaker 1: versions of, to concluding that we should go out in 85 00:05:59,116 --> 00:06:03,156 Speaker 1: the United States and approve boosters for a wide swath 86 00:06:03,396 --> 00:06:06,876 Speaker 1: of the population, which the Biden administration had already done 87 00:06:07,276 --> 00:06:11,156 Speaker 1: weeks ago, now saying by September twentieth they hoped to 88 00:06:11,156 --> 00:06:15,956 Speaker 1: start approving boosters. And so that's a huge practical difference. 89 00:06:15,996 --> 00:06:19,676 Speaker 1: And just another piece of detail there that seems salient 90 00:06:19,716 --> 00:06:23,756 Speaker 1: to me is that the Lancet study also questioned the 91 00:06:23,876 --> 00:06:27,716 Speaker 1: israel data, not the version that was published a couple 92 00:06:27,756 --> 00:06:30,636 Speaker 1: of days later, but their preliminary version, by pointing to 93 00:06:30,716 --> 00:06:34,996 Speaker 1: some potential methodological flaws in that Israel's study, not that 94 00:06:35,036 --> 00:06:36,796 Speaker 1: they were flaws in the way the study was done, 95 00:06:36,836 --> 00:06:39,076 Speaker 1: but just in the data that was available at the time, 96 00:06:39,396 --> 00:06:41,476 Speaker 1: namely that it was a relatively short period of time 97 00:06:41,676 --> 00:06:44,476 Speaker 1: that was being studied after vaccination, and the fact that 98 00:06:44,476 --> 00:06:47,876 Speaker 1: they bothered to do that in the Lancet study sent 99 00:06:48,036 --> 00:06:51,716 Speaker 1: to me the message that this is really about two 100 00:06:51,756 --> 00:06:56,756 Speaker 1: approaches to boosters, one approach saying full steam ahead, the 101 00:06:56,796 --> 00:06:59,156 Speaker 1: one that the Biden administration had originally taken and now 102 00:06:59,196 --> 00:07:02,796 Speaker 1: seems to be backpedeling from, and the other the more 103 00:07:02,836 --> 00:07:06,876 Speaker 1: cautious Let's wait and see. Let's not acclimate the public 104 00:07:06,916 --> 00:07:09,436 Speaker 1: to thinking that it needs boosters all the time the 105 00:07:09,476 --> 00:07:13,756 Speaker 1: public lose faith in the phenomenology, in the phenomenon of boosters, 106 00:07:14,556 --> 00:07:17,756 Speaker 1: Let's be sure that the data really bear it out. 107 00:07:17,796 --> 00:07:19,996 Speaker 1: And let's not forget that if we have extra doses 108 00:07:20,036 --> 00:07:22,356 Speaker 1: for boosters, maybe we should be using those to send 109 00:07:22,356 --> 00:07:25,756 Speaker 1: them all around the world rather than using them in 110 00:07:25,756 --> 00:07:28,796 Speaker 1: the US on third doses. So I guess I want 111 00:07:28,796 --> 00:07:31,276 Speaker 1: to ask, am I overreading this? I mean, is it 112 00:07:31,356 --> 00:07:34,236 Speaker 1: unfair to say, as I am basically saying from a 113 00:07:34,316 --> 00:07:37,196 Speaker 1: late person's perspective that it seems like they're two pretty 114 00:07:37,196 --> 00:07:40,916 Speaker 1: opposed of viewpoints here. I might take the view that 115 00:07:40,956 --> 00:07:46,276 Speaker 1: it is possible for those who want to push forward 116 00:07:46,996 --> 00:07:53,156 Speaker 1: to see more evidence that might convince them otherwise. You know, 117 00:07:53,196 --> 00:07:55,516 Speaker 1: one of the really surprising things that came out of 118 00:07:55,516 --> 00:07:59,276 Speaker 1: that statement that was issued by those political appointees and 119 00:07:59,516 --> 00:08:04,636 Speaker 1: including the Acting Commissioner of the FDA, CDC director, US 120 00:08:04,676 --> 00:08:08,956 Speaker 1: Surgeon General and IH and so on, is that it's 121 00:08:08,956 --> 00:08:12,116 Speaker 1: not clear that they had all the information that say, 122 00:08:12,516 --> 00:08:16,236 Speaker 1: you know, the FDA Advisory Committee in its review process 123 00:08:16,396 --> 00:08:19,796 Speaker 1: did and I guess I'm up the view that what 124 00:08:19,956 --> 00:08:24,236 Speaker 1: the Lansward article was doing was trying to present additional 125 00:08:24,276 --> 00:08:28,716 Speaker 1: information that might inform you, if you want to characterize it, Oh, 126 00:08:28,756 --> 00:08:31,916 Speaker 1: here's an opposing view of full speed ahead, sort of saying, hey, 127 00:08:32,156 --> 00:08:35,076 Speaker 1: here are some additional considerations you might not have thought about. 128 00:08:35,316 --> 00:08:37,636 Speaker 1: I think one of the most interesting things that came 129 00:08:37,636 --> 00:08:40,276 Speaker 1: out of the Advisory Committee on Friday, in case you 130 00:08:40,356 --> 00:08:42,796 Speaker 1: didn't have the time to watch all eight hours of it, 131 00:08:42,836 --> 00:08:46,116 Speaker 1: was to highlight that one of the pieces of evidence 132 00:08:46,196 --> 00:08:50,756 Speaker 1: that Fiser presented as justifying the need for boosters, they 133 00:08:50,796 --> 00:08:54,436 Speaker 1: had not made that data available to the FDA to review. 134 00:08:54,836 --> 00:08:57,436 Speaker 1: This was one concern that was highlighted in the lanswerd article, 135 00:08:57,836 --> 00:09:00,956 Speaker 1: and it is a concern that maybe those who made 136 00:09:00,956 --> 00:09:04,036 Speaker 1: the political pointies that made the decision to have a 137 00:09:04,116 --> 00:09:06,116 Speaker 1: plan to set a date and to go ahead with 138 00:09:06,156 --> 00:09:09,996 Speaker 1: it may not have fully taken into account. That was 139 00:09:10,076 --> 00:09:12,196 Speaker 1: very helpful. I think it would be helpful for me 140 00:09:12,436 --> 00:09:16,196 Speaker 1: and possibly for listeners to march through for a moment 141 00:09:16,316 --> 00:09:19,156 Speaker 1: all of the different actors who have been involved in this, 142 00:09:19,516 --> 00:09:22,396 Speaker 1: because in preparation for our conversation, I made myself a 143 00:09:22,476 --> 00:09:25,116 Speaker 1: little chart, and I was myself kind of mind blown 144 00:09:25,156 --> 00:09:27,236 Speaker 1: by just how many actors are involved right now. So 145 00:09:27,316 --> 00:09:30,716 Speaker 1: let's take a half step back. First of all, you've 146 00:09:30,756 --> 00:09:34,796 Speaker 1: got the White House, which has the authority to say 147 00:09:34,796 --> 00:09:36,956 Speaker 1: what it plans to do, but not in every case 148 00:09:36,996 --> 00:09:40,796 Speaker 1: the full authority to order the FDA or the CDC 149 00:09:40,956 --> 00:09:43,796 Speaker 1: to dirt and do certain things, because there's a complex 150 00:09:43,916 --> 00:09:47,956 Speaker 1: regulatory procedure a law that they would have to follow. 