WTH is going on with the COVID vaccines? Dr. Scott Gottlieb with everything you need to know about the end of the COVID road
Episode #80 | November 23, 2020 | Danielle Pletka, Marc Thiessen, and Dr. Scott Gottlieb
Danielle Pletka: Hi, I'm Danielle Pletka.
Marc Thiessen: And I'm Marc Thiessen.
Danielle Pletka: Welcome to our podcast, "What the Hell Is Going On?" Marc, what the hell this week?
Marc Thiessen: Well, have you finished your sandwich yet? Are you ready for the podcast now, Dany?
Danielle Pletka: Yes, I'm ready for the podcast now, honestly. Basically, our listeners can just feel like they've moved into a really, really small house in which we've been living together alone for the last eight months.
Marc Thiessen: While you finish your sandwich, I'll tell you what the hell's going on. What the hell is going on is both the best news and the worst news about the pandemic coming at once. We are entering or are in quite frankly, the worst phase of the pandemic yet. More hospitalizations, more viral spread, more people dying than at any point since the virus hit our shores. We're going to what Joe Biden has called a "dark winter," and it is very dark. But the good news is that there is a light at the end of the tunnel that as we get through this storm, we have now not one but two vaccines, one from Pfizer and one from Moderna, close behind, that have been proven to be 95% effective.
Marc Thiessen: We have Operation Warp Speed, the Trump administration initiative that has purchased in advance hundreds of millions of doses of each of these vaccines. We have an Army General who is in charge of logistics in terms of distributing these vaccines and making sure they get to people. So, we're at a point now where in the next couple of weeks, we will have FDA approval for the first of those vaccines, hopefully FDA approval of the second one soon. We're weeks away from people getting immunized from this virus. It's an unprecedented achievement in the history of public health.
Danielle Pletka: It is but it's also an unprecedented challenge. I mean, when we think about the backs and the forths and the forths and the backs and the information, the misinformation, the theories, the counter theories, it's been an exhausting and confusing year. I never doubted the ability of the United States of America to not
2 just surmount this, but to innovate in ways that others would not first and better, because we are still the freest, best, most innovative country in the world. But it's been hell. There are a lot of lessons learned that I hope we're really going to be able to take to heart in the coming years.
Marc Thiessen: Oh, no doubt. I mean, through all of that, let's keep in mind that this is quite literally the greatest public health achievement in human history. The previous record for developing a vaccine for a novel virus was five years. So, we've done it in a matter of months, and not just one, but two that are proven. There's a Johnson & Johnson vaccine that's close behind. The Trump administration invested about $10 billion in I think 10 vaccine candidates. Some of those are still in development, and we're coming behind. I know this has been a very hard year. It's going to get worse before it gets better, but it's going to get better.
Marc Thiessen: We're going to be able to vaccinate starting in December, the elderly population, which is the most vulnerable population. Soon after that, we're going to be able to vaccinate healthcare workers and people on the front lines. You don't have to vaccinate the entire population, because most people don't have bad outcomes from COVID. It's really a smaller cohort of people. Once you vaccinate those people, you've basically lifted the burden of the virus from society.
Marc Thiessen: Why are we shutting down schools and kids go to school? It's not because we're afraid and we're trying to protect the children. It's because the teachers' unions are upset, because the teachers might get sick, and they might get it from the kids. Kids don't have bad outcomes. I think there's only 18 kids in the whole city of New York that have died from COVID. So, if you can get teachers vaccinated, then we go back to school and there's no problem.
Danielle Pletka: I mean, there are kids who have had very, very serious outcomes, but you're right.
Marc Thiessen: The reason we shut down the schools in spring was because most viruses attack kids first, but this one, it's actually the opposite. It's the elderly and the older people who are more vulnerable. So, the point is by next spring, it's not going to be over, but it's going to be pretty close to over. We're going to be heading of this horrible year of 2020 and all the disease burden. That's great news. America is just the best country in the face of the earth.
Danielle Pletka: Well, I'm not going to disagree with you about that, because it is. But one thing I will say that will absolutely stay with me is the utterly reprehensible, disgusting, politicization of this whole thing that was so awful and so exhausting and so counterproductive in this year. I think there's probably blame to go around, but I still remember when I heard that it's only in red states that people are getting sick, because the governors just deserve it because they're so awful. It's unspeakable. We look back at ourselves and we think about ourselves as this amazing country that has done amazing things. That is really a low point for us. Do you agree or not?
