Speaker 1: Pushkin from Pushkin Industries. This is Deep Background, the show
Speaker 1: where we explore at the stories behind the stories in
Speaker 1: the news. I'm Noah Feldman. Regular listeners of this podcast
Speaker 1: know that we view one of our chief jobs as
Speaker 1: keeping you updated on the twists and turns of developments
Speaker 1: relating to COVID, in particular when we seem to be
Speaker 1: at a confusing or complex juncture point in the process.
Speaker 1: We are at one of those points now, particularly with
Speaker 1: respect to the question of boosters. Back in August, the
Speaker 1: Biden administration announced that by September twentieth they plan to
Speaker 1: be giving out boosters on a broad scale in the
Speaker 1: United States. Almost immediately, this announcement met with pushback from
Speaker 1: senior career scientists, and then from scientists outside the government,
Speaker 1: and then ultimately from the politically appointed leaders of Scientific
Speaker 1: Agencias events seem to come to a head in the
Speaker 1: last week or so, they were dueling articles in different
Speaker 1: medical journals, the Lancet out of the United Kingdom and
Speaker 1: the New England Journal of Medicine advising, roughly speaking, different
Speaker 1: approaches or paths on the booster question. Then an advisory
Speaker 1: committee of scientists and physicians to the FDA focusing on vaccines,
Speaker 1: had a public meeting last week to discuss these matters. Meanwhile,
Speaker 1: this week, a separate advisory committee, also of independent scientists
Speaker 1: and physicians, that advises the CDC is also expected to
Speaker 1: weigh in. The upshot is a lot of confusion, certainly
Speaker 1: for me, but I think also for many people who
Speaker 1: like me, have been trying to figure out what's going on.
Speaker 1: To help us walk through this confusion and give us
Speaker 1: some clear understanding the process and of the opinions, we're
Speaker 1: turning today to doctor Genevieve Cantor, who is a Research
Speaker 1: Assistant Professor at the Perilman School of Medicine at the
Speaker 1: University of Pennsylvania. Doctor Cantor is trained as an economist,
Speaker 1: which means her central expertise is on the modeling and
Speaker 1: the measuring of causation, precisely the issues at hand today. Furthermore,
Speaker 1: her substantive area of expertise includes regulatory policy and the
Speaker 1: regulation of biomedical technologies, including vaccines, and the relationship between industry, government, politicians,
Speaker 1: and regulators. In short, doctor Cantor is the perfect person
Speaker 1: with whom to get some clarity in these very complex waters.
Speaker 1: Doctor Cantor thank you so much for joining me. Let's
Speaker 1: start with the underlying fascinating challenge of the science here.
Speaker 1: Just in the last week, two studies in highly respected
Speaker 1: places with roughly speaking at least in Layman's terms, contradictory
Speaker 1: messages about boosters, with the Lancet article suggesting that it's
Speaker 1: too soon to recommend boosters for people other than the
Speaker 1: oldest and the most infirm, and then the new England
Speaker 1: Journal study relying on Israel data suggesting that boosters had
Speaker 1: a substantially helpful effect for the part of the population
Speaker 1: that was studied. There. What is a reasonable person to think, right, So,
Speaker 1: the way it would interpret these two new papers is
Speaker 1: that the Journal article reports on one particular case, which
Speaker 1: certainly compelling case in Israel, where Israel launched its third
Speaker 1: vaccination campaign involving boosters, and in that study they staggered
Speaker 1: their role out, initially targeting the sixty plus population, eventually
Speaker 1: reaching the younger population. They found that administering boosters to
Speaker 1: the oldest population did reduce infections as well as severe
Speaker 1: disease and hospitalizations. That's pretty compelling evidence. And although there
Speaker 1: are some critiques that can be made of that study,
Speaker 1: which I'm happy to go into in general. This was
Speaker 1: a study that was presented, as you may know, during
Speaker 1: last week's Friday's f Day Advisory Committee meeting, and on
Speaker 1: the whole, that committee found that study to be compelling.
Speaker 1: The Lancet paper, I would say it doesn't present new information,
Speaker 1: As you said, it's sort of a study of studies.
Speaker 1: I might actually even just say that it's more of
Speaker 1: a framework, a holistic framework how we might consider the
Speaker 1: various pieces of data that we're seeing to justify boosters.