151 00:09:47,996 --> 00:09:49,396 Speaker 1: So when they say they're going to do something, what 152 00:09:49,436 --> 00:09:52,476 Speaker 1: they mean is we hope this will happen, not we 153 00:09:52,556 --> 00:09:56,076 Speaker 1: can order even our political appointees at the FDA to 154 00:09:56,436 --> 00:10:00,076 Speaker 1: approve things. If it were otherwise than Donald Trump, you 155 00:10:00,516 --> 00:10:02,716 Speaker 1: could have ordered and probably would have ordered, the FDA 156 00:10:02,716 --> 00:10:04,556 Speaker 1: and the CDC to do all sorts of things independent 157 00:10:04,556 --> 00:10:07,636 Speaker 1: of the science. So there's the White House. Then there's 158 00:10:07,636 --> 00:10:15,836 Speaker 1: the f which is in charge of formal approvals of 159 00:10:16,596 --> 00:10:20,396 Speaker 1: new vaccines or new uses for vaccines, and is also 160 00:10:20,676 --> 00:10:26,196 Speaker 1: authorized to issue emergency use authorizations. Then there are career 161 00:10:26,276 --> 00:10:30,196 Speaker 1: scientists as opposed to political appointees within the FDA and 162 00:10:30,236 --> 00:10:34,236 Speaker 1: the Centers for Disease Control. And then last, but not least, 163 00:10:34,796 --> 00:10:39,716 Speaker 1: there is an Advisory Committee on vaccines that advises the 164 00:10:39,756 --> 00:10:44,196 Speaker 1: FDA that's made up of outside physicians and scientists. And 165 00:10:44,276 --> 00:10:46,356 Speaker 1: in the last week it seems like all of these 166 00:10:46,396 --> 00:10:49,236 Speaker 1: actors have been doing things right. There was this meeting 167 00:10:49,356 --> 00:10:52,196 Speaker 1: of the FDA Advisory Committee that's the committee of outsiders. 168 00:10:52,396 --> 00:10:54,596 Speaker 1: But then there was a public statement from a whole 169 00:10:54,636 --> 00:10:57,476 Speaker 1: bunch of political appointees that itself seemed to push a 170 00:10:57,516 --> 00:11:00,796 Speaker 1: little bit against the Biden administration. And then the Biden 171 00:11:00,836 --> 00:11:05,116 Speaker 1: administration itself, through a spokesperson, said well, we were always 172 00:11:05,116 --> 00:11:07,036 Speaker 1: planning to follow the science and we will continue to 173 00:11:07,036 --> 00:11:09,796 Speaker 1: follow the science. But they, of course had been criticized 174 00:11:09,836 --> 00:11:12,716 Speaker 1: for being out ahead of the science on these things. 175 00:11:13,436 --> 00:11:15,796 Speaker 1: So I guess let me start by asking have I 176 00:11:15,916 --> 00:11:18,996 Speaker 1: left out any important actors here? And since you study 177 00:11:19,076 --> 00:11:22,156 Speaker 1: this process for a living, how do you think about 178 00:11:22,156 --> 00:11:25,636 Speaker 1: the different actors here? And they're different roles because this 179 00:11:25,676 --> 00:11:28,356 Speaker 1: is one of those instances where the distribution of political 180 00:11:28,396 --> 00:11:32,676 Speaker 1: authority and regulatory authority has huge practical implications for us 181 00:11:32,676 --> 00:11:34,676 Speaker 1: on a day to day basis. It's going to determine 182 00:11:35,036 --> 00:11:37,916 Speaker 1: whether we're going to get shots in our arms or not, 183 00:11:38,076 --> 00:11:41,036 Speaker 1: and who's going to get them, you know. To add 184 00:11:41,116 --> 00:11:43,636 Speaker 1: more fun to the mix, I would actually add two 185 00:11:43,676 --> 00:11:47,756 Speaker 1: other entities that are parallel to what you mentioned with 186 00:11:47,836 --> 00:11:51,796 Speaker 1: the FDA, So the CDC because we're talking about infectious 187 00:11:51,836 --> 00:11:56,156 Speaker 1: diseases and vaccines in particular, as well as its advisory committee, 188 00:11:56,396 --> 00:12:00,996 Speaker 1: the ACIP, which is the Advisory Committee on Immunization Practices. 189 00:12:01,476 --> 00:12:05,316 Speaker 1: So yes, so they're all interacting. I have the feeling 190 00:12:05,356 --> 00:12:08,156 Speaker 1: in China, where they've vaccinated a billion people, they don't 191 00:12:08,196 --> 00:12:11,556 Speaker 1: have six different is pushing against each other. That's right. 192 00:12:11,596 --> 00:12:14,836 Speaker 1: They either don't or they do, but it's all behind 193 00:12:14,876 --> 00:12:17,356 Speaker 1: the scenes, and then they issue a single statement that 194 00:12:17,476 --> 00:12:20,876 Speaker 1: everyone nods and agrees. In this case, and I think 195 00:12:20,916 --> 00:12:23,756 Speaker 1: it is an unusual case of the interaction between the 196 00:12:23,756 --> 00:12:27,676 Speaker 1: FDA and the CDC because a of the particular condition 197 00:12:27,796 --> 00:12:32,076 Speaker 1: which is infectious, and secondly because of vaccines being the 198 00:12:32,116 --> 00:12:35,236 Speaker 1: issue here as opposed to therapeutics, where then FDA would 199 00:12:35,276 --> 00:12:38,836 Speaker 1: have full authorization for the regulation. And actually one thing 200 00:12:38,836 --> 00:12:41,756 Speaker 1: we've one entity we've also forgotten are the drug companies 201 00:12:42,076 --> 00:12:47,396 Speaker 1: or the manufacturers themselves issuing these vaccines. So boy, in 202 00:12:47,516 --> 00:12:49,836 Speaker 1: terms of summarizing how they all fit together, you know, 203 00:12:49,996 --> 00:12:53,276 Speaker 1: we have a vaccine manufacturer, in