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In the Bubble with Andy Slavitt: Our Shot
All Podcasts Omicron in the US: What You Need to Know (with Scott Gottlieb)

Omicron in the US: What You Need to Know (with Scott Gottlieb)

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Description

Andy digs into the latest science behind Omicron with former FDA Commissioner Scott Gottlieb. They discuss what we know about the origin of Omicron, how it’s likely to play out in the US, and if we’ll need an Omicron-specific vaccine. It’s still early, but Andy and Scott have you covered with the most up-to-date information out there about this new variant and the risk it poses.

Keep up with Andy on Twitter @ASlavitt and Instagram @andyslavitt.

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Transcript

SPEAKERS

Andy Slavitt, Dr. Tony Fauci, Dr. Scott Gottlieb

Dr. Tony Fauci  00:00

Clearly, in South Africa Omicron has a transmission advantage because if you look at the number of cases now they were very much at a low level, then they had almost a vertical spike upwards, which is almost exclusively Omicron. Thus far, though it’s too early to really make any definitive statements about it. Thus far, it does not look like there’s a great degree of severity to it. But we really got to be careful before we make any determinations that it is less severe or really doesn’t cause any severe illness comparable to Delta. But thus far, the signals are a bit encouraging regarding the severity, but again, you got to hold judgment until we get more experience.

Andy Slavitt

Welcome IN THE BUBBLE, this is Andy Slavitt. It’s December, and time to bring you another podcast about the latest Greek letter in the alphabet. We have a great conversation today with Scott Gottlieb, who many of you know and you’re going to want to listen to the clip we just heard was from Tony Fauci. And I think that the question of the moment, and there are many of them are, what is this Omicron variant going to look like when it hits real people? And let’s just to review some of the bidding, which we’re going to get into Scott. You know, there is a case that I talked about on Monday, that, Tony here just kind of reiterated, which is that we could only be dealing with a virus that affects people more mildly, than past viruses. That would be delightful if it were the case. There are more people now saying there’s reason for optimism. Scott has a very specific perspective on that that I want you to listen to. It’s detailed, so I’m not going to preview it. But I think it’s very understandable. It’s an important question, obviously, because it indicates not only who is going to be affected today, but potentially what the long-term evolution of this virus looks like. It’s got may also get into the question of what’s going to happen in the vaccine development. And he has a very specific view about vaccine development.

Andy Slavitt  02:32

And, you know, I will let you hear that from him as well. But really probe that hard because you might know Scott, in addition to being kind of the former FDA commissioner in the Trump administration, and being on top of things from a public health standpoint, and frequently on CNBC and on CBS Sunday show is also on the board of Pfizer. And so he has a view as to what their plans are with the mRNA platform, and also with regard to the new oral therapeutic that they’re introducing. And so very interesting. And you’ll want to hear that as well. Actually, I think you’ll come away with this with the latest of what’s going on. Scott and I both appeared at a conference yesterday. It was a long conference that was for kind of senior leaders in the healthcare industry. And he was tasked with being the opening keynote, and I was asked to be the closing keynote. So as you’ll see, with this episode, I always want to have last word, he has a new book out, which if you want to read more about the pandemic, then you read when you read Preventable, which is of course a great book. His book is called Uncontrolled Spread. And it’s a very comprehensive book in a very thorough book and a really good book. If you want more detailed minds more of a day in the life of the pandemic, kind of a story, I guess, but nonetheless, interesting. Without wasting any more time. Let’s bring on Scott Gottlieb.

Andy Slavitt  04:10

Scott Gottlieb, my friend, how are you, buddy?

Dr. Scott Gottlieb 

Good to see you. How are you?

Andy Slavitt

It’s good to see you. Yeah, I think last time we saw each other was actually in person physically in person in Boston doing a co-book signing. That’s right. If people often I think, try to wonder if they’re gonna hear two sides of an argument when they pulled us up on the stages. And more often than not, I think they’re disappointed.

Dr. Scott Gottlieb 

That’s a good discussion, I thought.

Andy Slavitt 

Yeah, that’s great discussion, mostly because of me. I’m kidding. I’m kidding. So we got Omicron going on. How surprised were you to see another variant of concern emerge?

Dr. Scott Gottlieb

And I wasn’t surprised to see another variant emerge. What I was surprised was it wasn’t a very an adult lineage. My expectation was I think others as well. Was that Delta was so transmissible that the future variants that we would see would be within the Delta lineage. They’d be mutations on Delta that had partial immune escape and became more transmissible. In fact, there’s probably at this point almost 20 different versions of Delta that have circulated in one fashion or another. I think what was surprising was to see a variant emerge that had sort of divergent evolution that somehow this variant first emerged over a year ago, the trail went cold, and it re-emerged with all these excessive mutations on it. So it had been sequestered somewhere, either in an individual immunocompromised individual where..

Andy Slavitt 

Is that your suspicion?