Speaker 1: It addresses do we know whether there's a need at all,
Speaker 1: is it greater among certain populations? How can we interpret
Speaker 1: some of that observational data. It also talks about considerations
Speaker 1: in terms of what impact that booster shot would have
Speaker 1: on either severe disease and hospit realizations or on infections.
Speaker 1: Those are two very distinct and important things. So I
Speaker 1: would consider that less a summary of the existing knowledge,
Speaker 1: but more of here the considerations we need to take
Speaker 1: into account. And perhaps there are also some political purposes
Speaker 1: behind that article, which I'm happy to also get into. Well,
Speaker 1: we need to talk about the political purposes, but again
Speaker 1: I'm trying to the extent we can and it's always
Speaker 1: hard here, and that's one of the reasons this topic
Speaker 1: is so fascinating to differentiate the policy, the regulatory component,
Speaker 1: and the scientific component, and they're intertwined. In my reading
Speaker 1: of the Lancet it sounded to me as though they
Speaker 1: were making a pretty substantive policy point, namely, do not
Speaker 1: jump from the Israeli data, which they had seen preliminary
Speaker 1: versions of, to concluding that we should go out in
Speaker 1: the United States and approve boosters for a wide swath
Speaker 1: of the population, which the Biden administration had already done
Speaker 1: weeks ago, now saying by September twentieth they hoped to
Speaker 1: start approving boosters. And so that's a huge practical difference.
Speaker 1: And just another piece of detail there that seems salient
Speaker 1: to me is that the Lancet study also questioned the
Speaker 1: israel data, not the version that was published a couple
Speaker 1: of days later, but their preliminary version, by pointing to
Speaker 1: some potential methodological flaws in that Israel's study, not that
Speaker 1: they were flaws in the way the study was done,
Speaker 1: but just in the data that was available at the time,
Speaker 1: namely that it was a relatively short period of time
Speaker 1: that was being studied after vaccination, and the fact that
Speaker 1: they bothered to do that in the Lancet study sent
Speaker 1: to me the message that this is really about two
Speaker 1: approaches to boosters, one approach saying full steam ahead, the
Speaker 1: one that the Biden administration had originally taken and now
Speaker 1: seems to be backpedeling from, and the other the more
Speaker 1: cautious Let's wait and see. Let's not acclimate the public
Speaker 1: to thinking that it needs boosters all the time the
Speaker 1: public lose faith in the phenomenology, in the phenomenon of boosters,
Speaker 1: Let's be sure that the data really bear it out.
Speaker 1: And let's not forget that if we have extra doses
Speaker 1: for boosters, maybe we should be using those to send
Speaker 1: them all around the world rather than using them in
Speaker 1: the US on third doses. So I guess I want
Speaker 1: to ask, am I overreading this? I mean, is it
Speaker 1: unfair to say, as I am basically saying from a
Speaker 1: late person's perspective that it seems like they're two pretty
Speaker 1: opposed of viewpoints here. I might take the view that
Speaker 1: it is possible for those who want to push forward
Speaker 1: to see more evidence that might convince them otherwise. You know,
Speaker 1: one of the really surprising things that came out of
Speaker 1: that statement that was issued by those political appointees and
Speaker 1: including the Acting Commissioner of the FDA, CDC director, US
Speaker 1: Surgeon General and IH and so on, is that it's
Speaker 1: not clear that they had all the information that say,
Speaker 1: you know, the FDA Advisory Committee in its review process
Speaker 1: did and I guess I'm up the view that what
Speaker 1: the Lansward article was doing was trying to present additional
Speaker 1: information that might inform you, if you want to characterize it, Oh,
Speaker 1: here's an opposing view of full speed ahead, sort of saying, hey,
Speaker 1: here are some additional considerations you might not have thought about.
Speaker 1: I think one of the most interesting things that came
Speaker 1: out of the Advisory Committee on Friday, in case you
Speaker 1: didn't have the time to watch all eight hours of it,
Speaker 1: was to highlight that one of the pieces of evidence
Speaker 1: that Fiser presented as justifying the need for boosters, they
Speaker 1: had not made that data available to the FDA to review.