Marc Thiessen: I do agree. I thought you were going somewhere else with this. Usually, when you use disgusting and reprehensible, it's targeted at the 1600 Pennsylvania
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3 Avenue. So, I didn't know you're going the other way.
Danielle Pletka: Well, that's a truism.
Marc Thiessen: In modest defense of our country, keep in mind that there was a confluence of events happening and that this virus hit in the midst of an election year in the most hotly contested election in our memory, right? So, it was almost inevitable that this would be politicized.
Marc Thiessen: I found just the constant refrain and blaming Donald Trump for the virus and for everything that's gone wrong. He's made his share of mistakes and the reluctance to support masking and some of the things he said about the virus just disappearing and all the rest of it. I don't defend any of that. I've criticized him in this podcast and my columns and all the rest of it. But a lot of the mistakes were made by the public health experts. They screwed up the testing for six weeks. They told us that there was nothing to worry about. Until mid-March, Dr. Fauci and all these people were out there saying, "Americans, don't change your lives. Nothing to worry about. This is not something that is going to affect most Americans."
Marc Thiessen: Until all of a sudden, everybody set their hair on fire. Told us that masks don't work and not to wear masks. So, months later, when they decided masks do work, people didn't believe them. So, there was a lot of mistakes that went on that had nothing to do with him. And then also, the other thing that I found incredibly shameful was Harris and Biden both talking down the vaccine, because they knew that for all the mistakes that Donald Trump made, the vaccine is the solution. If he got credit for it, it would have hurt them enormously.
Marc Thiessen: So, they started questioning whether the vaccine would be reliable, whether it would be safe. Now, you've got a population where a lot of people out there think, "Well, I don't know if I can trust this vaccine or not." I think deliberately pushed down that trust for political purposes, which I find shameful.
Danielle Pletka: Yeah, look, I mean, I agree with you wholeheartedly about that. Listen, if we can get through this, we can figure out where we went wrong and where we went right. In the meantime, we still have a lot to learn.
Danielle Pletka: We've got an amazing return guest who was gracious enough to find time to be with us today, Dr. Scott Gottlieb. He's a resident Fellow at AEI. He was the 23rd, Commissioner of the Food and Drug Administration. He has been working in public health as both a physician and as an entrepreneur for a very long time. He's on the Board of Pfizer. We should remind people of that, because of the vaccine, we're going to be talking a lot about Pfizer. Really one of the most astute, balanced analysts, and someone who I would listen to before almost any public health expert. So, without further ado, Scott.
Marc Thiessen: Scott, welcome back to the podcast.
Dr. Scott Gottl...: Thanks for having me.
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4 Marc Thiessen: So, we've got a bad news, good news situation. The bad news is we're having the worst COVID spike since the pandemic began. Lots of people getting hospitalized, lots of people dying. The good news is there's light at the end of the tunnel. Pfizer has a vaccine that reports it's 95% effective. Moderna is not far behind with a vaccine that's 94.5% effective. I leave it to you. Do you want to talk about the good news or the bad news first?
Dr. Scott Gottl...: Well, we'll talk about the bad news. I think the situation is going to change quite dramatically as we enter into 2021. We're having, as you said, the worst surge of infection in the course of this pandemic. We always knew the fall and the winter was going to be the most difficult time. We have pretty pervasive spread around the whole country right now. There's really no region that's spared. Whereas before, the different waves of infection were concentrated in certain parts of the country initially in the tri-state region and the south. This one's really distributed. You're seeing some parts of the country that are doing better. The tri-state region is doing better than Mid-Atlantic, I think, because they've had a lot of infection already.
Dr. Scott Gottl...: So, you have more people who have some immunity. They also have a more aware public. So, there's more adherence to things like masks. They have policymakers that have taken more aggressive steps to try to contain spread early, but there's really no region that's spared. So, we're going to see a lot of infection build simultaneously across different parts of the country. In terms of where things can head, the one thing we worry about is the healthcare system getting overwhelmed and not really being able to care for the sick. While capacity looks okay right now in terms of the availability of beds and different kinds of equipment, what we're going to run out of first is personnel.
