Call Me Back - with Dan Senor - How Omicron Stunned The Scientific Community - With Scott Gottlieb

Episode Date: December 17, 2021

What about Omicron has most surprised the scientific community? What does it tell us about vaccines and where we’re heading? These are among the big questions we have for Dr. Scott Gottlieb, former Commissioner of the FDA and author of The New York Times Bestseller: “Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic”. Scott currently serves on the boards of Pfizer, Illumina, Aetion, and Tempus. He is a special partner with the venture capital firm New Enterprise Associates, and a senior fellow at the American Enterprise Institute. You can order Scott Gottlieb’s book here: https://www.barnesandnoble.com/w/uncontrolled-spread-scott-gottlieb/1139568341 And you can follow him on twitter here: @ScottGottliebMD

What happened with this virus was this virus first emerged at some point in 2020. Then all of a sudden the trail goes cold. And then all of a sudden this virus reemerges in November in this heavily mutated form and it starts spreading very quickly in South Africa. So the question is, where was it for, you know, over a year? And that's why this was so surprising, because we thought all the future mutations would be within that Delta lineage. But somewhere in the world was this other strain continuing to mutate and then all of a sudden explodes in South Africa. What are we learning right now about Omicron that has most surprised the scientific community?

What does it tell us about vaccines and where we're heading? These are among the big questions I have for Dr. Scott Gottlieb, former commissioner of the FDA, member of the Pfizer board, author of the New York Times bestseller, Uncontrolled Spread, Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic. And most importantly, a returning guest of our podcast. This is Call Me Back. And I'm pleased to welcome back my friend Scott Gottlieb to the podcast, a regular, a fan favorite for our listeners. Hey, Scott, how are you?

Good, thanks. Thanks for having me. Thrilled to have you. Great to have you back on. Actually, we haven't had you back on since your book, Uncontrolled Spread, was released. I've been meaning to get you on about that, which was excellent. I devoured it. We talked a lot about it while you were writing it. It was great when you were drafting it, and then obviously it was received exceptionally well. But I didn't expect we'd have a new variant to talk about when we had you back on. I just thought we'd be talking about your book.

But I want to start with the big question on everyone's mind the big question is omicron why did we skip all these letters in the greek alphabet and land at omicron we skipped new we skipped xi which could be pronounced as g we why who's choosing these names well Well, the WHO is choosing the names. They actually were asked this question and put out a statement. So they skipped new because they didn't want to call the new variant new. And they skipped Xi because it's a common surname. Right. It's something like over like something like the top 200 surnames in China. Right. As in Xi Jinping.

Right. Exactly, exactly. So it would be like calling it the Trump virus or the Biden virus. Yeah, exactly. All right, so they are very politically astute in their name selection. Although I'll tell you who got screwed in all of this is Macron. Because, you know, I'm sure Macron was calling the WHA saying, but why are you calling it O-Macron? Well, you know who's happy, Delta Airlines.

That is true. But Delta Airlines is not in the middle of a re-election campaign. Macron, a friend of mine from France pointed out that Macron's running for re-election. Some say running for his life. And then he gets a variant named after a version of his name. I don't know if you ever caught one of the earnings calls from the Delta Airlines CEO, but he wouldn't refer to the virus as Delta. He kept referring to it by its number. There you go. There you go. Wow. All right. Okay, so there's a lot I want to cover today, obviously specifically about Omicron, or uh yeah uh or as omicron as the

french call it uh and also i want to talk a little bit about your book because i think there are some learnings from your book that are actually extremely relevant to what's happening now but first last we spoke when you were last on our podcast which was around the time uh of the last variant delta it was just after it arrived on the scene and you had you said that you had serious on our podcast, which was around the time of the last variant, Delta. It was just after it arrived on the scene. And you said that you had serious doubts that the next variant evolving beyond Delta would have much of sort of much evolutionary ammo, that there wasn't much of a path for continued evolution, that the path was extremely narrow. So are you surprised

by the evolution of Omicron, as most of the scientific world seems to have been? Yeah, I am surprised. I had been saying that Delta would be the last major wave of infection and that future mutations would be within the Delta lineage, and we may eventually change the vaccine to make the vaccine a Delta backbone vaccine. The reason why I and others assumed that was because Delta was so highly contagious, it had effectively crowded out other variants. It was hard to envision a variant that was going to be more contagious than Delta, although it was possible. But the evolution of this virus has been along an evolutionary trace. So Delta and all these variants have emerged out of a common set of mutations,

if you will. And the presumption was that Delta was so dominant that Delta itself would start mutating and start finding ways to evade our immune system so that it could continue to spread. In fact, there's probably about at least 20, maybe more different varieties of Delta right now. So in fact, Delta is mutating. Delta is starting to find ways to spread more efficiently, subtly. What happened with this virus was this virus emerged out of a completely different evolutionary tree. And actually,

some of the other variants have done the same thing, which should be a cause for concern. But this one was the most stark in that this virus first emerged at some point in 2020. Then all of a sudden, the trail goes cold. We don't have any record of this virus spreading in the human circulation. And we've sequenced tens of thousands of viruses. So we've been able to sort of track the genealogy, the family tree of these viruses as they've moved around the world. And then all of a sudden, this virus reemerges in November in this heavily mutated form and it starts spreading very quickly. And that's we have all the sequences from the spread in South Africa. So the question is, where was it for, you know, over a year?

Because it wasn't in human circulation. So it had it was sequestered somewhere. And that's why this was so surprising, because we thought all the future mutations would be within that Delta lineage, because Delta was so dominant, everyone had Delta. But somewhere in the world was this other strain continuing to mutate, probably not spreading in human circulation at any appreciable level, and it all of a sudden explodes in South Africa. What functions did it gain? Well, the short answer to that question is we don't know for sure.