Dr. Scott Gottlieb 

Well, I think the two there’s three theories, one is that it was mutating continuously in a single individual. And that’s how other variants have emerged as well. And immune compromised, individuals become persistently infected. The other is that it was mutating in an animal reservoir. Anderson thinks that that’s the most likely theory, I think, Trevor and others, Trevor Bedford and others, probably put that lower down in the list, but it’s certainly on the list. And then the other is that this has been spreading cryptically, and, you know, got into a number of super spreader events and sort of exploded, I think that theory is becoming less likely. That’s that would have been my theory maybe 10 days ago. But I think it’s becoming less likely just watching the velocity of the spread of this virus in South Africa, it’s hard to believe that it was spreading furtively, and only just exploded with the kind of transmissibility we’re seeing now that said, we really don’t know for sure what’s spreading in South Africa. I mean, we presume it’s all Omicron. But there’s been some evidence, you know, over this weekend, that Delta is still spreading there. If you look at the sequencing data coming out of South Africa, that actually have sequence more Delta strain in recent days than they were sequencing maybe a week ago. And you’ve seen the cases start to the trajectory change a little bit on the scope of the epidemic. So it’s the data coming out is hard to interpret right now.

Andy Slavitt

Yeah, well, actually, we have Trevor on our next episode, so we’ll be talking a little bit about that. But this Trevor Bedford, for those of you who want to see on Twitter is very smart guy. Let’s talk about what we know what we don’t know what we suspect. Let’s start with something that is a big mystery. But quite an interesting question, which is severity of illnesses people get with Omicron. I assume you’re watching kind of hospitalizations and hospitalization data, but also the need for assisted oxygen and those kinds of things. Is it too early to tell anything? What do you suspect?

Dr. Scott Gottlieb 

What I think is too early to draw conclusions. And if you look at the demographic in which the virus is spreading right now, it’s any younger demographic that was probably heavily exposed to Delta. We know probably upwards of 90% of the population in South Africa, but some vaccinated was infected with Delta. So even the data that’s been collected so far, the clinical data shows that the vast majority of people who’ve been infected with this new variant have had previous infection with Delta. So the question is, there’s evidence that it’s causing less severe disease on the whole you hear that anecdotally, from South African physicians, but you also see it in some of the hospital data, although it’s early to […] put out a report over the weekend. Looking at their experience with COVID 166 submissions, they found 38 COVID positive patients most were incidental pickups of people who are hospitalized for other reasons. Of the 9 patients with COVID pneumonia requiring supplemental oxygen all unvaccinated.

Dr. Scott Gottlieb  08:37

So there’s some evidence that it’s causing less serious disease. But we don’t know if that’s because it’s innately less virulent strain, or it’s just infecting people who’ve been previously exposed to COVID. So they have residual cellular immunity. So they’re able to fight off the infection better. So they’re getting infected, but they’re not getting as symptomatic. I think the latter scenario is certainly a play here. That’s why I’m reluctant to say this is a less serious virus. And if that’s the case, if the reason why it looks less virulent right now, is because it’s mostly infecting a population that has some COVID. Immunity. The worry would be that as it spreads more widely, it’s going to steep into pockets given us transmissibility of individuals where there’s low vaccination rates, low prior exposure to COVID infection who are still vulnerable. And you know, what’s the most immune protected pocket right now of society around any country, it’s children’s toddlers, you know, most haven’t had COVID Because parents have sheltered their children most haven’t been vaccinated because the vaccines aren’t available. So I would worry a lot about that population and other vulnerable populations that have protected themselves thus far from COVID.

Andy Slavitt

We did see a number of under five cases of that in South Africa. So you’re right. That’s interesting. So are you saying that people who had prior exposure to COVID while it doesn’t seem to do much to prevent illness with Omicron, that it may, in fact lessen the severity on Omicron when they get it?

Dr. Scott Gottlieb  10:09

Well, you would expect it to just sort of based on immunology because the first line of defense against an infection of circulating antibodies, people who’ve been previously infected who’ve been vaccinated have circulating antibodies that decline over time. But those circulating antibodies are very specific to the spike protein, spike protein becomes heavily mutated that are existing antibodies don’t recognize it, we’re going to get infected. But the second line of defense is cellular immunity, its memory B cells that have the capacity to engineer antibodies specific to the virus and is T-cells that are primed to attack the virus, the epitopes that the T-cells react to so the surface proteins or the surface targets on the virus that the T cells react to are pretty well preserved. So even with the virus mutates, those T-cell targets should be preserved. And in fact, we think they are and if memory B-cells are adaptable, they they’ll adapt to the new contours of the viral surface. But the problem is that those secondary components of immunity, the memory B-cells, and the T-cells take two to three days to start kicking in.

Dr. Scott Gottlieb

So you get infected, the infection pierces your first line of defense, which is your circulating antibodies. Now you’re infected you becoming symptomatic, perhaps, and now your cellular immunity kicks in to fight the infection and prevent you from becoming severely ill. And so you would expect that those cellular components of immunity that memory B-cells and T-cells would be largely intact, maybe fully intact, but certainly largely intact against this virus. And that may be why we’re seeing people get less seriously ill in South Africa, but because many of them have cellular immunity, they’ve been infected with Delta. But you know, it’s not going to prevent people from getting infected. And if you infect enough people, eventually you’re going to find some sub population that, that infection is going to break through and cause more serious disease. And even if it’s a small percentage, a small percentage of a big number is still a big number. And the worry here is that this is so infectious, and we don’t know that yet. But the worry is that it could be so infectious, that it’s going to infect a lot of people, most people will be okay. They’ll either have you know, immunity from vaccination or delta and they won’t get severely ill. But there’s going to be pockets that either don’t have that prior immunity, or even with that prior immunity, their immune systems are sufficiently weakened, that they’re not going to be all mount that good response. And that’s the worry right now.