Dr. Scott Gottl...: What happened during the epidemic spike in in the spring and then again in the summer, was we were able to surge healthcare personnel into those regions to backstop the existing healthcare workforce in those parts of the country. Right now, with the whole nation really a hot zone, where you don't have a swing army of healthcare personnel that we can move around to backstop some of these hotspots. So, I think what you're going to see is there may be available beds or they may have the capacity to create new beds in a lot of these hospitals, but they won't have the doctors and nurses and technicians to staff those beds. So, the ability to triple your ICU bed capacity isn't going to be there, if you don't have people who can actually staff those beds. So, that's what's going to actually run out.
Dr. Scott Gottl...: I think that over the next probably three weeks, we're going to start to see those situations emerge. That's where we could get into trouble. As far as the light at the end of the tunnel that you mentioned, we do have what looks like two vaccines that show significant efficacy. I'm on the board of Pfizer, which has one of those vaccines. Moderna has the other. Pfizer has submitted a request to the FDA for emergency use authorization for the vaccine. Moderna is said to be not far behind.
Dr. Scott Gottl...: I do believe that we're going to have one or more vaccines available, maybe as early as mid-December to start vaccinating the highest risk population, which is probably going to be elderly individuals who are maybe living in institutions
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5 where they're at high risk of contracting the infection, because they live in a nursing home or long term care facility and a very high risk of having a bad outcome because of their advanced age. But the vaccine really isn't going to be widely available until next year.
Dr. Scott Gottl...: So, while it could be used as a tool to de-risk COVID for the highest risk individuals during this spike of infection, it's probably not going to have a really big impact on what we're going through right now. We're going to have to grapple with this the old-fashioned way with testing, tracing, mitigation, and all the other public health tools that we've been using.
Marc Thiessen: How long will it take to vaccinate the high-risk population? So, elderly people, healthcare workers, maybe teachers, the people who are most likely to have bad outcomes. Because we have Dr. Slaoui on the podcast. He was pointing out that once you vaccinate the high-risk population, you've really relieved the huge burden of the disease on society, because most people don't have bad outcomes. So, you seem pessimistic. I'm just wondering if there's a more optimistic way of looking at this, that once we get those high-risk people vaccinated... If teachers are vaccinated, kids can go back to school, can't they?
Dr. Scott Gottl...: Right, I'm not pessimistic. This is just going to take some time to get to the heart of your question. First of all, we're supply constrained in 2020. So, we're not going to have enough supply to really vaccinate all the people who would qualify as higher risk for bad COVID outcomes. So, I think it's going to be focused particularly on elderly individuals and particularly on elderly people who are living in settings where they're more likely to contract infection. We probably could get through that population this year. If there's an authorization in mid- December, you could probably start vaccinating that population very quickly, because you know where those individuals are. You can distribute the vaccines efficiently.
Dr. Scott Gottl...: But remember, this is a two-dose vaccine. So, if you administer the first dose, let's say, over the course of the last two weeks in December... Let's say we get an authorization in mid-December. This is just speculation. I don't have insight into when these things may happen. So, let's say you're able to distribute the vaccine very quickly and you're able to vaccinate that first eligible population within two weeks, which would be I think a pretty significant feat but perhaps achievable. So, now, with the Pfizer vaccine, you have to wait three weeks. With the Moderna vaccine, you have to wait four weeks to administer the second dose. You get some protective immunity after the first dose, but really the full immunity doesn't kick in until you get the second dose and optimally until a week after the second dose.
Dr. Scott Gottl...: So, let's say we're at the end of December and you vaccinated that first tranche of very high-risk individuals, you have to wait three weeks. You start vaccinating them, then giving them a second dose. Maybe you get done with that by the end of January. And then you wait a week and full immunity is kicking in. So, we're now talking about February. My belief is that this current epidemic wave that we're going through right now is probably going to peak sometime over the next six weeks.
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6 Dr. Scott Gottl...: So, we're going to be coming down the epidemic curve by the time immunity's kicking in as a result of the vaccination that we've deployed. So, while it could affect the tail end of the epidemic, what I'm saying is we're largely going to have to deal with this epidemic without the full benefit of a vaccine, even among the high risk population, just because of that sequential process that I've just laid out.
Danielle Pletka: So, Scott, let's just talk about how we deal with it. I mean, we've been to this rodeo before. We've watched other countries contend with it, and we've watched different approaches to it. On the one hand, we have a much better palliative system. We understand better how to keep people alive, but we also have a population that's sick and bloody tired of this. So, you're seeing people who are just not observing protocols because they don't want to anymore. So, how are we going to deal with this, this time around, understanding that that magic cure at the end of the rainbow is just not going to come quite fast enough for this wave?