I mean, most of these questions about what the impact of the different mutations means is going to be derived from clinical data from actually watching the behavior of the virus. And we don't really have enough data set yet to make firm conclusions. But when you look at the types of gene mutations that it acquired, and when you look at some of its early behavior based on data we're getting out of UK, data we're getting out of South Africa, other parts of the world at this point, it appears to be more transmissible. And it appears that a lot of that enhanced ability to transmit through the human population isn't driven by its innate transmissibility, but by its ability to evade immunity. So the two ways something can spread very quickly is it's either innately more transmissible.

But that's hard because we have baseline immunity. We have a lot of immunity in certain populations, like the UK has a lot of immunity. They have an immunity wall when you consider people who've been vaccinated, people who've been infected and vaccinated, people who've been infected. And because they spread out the length of time between vaccine shots, right? They probably, by giving the first two doses further apart, they probably captured more durability from that. And the other way a virus spreads is by piercing that immunity. And this appears to be spreading largely, maybe primarily, but we don't know, by being able to pierce the baseline immunity that people have. And so just to put that, put it in perspective, based on some of the modeling right now, and I think these estimates are going to come down because I think that some of the assumptions

we've made about this based on the early data are probably a little bit off. And we often overestimate how transmissible a virus is early on. But based on the estimates right now, we are saying that the RT, which is the rate of transfer in the real world, so the R0 is what is the innate transmissibility of a virus. That's called the R0. Measles has an R0 of 12, meaning for every person who gets infected, 12 people will go on to catch that infection. But that's the virus if you took a person who was infected and put them in a crowded room with poor air circulation with people who have no immunity, how many would get infected? Sort of, you know, experimental settings. But in the real world,

people have immunity. People have, you know, innate immunity. People wear masks. People do all kinds of things to avoid getting infected. People are vaccinated. So then you look at the RT. What is the rate of transfer in the real world? We're estimating that the RT of this virus is 3.0, meaning for every person who gets infected in the real world, three people are getting the infection. That's very high. Anything above one means you have an expanding epidemic. To put that in perspective, during the early days of the outbreak of the wuhan strain in new york when new york was crushed before we implemented the mitigation before we got control of that epidemic the rt was about 3.5 during the peak of during the worst days of the epidemic of delta in florida the rt of delta was about 1.6. So three is pretty, pretty high.

What story does Omicron tell you about the future evolution of the COVID virus? Because to your point, we thought we had a theory of the case, right? We thought we had a theory about the evolution. And so does Omicron just jumble for all of us, how we think about its evolutionary path going forward? I think Omicron makes certain truths now self-evident. One is that people who have so-called natural immunity and just got infected with Delta and thought that they were going to be impervious will not be impervious, that the vaccines are going to need to be updated on probably an annual basis, and that this is going to become an end need to be updated on probably an annual basis and that this is going to become an endemic virus. This is not going away. We're not going to get a vaccine that's a one and done vaccine. This isn't like smallpox where you get it once and

you're never going to get it again or like chickenpox. This is more like the flu. And we need to come to grips with that. People have a misconception about what this virus is going to mean for human civilization and human circulation. This is going to be with us. Now, it will settle into a seasonal pattern. It's not going to be this pervasive spread all 12 months of the year. We're sort of still in the pandemic phase. I think 2022 is going to be a transition year between the pandemic and the endemic phase.

So this will become seasonal. It's a coronavirus. Coronaviruses are typically late winter pathogens. It'll coincide with flu season, which is going to be tough. So we're going to have to think differently about respiratory health in the wintertime. But this is not going away because if this has the capacity to mutate both within dominant lineages, so it's mutating within Delta, and then have sort of divergent evolution,

which was this Omicron, this emergence of Omicron, then this virus is going to continue to find ways to elude us. So you're saying basically there's a pattern, right? Virus evolves, you know, kind of 8 to 12 months later, we deploy an adjusted vaccine. And then eight to 12 months later, it evolves further, and we adjust the vaccine further and so on. And that's, are you saying that that could be life for us? You know, for decades to come? I think so. With with one, you know, with two caveats. One is that we get a dominant strain that crowds out all other strains that's largely, I don't want to say benign, but it's less virulent. And that gives everyone a baseline

immunity against a strain that doesn't cause a lot of death and disease. So it sort of evolves into more like a common cold. You know, it's that there's no reason why that will happen. There's no reason why a virus is going to necessarily mutate into a form that's less virulent. It doesn't it doesn't have to go that way. It could go the other way. People sort of assume that as a virus evolves, it becomes less dangerous to a population.

That's not necessarily so. The other possibility, which is why things look less dangerous over time, is that after we've seen this so many times, after we've been vaccinated to it, you know, a couple of years in a row, after we've probably most of us have gotten some kind of infection, either a subclinical or a mildly virulent strain or infection, mildly symptomatic infection, we're going to have so much baseline immunity in the population that even if this thing continues to evolve, it's just not going to represent the same level of threat. And that's kind of what we are hoping we start to see in the UK. You know, if the UK has a really bad experience with this, it's going to portend really concerning things for the United States, because probably the UK and the US are very similar in the fact that they both have a high level of immunity. They have a large immunity wall and they have a large diversity of immunity. You have a lot of people who've been vaccinated,

a lot of people who've been infected and vaccinated, who seem to have the broadest possible immunity. You've had a good number of people who've had three doses at this point. Both countries have rolled out boosters. You've had a lot of people who've just been infected. So if this spreads very rapidly in the UK, which there is some indication it's spreading very quickly in the UK, and it ends up causing a lot of death and disease, that's going to be deeply concerning.