Speaker 1: This was one concern that was highlighted in the lanswerd article,
Speaker 1: and it is a concern that maybe those who made
Speaker 1: the political pointies that made the decision to have a
Speaker 1: plan to set a date and to go ahead with
Speaker 1: it may not have fully taken into account. That was
Speaker 1: very helpful. I think it would be helpful for me
Speaker 1: and possibly for listeners to march through for a moment
Speaker 1: all of the different actors who have been involved in this,
Speaker 1: because in preparation for our conversation, I made myself a
Speaker 1: little chart, and I was myself kind of mind blown
Speaker 1: by just how many actors are involved right now. So
Speaker 1: let's take a half step back. First of all, you've
Speaker 1: got the White House, which has the authority to say
Speaker 1: what it plans to do, but not in every case
Speaker 1: the full authority to order the FDA or the CDC
Speaker 1: to dirt and do certain things, because there's a complex
Speaker 1: regulatory procedure a law that they would have to follow.
Speaker 1: So when they say they're going to do something, what
Speaker 1: they mean is we hope this will happen, not we
Speaker 1: can order even our political appointees at the FDA to
Speaker 1: approve things. If it were otherwise than Donald Trump, you
Speaker 1: could have ordered and probably would have ordered, the FDA
Speaker 1: and the CDC to do all sorts of things independent
Speaker 1: of the science. So there's the White House. Then there's
Speaker 1: the f which is in charge of formal approvals of
Speaker 1: new vaccines or new uses for vaccines, and is also
Speaker 1: authorized to issue emergency use authorizations. Then there are career
Speaker 1: scientists as opposed to political appointees within the FDA and
Speaker 1: the Centers for Disease Control. And then last, but not least,
Speaker 1: there is an Advisory Committee on vaccines that advises the
Speaker 1: FDA that's made up of outside physicians and scientists. And
Speaker 1: in the last week it seems like all of these
Speaker 1: actors have been doing things right. There was this meeting
Speaker 1: of the FDA Advisory Committee that's the committee of outsiders.
Speaker 1: But then there was a public statement from a whole
Speaker 1: bunch of political appointees that itself seemed to push a
Speaker 1: little bit against the Biden administration. And then the Biden
Speaker 1: administration itself, through a spokesperson, said well, we were always
Speaker 1: planning to follow the science and we will continue to
Speaker 1: follow the science. But they, of course had been criticized
Speaker 1: for being out ahead of the science on these things.
Speaker 1: So I guess let me start by asking have I
Speaker 1: left out any important actors here? And since you study
Speaker 1: this process for a living, how do you think about
Speaker 1: the different actors here? And they're different roles because this
Speaker 1: is one of those instances where the distribution of political
Speaker 1: authority and regulatory authority has huge practical implications for us
Speaker 1: on a day to day basis. It's going to determine
Speaker 1: whether we're going to get shots in our arms or not,
Speaker 1: and who's going to get them, you know. To add
Speaker 1: more fun to the mix, I would actually add two
Speaker 1: other entities that are parallel to what you mentioned with
Speaker 1: the FDA, So the CDC because we're talking about infectious
Speaker 1: diseases and vaccines in particular, as well as its advisory committee,
Speaker 1: the ACIP, which is the Advisory Committee on Immunization Practices.
Speaker 1: So yes, so they're all interacting. I have the feeling
Speaker 1: in China, where they've vaccinated a billion people, they don't
Speaker 1: have six different is pushing against each other. That's right.