this case Viser. They 204 00:12:53,316 --> 00:12:56,636 Speaker 1: have a product of vaccine that's been approved and so 205 00:12:56,716 --> 00:13:00,756 Speaker 1: they submitted that application to the FDA. The FDA can 206 00:13:00,836 --> 00:13:04,716 Speaker 1: make a decision on that application, with or without the 207 00:13:04,756 --> 00:13:09,396 Speaker 1: Advisory Committee consultation. In this case, they've chosen to do that, 208 00:13:09,756 --> 00:13:12,356 Speaker 1: and in general that's considered a good thing. It's generally 209 00:13:12,356 --> 00:13:16,236 Speaker 1: more transparent. Probably perceived it correctly as being less political 210 00:13:16,396 --> 00:13:21,156 Speaker 1: because these are outside experts, they're independent, and they can 211 00:13:21,156 --> 00:13:24,116 Speaker 1: give the recommendation to the FDA. So I would say 212 00:13:24,196 --> 00:13:26,676 Speaker 1: that's one part of this process that's a little unusual 213 00:13:26,836 --> 00:13:31,916 Speaker 1: as well. The FDA doesn't always send applications to the 214 00:13:31,956 --> 00:13:35,276 Speaker 1: Advisory Committee. In fact, you know, our study which covered 215 00:13:35,316 --> 00:13:39,396 Speaker 1: about twenty years of vaccine licensure history, showed that about 216 00:13:39,396 --> 00:13:42,396 Speaker 1: the half of all new vaccine applications are actually sent 217 00:13:42,436 --> 00:13:45,196 Speaker 1: to the Advisory Committee. But Steve Hahn, you know, when 218 00:13:45,196 --> 00:13:48,636 Speaker 1: he was Commissioner, made a commitment to say everything involving 219 00:13:48,716 --> 00:13:51,556 Speaker 1: COVID would go to the Advisory Committee. So that's been 220 00:13:51,596 --> 00:13:54,876 Speaker 1: a big and i think helpful change. So what happened 221 00:13:54,956 --> 00:13:57,836 Speaker 1: last week the Advisory Committee for the FDA men, they 222 00:13:57,836 --> 00:14:01,396 Speaker 1: gave their recommendations, which I'm sure we'll go into. The 223 00:14:01,436 --> 00:14:04,236 Speaker 1: FDA then has to make a decision based on the 224 00:14:04,276 --> 00:14:08,596 Speaker 1: recommendations of the Advisory Committee. Most of the time seventy 225 00:14:08,596 --> 00:14:11,636 Speaker 1: five percent of the time they do follow those recommendations, 226 00:14:11,636 --> 00:14:15,636 Speaker 1: but sometimes significantly they do not. They issue that recommendation 227 00:14:16,036 --> 00:14:20,236 Speaker 1: for the conditions under which the vaccine is able to 228 00:14:20,236 --> 00:14:24,876 Speaker 1: be administered. Advisor can market that product. After that, the 229 00:14:25,116 --> 00:14:30,236 Speaker 1: Advisor Committee to the CDC, which is ACIP, convenes, uses 230 00:14:30,276 --> 00:14:33,316 Speaker 1: its own information, which includes what the FDA saw but 231 00:14:33,356 --> 00:14:37,236 Speaker 1: also actually includes other types of data issues its recommendation, 232 00:14:38,036 --> 00:14:40,676 Speaker 1: and then the CDC can decide to follow it or not. 233 00:14:41,036 --> 00:14:45,556 Speaker 1: Whatever the decides is generally considered vaccine policy for this 234 00:14:45,636 --> 00:14:49,676 Speaker 1: particular vaccine. After that, then the White House comes in 235 00:14:50,076 --> 00:14:53,036 Speaker 1: and to the extent that they can execute a plan 236 00:14:53,156 --> 00:14:56,636 Speaker 1: for distribution help the states to do so. That's where 237 00:14:56,636 --> 00:15:01,276 Speaker 1: their authority lies. So the statement was highly highly unusual. 238 00:15:01,316 --> 00:15:03,876 Speaker 1: They statement they issued in August about we have a 239 00:15:03,916 --> 00:15:06,076 Speaker 1: plan and by the way, we're going to execute at 240 00:15:06,076 --> 00:15:10,676 Speaker 1: September twentieth. Yes, the White statement, that's right, and we 241 00:15:10,756 --> 00:15:13,596 Speaker 1: have a plan. We're going to execute it on September twentieth, 242 00:15:13,836 --> 00:15:16,876 Speaker 1: before the FDA Advisory Committee has reviewed it, before the 243 00:15:16,956 --> 00:15:20,316 Speaker 1: FDA it's made its decision, before the CDC Advisory Committee 244 00:15:20,356 --> 00:15:23,636 Speaker 1: has reviewed it, before the CDC has made its recommendation. 245 00:15:24,236 --> 00:15:27,796 Speaker 1: That's highly unusual. And yes, so that is an anomaly 246 00:15:28,116 --> 00:15:31,396 Speaker 1: in the typical process. That was wildly helpful. I feel 247 00:15:31,396 --> 00:15:33,476 Speaker 1: like I know a lot more than when I started. 248 00:15:33,676 --> 00:15:37,636 Speaker 1: Before we turn to the advisory committee's opinion. I actually 249 00:15:37,716 --> 00:15:40,916 Speaker 1: now have to pause to ask you, is this process 250 00:15:41,036 --> 00:15:43,516 Speaker 1: a good process? I mean that is to say, it 251 00:15:43,596 --> 00:15:47,356 Speaker 1: may be a great process under ordinary circumstances where time 252 00:15:47,436 --> 00:15:50,636 Speaker 1: is not of the essence, where time is of the essence. 253 00:15:51,076 --> 00:15:55,996 Speaker 1: Is this very elaborate, complex, multi step process really value 254 00:15:55,996 --> 00:15:59,156 Speaker 1: adding or is it primarily just about protecting us from 255 00:15:59,156 --> 00:16:02,316 Speaker 1: an administration whether Biden's or Trumps that just says this 256 00:16:02,356 --> 00:16:04,516 Speaker 1: is what we're doing and here's how we're doing it, 257 00:16:04,836 --> 00:16:09,716 Speaker 1: without listening to the scientists. I do believe that process 258 00:16:09,956 --> 00:16:15,796 Speaker 1: is important and that this particular process, which respects external 259 00:16:16,556 --> 00:16:21,036 Speaker 1: expert independent advice through the formal process of advisory committees 260 00:16:21,316 --> 00:16:28,476 Speaker 1: is almost indispensable, especially under these circumstances where public trust 261 00:16:28,596 --> 00:16:31,516 Speaker 1: is