So far, we're not seeing the extreme outcomes from this that we saw from past waves in terms of hospitalizations and deaths. We're not seeing it in South Africa. We're not seeing it in the European early experience. And that may be because we're getting to the point where we have a population now that has a large baseline of immunity. There's one caveat to that. If this spreads in a population that's largely, you know, no longer immune naive, we have vaccines, we've had prior infection, so it doesn't cause a lot of bad outcomes. There are pockets of people in our populations that have neither vaccination nor prior infection. And the biggest pocket of preserved immune exposure is children. Most children haven't been vaccinated, especially

young kids. The prevalence among kids is much lower because we've done a pretty good job sheltering them. So, and you're saying there's a risk that i mean i i often i've said on this podcast that it often feels like divine intervention that that with this pandemic it barely touched children and um had it had it affected children in a more severe way uh it would have completely changed how we dealt with it and thought about it. And you're saying that what you're learning now is making that risk at least more real than we've come to assume? Not necessarily. I think you're exactly right that if this virus was affecting kids the way it's affecting older individuals, the whole ballgame would have been different.

You know, the policy response would have been different. We would, a lot of the restraint that policymakers have shown would have been extinguished. You know, flu, a pandemic strain of flu affects kids badly and affects older individuals badly. This didn't behave that way. This only affected older individuals badly. It largely preserved, you know, largely kids were protected from it or they didn't get seriously ill. And I'm not, I don't mean to dismiss the extreme death and disease among older individuals, but an older individual can take precautions more easily than a child can. And so children are excessively vulnerable. There's no evidence that this strain is going to be more virulent in kids than the old strain. But there are certain features of its genetic sequence that suggest

that it could be more dangerous. Like when you look at it and you say, okay, this is a virus, it's going to be more transmissible and probably be a worse infection. So far, it's been more transmissible. So we've been right on that front and it hasn't been a worse infection. And the question is, is it a more mild infection because it's only infect most people who are getting this are people who have at least had Delta infection. That doesn't mean when it gets into people who haven't been infected and haven't been vaccinated, it's going to be any worse than run of the mill coronavirus. It might be no worse. It might be the same. But my concern is twofold. Number one, it is worse. We don't know. But let's just we have to assume the worst. And let's just assume that it will be worse. Number one, okay, that we're let's just assume that it will be worse.

Number one, OK, that we're going to figure out that's right or wrong. Number two, the other scenario that worries me is this becomes widely epidemic in the U.S. We largely I don't want to say shrug it off, but we bear it. You know, we're three years into this. People are tired. People aren't going to stay at home. Businesses are going to have meetings.

You know, we're going to use testing and masks and vaccination to try to protect environments. But I think if this sweeps across the U.S., you're not going to see shutdowns, certainly. We're not going to be closing businesses. So let's just say this sweeps across the U.S., becomes widely epidemic. You know, small percentages of big numbers are still big numbers. So even if a small percentage of people get sick, you're still going to see a lot of hospitalizations. Maybe, you know, we're going to take steps to preserve the healthcare system.

But, but, but, and this is the big but, if it gets widely epidemic in the US, it's eventually going to get into the pockets of vulnerability. You can't, you can't have a raging epidemic with this in the backdrop and not expect there to be outbreaks in schools. And so then the question is, what's going to happen when it gets into those pockets of people that so far we have done a reasonably good job of protecting? And that's what I worry about. So I want to talk about

vaccinations. Obviously, the evidence suggests that two vax doses provides, you know, virtually, well, very little protection against infection from Omicron, but significant protection against severe disease and certainly high, high, high protection against hospitalizations and even higher protection against deaths. So the press tends to sort of hyperventilate in terms of its coverage of case counts of infection rates and that was understandable i think in the first phase of this pandemic but given what we know now something like and you were you and i were talking about this earlier approximately 83 percent of americans over 18 years old have had at least one dose so of vaccine. So that's a lot of protection. That's like, you know, 180, 190 Americans

have had at least one dose of the vaccine. And knowing that that really reduces likelihood of severe health complications as a result of Omicron or Delta, why are we so fixated on case counts? Well, I think we're going to shift our focus. I think we're becoming more fixated on hospitalizations than case counts. Part of it's just culture and psychology.

It's hard to shift people's orientation in terms of how we've come to track this pandemic all the way through. But, you know, eventually we're not going to be as focused on case counts because what really is going to matter is what you said, the outcomes and how much of a burden it's causing on the health care system and how much morbidity it's causing. And, you know, frankly, the case counts aren't accurate anymore. There's a lot more infection than what we're measuring in the case counts because a lot of the cases that are getting turned over are getting turned over on home diagnostic tests that aren't getting reported. So we know that. So the case counts are a crude

measure of the epidemic, but there's a lot more spread than what we're picking up. And much of it probably is mildly symptomatic, asymptomatic, and goes unrecognized. Just to give you sort of an anecdote about that, if you look at the COVID, the coronavirus being shed into the wastewater of Massachusetts right now, so Massachusetts does analysis of wastewater. When you have a virus, when you have this virus and other viruses, but particularly this virus, you shed it into your feces. And so you could look at pooled wastewater and look at the overall level of viral RNA in wastewater to get a measure of how much virus is in the population.

If you look at the data out of Massachusetts, it's off the charts. The amount of virus in their wastewater is higher than it's ever been. But if you look at hospitalization... How recent? That's very recent? Very recent, yeah. It's been trending for a while that way. And so that's one of two things. Either it portends that all of a sudden we're going to see an

explosion in cases and hospitalizations, which is probably partly true. But it's been high for a very long time now. So you should start to see the cases and hospitalizations catching up and cases are high, but they're not exploding at the same level. Or there's another scenario. And the other scenario is that there's actually a lot of infection going on that we're not picking up. Why? Because it's people who've been vaccinated, who develop subclinical infections. It's people who've had it before and are getting reinfected, but develop very mild infections. And they say, I just have a cold. I don't have COVID. So there's probably a lot more spread happening in a population like us that is going undetected. And that's probably how the Omicron experience is going to be, too, if sort of what's happening in other countries is any guide.