Speaker 1: They either don't or they do, but it's all behind
Speaker 1: the scenes, and then they issue a single statement that
Speaker 1: everyone nods and agrees. In this case, and I think
Speaker 1: it is an unusual case of the interaction between the
Speaker 1: FDA and the CDC because a of the particular condition
Speaker 1: which is infectious, and secondly because of vaccines being the
Speaker 1: issue here as opposed to therapeutics, where then FDA would
Speaker 1: have full authorization for the regulation. And actually one thing
Speaker 1: we've one entity we've also forgotten are the drug companies
Speaker 1: or the manufacturers themselves issuing these vaccines. So boy, in
Speaker 1: terms of summarizing how they all fit together, you know,
Speaker 1: we have a vaccine manufacturer, in this case Viser. They
Speaker 1: have a product of vaccine that's been approved and so
Speaker 1: they submitted that application to the FDA. The FDA can
Speaker 1: make a decision on that application, with or without the
Speaker 1: Advisory Committee consultation. In this case, they've chosen to do that,
Speaker 1: and in general that's considered a good thing. It's generally
Speaker 1: more transparent. Probably perceived it correctly as being less political
Speaker 1: because these are outside experts, they're independent, and they can
Speaker 1: give the recommendation to the FDA. So I would say
Speaker 1: that's one part of this process that's a little unusual
Speaker 1: as well. The FDA doesn't always send applications to the
Speaker 1: Advisory Committee. In fact, you know, our study which covered
Speaker 1: about twenty years of vaccine licensure history, showed that about
Speaker 1: the half of all new vaccine applications are actually sent
Speaker 1: to the Advisory Committee. But Steve Hahn, you know, when
Speaker 1: he was Commissioner, made a commitment to say everything involving
Speaker 1: COVID would go to the Advisory Committee. So that's been
Speaker 1: a big and i think helpful change. So what happened
Speaker 1: last week the Advisory Committee for the FDA men, they
Speaker 1: gave their recommendations, which I'm sure we'll go into. The
Speaker 1: FDA then has to make a decision based on the
Speaker 1: recommendations of the Advisory Committee. Most of the time seventy
Speaker 1: five percent of the time they do follow those recommendations,
Speaker 1: but sometimes significantly they do not. They issue that recommendation
Speaker 1: for the conditions under which the vaccine is able to
Speaker 1: be administered. Advisor can market that product. After that, the
Speaker 1: Advisor Committee to the CDC, which is ACIP, convenes, uses
Speaker 1: its own information, which includes what the FDA saw but
Speaker 1: also actually includes other types of data issues its recommendation,
Speaker 1: and then the CDC can decide to follow it or not.
Speaker 1: Whatever the decides is generally considered vaccine policy for this
Speaker 1: particular vaccine. After that, then the White House comes in
Speaker 1: and to the extent that they can execute a plan
Speaker 1: for distribution help the states to do so. That's where
Speaker 1: their authority lies. So the statement was highly highly unusual.
Speaker 1: They statement they issued in August about we have a
Speaker 1: plan and by the way, we're going to execute at
Speaker 1: September twentieth. Yes, the White statement, that's right, and we
Speaker 1: have a plan. We're going to execute it on September twentieth,
Speaker 1: before the FDA Advisory Committee has reviewed it, before the
Speaker 1: FDA it's made its decision, before the CDC Advisory Committee
Speaker 1: has reviewed it, before the CDC has made its recommendation.
Speaker 1: That's highly unusual. And yes, so that is an anomaly
Speaker 1: in the typical process. That was wildly helpful. I feel
Speaker 1: like I know a lot more than when I started.
Speaker 1: Before we turn to the advisory committee's opinion. I actually
Speaker 1: now have to pause to ask you, is this process
Speaker 1: a good process? I mean that is to say, it
Speaker 1: may be a great process under ordinary circumstances where time
Speaker 1: is not of the essence, where time is of the essence.
Speaker 1: Is this very elaborate, complex, multi step process really value
Speaker 1: adding or is it primarily just about protecting us from
Speaker 1: an administration whether Biden's or Trumps that just says this
Speaker 1: is what we're doing and here's how we're doing it,
Speaker 1: without listening to the scientists. I do believe that process
Speaker 1: is important and that this particular process, which respects external
Speaker 1: expert independent advice through the formal process of advisory committees
Speaker 1: is almost indispensable, especially under these circumstances where public trust
Speaker 1: is important. Can I just pause there for one second, Jenny,
Speaker 1: because I totally agree the contradictory messages, or let's call
Speaker 1: them to be more polite messages in tension with each other,
Speaker 1: even though, as I just explained, I think their contradictory
Speaker 1: I think those are undercutting public trust. I think if
Speaker 1: you want public trust, you want the leading regulatory authorities
Speaker 1: and the scientists to speak publicly to the extent possible
Speaker 1: with one voice. It takes a very sophisticated public to say, well,
Speaker 1: there's real disagreement among epidemiologists and statisticians and scientists, and
Speaker 1: therefore I really trust this process because they're disagreeing with
Speaker 1: each other writing the public eye. I mean hard to
Speaker 1: imagine that in real life, very many actual people have
Speaker 1: such a worldly, sophisticated conception of the value of this
Speaker 1: kind of disagreement. So the alternative that you're proposing is, well,
Speaker 1: do it behind closed doors, you know, have the input,
Speaker 1: have a more streamlined process, or at least under emergency
Speaker 1: conditions have a more streamline process, so that what the
Speaker 1: public hears is the US government is recommending boosters, or
Speaker 1: the US government is not recommending boosters. I'm not recommending that.