Andy Slavitt  12:32

Got it. Got it. That’s a great explanation. I mean, it feels like on the one hand, these are words you use to tell me if you disagree with this, that this is a step toward or an evolutionary process towards a form of herd immunity, not necessarily the kind of herd immunity that we all talked about, where it makes the virus disappear. But the gradual gathering of more and more people with memory B-cell and T-cell responses, whether they’ve been vaccinated, or if they’ve had prior infections, so that even equally severe versions of COVID, over time, over the course of you know, months and years, have less of an impact on the population, or in fact that less severe variants emerge in their own right. So before we get to the second part of what you said, which I think is really important and concerning about the aspects of the population, that are still vulnerable. Is this potentially a step on the path towards making COVID easier to live with?

Dr. Scott Gottlieb

Potentially, but I don’t know that I’d be comfortable concluding that because, you know, we were sort of on a path towards herd immunity with Delta, Delta was going to infuse enough meaning in the population that between that and vaccination, most of the population would have some delta immunity. And if future variants were within adult, the lineage, there’d be a lot of meaning in the population. And that’s why I said, I think Delta is the last major wave of infection barring something very unexpected. I would always say that. And it wasn’t just sort of a hedge, it was barring something unfair. And this is very unexpected. I mean, I think what’s concerning about this is this could be sort of divergent evolution, where you could have this coexist with Delta, that the immunity that you achieve from this virus, if you’re infected with this virus, you get immunity to this virus, it might be distinct enough that it doesn’t protect you against the other variants. And you know, maybe this becomes a dominant variant, but probably not. And Delta still continues to circulate. Now people will have Delta immunity that hold me to this cell immune from vaccination. So they’re going to hopefully have enough COVID immunity that COVID will become less fearsome virus over time to our population. But this is very distinct from Delta, in terms of how it’s mutated, and there’s no reason to believe that the immunity that we get to this virus is going to be protected against the other variants, and also the way this is spreading as we believe is not necessarily because it’s innately more transmissible, although it might be you know, the R-naught, which is the innate transmissibility of the virus may not be as high as Delta. The reason why it’s spreading is because it’s able to pierce the immunity people have acquired so it’s spraying through a population that is effectively immune naive.

Andy Slavitt

Yeah, well, sort of the ironite equation right has a subtraction for people that are immune. And your point is that this subtraction may not be very large when it when it comes to this and that’s let me take a step back this could be growing rapidly for two reasons. One is it just grows more rapidly and the other is it infects more people that thought they were protected.

Dr. Scott Gottlieb

Exactly so R-naught is the innate infectivity the of the virus. How many people in a you know sealed room where there’s no immunity? How many people will get infected from a single individual? You know, they are not of measles is 11 or 12. They are not a flu is to the ornata of Delta was I think like five, but the RT is the transmission in the real world. And in the real world, people wear masks people have been exposed before people socially distance. And so the RT is lower than the R-naught. But the question is, is this innately more transmissible? So is the R-naught higher than Delta? Or is this just have a high RT? Because it’s able to spread to a population because it has immune evasion? And the answer is probably an element of both probably the R-naught is higher than the old Wuhan variant, certainly. So there’s as greater inherent transmissibility, and it has immune evasion, and which one is the driver of its sort of explosive growth in South Africa is such that we can tell most people think it’s probably the immune evasion, but we don’t know for sure. And, you know, we also we don’t have a good window into what’s going on in South Africa. We’re not I know; you’re going to have Trevor on. But we’re not sequencing a lot of samples. So we don’t have a true prevalence estimate of how much is this new variant, the samples that are getting sequence are samples that are specifically plucked, because they’re presumed to be Omicron, because they have a special finding on PCR called SG dropout, where you can’t detect the S-gene, because it’s been so heavily mutated. So it stands to reason that 100% of the samples that again, sequence would be this new variant, but when you’re only sequencing 150 samples a week, you’re not getting enough that you can get a representative sample. And then to the extent that this can be detected on PCR, and it can be they’re not running it, by and large, are not running the right assay to detect it. So we don’t have an estimate of how much is Omicron people assume it’s 100%. But it looks more and more like there’s some Delta still spreading in South Africa. And it could be something else that we’re not picking up.

Andy Slavitt  18:20

Okay, so, so given that, let’s, let’s talk about how you think, if we play forward a couple of months, how mccrane is likely to spread in the US environment. Now, the US environment has, first of all, it’s a big country. So there’s not just one environment, I think we probably both agree to that. Secondly, there’s a lot of parts of the country with low vaccine use not as low as South Africa, but pretty low still. But with high prior infection, let’s call that a Mobile, Alabama, then we got other parts of the country, let’s call it a San Francisco that has high amount of prior vaccine use. But not necessarily a higher amount, a very high amount of prior infection. And those are both in both cases from Delta. So when you think about how an Omicron is likely to evolve in those environments, you’ve talked about co-existing you’ve talked about one being dominant, you’ve talked about another being dominant. What is what you’ve seen so far tell you is most likely?