This could very well spread. And a lot of it will go unmeasured because a lot of it will be reinfections in people who have baseline immunity. And they're not going to get very sick. And, in fact, that may be what's happening in South Africa as well. I mean, South Africa, you've seen now, you saw explosive growth in cases, which the modelers all put these estimates on in terms of what the transmissibility of this virus, and now you're kind of seeing a leveling off. And it's not clear if you're seeing a leveling off because they've reached the sort of peak of their epidemic, or they've reached the natural limit of their testing. They just they can't test enough to actually,

truly measure the trajectory of the pandemic. But you've seen a number of days now of this. So if in fact, this is closer to the peak of the epidemic in South Africa, and we didn't actually catch the beginning of the epidemic, but we caught it somewhere along the curve while it was coming up the curve, that will start to change the estimates of how transmissible this is. It'll change that modeling. And the reason why it's possible that this was spreading longer than we detected, and that we kind of found it after it had already

reached a very high level of spread, is the fact that a lot of people who get this probably are aren't presenting for testing. So you had to wait until this got dead, the epidemic got dense enough and started to get into pockets of society where people were more likely to manifest symptoms because they had less baseline immunity because they were immun likely to manifest symptoms because they had less baseline immunity, because they were immunocompromised, because they were older until you detected it. You know, if this is spreading in a younger population that's already been infected, a working age population, it could probably spread for a while before you really pick it up. Now, in other countries, they're picking it up, like the UK, the Netherlands,

because they have really good surveillance. South Africa has good surveillance, but their surveillance had come way down when they came off their delta wave, and they weren't doing a lot of testing, and they weren't doing a lot of sequencing, because they had this extraordinary delta wave. It has subsided. Their surveillance also subsided. And so it's possible that in that moment, things had dipped down and they had relaxed a little bit their provisions, that this started to spread furtively in the backdrop. And then we detected it not when it was first emerging, but when it was already fully manifest. When we look back at history, the history of pandemics, we look at them as they all have this sort of two to three year lifespan. And then we treat it from a historical perspective as gone, right? The Spanish flu, 1918, 1919, into 1920, a little bit. The Asian flu, 1957, 1958, then gone. Were these actually ever just gone? Like, what actually happened to the Spanish flu strain?

Did it go away or just evolve into the common cold? It evolved into the common flu. I mean, the same strain of Spanish flu we still get infected with, but we've seen it many times. We get vaccinated for it. I mean, the sort of successor to that strain still exists. Same with coronaviruses. There's four circulating strains of coronavirus that cause nothing more than the common cold for most people.

Some people get very sick from coronaviruses. We now think when those coronaviruses made their first entry into human circulation, some dated hundreds of years ago, it was a global pandemic. And so when a new virus makes its first entry into human circulation, if it has any characteristics that allow it to cause severe disease, you're going to it's going to trigger something like what we're seeing now. And in the population develops baseline immunity, we learn how to defeat it with technology in the modern age, and it becomes something far less fearsome. It's hard to really put a point estimate on where this coronavirus is going to settle out.

Is this going to settle out as something like the flu? Will it be more virulent than the flu, less virulent than the flu? I think it's hard right now to figure that out. If I was going to sort of base case this, what the next four years are going to look like, I would say it's going to look like a second circulating flu in terms of the level of destruction that it wreaks. Now, what could change that is, first of all, maybe we'll develop better baseline immunity, and that immunity is going to be more protective than we now surmise. Or the other thing that could change is technology. And this is where I grimace a little bit when some of the medical historians say to me,

this is going to be a three year pandemic or a four year pandemic, all pandemics are three or four years. And I said, my response that is all pandemics have been three or four years, but we've never developed a vaccine in, you know, eight months and oral antivirals, you know, in a year and home diagnostic tests allow people to test for it. You know, we didn't we didn't have ubiquitous availability of N95 masks for people who want to and need to protect themselves. So our toolbox is so different. There's no reason we shouldn't be able to quell this pandemic earlier.

Now, we would have. The other the other big difference is in past pandemics, we haven't been able to basically shut the economy down and shut society down and yet keep big parts of our economy functioning. We didn't have technology that enabled everybody to, or a lot of people to work from home and get products and services delivered to home. If people wanted their lives to function, they had to go out in the world every day. Right. Well, I don't think we're going to be shutting down things again, even if Omicron spreads and even if it ends up being more virulent. I think now with the tools that we have, we're going to we're going to, you know, be able to manage this better. I think you

could certainly see a reimplementation of mitigation in some cities. I think you could see mask mandates come back into force. But I don't think you're going to see the economic disruption from policy that we saw we saw before. But you're't think you're going to see the economic disruption from policy that we saw before. But you're right. And that still plays out even now. Because when you think about mitigation in a society, I remember one study when we were looking at the emergence of Wuhan, the Wuhan variant. And basically, they had modeled that if everyone goes to the grocery store once a week instead of twice a week, that intervention alone will substantially reduce the spread of the virus. Like if we just, all of us, just marginally

limit our human interactions in the aggregate, that could have a big impact on a virus. And so think about all the ways that a lot of people have been able to substitute interactions with technology inputs. Even now, I mean, you know, my wife and I don't go out to eat, we order food. So some of my doctor visits that would have been in person have been virtual. So we're all limiting some level of interaction with technology, and that's going to persist. And that lowers the RT. And so societies that can do that will have a organically lower RT than societies that can. And not every society around the world can do that. Why has the data out of South Africa been so unreliable? I wouldn't say it's unreliable. I think it's incomplete. And two reasons. Number one,

their surveillance is good, but it's not UK good. I mean, the UK has better surveillance than anyone, including the United States. And so, you know, we're comparing countries and we need to recognize not every country has made the same investments, including the United States. I mean, we are behind the curve relative to European countries, even though we're much better than we were. The other is that I think the travel restrictions did have an impact on the ability to get things into that country. I know that with respect to the sequencing and their ability to get reagents into South Africa. So it slowed them down. A lot of cargo, as you know, flies in the