Speaker 1: I'm raising that as an alternative. And you yourself mentioned that,
Speaker 1: you know, in the Chinese system, there of course is
Speaker 1: internal disagreement, but it's mostly behind closed doors. But then
Speaker 1: the government does speak with a single voice. It is
Speaker 1: interesting that you're saying that this chaotic process, the way
Speaker 1: it's played out in the public, at least in recent times,
Speaker 1: has ledged you or conjecture that public trust is diminishing.
Speaker 1: You know. My read of the issue is that really
Speaker 1: the tension is between the White House and it's political
Speaker 1: or partisan motives versus the scientists FDA, CDC, and IH
Speaker 1: and so on. And so I read the Lancet article
Speaker 1: as saying, especially since it was written by two career
Speaker 1: scientists who are resigning, as sort of a signal saying,
Speaker 1: you know, we had thought that this political risk that
Speaker 1: we experienced in the previous administration was over, and perhaps
Speaker 1: in its extreme form it is. But you know, there
Speaker 1: are also political risks here, and we'd like to raise
Speaker 1: this issue and also set out a framework for what
Speaker 1: we think should be driving the scientific decision as opposed
Speaker 1: to whatever is driving the White House action. We'll be
Speaker 1: right back. So now you've offered a kind of master
Speaker 1: interpretation of what's going on here for me and for listeners.
Speaker 1: So let me say it back to you, and to
Speaker 1: make sure that I'm hearing what you're saying correctly. What
Speaker 1: I think I hear you saying is actually, although there
Speaker 1: are lots of different actors here, what really matters is
Speaker 1: there two voices. There's the White House, which is elected
Speaker 1: politicians and the people who work for them, who said
Speaker 1: in August we're gonna get boosters out there on September twentieth,
Speaker 1: because we've heard some early reports from Israel that seemed
Speaker 1: like boosters are a good idea, so we're doing it.
Speaker 1: They wanted to get out ahead of it, and then fairly, unifically,
Speaker 1: fairly with one voice, the senior scientists within the government
Speaker 1: and the senior scientists outside the government who advised the
Speaker 1: government are saying in response, WHOA not the right move,
Speaker 1: don't do it right away, Maybe only do it for
Speaker 1: the oldest and potentially sickest people. We're going to have
Speaker 1: to follow a process here, and that's way these things
Speaker 1: should be done. And as you're adding, we thought we
Speaker 1: had to deal with this kind of thing from the
Speaker 1: Trump people, We never imagine we'd have to deal with
Speaker 1: it from the Biden people. And in that context, this
Speaker 1: Lancet article, which as you point out, was written by
Speaker 1: two senior career scientists who announced just before the article
Speaker 1: came out that they would be quote unquote retiring, which
Speaker 1: effectively means resigning, was a kind of way of saying
Speaker 1: to the White House, we can't work with you, guys.