Dr. Scott Gottl...: Yeah, I mean, I would hope that we could galvanize more collective action and more adherence to some of the prudent measures that you alluded to, because people can now work on the knowledge that this is the last wave, that we are going to thwart this in a reasonable period of time using technology. It's not just the vaccines. It's also the antibody drugs that are going to be in wide distribution by next year as well, which look very effective as well, which can be delivered to not just prophylax people but also treat people if they become infected. So, there's an endpoint to this. We're going to vanquish this with the technology. This is the last time we have to grapple with this acute wave of infection across the country.
Dr. Scott Gottl...: So, how do we deal with it? You're going to have to take some targeted mitigation steps to close or curtail certain congregate activities that you know are sources of spread. You've seen governors do things like close bars, close social halls, limit capacity in restaurants. That will have an impact, but it won't have a dramatic impact. That's largely what the southern states did. That's what Texas and Arizona eventually did to try to get a handle on their own epidemics. That combined with the fact that we now are going to have a lot of spread, combined with the fact that as the epidemic sweeps through a population, people do withdraw. They start wearing masks more. They start becoming more vigilant. You see Google mobility trends go down.
Dr. Scott Gottl...: That combination probably is enough to start to bend the epidemic curve, but it's going to be slow. We're not going to see the declines that the Europeans are seeing right now, because they impose pretty dramatic, draconian action. I mean, they've imposed the equivalent of lockdowns that were obviously tweaked. They didn't close schools, things like that. We're not going to do that. To your point, there's no political support to that. So, we're going to take a more calibrated approach. We're going to be frankly partly dependent upon just the continued spread of this virus to eventually be a backstop to more spreads.
Dr. Scott Gottl...: Once you infect a certain percentage of the population, it starts to slow. Where is that percentage? It's probably going to be about 20% to 30%, you start to see the rate of transfer slow at that level. That combined with the targeted mitigation combined with the fact that the population is going to become more vigilant will
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7 be enough, like it was in Texas and Arizona and Florida to eventually break the epidemic cycle.
Danielle Pletka: Scott, you said one thing that stuck with me, because it had so much finality. I think, for a lot of people, the source of despair, even if they haven't suffered, even if they're not losing loved ones, even if they still have their job and they're doing okay, the source of despair is not knowing where the end of the tunnel is. You really were emphatic about that. We're looking at the last wave. We're looking at the end of this.
Danielle Pletka: Here's the question that I think will be on people's minds as we start to administer the vaccine. Can't this virus mutate? You have lots of clinical understanding. Will the vaccines as they are constituted, the ones from Moderna, Pfizer, some of the newer ones... Novavax has one, a couple of others have one. Are those going to be able to deal with a mutated virus, or are we looking at something that could come back?
Dr. Scott Gottl...: The virus can drift. The part of the virus that we use to vaccinate people called the spike protein, which is a protein on the surface of the virus, that can change over time. We may have to use a different spike protein in the vaccines. So, we may want to tweak this vaccine, maybe annually, maybe every couple of years. It's unlikely the virus is going to mutate in a way where you have a sudden mutation and that mutation is more contagious than the prevailing strain and it just races around the world before we're able to reformulate these vaccines.
Dr. Scott Gottl...: One of the virtues of the platforms we're using for these vaccines is that they can be reformulated very quickly. Reformulating the Moderna and the Pfizer vaccine is as simple as changing the mRNA sequence to match whatever changes take place with respect to that spike protein.
Dr. Scott Gottl...: So, I don't believe that this virus is going to mutate in a way that it's going to evade our technology. I think that our technology is going to be able to keep pace with whatever changes happen. This virus doesn't mutate as rapidly as the flu. So, I don't think that what we see with the flu, where it could literally mutate within the span of a single season, is going to happen here. It'd be unlikely given the biology of this particular virus. So, I do believe that there is a technological backstop here. I think the most likely scenario is we have a pretty dense epidemic over the next six weeks, maybe eight weeks depending on what steps we take and whether or not people start to become more prudent.
Dr. Scott Gottl...: Thanksgiving's a real challenge now, because that's probably going to create a spike in spread at the very time that we should be reducing our activity. People are going to increase it. So, we'll get to a point hit the peak of the epidemic. We'll start coming down the other side. As we enter into the late winter or spring, transmission will naturally break off, because we've had a dense epidemic, because we've affected 30% of the population, because we're starting to deploy the vaccine, because people have become more cautious.