belly of commercial aircraft. And then the third is it's very hard to develop good data in the setting of the fog of viral war and when you're dealing with a crisis. And we saw that in New York when the Wuhan variant made its first entry. We were getting no bottom line clinical data and clinical reporting from CDC and clinicians. And it wasn't because clinicians didn't want to aggregate and report the data. It was because they were crushed. They were delivering crisis levels of care. They didn't have time to tabulate data and publish it in the New England Journal of Medicine. And the CDC did an inadequate job

coming in to support that effort. I think you're seeing some of the same challenges in South Africa, that they're focused on the current crisis and it's hard to aggregate and disseminate data when you're focused on dealing with the current crisis and scaling up testing and scaling up vaccination because it's the same public health workers. That said, we have gotten pretty good data out of South Africa. Some

of the clinical series that we've been getting are pretty informative. And I think they've done a very good job of reporting on this very early in the setting of a new outbreak. Given that they're managing a crisis. Exactly. Okay, so let's stay on that because you, in a separate conversation, have been critical of, well, you're certainly critical Omicron from your country, please submit it to, you know, this website. And you were sort of struck like, this is a pretty passive approach to data collection in the middle of, I wouldn't call it a crisis, but in the middle of like, we're trying to

understand a real live new variant. And you're like, really? Like, that's the best we can do after everything we've been through? That this is how the WHO is now collecting data about a new variant? Like, why aren't they deploying resources on the ground to actively gather data and take pressure off the healthcare professionals that are on the front lines trying to manage the crisis and not have them have to deal with collecting, publishing, analyzing? Well, look, if you criticize the WHO, and I was critical of them last week on TV recently, and literally it elicited tweets from the leadership of the WHO. I mean, this is what the organization's doing.

They're tweeting responses to my criticism on TV. Senior leaders, I'm not talking about their junior people, their comms people, but their senior leaders. I mean, talk about beneath an organization, right? But they are a largely political organization. That was my comment. They don't do logistics on the ground. Now, that said, do they do logistics on the ground?

Sure. Can they point to all the things they're doing in country? Absolutely. They can always find anecdotes. They have, you know, a global web of offices. But in terms of doing really heavy lift on the ground, the kind of deployment that was needed to mass distribute vaccines in austere settings, they don't have the capability. They don't make the investments. They're not focused on it. They haven't even been able to galvanize and organize the world behind such an effort. In West Africa, when we had to quell the epidemic of Ebola in West Africa, it wasn't the WHO

that was able to do it. It was the United States military. It was President Obama sending U.S. forces in to set up field hospitals and set up the mechanisms to do ring vaccination. It took a heavy lift capability. Now, WHO isn't going to be able to mothball that kind of logistical capacity, but they can certainly exert global leadership. But what are they doing every day on their conference calls? They're browbeating, you know, drug makers in Western

countries over not delivering enough vaccines. And as you know, I'm on the board of Pfizer. I will tell you, there's more vaccine right now than what's being pulled out. There's tens of millions of doses available, but the inability to deliver it on the ground. And that was the WHO's global responsibility to get that capacity. And it was the responsibility of the drug makers to manufacture it and get it into the country to make it available. The West was slow to do that. We have caught up. There's a lot of supply coming online. And it's the WHO's responsibility to galvanize the world to put in place logistics.

They announced. So I was critical of them recently. They said, no, this isn't true. You know, we have logistics. And then subsequently, literally the next day from their nasty tweets, they announced a 400 million dollar U.S. infusion of capital in this new global effort to actually put logistics on the ground. And they announced a new global coordinator to oversee all this. So on one day they were saying they had it all.

And then the next day they announced this major international initiative to actually do it for the first time. That'll take months. Spending $400 million to put in place cold chain storage in austere settings and set up vaccination sites. We should have done that a year ago. That will take months to get that in place. You can't just you can't just go on Amazon and buy the cold chain storage and have it delivered. It will take months and months to get that in place. And so if we wanted to be prepared to vaccinate the world, this had to start a long time ago. But what was happening a long time ago,

and I'll pause here, was, you know, the focus was the West hasn't done enough to generate supply. And supply was always going to be late. You know, this was an effort that started from zero. It was always going to have to ramp up. But now we're in a position where there are literally going to be billions of doses available. Pfizer alone, the company I'm on the board of, has committed to donate 2 billion doses over the course of this and next year to low-income countries, low- and middle-income countries. But crossing the 60% to 70%, call it, vaccination threshold, at least globally, seems to be a pretty high hurdle.

And, you know, unvaccinated, that unvaccinated population is is largely where the virus mutates. So if for a variety of reasons, including the ones you're citing, the WHO isn't helping in a constructive way get a global vaccination rate up to a standard that we need. And our best bet for reducing the risk of a more dangerous variant is crossing that threshold. It does seem like the odds are stacked against us. Yeah, well, look, I think this is going to be a difficult, long global fight. And, you know, I don't think there's anything magical about that threshold either. You know, the goal has to be to get more people vaccinated. And we're going to have to keep people vaccinated. We now know this isn't a one and done vaccine. This isn't like,

this isn't polio. This isn't, you go in, you do a vaccination campaign, you can eradicate a virus. We're going to have to put in place infrastructure. We're going to have to educate populations and build the willingness to come back over and over again to get vaccinated. I think this is going to probably be for at least a period of time, an annual vaccination. So it's not just about getting one shot in everyone's arm. It's about building the infrastructure to actually maintain a vaccination campaign. And that's going to be very hard in settings where you don't have good health care delivery.

And that's where we should be making investments right now. In addition to the supply, there's no I don't I don't think there's adequate attention to that. I think that there's this perception that we can just get a shot in everyone's arm. Suddenly, this is going to end globally and the risk of a global a new mutation emerging is going to go substantially down. We actually need to get the infrastructure on the ground in a sustainable and sustained fashion. And that's a much harder exercise. And no one's really talking about that. The WHO certainly isn't talking about that. They are still, when they go out and talk about this, they still create this perception that it's just about getting a shot in everyone's arm. And then this challenge will have been solved.