Speaker 1: You know we're gonna We're willing to go down with
Speaker 1: the ship in order to stand up for the processes
Speaker 1: of science. And if that's the interpretation that you're saying,
Speaker 1: that's very clarifying. It's also reassuring. It basically suggests that
Speaker 1: is to say, at least, it's reassuring if you trust
Speaker 1: the scientists, that the scientists are saying, slow down, and
Speaker 1: they will probably win. I mean, we can talk about
Speaker 1: that in a moment too, but it seems like they
Speaker 1: will probably win. Since the public statement by the advisory
Speaker 1: body to the FDA did seem very much to be
Speaker 1: in line with the Lancet article written by among there's
Speaker 1: these two senior career scientists. It is my hope that
Speaker 1: the scientific process will work itself out. And it's even
Speaker 1: more compelling that these external career scientists, Marin Gruber and
Speaker 1: Phil Krause were at the FDA meeting, the Advisor Committee
Speaker 1: Meeting's what they said to tell us what they said. Sure,
Speaker 1: there are two aspects of the booster decision. One is
Speaker 1: to establish the claim that the protection from the initial
Speaker 1: series of two doses is diminishing, and the second is
Speaker 1: a booster shot of the same dose, the same vaccine
Speaker 1: six months later will be effective in increasing protection. So
Speaker 1: there are issues actually with both of those claims, and
Speaker 1: so that's why the Advisor Committee sort of, if you like,
Speaker 1: split the baby the way they did so. In terms
Speaker 1: of establishing the need for boosters, you would think this
Speaker 1: would be pretty straightforward, you know, the measures that we
Speaker 1: are most interested in, is the protection from severe disease
Speaker 1: and hospitalization and death diminishing over time, and is it
Speaker 1: losing its ability to protect against infection and to establish
Speaker 1: the need both basically, what we've what Feiser has appealed to,
Speaker 1: in general, what people supporting boosters have appealed to, are
Speaker 1: these observational studies that have tracked people who got the
Speaker 1: vaccine and compared them to people who didn't, and have
Speaker 1: we seen over time and increase in hospitalizations and severe disease,
Speaker 1: increase in infections. Now, as it happens, we did, you
Speaker 1: would think that, you know, you can do a straightforward inference,
Speaker 1: but it turns out there comes some complicating factors. The
Speaker 1: two big complicating factors are one, at the same time
Speaker 1: that you're seeing increase in hospitalizations in cases, you're also
Speaker 1: seeing the emergence of the delta variant. So you know,
Speaker 1: are we seeing these increase in hospitalizations because of the
Speaker 1: delta variant where the vaccine may not be as effective,
Speaker 1: or because the protection conferred by the vaccine is waning?
Speaker 1: But connection about So this is the part really, I
Speaker 1: think where you're getting to now, where the rubber really
Speaker 1: meets the road. There is this data that suggests inferentially
Speaker 1: that even against delta, you get reduced hospitalizations and reduced
Speaker 1: severity of illness, at least in the older population by
Speaker 1: adding the booster. So even though I hear you when
Speaker 1: you say that it might be delta that's doing it,
Speaker 1: I would have thought that it wouldn't and that sounds plausible.
Speaker 1: I would have thought that that wouldn't matter if we
Speaker 1: know that even under conditions of delta we get some reduction.
Speaker 1: So what's wrong with that straightforward inference? Why is it
Speaker 1: such an implausible inference to say, look, we've got this.
Speaker 1: It's only one study, but it's a relatively powerful study
Speaker 1: with highly statistically significant results. And if we know from
Speaker 1: that study that there were substantial reductions and hospitalization and
Speaker 1: severe illness in that older population, why wouldn't we just
Speaker 1: make the inference even knowing that the inference isn't absolutely
Speaker 1: perfect and that there could be some confounding elements and
Speaker 1: that delta may play a role. Why does that matter?
Speaker 1: If the efficacy seems to be improved even against delta,
Speaker 1: this is a great, great point we can make that inference.
Speaker 1: And the question is for whom can we make that inference?
Speaker 1: Is it for the older population where the evidence seems strongest.
Speaker 1: There does seem to be a lot of evidence for
Speaker 1: the older population seventy five plus sixty plus that it
Speaker 1: is protective against both non delta and delta variants. There
Speaker 1: are two additional factors here. One is, if we want
Speaker 1: to extend it to the sixteen to sixty five. They're
Speaker 1: the evidence is less clear in terms of the actual effect.
Speaker 1: The second thing, and this is where we get into
Speaker 1: the scientific weeds on this is when you get a vaccine,
Speaker 1: there are two immune responses that are elicited. One is
Speaker 1: more of a short term immune response that's mediated by antibodies,
Speaker 1: and then there may also be and one hopes there
Speaker 1: is a longer term immune response which is cell mediated,
Speaker 1: so not antibody mediated, but cellular mediated that tends to
Speaker 1: be later on. Takes a while for these cells to
Speaker 1: get going and to be generated, but it is much
Speaker 1: much more durable now when we see the evidence presented
Speaker 1: by fiz Or, which is actually depended a lot on
Speaker 1: this huge Kaiser population that they tracked, as well as
Speaker 1: their clinical trial which focus only on antibodies, not on
Speaker 1: the memory cells, which are more of a measure of
Speaker 1: the during protection, they saw antibodies declining. Now this is
Speaker 1: not at all surprising. After a month or so, your
Speaker 1: antibodies will decline, but it does not mean that the
Speaker 1: protection has actually decreased, because at the same time your
Speaker 1: cellular immunity is ramping up. And so that was also
Speaker 1: one of the issues is okay, the antibodies are declining,
Speaker 1: but that may not be what we really care about.