Dr. Scott Gottlieb

Well, look, first of all, if you look at B117 and Delta, the time from epidemic in another country to epidemic in some region in the US, because you’re right, these didn’t become confluent epidemics in the US they became regional epidemics was three months. That was what we saw a B 117. That’s what we saw with Delta. Some argue that this could be more rapid because of, you know, greater transmissibility, but on the other hand, we have better testing in place,  better tracking, tracing, mitigation, so it could be slower too. So I think that this is going to become epidemic in some region in the US, it’s two to three months away. Given what we’re doing could be quicker. I mean, some people think January sort of end of January could be the point at which we see this start to have explosive growth in some region, I would worry about parts of the country. So the presumption right now and this presumption could be wrong and this is important to watch is that the properly boosted vaccines are going to provide a meaningful measure of protection against severe disease, a moderate degree of protection against symptomatic disease and some protection against infection, although not nearly as well as they currently provide. We’re not going to know that until we see the clinical data.

Andy Slavitt  20:26

And that’s with booster.

Dr. Scott Gottlieb

That’s with boosters, yeah. And there’s enough clinical data now available that we can answer that question, but we’re not doing a good job […].

Andy Slavitt

How about without boosters, since most? Probably the largest part of the population is vaccinated but not boosted.

Dr. Scott Gottlieb

Yeah, I think without boosters, it’s an open question what I just so I quoted the other day, I said, you know, this is sort of not even an estimate. This is just like speculation to ground the discussion. Let’s say that vaccines 40% boosted vaccine is 40%, protect them against infection 60% protect them against symptomatic disease and 85% protective or maybe better against severe disease, let’s just say that’s the profile of a boosted vaccine against this, that would be from public health standpoint, pretty profound. That doesn’t sound good to people, probably given what their assumptions are about the vaccine. But that is, quite frankly, the level of protection that someone probably has against Delta right now, if they haven’t gotten a booster and then more than six or eight months out from their original series, that’s probably the level of protection would be sufficient to be a backstop against this becoming, you know, very widely epidemic if we can get more people boosted. So what would I worry about? I would worry about parts of the country where you have low vaccination rates, high Delta infection, so the prevalence has declined because there has been a lot of Delta immunity, i.e. the south and you know, frankly, overconfidence that there was a view that that COVID’s over, prevalence is low and mitigation is really lifted, I would worry about, you know, states like Florida, Mississippi, Alabama, South Carolina, you know, the states Georgia, are to the south where they had a devastating delta wave. But they’ve now achieved something, you know, sort of not you don’t have herd immunity, but they’ve achieved the level of prevalence has really declined. And now there’s a sense that COVID has passed. I think those environments are uniquely vulnerable to this. And  that looks like South Africa. I mean, South Africa had devastating Delta waves, they have vaccinations that are low-ish. The only difference is they haven’t deployed boosters. So but neither has a lot of Southern states.

Andy Slavitt  22:36

What about in a kind of quote, unquote, San Francisco prototype environment or a place where you’ve got high vaccination levels? Do we think in that environment that Omicron spreads to think Delta defeats it? Do we think it defeats Delta, how is it different?

Dr. Scott Gottlieb

I don’t think that Delta is necessarily going to defeat it based on what we’ve seen in South Africa so far, and one side has come out showing a lot of the infections or reinfections of Delta infected people. I think the question is, will the vaccines be more protective? I still lean in the direction of yes, based on again, very limited data, and it’s all public. And so in high vaccination environments where you have both high vaccination rates, and then delta has swept through and people who are unvaccinated got Delta, I think those places are more protected. I think this could be a less of a fear some issue in those environments. But that doesn’t describe probably the majority of America right now. And it’s also dependent on polling what we learned from the vaccines, I’m still of the opinion that the vaccines are going to be more protective than the immunity offered by Delta. And one final point on this, and I’ll just I’ll pause here, but there’s reasons to believe that, you know, if you’re infected with Delta, and that’s the only protection you have, you may well have better immunity from reinfection from Delta than someone who’s been vaccinated. It might be the case. And there has been some data suggest that but you may well have less protection against everything else. Because what the vaccines do is give you and especially the boosted vaccine gives you a broad complement of amplifies what we call polyclonal effect. The other people who have that polyclonal effect that broader antibodies are people who are infected and then vaccinated. But when you get infected, the virus does a good job as it’s mutated, it’s done a better and better job of hiding viral epitopes. And so it kind of shields most of its immune dominant epitopes on its surface. And so what you develop is immunity against Delta, the Delta epitope but not against everything else, and you end up with maybe very robust immunity against Delta but narrow immunity against everything else. So it’s a reason why people who’ve had Delta maybe well protected against Delta, but not so well protected against this but someone who’s been vaccinated may be protected against […]

Andy Slavitt  24:59

So you talked about monoclonal polyclonal. We’ve talked we people talked about by […]. We’re gonna go to all those expressions in a bit because they all have real meaning here. I feel like slowly but surely, like we’re all of us are being forced to learn, like all of these all these new things. But it really is, I mean, at some level, you step back and say, well, science is really remarkable at being able to handle and manage these things. So let’s talk about these interventions. I don’t want to talk about too. One, I want to talk about vaccines and the other want to talk about therapeutics. And as you’ve always rightly stated, and I stated in the introduction, among other things, that they should have been a very smart guy and the former FDA commissioner, you’re also on the board of a company called Pfizer. That’s how it’s pronounced. It’s relevant for two, for obvious reasons, but I’ll restate them. One is that that the mRNA platform, which is the platform, that is the one that is been the most effective platform, to date against COVID, is also a platform that allows for rapid development. So love for you to talk a little bit about the options there. And then Pfizer is also developing what is a potentially a very interesting and promising therapeutic. So I want to carve that into a second question in a bit. But I want to talk about how those interventions might evolve to address what we’re seeing with Omicron.