It won't be solved. We're going to have to get shots in people's arms probably over and over again. This is going to be like the flu. On the comparison to the flu, the evolutionary sort of path of the flu is, the flu virus has always been pretty stable, I guess, in terms of how it evolves. So the difference with COVID is that it's much more prone to mutations, and we could have a bunch of dominant mutations all at once.

So I know you keep coming back to the flu, but is it really the right comp? Yeah, this is actually less prone to mutations. Right now, this is flu, this is mutating at the rate of influenza B, but its rate of mutation should slow down as it reaches a new fitness level. And in fact, it was slowing down with the Delta variant. This new Omicron is sort of divergent evolution. It's like been a curveball. But this given the way this virus isn't segmented, so it can't sort of reassort genes within itself. It should mutate at a rate slower than flu. So the evolution of this won't be as quick, I think, once this reaches a steady state. And that's the hope.

And so maybe we won't have to update the vaccines quite as quickly as we update the flu vaccines. And with the flu vaccine, we have to update it every year. We have to do a multivalent vaccine, meaning we vaccinate for four different strains of flu simultaneously because the flu mutates so quickly. It's very hard to predict what the dominant strain is going to become. This may be something where it evolves, but it evolves a little bit more slowly. So instead of updating the vaccine every year, we're doing it every two years, or instead of using a quadrivalent vaccine or trivalent vaccine, we use a monovalent vaccine or a bivalent vaccine, where it's just one or two strains that we're inoculating against. This is going to be different than the flu. I use the flu as a proxy because it's very contagious like the flu. And, you know, it does evolve over time. It

does mutate in ways that it's going to evade the baseline immunity and the vaccines against it. I mean, it's now apparent that the vaccines against it, all of them, don't give you sterile sterilizing immunity. This is not a one and done vaccine. And, you know, people say we need to get to a vaccine where you're back where it's a universal vaccine, it's going to work against any coronavirus. Maybe we'll get that. We've been talking about a universal flu vaccine for literally 40 or 50 years. You know, not exaggerating. Tony Fauci, his entire career at NIAID has been focused on coming up with a universal flu vaccine and being able to vaccinate against components of flu that don't mutate, that are preserved. And we haven't been

able to do it. So will we be able to do it with coronavirus? Can we develop a vaccine against the nucleocapsid protein or some other component that doesn't mutate or is more more heavily preserved as this thing evolves? Maybe. But the reason why, you know, the reason why we vaccinate against the spike protein, and the spike protein is what mutates in this coronavirus is it's the immune dominant epitope, meaning it's the part of the virus that our bodies recognize the most easily and develop antibodies against the best. We develop our best antibodies against the spike protein. So it's a fact of virology that very often the immune dominant epitope is also the epitope, the part of the virus that the virus learns how to mutate because it's trying to evade our immunity. So if we vaccinate everyone against some other component of the virus, we might find that,

and we probably will find that the antibodies we develop against that component of the virus don't do as good of a job clearing the virus as the ones we develop against the part of the virus that the virus knows how to change. In your book, you are very critical, in addition to being critical of the WHO, which sounds like you're still critical of the WHO with good reason, you are very critical of the CDC. Can you just briefly summarize your observations from your book in terms of what the CDC got wrong early? And here we are now, two plus years into this, are they evolving? Are they learning from the issues you cited? Because what you zero in on as the problems of the CDC,

I've heard officials from the CDC, albeit not on the record, they're not as defensive off the record as the institution is on the record about their early failings. Yeah, I think there's more self-awareness in the institution is on the record about their early failings? Yeah, I think there's more self-awareness in the CDC certainly than the WHO. I mean, the WHO has a perception that they're infallible and their response has been perfect and there's not a lot of introspection. So you're not going to get reform out of the WHO. Very proud organization regardless of what they do and don't do. The CDC, I think, has more self-awareness. But, you know, it's culturally going to be hard to drive change because a lot

of the challenges early on were driven by the culture of the organization. That's pretty ingrained. I think, you know, the fairest way to sort of summarize the CDC is the CDC is a high science organization that does very exquisite scientific research. It's deeply retrospective. They do analytical work on things that have already happened. And they give you sort of a definitive conclusion about outbreaks, about the spread of human disease. But that takes, you know, it takes them six months to put out an MMWR. If you look at the flu, they put out a really detailed analysis about the severity of the flu season every year,

about six months after the flu season's over. That's literally, I mean, I'm not exaggerating. If you go to their website, that's when the analysis comes out. They'll tell you, yeah, they'll tell you how many people died of flu this winter, some point at some point in July or August. But, and they don't have a logistical capability. I mean, people have this sort of perception of the CDC as people in the field. They have that component, but it's a bespoke component of the organization. They're not FEMA. They can't respond to a public health emergency of this magnitude. We really don't have that capacity in the United States. We've only developed that capacity to deal with limited public health emergencies. And it's mostly in the context of thinking about deliberate attacks on the country. So you're like Operation Warp Speed and some other functions that were set up in the government,

you make this point in the book, were set up to fill this vacuum. There actually is no permanent capability within our government to deal with very complex logistical elements of pandemic management. And that's why we couldn't scale the development of a diagnostic test early on. CDC failed to do that. That's why we couldn't deploy it. Why we couldn't set up mass testing and vaccination sites. We had no capability to do that.