Dr. Scott Gottl...: I think as we get into the spring and summer, this will be relatively quiescent. We could take a breather. We won't see major spread, hopefully. There'll be a seasonal backstop, combined with all those other things I talked about, and the
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8 fact that 30% of the population have been affected by that point. And then as we get into summer, then we'll be deploying the vaccine more widely. So, we'll more fully break off the chains of transmission.
Dr. Scott Gottl...: The reality though is between now and then, we could lose another upwards of 200,000 people. If you believe that we've infected 15% of the population already, if you believe that the infection fatality rate has been cut in half, which I think it has to about 0.45%, and if you believe that we're going to infect another 15% of the population over the next three months, which is the current run rate that we're on, then you're probably going to see another 200,000 deaths as a result of COVID between now and the end of January.
Marc Thiessen: That's very depressing. So, I want to bring your optimistic side out, Scott. One of the things that we talked about early on in this pandemic, you and I, was how this resistance to masking among some people... You were pointing out that it's not like you're going to have to wear masks forever. We got to get through a period of time, where it's very tough. And then we're going to get a vaccine.
Marc Thiessen: We're going to be able to go, not completely back to the way we were, but relatively back to normal at some point. But we're not going to do the masking all the time. We're not going to be having the social distancing in the way we are. If we want people to do the right thing over the next six to eight weeks, we got to give them that light at the end of the tunnel. Can you paint a picture of both when and how life becomes more normal for Americans again?
Dr. Scott Gottl...: I think life becomes more normal in the spring. I think as we get through this and we start coming down the other side of the epidemic as we get into the spring, we'll be able to do more normal activity. We're not going to see wide transmission of this virus. There'll be sporadic outbreaks. We'll have good testing in place. We'll be tracking it. But I don't think this is going to be a pervasive part of our daily lives. In terms of masks, I think we really need to mask up for the next two months. If everyone can reduce their activity over the next two months, wear masks when they're in congregate settings, that's going to go a long way. The quality of masks really matters.
Dr. Scott Gottl...: The reason we ask people to wear masks initially, so going back to the spring, the reason why we started to say, "We should have recommendations for masking," is because we knew a lot of the spread was from people who either are pre-symptomatic or asymptomatic. We knew that if we put a mask on people who were asymptomatic, they were going to be less likely to spread the virus. So, if you could put a mask on all the 20- and 30-year olds who are getting infected and were asymptomatic and spreading the infection, you would reduce transmission. We know that. There's data with flu that that's pretty reliable, but the masks don't necessarily protect you from getting infected.
Dr. Scott Gottl...: What they do is they prevent you from spreading the infection. But a mask can protect you from getting infected, that's where the quality of the mask becomes important. If you want the mask to also protect you, you have to wear a higher quality mask. So, if all you can get is a cloth mask, then wearing a thicker cloth mask, ideally one that has polyester in it along with cotton is going to afford more protection. It might be about 30% protective.
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9 Dr. Scott Gottl...: If you can get a true level two or level three procedure mask... So, a true surgical mask, not necessarily was sold on Amazon. It has to say at the level two or level three mask. ... that might be 60% protective. If you can get your hands on an N95 mask, that's going to be 90, 95% protective if you wear it appropriately. So, if you want to protect yourself, you have to be aware of the quality of the mask that you're wearing. Otherwise, the mask won't necessarily give you a lot of protection. It'll just prevent you from transmitting the virus or lower your odds of transmitting the virus. So, it won't prevent it. It'll reduce the likelihood.
Marc Thiessen: How are these KN95 masks that you see a lot of people wear... Are they better than the surgical mask?
Dr. Scott Gottl...: They could be, I mean if they're true KN95 masks. So, the European designation is called FFP2. The Chinese and Asian designation is called KN95. The US designation is called N95. The difference between the US mask and the European and Chinese masks typically are that in Europe and China, they allow the masks to have ear loops, where it just goes around your ears. In the US, they require two headbands. The presumption is among regulators that the headbands give you a more secure, more consistent fit.
Dr. Scott Gottl...: The problem with the KN95 masks is there's a lot of stuff in the market that says they're KN95 masks and you don't know if it's truly a KN95 mask that's undergone testing and really is reliable and does filter out 95% of particles. So, there, you can go to FDA's website. FDA has authorized a lot of different KN95 masks now. So, if it has an FDA authorization, you're getting it from a reliable supplier, chances are it's going to be good.