Dr. Scott Gottlieb  26:24

Well, look, I think on a therapeutically, we lose sight of the fact that we’re in a much different situation with the toolbox that we have. And it’s not just the vaccines, it’s not just that therapeutic, we have wildly deployable diagnostic tests, we have massive sequencing that we put in place to CDC. So we’re able to detect things more quickly. We’re using track and trace now to actually try to reduce the spread of this new variant, we were never able to do that. I mean, during the first wave we couldn’t do testing, tracking and tracing now we’re actually able to do and do it effectively, that’s not going to prevent the US epidemic, if this is going to become epidemic, but it’s going to buy us time, and it’s probably in has a potential to reduce the scope of the epidemic. So our toolbox is completely different. The orally available, antiviral could be a real game changer here, because, you know, this is a drug that has the potential to reduce the likelihood of someone progress the severe disease, hospitalization, death by a substantial amount based on the interim data that we have so far. And so if you have a drug like that, that’s widely accessible, can be prescribed easily got over the counter at any pharmacy has to be taken within three to five days of symptom […], so you have a window, that can be a real game changer, you know, the challenge is, we’re not going to have unlimited supply of it, at least initially. But that could be a real bridge through a new epidemic that we never had before. And the antibodies, I mean, the antibodies we could be using as much more aggressively.

Andy Slavitt

Let’s dig in a little bit on that, because look, we’ve got a Merck drug, which barely passed approval of the FDA advisory group, and it has relatively low, I’d say modest efficacy numbers, something like 30% a very expensive drug, and also kind of a side effect profile. That is That is real. And I’m asking you now, not in the context of your role at Pfizer to talk about but just really as you’re as a public health leader, you know, and then the Pfizer drug, which appears at least so based on less data to have more of a 90% efficacy level. You know, based on what I’ve heard so far, people tend to think both of these will not degrade significantly against Omicron. And I should tell you one other thing, I think you’re very related beta related point, which is that we still have to increase manufacturing quite significantly, for there to be a lot of these medications available here in the US. You know, I think it’s going to really be probably September of 2022. Before we have kind of an abundance of at least the Pfizer drug although, you know, I think they’re probably advances in manufacturing happening all the time.

Dr. Scott Gottlieb 

Yeah, I mean, the Pfizer drug, you mentioned I’m on the board of Pfizer as a protease inhibitor, we know how to make protease inhibitors the timeline from sort of […]

Andy Slavitt 

Won’t you tell us what a protease inhibitor is?

Dr. Scott Gottlieb 

It inhibits an enzyme that the virus uses to replicate the commonly used for other viruses, hepatitis, HIV. So we understand the mechanism of interfering with protease as a way to inhibit viral replication. You know, the manufacturing of protease numbers generally is complex. The timeline from starting, the manufacturing process with the starting ingredients to make a single pill is typically six to nine months. And so, you know, it’s a long complex manufacturing process. Pfizer said they’ll be able to produce 80 million doses next year. But that’s spread out across the year, productions coming up but you sort of amortize 80 million doses of course a year you know how much you’re going to have per month, and some of its backloaded towards the second half of the year versus the first half of the year. So we are going to be in a supply constrained environment. And remember also, this is a global supply. Pfizer has said they gave the patents to the medicine to the UN for low- and middle-income countries. So they put it in a sort of public trust, and the UN and WHO are now going to be partnering with Indian generic manufacturers to manufacture it at scale for low- and middle-income countries. So Pfizer’s producing it for Europe, the US, higher income countries, and there’ll be producing a low, low middle income countries too, and providing some supply there too.

Andy Slavitt  30:39

Just out of curiosity, why did they make that decision for the therapeutic but not the vaccine?

Dr. Scott Gottlieb 

Well, two reasons. Number one, I think that the policy environments changed. And there’s sort of an X, there’s a demand that, you know, you make the IP available and try to put it in two markets and allow them to develop themselves sufficient supply. Will this this will be one of the first times that we’re testing this in a crisis at scale. And we’ll see if the UN and who are able to actually scale up manufacturing effectively. Hopefully they are because I think a lot of countries are dependent upon him, Pfizer’s obviously still available to manufacture this and try to backstop that. The other is that, you know, manufacturing an orally available protease inhibitor, it’s very different than manufacturing an mRNA vaccine, the Indian generic manufacturers have manufactured plenty of protease inhibitor successfully, the high-quality manufacturers know how to do this, you know, the mRNA vaccines, the process is very complex, and it doesn’t lend itself to being done at sub scale, you know, the manufacturing for Pfizer is done at single facilities for everything. Because if you don’t do it at massive scale, it becomes very inefficient, you know, prone to manufacturing challenges and much higher costs.