That's why we couldn't collect good information. Why we were in the fog of war for so long and CDC couldn't ascertain that this was spreading through asymptomatic transmission, that it was airborne. We didn't adequately track how many people were being hospitalized on a daily basis. Something as simple as how many people were being hospitalized, CDC wasn't actually gathering that data. They were estimating it off of a small sample set and then modeling how many hospitalizations they thought were happening around the country. If you go to the CDC's website right now for how many people have been hospitalized for COVID on a daily basis, it'll say all the data before August can't be relied upon. I think that's

almost the language on the website. The reason why it says all the data before August of 2020 can't be relied upon is because before August of 2020, CDC was collecting that data. And it was this modeled estimate. After August, the HHS figured out that CDC wasn't really actually collecting real hospital data and they needed a real point estimate. And they took over the responsibility for doing that and set up a new system. And they were actually able to capture how many people were being hospitalized for COVID every day. And it's actually one of the most reliable data sets that we have in this country, even more reliable than cases or deaths, because it gets reported on a daily basis and every hospital reports.

So and the other place has played out also, and I'll pause here, is in the early days of this crisis in New York, we had no bottom line reporting on clinical information. Who is getting sick? What interventions were being used, what were the outcomes, just simple reporting on the clinical, the collected clinical experience in New York could have been very informative to help guide clinical practice in other settings. That reporting just didn't happen. The clinical information that we were looking at in March, April, May into June was coming out of Italy and China, where they were actually reporting on their clinical experience. And the Chinese government and Chinese health officials did a very good job of reporting their bottom line clinical information, their experience.

They didn't report all the information that could help us determine where this virus came from, but their experience with patients, they did a very good job reporting the clinical series. I want to switch gears again. Mask mandates. The efforts by the Biden administration to, by executive order, to mandate as many employees as possible to wear masks. A lot of these efforts have been defeated in the courts. I don't think they'll be upheld in any of the courts. The implementation of this seems to have been a colossal failure. And the most interesting one is federal contractors, mandating federal contractors that all their employees have to wear masks.

And I don't think people realize how many people in this country are employed by companies that have federal contracts. It's a lot. And these are often employees who were working from home and not wearing a mask. And suddenly they're told they have to come back to work for, say, three days a week and they must wear a mask. And these are often employees who are not in or and be back in some cases be vaccinated. They're not interacting with other employees. They're not, you know, sort of customer facing, if you will. And this is creating enormous tension between large employers and unions. And this is all in the context of very high inflation reports, labor shortages, supply chain shortages. It's having medical, it's having implications in the medical community, something like one in five medical professionals now are refusing to work because of all these various mandates.

And these are, you know, nurses and respiratory therapists. And it just seems like things are tense right now in the labor markets. And this is adding tension. I'm not saying we shouldn't be strongly encouraging vaccines and we shouldn't strongly be encouraging masks where appropriate. But what is your sense of this dynamic that's going on? Because the macroeconomic implications are real, and they don't seem to be going away anytime soon. Yeah, look, I think that the mask requirements and mandates

are different than the vaccine mandates. I don't think a city that has an epidemic going on telling people that they have to wear masks on mass transit and in buildings is the same as telling everyone they have to get vaccinated in terms of, you know, the level of perceived intrusion into someone's life's life and and and that policy is trying to uh trying to dictate and i think you're going to see a lot of cities if omicron does become epidemic i think you're going to see a lot of cities try to employ light mitigation like mask mandates and if we can't get a consensus around that and we can't actually implement things like that and get people high quality masks we can't do anything. So I would I would set that in a different bucket than shutting down businesses and telling restaurants they have to close and even telling everyone they have to go get vaccinated. In terms of the vaccine

mandates, look, I think it makes eminent sense that the federal government put in a mandate for federal workers. It's well within the president's right to do that. It's an issue of federal readiness. I think the mandates among health care workers make sense. You know, we require health care workers to be vaccinated for chickenpox, for flu, for hepatitis. I don't know why COVID should be treated any differently. Including medical workers that aren't patient facing? Anyone in a medical setting, because they can introduce an infection into that setting. We've seen outbreaks in hospitals and nursing homes where dozens of people have become infected, and we've seen some really bad outcomes in nursing homes. I think that for me, the line was the mandate on private businesses down to

businesses with 100 or more employees, because that clearly created a political fault line. It made this something that was sort of furtively political, overtly political, the issue of vaccination, the government asking you to get vaccinated. You now see political leaders campaigning for and against it. And so this is now something that people are going to like fashion their campaigns around. And my worry is that there's not enough bang for the buck there that that for the incremental pickup we'll get in terms of the number of people who get vaccinated, there's going to be a very heavy price to get paid, be paid. And the price will be that you're going to harden positions on this. People will now define their political virtue around whether or not they were willing to get vaccinated.

You'll see people campaigning against vaccine mandates broadly, not just COVID, but broadly. And all of a sudden, the consensus that we've had in this country around measles, mumps, and rubella, and polio, and all these other vaccines that we require, and even, you know, the hepatitis B vaccine or the chickenpox vaccine in medical settings, we've had these vaccine mandates in place for a long time. And we've kind of accepted it. We understood the public health rationale. Now you're going to see them all get called into question. Now the whole idea of the government mandating any vaccine and not just the COVID vaccine will be called into question. And you'll see declining vaccination rates because vaccines will be another thing that we fight over politically. That's my big concern

here. And my question to the Biden folks was, what is your goal? Like, do you think that if we get to 90% of the public with a vaccine that this epidemic will end or 85%? Tell me what the goal is. And number one, they couldn't define it. Just the goal was more. And that's, that's not that we should have like a policy goal that's prescribed by actual data. And then my second question was, okay, how much will the vaccine mandate get you closer to more? And nobody can answer that. We are now, as you said, OK, how much will the vaccine mandate get you closer to more? And nobody can answer that. We are now, as you said, 83 percent of adults over the age of 18 with at least one dose. Most of those will complete the series. 90 percent of people get one dose, go on to get the second dose. That's been fixed through the pandemic. We're not going to change that. Some people just fall off as attrition and everything.