important. Can I just pause there for one second, Jenny, 262 00:16:31,596 --> 00:16:36,196 Speaker 1: because I totally agree the contradictory messages, or let's call 263 00:16:36,236 --> 00:16:38,556 Speaker 1: them to be more polite messages in tension with each other, 264 00:16:38,796 --> 00:16:41,516 Speaker 1: even though, as I just explained, I think their contradictory 265 00:16:41,596 --> 00:16:44,556 Speaker 1: I think those are undercutting public trust. I think if 266 00:16:44,596 --> 00:16:48,316 Speaker 1: you want public trust, you want the leading regulatory authorities 267 00:16:48,316 --> 00:16:51,556 Speaker 1: and the scientists to speak publicly to the extent possible 268 00:16:51,876 --> 00:16:55,916 Speaker 1: with one voice. It takes a very sophisticated public to say, well, 269 00:16:56,036 --> 00:17:01,436 Speaker 1: there's real disagreement among epidemiologists and statisticians and scientists, and 270 00:17:01,476 --> 00:17:04,476 Speaker 1: therefore I really trust this process because they're disagreeing with 271 00:17:04,476 --> 00:17:07,276 Speaker 1: each other writing the public eye. I mean hard to 272 00:17:07,316 --> 00:17:10,316 Speaker 1: imagine that in real life, very many actual people have 273 00:17:10,596 --> 00:17:14,756 Speaker 1: such a worldly, sophisticated conception of the value of this 274 00:17:14,796 --> 00:17:21,436 Speaker 1: kind of disagreement. So the alternative that you're proposing is, well, 275 00:17:21,516 --> 00:17:25,316 Speaker 1: do it behind closed doors, you know, have the input, 276 00:17:25,596 --> 00:17:28,436 Speaker 1: have a more streamlined process, or at least under emergency 277 00:17:28,436 --> 00:17:31,236 Speaker 1: conditions have a more streamline process, so that what the 278 00:17:31,276 --> 00:17:35,276 Speaker 1: public hears is the US government is recommending boosters, or 279 00:17:35,316 --> 00:17:38,956 Speaker 1: the US government is not recommending boosters. I'm not recommending that. 280 00:17:38,996 --> 00:17:41,996 Speaker 1: I'm raising that as an alternative. And you yourself mentioned that, 281 00:17:42,036 --> 00:17:44,556 Speaker 1: you know, in the Chinese system, there of course is 282 00:17:44,596 --> 00:17:48,676 Speaker 1: internal disagreement, but it's mostly behind closed doors. But then 283 00:17:48,676 --> 00:17:52,796 Speaker 1: the government does speak with a single voice. It is 284 00:17:52,836 --> 00:17:56,076 Speaker 1: interesting that you're saying that this chaotic process, the way 285 00:17:56,076 --> 00:17:59,116 Speaker 1: it's played out in the public, at least in recent times, 286 00:17:59,116 --> 00:18:04,156 Speaker 1: has ledged you or conjecture that public trust is diminishing. 287 00:18:04,596 --> 00:18:07,596 Speaker 1: You know. My read of the issue is that really 288 00:18:07,636 --> 00:18:12,516 Speaker 1: the tension is between the White House and it's political 289 00:18:12,636 --> 00:18:18,716 Speaker 1: or partisan motives versus the scientists FDA, CDC, and IH 290 00:18:18,756 --> 00:18:22,476 Speaker 1: and so on. And so I read the Lancet article 291 00:18:22,916 --> 00:18:26,756 Speaker 1: as saying, especially since it was written by two career 292 00:18:26,836 --> 00:18:32,316 Speaker 1: scientists who are resigning, as sort of a signal saying, 293 00:18:32,476 --> 00:18:36,556 Speaker 1: you know, we had thought that this political risk that 294 00:18:36,596 --> 00:18:40,276 Speaker 1: we experienced in the previous administration was over, and perhaps 295 00:18:40,276 --> 00:18:43,436 Speaker 1: in its extreme form it is. But you know, there 296 00:18:43,436 --> 00:18:47,636 Speaker 1: are also political risks here, and we'd like to raise 297 00:18:47,756 --> 00:18:50,276 Speaker 1: this issue and also set out a framework for what 298 00:18:50,316 --> 00:18:54,436 Speaker 1: we think should be driving the scientific decision as opposed 299 00:18:54,436 --> 00:18:59,916 Speaker 1: to whatever is driving the White House action. We'll be 300 00:19:00,036 --> 00:19:12,716 Speaker 1: right back. So now you've offered a kind of master 301 00:19:12,836 --> 00:19:16,036 Speaker 1: interpretation of what's going on here for me and for listeners. 302 00:19:16,236 --> 00:19:18,276 Speaker 1: So let me say it back to you, and to 303 00:19:18,316 --> 00:19:20,916 Speaker 1: make sure that I'm hearing what you're saying correctly. What 304 00:19:20,956 --> 00:19:24,116 Speaker 1: I think I hear you saying is actually, although there 305 00:19:24,156 --> 00:19:26,636 Speaker 1: are lots of different actors here, what really matters is 306 00:19:26,676 --> 00:19:30,436 Speaker 1: there two voices. There's the White House, which is elected 307 00:19:30,436 --> 00:19:32,996 Speaker 1: politicians and the people who work for them, who said 308 00:19:33,036 --> 00:19:35,876 Speaker 1: in August we're gonna get boosters out there on September twentieth, 309 00:19:35,876 --> 00:19:38,596 Speaker 1: because we've heard some early reports from Israel that seemed 310 00:19:38,596 --> 00:19:40,396 Speaker 1: like boosters are a good idea, so we're doing it. 311 00:19:40,396 --> 00:19:44,956 Speaker 1: They wanted to get out ahead of it, and then fairly, unifically, 312 00:19:45,076 --> 00:19:49,836 Speaker 1: fairly with one voice, the senior scientists within the government 313 00:19:50,636 --> 00:19:53,756 Speaker 1: and the senior scientists outside the government who advised the 314 00:19:53,796 --> 00:19:59,476 Speaker 1: government are saying in response, WHOA not the right move, 315 00:20:00,196 --> 00:20:02,436 Speaker 1: don't do it right away, Maybe only do it for 316 00:20:02,476 --> 00:20:05,716 Speaker 1: the oldest and potentially sickest people. We're going to have 317 00:20:05,756 --> 00:20:10,116 Speaker 1: to follow a process here, and that's way these things 318 00:20:10,196 --> 00:20:13,036 Speaker 1: should be done. And as you're adding, we thought we 319 00:20:13,076 --> 00:20:14,316 Speaker 1: had to deal with