Andy Slavitt  32:00

Got it. Two things. One is a response to the world political environment. And its second, the sort of tech transfer is more difficult for the vaccine than it is for the therapeutic?

Dr. Scott Gottlieb

You know, the tech transfer is not hard. And so far as you can teach people to know how, right, I mean, there’s qualified people in every country, you can scale this up. And it’s not insurmountable insofar as you, you can’t build a facility, you can build a facility, it’s that if you operate a facility at sub scale, it becomes exceedingly inefficient and hard to control the process. That’s why like, you know, if you look at a biological and you know this very well, like, if you look at Eylea, Eylea, a biological drug by Regeneron, I just sort of picked that one or, you know, pick a toxin. It’s not made in 10 different facilities distributed around the world, it’s made in a single facility, the reason it’s a biological manufacturing process. And the way to tightly control the characteristics of the product is to manufacture a single site, because so much of the characteristics of the product are tied to the way it’s manufactured. It’s hard to replicate that manufacturing process over and over and over again, with a pill, you know, it’s chemistry, you can have multiple facilities making the same pill. And there’s only certain things that can go wrong. And so it’s easy to punch out the exact same pill at multiple different sites, harder with a very complex biologic, especially something as novel as an mRNA vaccine where we haven’t done it a lot before. So that’s part of the reason why it’s hard to transfer. Now, you know, you know, Pfizer entered into a partnership with one of those vaccine manufacturers in South Africa to start manufacturing it in South Africa, they plan to produce at least 100 million doses there for the African continent in 2022, that partnerships well underway. But, you know, it’s important to do I think it’s very important to get self-sufficient production into these markets for a whole host of public health reasons. But if you’re looking at it purely from a business operation standpoint, it’s going to cost more and substantially more, you’re probably not going to be able to do it profitably. Certainly, because doing it at small scale is challenging. But there’s other reasons to do it. And there’s other reasons why the companies and Pfizer isn’t the only one, J&J is invested in local manufacturing in Africa well as well substantial manufacturing I think AZ has as well.

Andy Slavitt  34:56

Okay, so let’s get back on track a little bit to talk about what but need to happen to alter the vaccine if it needs to be altered for Omicron? That is really is a good news story of the mRNA platform.

Dr. Scott Gottlieb 

Yeah, it’s plug and play. I mean, it’s easy to do that it’s just changing this sequence in the mRNA sequence. And you can basically be superimposed on the existing manufacturing processes.

Andy Slavitt 

So we had both Stefan and Albert on the show separately. And I think the thing that kind of blew me away more than anything else, and I don’t think I knew this was just one area, I chose how much less I know than you was what Stefan said that the entire vaccine was built on iPads and laptops and not in labs. And I think that kind of helped me see how very different this type of science is. Then the kind of science we’re used to thinking about occurring in laboratories.

Dr. Scott Gottlieb 

Yeah, this was a technological inflection point where these vaccines were fully synthetically derived. I talk a lot about this my book, which you have mentioned. Uncontrolled Spread.

Andy Slavitt  36:07

Uncontrolled Spread? Never heard of it.

Dr. Scott Gottlieb 

This was a technological..

Andy Slavitt 

Wasn’t that a New York Times bestselling?

Dr. Scott Gottlieb 

Yes. But so let me just let me just table set with the, you know, this sort of Omicron specific vaccine, I think there’s a lot of reasons why we wouldn’t want to switch to a new variant vaccine unless we really had to there is reasonably biologically that a new variant vaccine might work well against that new variant, but not so well against everything else. And we saw that with 1351, the old South African variant, when Pfizer developed a vaccine just for 1351, when you looked at the plasma from people who were inoculated with that vaccine, the plasma neutralize 1351 very well, but then neutralize everything else very well. Because again, you get back to the issue that as this virus mutates, it may be becoming better at hiding different portions of its viral coat and just exposing one that’s very specific to that that new very, that’s a very sort of crude way of describing it. A virologist would now say that I’ve like, you know, mangle that. But basically, the virus is able to make itself much more specific, if you will. So when you develop antibodies is just to the unique attributes of that variant. And they’re not, they’re not relevant to everything else that came before. So there’s a good reason why we’d want to stick with the old Wuhan, the ancestral strain as long as we can and not switch right away. I think if we, if I was..

Andy Slavitt 

Does that mean evolutionary, from an evolutionary standpoint, if you create more vaccines to target specific variants that, that causes the variant to evolve away? Is that what you’re saying?