So assuming we're at 83 percent right now above the age of 18, where do we get? We're not going to get above 90%. We don't even get much above 90% with childhood immunizations. We'll get to 85, maybe 87. Well, actually, Scott, and the balance, I mean, just back at the end of the math, the balance of the 17% that hasn't gotten a shot, some subset of them have natural immunity. Let's say 25% of them or 50% of that 17%. More. More. Okay, more. So you're talking about, I don't know, 20 million Americans? Well, that's my point. You're not picking up a lot of immunity with a mandate down to small businesses. I mean, if you get from 83% to 87% with the mandate, I would argue that that 4%, probably three quarters have had Delta infection or will. Now that said, the Delta

infection is probably not going to be protective against Omicron, but neither will two doses of the vaccine. So I just don't think that what they've opened up, the wounds they've opened up was worth the incremental gain. And I would have focused much more on getting kids vaccinated, more kids vaccinated and getting more people who've been vaccinated boosted. It's going to be much easier to convince someone who's had two doses to get a third dose to convince one of the 15 percent of people who so far have held out to go get a dose for the first time. Now, we'll we'll get to 85 percent. Maybe we'll get a little bit above that. We're not going to do much better than that. There are 10 percent

of the Americans at this point who will not get vaccinated under any circumstance unless it unless you implement extreme duress, which we are not going to do. I mean, we were not going to force these mandates to a point where you're really hurting people's lives. Although some of the mandates have cost people their jobs. Right. Two quick questions before we wrap. One, there's all these other measures being put in place. In New York State, where I live, the governor, Hochul, has put a ban on elective surgeries, preparing the medical community here to go full Omicron crisis response and put everything

else on hold and taking a number, Mayor de Blasio has taken a bunch of steps that seem excessive, at least excessive to me. What's your reaction to this? Well, look, I'm loathe to criticize. I don't think the federal government should be implementing national sort of requirements where it's avoidable. I mean, there's certain things that the federal government has done, you know, masks on airplanes, things like that, things that are sort of in the federal purview. But I think these things should be left up to states and cities because this epidemic has been highly, highly regional. You know, even Delta, look, Delta was epidemic in the south, and it became epidemic in the Pacific Northwest, in the southwest, now New England and the Great Lakes region, the Great Plains and the Mountain States were somewhere in between. So you need to allow states and cities flexibility to implement public health mandates and ordinances and other

measures. And every city has a different experience. I mean, New York is the most dense city, one of the most dense cities in the world, and certainly the most dense city in the United States faces a much different risk than other parts of the country. So I think we need to leave local officials discretion. Now, that said, New York is looking at the data globally and seeing this spread very fast, and they know their city is uniquely vulnerable. So the idea of trying to put in place some advanced mitigation with measures that don't aren't, they might be annoying to people, you know, that people might feel they're being told what to do, but they're not shutting down commercial activity. I think we need to use as many of the tools as we can that could allow people to continue to go about their lives and allow commercial activity to continue and perhaps put some downward pressure on the spread of this so that we avoid having to reach

for those other measures and seeing a health care system get overwhelmed again. Because ultimately, the metric that they're going to use is what's happening in the hospitals. Are the hospitals getting overwhelmed, even with limits on elective surgery? And Omicron in a city like New York, based on what we've seen internationally, the potential is there that you could see another surge on the health care system. So trying to get people back to habits that we know have some downward pressure on the rate of spread right now, I don't I don't I wouldn't second guess the mayor's decision to do that because this this could move very quickly.

Last question. I'm struck by how many officials who've served in the Trumpations have not, shall we say, been as intact in terms of their as they try to make contributions to public policy debates going forward since government. You are one of the few who who served in the Trump administration. And yet everyone seems to call on you from the left, from the right. Democrats, Republicans, Trump administration, Biden administration. It's interesting to me. I mean, there aren't many people who pulled that off. And it certainly pulled it off in a highly polarized moment, which is this pandemic. So you've not just done it on like some random issue. It's a highly polarized issue where there's a lot of distrust. Have you thought about that? Like, have you thought about, have you been conscientious about preserving your reputation and to enable you to contribute in this way?

Look, I haven't been conscientious of it in the context of trying to preserve my ability to have a broad dialogue, you know, work with people on different sides of the political fence. What I've been conscious about is just sort of how I've conducted myself. You know, when I was in government, I didn't give preferential treatment to Republican members on Capitol Hill. I gave the same treatment to all members. I was open to all members. I picked up the phone and called members when there were issues that I knew were going to be important to them, whether they were Republicans or Democrats. If something, if we took a regulatory action and affected a district of a congressman, I would call that congressman a congresswoman.

And I didn't look at whether there was a D after the name or an R after the name. So I've tried to, you know, sort of operate in a way where I wasn't changing my behavior when I was in an official position based on the party someone was in. And I've also tried to be very conscious not to criticize individual people and especially attack their motives. I think where the political dialogue really breaks down and where people make mistakes in public life is when they start to question the motives of other individuals. I've operated from a principle where I assume everyone who's in public policy is there because they have good motives and they want to see good outcomes. They just have a different point of view about how to achieve those ends.

They're not trying to do evil things. They're not trying to steal people's liberty or, you know. They're not fascists. They're not communists. Right. They go in there. They might have bad ideas, but they have good motives. And I think where it breaks down is when you start to think people have bad motives and you start to attack people individually. That seems like a perfect note on which to end, Scott.

Thanks again for your candor and your clarity and your wisdom. Like I said, you're a big hit with our listeners, so we'll probably rope you in again to come back on. And we will include the title and the link to your book in our show notes, which I highly recommend. I devoured the book and look forward to keeping you in touch. Thanks, Scott. Thanks a lot. Thanks for having me. That's our show for today. Be sure to purchase Scott's excellent book, Uncontrolled Spread,

which you can get at your favorite independent bookseller at Barnes & Noble or BarnesAndNoble.com or at that online e-commerce site. I think they call it Amazon. Call Me Back is produced by Ilan Benatar. Until next time, I'm your host, Dan Senor.