this kind of thing from the 320 00:20:14,316 --> 00:20:16,436 Speaker 1: Trump people, We never imagine we'd have to deal with 321 00:20:16,476 --> 00:20:20,116 Speaker 1: it from the Biden people. And in that context, this 322 00:20:20,196 --> 00:20:22,236 Speaker 1: Lancet article, which as you point out, was written by 323 00:20:22,276 --> 00:20:25,756 Speaker 1: two senior career scientists who announced just before the article 324 00:20:25,796 --> 00:20:27,676 Speaker 1: came out that they would be quote unquote retiring, which 325 00:20:27,716 --> 00:20:31,916 Speaker 1: effectively means resigning, was a kind of way of saying 326 00:20:31,916 --> 00:20:34,076 Speaker 1: to the White House, we can't work with you, guys. 327 00:20:34,716 --> 00:20:36,476 Speaker 1: You know we're gonna We're willing to go down with 328 00:20:36,516 --> 00:20:39,236 Speaker 1: the ship in order to stand up for the processes 329 00:20:39,236 --> 00:20:41,276 Speaker 1: of science. And if that's the interpretation that you're saying, 330 00:20:42,196 --> 00:20:46,356 Speaker 1: that's very clarifying. It's also reassuring. It basically suggests that 331 00:20:46,396 --> 00:20:47,956 Speaker 1: is to say, at least, it's reassuring if you trust 332 00:20:47,956 --> 00:20:51,916 Speaker 1: the scientists, that the scientists are saying, slow down, and 333 00:20:52,356 --> 00:20:54,276 Speaker 1: they will probably win. I mean, we can talk about 334 00:20:54,276 --> 00:20:55,636 Speaker 1: that in a moment too, but it seems like they 335 00:20:55,676 --> 00:21:01,316 Speaker 1: will probably win. Since the public statement by the advisory 336 00:21:01,356 --> 00:21:05,196 Speaker 1: body to the FDA did seem very much to be 337 00:21:05,276 --> 00:21:09,436 Speaker 1: in line with the Lancet article written by among there's 338 00:21:09,956 --> 00:21:14,676 Speaker 1: these two senior career scientists. It is my hope that 339 00:21:14,716 --> 00:21:18,556 Speaker 1: the scientific process will work itself out. And it's even 340 00:21:18,636 --> 00:21:23,036 Speaker 1: more compelling that these external career scientists, Marin Gruber and 341 00:21:23,276 --> 00:21:26,476 Speaker 1: Phil Krause were at the FDA meeting, the Advisor Committee 342 00:21:26,476 --> 00:21:29,316 Speaker 1: Meeting's what they said to tell us what they said. Sure, 343 00:21:29,716 --> 00:21:34,516 Speaker 1: there are two aspects of the booster decision. One is 344 00:21:34,556 --> 00:21:40,356 Speaker 1: to establish the claim that the protection from the initial 345 00:21:40,436 --> 00:21:45,876 Speaker 1: series of two doses is diminishing, and the second is 346 00:21:46,076 --> 00:21:49,876 Speaker 1: a booster shot of the same dose, the same vaccine 347 00:21:50,436 --> 00:21:55,676 Speaker 1: six months later will be effective in increasing protection. So 348 00:21:55,836 --> 00:21:59,556 Speaker 1: there are issues actually with both of those claims, and 349 00:21:59,636 --> 00:22:02,996 Speaker 1: so that's why the Advisor Committee sort of, if you like, 350 00:22:03,036 --> 00:22:06,196 Speaker 1: split the baby the way they did so. In terms 351 00:22:06,236 --> 00:22:08,996 Speaker 1: of establishing the need for boosters, you would think this 352 00:22:09,156 --> 00:22:12,556 Speaker 1: would be pretty straightforward, you know, the measures that we 353 00:22:12,596 --> 00:22:16,196 Speaker 1: are most interested in, is the protection from severe disease 354 00:22:16,196 --> 00:22:20,516 Speaker 1: and hospitalization and death diminishing over time, and is it 355 00:22:20,716 --> 00:22:24,996 Speaker 1: losing its ability to protect against infection and to establish 356 00:22:25,076 --> 00:22:29,516 Speaker 1: the need both basically, what we've what Feiser has appealed to, 357 00:22:29,796 --> 00:22:33,876 Speaker 1: in general, what people supporting boosters have appealed to, are 358 00:22:33,876 --> 00:22:39,236 Speaker 1: these observational studies that have tracked people who got the 359 00:22:39,316 --> 00:22:42,956 Speaker 1: vaccine and compared them to people who didn't, and have 360 00:22:43,076 --> 00:22:47,196 Speaker 1: we seen over time and increase in hospitalizations and severe disease, 361 00:22:47,436 --> 00:22:51,676 Speaker 1: increase in infections. Now, as it happens, we did, you 362 00:22:51,676 --> 00:22:53,756 Speaker 1: would think that, you know, you can do a straightforward inference, 363 00:22:54,116 --> 00:22:57,556 Speaker 1: but it turns out there comes some complicating factors. The 364 00:22:57,596 --> 00:23:01,196 Speaker 1: two big complicating factors are one, at the same time 365 00:23:01,236 --> 00:23:04,996 Speaker 1: that you're seeing increase in hospitalizations in cases, you're also 366 00:23:05,036 --> 00:23:08,516 Speaker 1: seeing the emergence of the delta variant. So you know, 367 00:23:08,556 --> 00:23:11,236 Speaker 1: are we seeing these increase in hospitalizations because of the 368 00:23:11,276 --> 00:23:14,396 Speaker 1: delta variant where the vaccine may not be as effective, 369 00:23:14,756 --> 00:23:18,476 Speaker 1: or because the protection conferred by the vaccine is waning? 370 00:23:18,876 --> 00:23:21,556 Speaker 1: But connection about So this is the part really, I 371 00:23:21,596 --> 00:23:23,596 Speaker 1: think where you're getting to now, where the rubber really 372 00:23:23,636 --> 00:23:28,156 Speaker 1: meets the road. There is this data that suggests inferentially 373 00:23:28,476 --> 00:23:35,356 Speaker 1: that even against delta, you get reduced hospitalizations and reduced 374 00:23:35,596 --> 00:23:39,316 Speaker 1: severity of illness, at least in the older population by 375 00:23:39,476 --> 00:23:42,916 Speaker 1: adding the booster. So even though I hear you when 376 00:23:42,916 --> 00:23:45,596 Speaker 1: you say that it might be delta that's doing it, 377 00:23:46,116 --> 00:23:48,756 Speaker 1: I would have thought that it wouldn't and that sounds plausible. 