Dr. Scott Gottlieb

Not necessarily. I mean, I don’t know that the, well, I mean, you could postulate that the new variant vaccine would sort of put the virus under more selective pressure. But it’s probably a reason why if, in the future, we may move to multi valent vaccines if there’s really multiple variants circulating simultaneously. But I think, you know, in a likely scenario, if I had to guess where we end up with this, I mean, if I had to guess where we end up with this, I think we end up, the boosted vaccine is effective enough that we’re not going to take the risk of switching over to a new vaccine. But if we have to, if it’s demonstrated that the boosted vaccine isn’t sufficiently protective, I think that what’s likely to be is that the boosted vaccine is sufficiently protective in a large cohort of the population that are younger, immuno competent, not at very high risk. But there may be a portion of the population, older individuals, immunocompromised individuals that need the extra protection of an Omicron specific vaccine. And so when this rolls out, initially, it’s rolled out to a subset of the population that’s at high risk, and the same way we rolled out the initial vaccines. I think that that’s it, I wouldn’t say it’s a likely scenario, I think it’s a possible scenario, that the booster vaccine is good for most people, but there’s a cohort that need the extra protection. We don’t know yet, I’m speculating. But I don’t think that you would want to roll this out to everyone. And part of the reason you wouldn’t want to roll out to everyone is you also, I’m not sure that from a public health standpoint, and immunological standpoint, you want to suddenly bias the entire immunity of the entire population away from everything else, and towards this new variant, knowing that this new variant may be causing less virulent disease on the whole, and that it may not be the last variant that we say, because then you’ll be wishing that you have to like reboost, with the old Wuhan variant.

Andy Slavitt 

Yeah. Like, what if we kind of said to ourselves, that, you know, the public really in general, you know, with as much as going on out there? Probably large doesn’t need to be boosted more than say, once a year. I mean, we could call it whatever done we could change the date on that. If you want to call it I’m not sure but just for simplicity sake, and then just say, you know, each year as we do with influenza, we will update the vaccine to include kind of a what. And now I’ll go back to that term By Vaillant or Multi Vaillant, which is to say, you know, we will add components. So if there’s let’s say, there is Delta swimming around, and there’s Omicron, swimming around, and there’s even a tiny bit of Beta swimming around and a little bit of Nu, this year’s vaccine, the one you’ll take 12 months after you took the last one will be amended to have these additional pieces. So that way, A, we’re not saying to people, hey, new booster, now another new booster. Now another new booster. Now another new booster every time something happens, but instead we’re saying, do it once a year. Each time we do it, there may be updates based upon what we think will make it most effective.

Dr. Scott Gottlieb  40:49

Yeah, look, I think we probably get there, I long thought this is going to end up being like the flu, that it probably will for the foreseeable future be an annual vaccine, you’ll get it alongside the flu vaccine maybe at the same time. And that eventually it may become a multi-Valent vaccine. And so instead of like just take the Pfizer vaccine, obviously what I know, so 30 micrograms of the Wuhan variant, you have 15 of this in 15 minutes, or 10, 10 and 10. And you can go with a lower dose in people who’ve been previously vaccinated because they don’t need as much of each of them to get a robust immune response because they’re already they have they have affinity maturation, their immune systems have already seen COVID. And so a lower dose is going to be sufficient. But the challenge with that right now, and there has been some sort of like Twitter chatter, and I’ve had some threads with people today about this, you know, why don’t we go to a multi-Valent vaccine now where we sort of reboost people with the Wuhan variant and this new variant? The challenge is that’s from a regulatory standpoint, I think FDA is going to say this is kind of a different product.

Dr. Scott Gottlieb

I mean, this isn’t, you know, the, the monovalent vaccine that we’ve been looking at. So they’re CMC challenges. Can you mix two different.. Chemistry Manufacturing Controls. So you’re just sort of from a manufacturing standpoint, see, FDA is gonna look at it differently. They’re gonna say, this is a different kind of product, we need to look at the CMC issues differently. And then there’s going to be clinical questions does somehow the immune response to one variant interfere with the immune response to the other and they might cancel each other out, or you might overstimulate one versus the other. So I think FDA is gonna want to see more clinical data to see what the behavior is of giving two different variants, especially these variants. I mean, these aren’t, this isn’t like delta and delta plus this is delta and something and a virus that some people you’ve talked to Hotez and others think of or even Trevor think are really distinct, and might even be able to circulate alongside Delta. So I don’t think that this is something that there’s a long way of saying, I don’t think from a regulatory standpoint, this is something that can happen in next two months. That we might need a vaccine as a backstop for certain population within the next two months to deal with the current crisis.

Dr. Scott Gottlieb 

And we could do that from a manufacturing standpoint, to extent that we need that I think from a regulatory standpoint, the only way to really make that achievable is to have a monovalent vaccine, that the multi villain option, I think, is really a fall 2022 option, the monovalent just the Omicron specific vaccine, look, you could deploy that if you have to, we have to deploy for the population, we can do it all those it will take time to ramp manufacturing. And they will be I think, rationed, at first, to more vulnerable people. And that’s where I think the booster vaccine will be good enough for most people. Worst case scenario is you deploy that you bias the immunity in the population towards this new Omicron variant, you find out by the fall Delta is picking up again, and you reboost the population with a you know, the old ancestral strain or maybe a Delta vaccine, it’s suboptimal. But if you have to do it, you do it. I don’t think we’re going to get there; I think what we’re going to find is that the boosted vaccine, based on what we’ve seen so far, and again, it’s really early to speculate this is my guess, I think it’s going to be sufficiently protective, maybe for everyone, but certainly for the vast majority of people. If there’s a subset of the population that really needs very specific immunity to this virus, because we’re uniquely susceptible to it, we will be in a position to provide that product, all the companies.