Speaker 1: We care about durable immunity, which is mediated by cells.
Speaker 1: Fiser did not present that information. The other reason cellular
Speaker 1: immunity is important is that that also varies. Going back
Speaker 1: to the original question, you know, to whom can we
Speaker 1: make these inferences about protection? And so it is entirely
Speaker 1: possible that we saw the boost response and that's based
Speaker 1: on antibody measures. We saw that, and that antibody response
Speaker 1: it's helpful in populations that don't have a particularly strong
Speaker 1: cellular response, and those particular populations are the immunocompromised. And
Speaker 1: that was the reason the FDA approved the use of
Speaker 1: the booster for immune compromise, you know, last month, and
Speaker 1: also sell you your immunity may be weakened in the
Speaker 1: elderly as well as those at risk of SEVERITYDS, those
Speaker 1: who have commor conditions, those who abies, and so on.
Speaker 1: So that's really the justification. And so you know, I
Speaker 1: think the median, at least the latest version of the
Speaker 1: study had a median follow up time of about two
Speaker 1: and a half months. So is it fair to say
Speaker 1: then that if that data, that two and a half
Speaker 1: month data were extended to say four months or five months,
Speaker 1: are we then going to see all of these scientists
Speaker 1: who were saying slow down, slow down. Are they just
Speaker 1: going to say, Okay, we asked you to slow down,
Speaker 1: Now you slow down. We're happy you slow down. Now
Speaker 1: the data extrapolates, now go ahead and approve boosters for
Speaker 1: I don't know, twenty five and up, thirty five and
Speaker 1: forty and up. Is that really what's going on here? Mean?
Speaker 1: Is this really just a question of speed, because there
Speaker 1: doesn't seem like there's any data actively suggest thing that
Speaker 1: it would be a bad idea to get the boosters.
Speaker 1: It's just that it seems like the scientists are saying,
Speaker 1: don't jump to the conclusion before we fully work through everything.
Speaker 1: So fair enough, I get the point. But in the future,
Speaker 1: if this data extrapolates, are we then going to have
Speaker 1: boosters a standard? So I would say no. I mean,
Speaker 1: on the one hand, that is a sentiment that is
Speaker 1: expressed that we just need more information. It's actually too
Speaker 1: premature to make a decision. I would say that there
Speaker 1: are a couple of additional considerations. So one is this
Speaker 1: is still the sixty plus population, we would have to
Speaker 1: keep an eye on the younger population. And there you know,
Speaker 1: the reason the age changes the calculus is that the
Speaker 1: older you are, the more benefit from protection against severe
Speaker 1: disease that you get from the vaccine. The younger you are,
Speaker 1: you know you're likely to have something mild asymptomatic, but
Speaker 1: the vaccine you may be at increased risk. And we
Speaker 1: saw this with young males increased risk of myocarditis. So
Speaker 1: that risk benefit calculation changes for the young population, so
Speaker 1: it's not simply an extension. The second factor is that
Speaker 1: people are still waiting to see what's happening with breakthrough infections.
Speaker 1: There are people who feel that some aspects of the
Speaker 1: Israeli situation actually don't really apply to the United States
Speaker 1: very well. And one aspect is that Israel, to its credit,
Speaker 1: has been amazing in its immunization coverage, you know, ninety
Speaker 1: five percent of sixty and older, and so the hospitalizations,
Speaker 1: the severe cases that they're seeing are actually primarily breakthrough
Speaker 1: infections of those who have been fully vaccinated. That is
Speaker 1: not the case in the US. In the US, most
Speaker 1: of the hospitalizations are from those who are unvaccinated. So
Speaker 1: we're seeing something very different, And so the question is
Speaker 1: are we better off just incrementally giving to dose people
Speaker 1: an additional boost in general if you wanted to expend
Speaker 1: it to the population where it will have sort of
Speaker 1: a marginal effect but some increased risk, versus targeting the unvaccinated,
Speaker 1: where you might have just a greater marginal return. Jenny,
Speaker 1: I want to just thank you for helping us walk
Speaker 1: through some very complicated waters, and your mastery, both of
Speaker 1: the science and of the complexity of the regulatory side
Speaker 1: is just it's a god send to us. So thank
Speaker 1: you very very much for your time and for your
Speaker 1: terrific work. Thank you so much for having me and
Speaker 1: for digging into these really important issues. We'll be right back.