378 00:23:48,836 --> 00:23:51,196 Speaker 1: I would have thought that that wouldn't matter if we 379 00:23:51,316 --> 00:23:55,436 Speaker 1: know that even under conditions of delta we get some reduction. 380 00:23:55,516 --> 00:23:59,436 Speaker 1: So what's wrong with that straightforward inference? Why is it 381 00:23:59,516 --> 00:24:03,196 Speaker 1: such an implausible inference to say, look, we've got this. 382 00:24:03,316 --> 00:24:06,916 Speaker 1: It's only one study, but it's a relatively powerful study 383 00:24:06,916 --> 00:24:10,236 Speaker 1: with highly statistically significant results. And if we know from 384 00:24:10,236 --> 00:24:14,156 Speaker 1: that study that there were substantial reductions and hospitalization and 385 00:24:14,196 --> 00:24:18,356 Speaker 1: severe illness in that older population, why wouldn't we just 386 00:24:18,436 --> 00:24:22,036 Speaker 1: make the inference even knowing that the inference isn't absolutely 387 00:24:22,076 --> 00:24:24,916 Speaker 1: perfect and that there could be some confounding elements and 388 00:24:24,996 --> 00:24:28,236 Speaker 1: that delta may play a role. Why does that matter? 389 00:24:29,156 --> 00:24:33,196 Speaker 1: If the efficacy seems to be improved even against delta, 390 00:24:34,476 --> 00:24:38,076 Speaker 1: this is a great, great point we can make that inference. 391 00:24:38,516 --> 00:24:41,796 Speaker 1: And the question is for whom can we make that inference? 392 00:24:42,636 --> 00:24:47,076 Speaker 1: Is it for the older population where the evidence seems strongest. 393 00:24:47,236 --> 00:24:49,676 Speaker 1: There does seem to be a lot of evidence for 394 00:24:49,716 --> 00:24:53,396 Speaker 1: the older population seventy five plus sixty plus that it 395 00:24:53,516 --> 00:24:59,196 Speaker 1: is protective against both non delta and delta variants. There 396 00:24:59,236 --> 00:25:04,876 Speaker 1: are two additional factors here. One is, if we want 397 00:25:04,916 --> 00:25:08,516 Speaker 1: to extend it to the sixteen to sixty five. They're 398 00:25:08,596 --> 00:25:13,996 Speaker 1: the evidence is less clear in terms of the actual effect. 399 00:25:14,436 --> 00:25:16,436 Speaker 1: The second thing, and this is where we get into 400 00:25:16,676 --> 00:25:21,476 Speaker 1: the scientific weeds on this is when you get a vaccine, 401 00:25:21,996 --> 00:25:26,636 Speaker 1: there are two immune responses that are elicited. One is 402 00:25:26,676 --> 00:25:30,276 Speaker 1: more of a short term immune response that's mediated by antibodies, 403 00:25:30,956 --> 00:25:34,196 Speaker 1: and then there may also be and one hopes there 404 00:25:34,316 --> 00:25:38,316 Speaker 1: is a longer term immune response which is cell mediated, 405 00:25:38,396 --> 00:25:43,156 Speaker 1: so not antibody mediated, but cellular mediated that tends to 406 00:25:43,196 --> 00:25:46,076 Speaker 1: be later on. Takes a while for these cells to 407 00:25:46,116 --> 00:25:49,076 Speaker 1: get going and to be generated, but it is much 408 00:25:49,356 --> 00:25:54,156 Speaker 1: much more durable now when we see the evidence presented 409 00:25:54,196 --> 00:25:56,956 Speaker 1: by fiz Or, which is actually depended a lot on 410 00:25:57,076 --> 00:26:00,796 Speaker 1: this huge Kaiser population that they tracked, as well as 411 00:26:00,796 --> 00:26:04,676 Speaker 1: their clinical trial which focus only on antibodies, not on 412 00:26:04,876 --> 00:26:08,636 Speaker 1: the memory cells, which are more of a measure of 413 00:26:08,676 --> 00:26:14,076 Speaker 1: the during protection, they saw antibodies declining. Now this is 414 00:26:14,116 --> 00:26:17,836 Speaker 1: not at all surprising. After a month or so, your 415 00:26:17,836 --> 00:26:21,436 Speaker 1: antibodies will decline, but it does not mean that the 416 00:26:21,476 --> 00:26:25,396 Speaker 1: protection has actually decreased, because at the same time your 417 00:26:25,436 --> 00:26:29,036 Speaker 1: cellular immunity is ramping up. And so that was also 418 00:26:29,076 --> 00:26:31,756 Speaker 1: one of the issues is okay, the antibodies are declining, 419 00:26:32,036 --> 00:26:34,116 Speaker 1: but that may not be what we really care about. 420 00:26:34,156 --> 00:26:37,116 Speaker 1: We care about durable immunity, which is mediated by cells. 421 00:26:37,396 --> 00:26:41,116 Speaker 1: Fiser did not present that information. The other reason cellular 422 00:26:41,156 --> 00:26:44,396 Speaker 1: immunity is important is that that also varies. Going back 423 00:26:44,396 --> 00:26:46,916 Speaker 1: to the original question, you know, to whom can we 424 00:26:46,956 --> 00:26:50,636 Speaker 1: make these inferences about protection? And so it is entirely 425 00:26:50,676 --> 00:26:53,716 Speaker 1: possible that we saw the boost response and that's based 426 00:26:53,716 --> 00:26:57,636 Speaker 1: on antibody measures. We saw that, and that antibody response 427 00:26:57,876 --> 00:27:01,516 Speaker 1: it's helpful in populations that don't have a particularly strong 428 00:27:01,796 --> 00:27:06,636 Speaker 1: cellular response, and those particular populations are the immunocompromised. And 429 00:27:06,676 --> 00:27:11,436 Speaker 1: that was the reason the FDA approved the use of 430 00:27:11,476 --> 00:27:14,636 Speaker 1: the booster for immune compromise, you know, last month, and 431 00:27:14,716 --> 00:27:18,076 Speaker 1: also sell you your immunity may be weakened in the 432 00:27:18,116 --> 00:27:22,396 Speaker 1: elderly as well as those at risk of SEVERITYDS, those 433 00:27:22,436 --> 00:27:25,276 Speaker 1: who have commor conditions, those who abies, and so on. 434 00:27:25,516 --> 00:27:28,796 Speaker 1: So that's really the justification. And so you know, I 435 00:27:28,836 --> 00:27:31,516 Speaker 1: think the median, at least the latest version of the 436 00:27:31,556 --> 00:27:35,356 Speaker 1: study had a median follow up time of about two 437 00:27:35,396 --> 00:27:37,676 Speaker 1: and