Andy Slavitt  44:19

So I want to talk about a little bit of the downside of what that world looks like. Because, to me, the implication of that is kind of remember where we all were before we got boosted, where we started to see the vaccines wane, we started to see a lot more infections, we didn’t see a lot more serious, illness, but we started to see a lot more infections. And so, you know, masks came back, and other sorts of things came back, it feels like what this implies is in 2022, we will again, again, this will be regional based upon bias and all these other things. We will again be using a number of interventions if we want to prevent ourselves just from getting sick, wearing masks, well ventilated spaces. somewhat avoiding crowds being careful around of travel, but another year, where if the vaccine efficacy for Omicron kind of has the same effect of kind of the waning of the vaccine against Delta, that we’re going to be in a year that is kind of very much the pandemic as a part of our lives.

Dr. Scott Gottlieb 

I think that the down case here is that this remains a sort of persistent risk, even if it remains a low level of risk. And for people who don’t want to get COVID or are vulnerable to it, it’s going to be something that they have to fashion their lives around. Whereas on the back end of this Delta wave, you know, I and others were really convinced that prevalence levels would get sufficiently low heading into the spring in the summer, even heading into late January that we could move beyond COVID. Like if you go to Florida right now, I was down there. No one’s wearing masks, people are in restaurants, people crowded and you know what? They’re not acting irrationally. prevalence is six cases per 100,000 people per day. I mean, it is way down. They should nobody should be wearing a mask on, you know, unless you really need it. Because you’re uniquely vulnerable. Why would you have a mask mandate down there right now, when prevalence is six or five cases per 100,000 per day, that’s as low as we’ve ever been, since this virus first emerged in any part of the country.

Dr. Scott Gottlieb  46:15

So I think the whole country could have gotten there. I think this room’s that narrative, potentially, if this spreads here, that this, it’s not going to be another huge delta wave. But it’s going to be this persistent risk, and people who are at risk will remain at risk and have to, you know, manage their lives around that risk. That’s the fear. Um, I think the vaccines still have the potential to mitigate that. But we need to remember, a lot of people aren’t vaccinated, a lot of people aren’t boosted. And so getting, you know, whereas I would have said, if you talk to me three weeks ago, I would have said, look, we’ve got 83% of adults with at least one dose. Kids are getting vaccinated, pretty high rate, let’s just focus on getting people boosting game more kids vaccinated stop fighting to get that last 10% of adults vaccinated. I think this changes the equation a little bit and we can’t sort of give up on trying to get the holdouts vaccinated, even if we pick up another 5% I think it will be meaningful.

Andy Slavitt

0 to 5’s, how close are we? This is the mo question, mo someone that Scott and I both know, who’s got a toddler. When do we think that will potentially be able to protect the kids under five?

Dr. Scott Gottlieb  

Data could be available by the end of this year; the trial has been expanded a little bit to get more clinical data. So I mean, it’s going to be at a regulatory time from FDA, I think, certainly Q1. But, you know, I would suspect that Omicron spreading here, they’ll see more urgency around trying to move that plus the FDA now has a data set and five to 12. That, you know, looks reassuring, to date. And so I think that that will also weigh into how they evaluate the vaccine for 2 to 4.

Andy Slavitt 

And what does that mean to approval if you played that forward?

Dr. Scott Gottlieb

Well, if you play it out, you know, take data would be available, take the Pfizer at least a couple of weeks to file an EUA based on that data, given past timeframes. And so you’d have a filing at some point in January maybe. And I think FDA is turning these things around within four weeks. And so you could have an approval within February, I think it’s a possibility.

Andy Slavitt  48:14

That would be good news. Well, we covered a lot of ground. I don’t want to take any more from you. But you’ve been very kind to come IN THE BUBBLE to contribute as you have. Uncontrolled Spread is the name of Scott’s actually very, very awesome and comprehensive book. I you know, I’ve typed up my own book on this show. But I would tell you that my book is different cover some things. Scott’s book is probably one of the most systematic looks if people want to want to say, ask me what’s the most systematic look at the pandemic and then what we should do about it what we should do next. Uncontrolled spread. phenomenal book.

Dr. Scott Gottlieb

Thanks a lot, Andy. Appreciate it.

Andy Slavitt

Thanks, Scott, great episodes coming up. Trevor Bedford, who we’ve never had on the show, I can’t believe it. Chris has been wandering around for a long, long time. He is the guy who does all the great computational work in the detailed work on how about viruses are spreading and he’s deep into Omicron. And where it came from, how it developed, what it looks like, should be interesting. After that, we have an episode on what is going on to fix the supply chain, how that’s impacting inflation, what that’s doing on the economy. Also very interesting with some great guests. And then we’ll do a special episode to wrap up 2021 and look ahead to 2022. Talk to you next week. Have a great rest of the week

CREDITS

Thanks for listening to IN THE BUBBLE. Hope you rate us highly. We’re a production of Lemonada Media. Kryssy Pease and Alex McOwen produced the show. Our mix is by Ivan Kuraev and Veronica Rodriguez. Jessica Cordova Kramer and Stephanie Wittels Wachs are the executive producers of the show, we love them dearly. Our theme was composed by Dan Molad and Oliver Hill, and additional music by Ivan Kuraev. You can find out more about our show on social media at @LemonadaMedia. And you can find me at @ASlavitt on Twitter or at @AndySlavitt on Instagram. If you like what you heard today, please tell your friends and please stay safe, share some joy and we will definitely get through this together.

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