Speaker 1: I am happiest here on deep background when I walk
Speaker 1: into an interview with a lot of confusion at a
Speaker 1: lot of questions, and I feel that the guests that
Speaker 1: we're talking to that week is able to guide me
Speaker 1: through the thicket and help me get much greater clarity.
Speaker 1: This conversation with doctor Genevieve Cantor was to me a
Speaker 1: model of that kind of improvement. Listening to Jenny, a
Speaker 1: clear narrative emerged of the way that the scientific community,
Speaker 1: both inside the government and outside, has been responding to
Speaker 1: the Biden administration's aggressive push to move in the direction
Speaker 1: of many boosters for many people very quickly. What I
Speaker 1: heard from Jenny is that the scientists think that this
Speaker 1: process is just going too quickly and is relying on
Speaker 1: a rapid mode inference from a relatively limited amount of
Speaker 1: data drawn from Israel on an older population to conclude
Speaker 1: prematurely that we all ought to be getting boosters as
Speaker 1: fast as possible. It's not only that the scientists think
Speaker 1: that the Biden administration moved too fast. It's also that
Speaker 1: they were frustrated that this administration, which pledges to follow
Speaker 1: the science, was actually out ahead of the science, substantially
Speaker 1: ahead of the science. As a consequence, the scientists are
Speaker 1: pushing or a slowdown for the gathering of more information
Speaker 1: and for the gathering of more data. The particular issue
Speaker 1: on which the focus seems to be most precisely is
Speaker 1: the question of whether the boosters are actually going to
Speaker 1: be very helpful in preventing serious disease and hospitalization in
Speaker 1: the population that isn't immunocompromised and isn't much older. That
Speaker 1: is to say, the population that is capable of having
Speaker 1: its body and its own immune system respond well in
Speaker 1: the wake of two shots and eventually be able to
Speaker 1: prevent disease in its more aggressive forms. Jenny also made
Speaker 1: the point that it may well be that none of
Speaker 1: the vaccines that we presently have are going to do
Speaker 1: a very good job against the possibility of passing along COVID. Rather,
Speaker 1: what they do a good job of, and they do
Speaker 1: a terrific job so far, is preventing serious illness and hospitalization.
Speaker 1: If that's the goal, then that is what we need
Speaker 1: to measure, and we need to measure it in a
Speaker 1: broader part of the population, not only among those who
Speaker 1: have weaker immune systems the way that older people statistically
Speaker 1: tend to do. It follows, says Jenny, that we should
Speaker 1: not assume that the data that exists will necessarily extrapolate
Speaker 1: to draw the conclusion that we should broadly have boosters
Speaker 1: for all that, truly, she says, remains to be seen.
Speaker 1: Will continue to watch this ongoing story here on deep background,
Speaker 1: will look for the CDC Advisory Committee's reports in the
Speaker 1: middle of this week, and I promise you that as
Speaker 1: this issue plays itself out and we get greater clarity
Speaker 1: on the Biden administration's overall policy and approach to boosters.
Speaker 1: We will revisit the issue for you here on Deep Background.
Speaker 1: Until the next time I speak to you. Breathe deep, think,
Speaker 1: deep thoughts, and booster or otherwise try to have a
Speaker 1: little fun. Deep Background is brought to you by Pushkin Industries.
Speaker 1: Our producer is Mola Board, our engineer is Ben Tolliday,
Speaker 1: and our showrunner is Sophie Crane mckibbon. Editorial support from
Speaker 1: noahm Osband. Theme music by Luis Gara at Pushkin. Thanks
Speaker 1: to Mia Lobell, Julia Barton, Lydia, Jean Coott, Heather Faine,
Speaker 1: Carlie Migliori, Maggie Taylor, Eric Sandler, and Jacob Weissberg. You
Speaker 1: can find me on Twitter at Noah R. Feldman. I
Speaker 1: also write a column from Bloomberg Opinion, which you can
Speaker 1: find at Bloomberg dot com slash Feldman. To discover Bloomberg's
Speaker 1: original slate of podcasts, go to Bloomberg dot com slash podcasts,
Speaker 1: and if you liked what you heard today, please write
Speaker 1: a review or tell a friend. This is Deep Background.