a half months. So is it fair to say 438 00:27:37,716 --> 00:27:40,596 Speaker 1: then that if that data, that two and a half 439 00:27:40,636 --> 00:27:44,276 Speaker 1: month data were extended to say four months or five months, 440 00:27:44,636 --> 00:27:46,676 Speaker 1: are we then going to see all of these scientists 441 00:27:46,716 --> 00:27:49,436 Speaker 1: who were saying slow down, slow down. Are they just 442 00:27:49,476 --> 00:27:51,556 Speaker 1: going to say, Okay, we asked you to slow down, 443 00:27:51,636 --> 00:27:54,196 Speaker 1: Now you slow down. We're happy you slow down. Now 444 00:27:54,196 --> 00:27:58,596 Speaker 1: the data extrapolates, now go ahead and approve boosters for 445 00:27:59,196 --> 00:28:01,116 Speaker 1: I don't know, twenty five and up, thirty five and 446 00:28:01,356 --> 00:28:03,236 Speaker 1: forty and up. Is that really what's going on here? Mean? 447 00:28:03,276 --> 00:28:05,476 Speaker 1: Is this really just a question of speed, because there 448 00:28:05,516 --> 00:28:10,076 Speaker 1: doesn't seem like there's any data actively suggest thing that 449 00:28:10,156 --> 00:28:12,476 Speaker 1: it would be a bad idea to get the boosters. 450 00:28:12,676 --> 00:28:14,436 Speaker 1: It's just that it seems like the scientists are saying, 451 00:28:14,596 --> 00:28:17,956 Speaker 1: don't jump to the conclusion before we fully work through everything. 452 00:28:17,996 --> 00:28:21,636 Speaker 1: So fair enough, I get the point. But in the future, 453 00:28:21,836 --> 00:28:24,836 Speaker 1: if this data extrapolates, are we then going to have 454 00:28:24,916 --> 00:28:31,276 Speaker 1: boosters a standard? So I would say no. I mean, 455 00:28:31,476 --> 00:28:33,516 Speaker 1: on the one hand, that is a sentiment that is 456 00:28:33,556 --> 00:28:36,476 Speaker 1: expressed that we just need more information. It's actually too 457 00:28:36,556 --> 00:28:39,676 Speaker 1: premature to make a decision. I would say that there 458 00:28:39,676 --> 00:28:44,516 Speaker 1: are a couple of additional considerations. So one is this 459 00:28:44,596 --> 00:28:50,276 Speaker 1: is still the sixty plus population, we would have to 460 00:28:50,596 --> 00:28:54,116 Speaker 1: keep an eye on the younger population. And there you know, 461 00:28:54,316 --> 00:28:57,876 Speaker 1: the reason the age changes the calculus is that the 462 00:28:57,916 --> 00:29:01,356 Speaker 1: older you are, the more benefit from protection against severe 463 00:29:01,436 --> 00:29:04,156 Speaker 1: disease that you get from the vaccine. The younger you are, 464 00:29:04,476 --> 00:29:08,876 Speaker 1: you know you're likely to have something mild asymptomatic, but 465 00:29:09,116 --> 00:29:11,956 Speaker 1: the vaccine you may be at increased risk. And we 466 00:29:11,996 --> 00:29:16,716 Speaker 1: saw this with young males increased risk of myocarditis. So 467 00:29:16,836 --> 00:29:21,196 Speaker 1: that risk benefit calculation changes for the young population, so 468 00:29:21,236 --> 00:29:25,116 Speaker 1: it's not simply an extension. The second factor is that 469 00:29:25,556 --> 00:29:28,916 Speaker 1: people are still waiting to see what's happening with breakthrough infections. 470 00:29:29,316 --> 00:29:32,556 Speaker 1: There are people who feel that some aspects of the 471 00:29:32,596 --> 00:29:36,316 Speaker 1: Israeli situation actually don't really apply to the United States 472 00:29:36,476 --> 00:29:40,836 Speaker 1: very well. And one aspect is that Israel, to its credit, 473 00:29:40,956 --> 00:29:44,996 Speaker 1: has been amazing in its immunization coverage, you know, ninety 474 00:29:45,036 --> 00:29:49,356 Speaker 1: five percent of sixty and older, and so the hospitalizations, 475 00:29:49,396 --> 00:29:53,236 Speaker 1: the severe cases that they're seeing are actually primarily breakthrough 476 00:29:53,276 --> 00:29:56,236 Speaker 1: infections of those who have been fully vaccinated. That is 477 00:29:56,276 --> 00:29:58,876 Speaker 1: not the case in the US. In the US, most 478 00:29:58,916 --> 00:30:02,476 Speaker 1: of the hospitalizations are from those who are unvaccinated. So 479 00:30:02,516 --> 00:30:05,996 Speaker 1: we're seeing something very different, And so the question is 480 00:30:06,036 --> 00:30:10,956 Speaker 1: are we better off just incrementally giving to dose people 481 00:30:11,076 --> 00:30:13,956 Speaker 1: an additional boost in general if you wanted to expend 482 00:30:13,956 --> 00:30:16,076 Speaker 1: it to the population where it will have sort of 483 00:30:16,076 --> 00:30:21,076 Speaker 1: a marginal effect but some increased risk, versus targeting the unvaccinated, 484 00:30:21,076 --> 00:30:25,396 Speaker 1: where you might have just a greater marginal return. Jenny, 485 00:30:25,396 --> 00:30:27,956 Speaker 1: I want to just thank you for helping us walk 486 00:30:27,996 --> 00:30:31,996 Speaker 1: through some very complicated waters, and your mastery, both of 487 00:30:32,036 --> 00:30:35,036 Speaker 1: the science and of the complexity of the regulatory side 488 00:30:35,156 --> 00:30:37,876 Speaker 1: is just it's a god send to us. So thank 489 00:30:37,876 --> 00:30:40,196 Speaker 1: you very very much for your time and for your 490 00:30:40,276 --> 00:30:43,076 Speaker 1: terrific work. Thank you so much for having me and 491 00:30:43,196 --> 00:30:47,276 Speaker 1: for digging into these really important issues. We'll be right back. 492 00:30:57,156 --> 00:30:59,836 Speaker 1: I am happiest here on deep background when I walk 493 00:30:59,876 --> 00:31:02,236 Speaker 1: into an interview with a lot of confusion at a 494 00:31:02,316 --> 00:31:04,516 Speaker 1: lot of questions, and I feel that the guests that 495 00:31:04,556 --> 00:31:07,276 Speaker 1: we're talking to that week is able to guide me 496 00:31:07,476 --> 00:31:10,716 Speaker 1: through the thicket and help me get much greater clarity. 497 00:31:11,156 --> 00:31:15,076 Speaker 1: This conversation with doctor Genevieve Cantor was to me a 498 00:31:15,116 --> 00:31:19,356 Speaker 1: model of that kind of improvement. Listening to Jenny, a 499 00:31:19,476 --> 00:31:23,156 Speaker 1: clear narrative emerged of the way that the scientific community, 500 00:31:23,316 --> 00:31:26,876 Speaker 1: both inside the government and outside, has been responding to 501 00:31:26,956 --> 00:31:30,516 Speaker 1: the Biden administration's aggressive push to move in the direction 502 00:31:30,596 --> 00:31:34,236 Speaker 1: of many boosters for many people very quickly. What I 503 00:31:34,276 --> 00:31:36,676 Speaker 1: heard from Jenny is that the scientists think that this 504 00:31:36,716 --> 00:31:40,196 Speaker 1: process is just going too quickly and is relying on 505 00:31:40,476 --> 00:31:44,436 Speaker 1: a rapid mode inference from a relatively limited amount of 506 00:31:44,516 --> 00:31:48,516 Speaker 1: data drawn from Israel on an older population to conclude 507 00:31:48,516 --> 00:31:51,636 Speaker 1: prematurely that we all ought to be getting boosters as 508 00:31:51,676 --> 00:31:55,116 Speaker 1: fast as possible. It's not only that the scientists think 509 00:31:55,156 --> 00:31:58,156 Speaker 1: that the Biden administration moved too fast. It's also that 510 00:31:58,196 --> 00:32:01,476 Speaker 1: they were frustrated that this administration, which pledges to follow 511 00:32:01,476 --> 00:32:05,236 Speaker 1: the science, was actually out ahead of the science, substantially 512 00:32:05,276 --> 00:32:08,596 Speaker 1: ahead of the science. As a consequence, the scientists are 513 00:32:08,596 --> 00:32:11,796 Speaker 1: pushing or a slowdown for the gathering of more information 514 00:32:11,836 --> 00:32:15,356 Speaker 1: and for the gathering of more data. The particular issue 515 00:32:15,396 --> 00:32:18,036 Speaker 1: on which the focus seems to be most precisely is 516 00:32:18,076 --> 00:32:21,196 Speaker 1: the question of whether the boosters are actually going to 517 00:32:21,236 --> 00:32:25,756 Speaker 1: be very helpful in preventing serious disease and hospitalization in 518 00:32:25,796 --> 00:32:29,836 Speaker 1: the population that isn't immunocompromised and isn't much older. That 519 00:32:29,996 --> 00:32:33,076 Speaker 1: is to say, the population that is capable of having 520 00:32:33,116 --> 00:32:36,556 Speaker 1: its body and its own immune system respond well in 521 00:32:36,596 --> 00:32:39,956 Speaker 1: the wake of two shots and eventually be able to 522 00:32:39,996 --> 00:32:45,076 Speaker 1: prevent disease in its more aggressive forms. Jenny also made 523 00:32:45,116 --> 00:32:48,076 Speaker 1: the point that it may well be that none of 524 00:32:48,116 --> 00:32:50,156 Speaker 1: the vaccines that we presently have are going to do 525 00:32:50,196 --> 00:32:55,316 Speaker 1: a very good job against the possibility of passing along COVID. Rather, 526 00:32:55,476 --> 00:32:57,516 Speaker 1: what they do a good job of, and they do 527 00:32:57,556 --> 00:33:01,956 Speaker 1: a terrific job so far, is preventing serious illness and hospitalization. 528 00:33:02,596 --> 00:33:05,836 Speaker 1: If that's the goal, then that is what we need 529 00:33:05,876 --> 00:33:07,956 Speaker 1: to measure, and we need to measure it in a 530 00:33:08,036 --> 00:33:10,996 Speaker 1: broader part of the population, not only among those who 531 00:33:11,036 --> 00:33:14,516 Speaker 1: have weaker immune systems the way that older people statistically 532 00:33:14,596 --> 00:33:19,236 Speaker 1: tend to do. It follows, says Jenny, that we should 533 00:33:19,276 --> 00:33:23,516 Speaker 1: not assume that the data that exists will necessarily extrapolate 534 00:33:23,596 --> 00:33:27,196 Speaker 1: to draw the conclusion that we should broadly have boosters 535 00:33:27,236 --> 00:33:32,476 Speaker 1: for all that, truly, she says, remains to be seen. 536 00:33:33,476 --> 00:33:37,356 Speaker 1: Will continue to watch this ongoing story here on deep background, 537 00:33:37,636 --> 00:33:41,756 Speaker 1: will look for the CDC Advisory Committee's reports in the 538 00:33:41,756 --> 00:33:44,596 Speaker 1: middle of this week, and I promise you that as 539 00:33:44,716 --> 00:33:47,956 Speaker 1: this issue plays itself out and we get greater clarity 540 00:33:48,196 --> 00:33:51,836 Speaker 1: on the Biden administration's overall policy and approach to boosters. 541 00:33:52,116 --> 00:33:55,596 Speaker 1: We will revisit the issue for you here on Deep Background. 542 00:33:56,636 --> 00:34:00,076 Speaker 1: Until the next time I speak to you. Breathe deep, think, 543 00:34:00,076 --> 00:34:03,756 Speaker 1: deep thoughts, and booster or otherwise try to have a 544 00:34:03,756 --> 00:34:08,116 Speaker 1: little fun. Deep Background is brought to you by Pushkin Industries. 545 00:34:08,356 --> 00:34:11,916 Speaker 1: Our producer is Mola Board, our engineer is Ben Tolliday, 546 00:34:12,076 --> 00:34:16,156 Speaker 1: and our showrunner is Sophie Crane mckibbon. Editorial support from 547 00:34:16,196 --> 00:34:20,356 Speaker 1: noahm Osband. Theme music by Luis Gara at Pushkin. Thanks 548 00:34:20,396 --> 00:34:24,036 Speaker 1: to Mia Lobell, Julia Barton, Lydia, Jean Coott, Heather Faine, 549 00:34:24,276 --> 00:34:29,116 Speaker 1: Carlie Migliori, Maggie Taylor, Eric Sandler, and Jacob Weissberg. You 550 00:34:29,116 --> 00:34:31,676 Speaker 1: can find me on Twitter at Noah R. Feldman. I 551 00:34:31,716 --> 00:34:34,156 Speaker 1: also write a column from Bloomberg Opinion, which you can 552 00:34:34,156 --> 00:34:38,236 Speaker 1: find at Bloomberg dot com slash Feldman. To discover Bloomberg's 553 00:34:38,236 --> 00:34:42,276 Speaker 1: original slate of podcasts, go to Bloomberg dot com slash podcasts, 554 00:34:42,596 --> 00:34:45,116 Speaker 1: and if you liked what you heard today, please write 555 00:34:45,116 --> 00:34:48,836 Speaker 1: a review or tell a friend. This is Deep Background.