Dr. Scott Gottl...: One website that sells directly to consumers, and I have no relationship with them, I'm just aware of it, is called ACCUMED, A-C-C-U-M-E-D, the website that sells KN95 masks. They sell surgical masks, level three procedure masks. They also sell N95 masks direct to consumer. All of the masks sold on their website have undergone independent testing. Many are either FDA cleared or NIOSH tested.
Danielle Pletka: So, Scott, let's talk a little bit about politics, not about Donald Trump, good man, bad man and all the crazy that's going on right now, because that would take a separate podcast. But let's just talk a little bit about different countries. This became a highly politicized fight in the United States and even globally. We saw that even in the most virtue signaling country of the world, New Zealand, they went through a bad bout of it until they met to eradicate it. What lessons should we have learned? Where did we really go wrong?
Dr. Scott Gottl...: Well, I think there's a lot of lessons learned. Just in terms of the galvanizing public action, Europe didn't do a lot better at this than we did. There was a lot of division over things like masks and the mitigation and closing certain venues. I think in our democratic system, these things are hard. It would have been better if we had clear, consistent messaging from our political leaders. I don't think the President had to say, "Everyone should be implementing a mask mandate," but a simple message that we don't necessarily need the government to tell us what to do and force us what to do. We know what to do.
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10 Dr. Scott Gottl...: We all need to band together and get through a difficult period that this is going to end, but we all need to take prudent steps in our daily lives to try to reduce spread and reduce risk for the population as a whole and for ourselves individually. So, this is what we need to do. I think that simple message would have been more constructive than the messages that we heard. The reality is I think that the Western world may be uniquely vulnerable to a respiratory pathogen. If you look at the Asian nations, they did a lot better than us. There's a lot of reasons for that. We had a very hard time implementing respiratory precautions here.
Dr. Scott Gottl...: I think we are uniquely vulnerable to a respiratory pathogen. I think it probably recalibrates our thinking about these kinds of risks going forward and maybe what adversaries would be willing to unleash on the world, quite frankly. We always thought bioterrorist threats and threats from rogue nations would be things that weren't infectious because nobody wanted it to blow back on them. But what other nations proved is that they're far more effective at thwarting off these things than we are.
Danielle Pletka: How hard would it be? Understanding that we have these weaknesses, understanding that we're probably not going to get much better at them, how hard would it be for an enemy to actually weaponize this against us?
Dr. Scott Gottl...: Well, I mean, you don't need to weaponize it. There's a lot of naturally occurring strains that if you help them make the zoonotic leap from animals to man, they'll spread pretty quickly. If a pathogen is not otherwise been in a population before, there's no cross immunity, it spreads pretty quickly as this one did as other pandemic strains have. It's not just that fact that Singapore and Taiwan, these countries are small countries. New Zealand didn't have tighter controls over the population.
Dr. Scott Gottl...: China is a pretty populous country and Japan and South Korea, they were able to get better control as well. I mean, part of it is cultural. They had better adherence to masks. They have been through SARS. They were an aware population. Part of it was the rapid deployment of technology. They were able to get testing out very quickly. South Korea really thwarted this through massive testing that they were able to get out quickly that we just didn't have the capacity. We didn't have the resiliency in our system as hard as it is to believe. So, we need to prepare that better for the future as well. There's technological things we can do to be better prepared for the future in addition to the cultural things.
Dr. Scott Gottl...: But if you look at the entire Pacific Rim, right now, they have more infections, it's going up, but it's still not anything on the order of what's in the US. You look at the entire Pacific Rim on a daily basis. They're registering collectively as many cases as a single large city here in the United States, maybe less. So, they're doing something right. I think that there's some lessons to be learned. The one thing that they are doing is they were able to lean very early on massive testing to know where the infection was spreading and take more targeted mitigation steps.
Dr. Scott Gottl...: I mean, what happened with us in the spring was we had no idea where it was spreading. We had to presume it was spreading across the country. It wasn't. So,
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11 we went towards a uniform national policy of a stay-at-home order when we really didn't have to. We could have targeted that better. And then we would have reserved, I think, more popular support for taking mitigation steps down the road. But because we did that early, by the time the virus eventually spread in the South and spread in the Midwest, people had had it. They said, "We already shut down in the spring. We're not going to shut down again."
Dr. Scott Gottl...: So, the big failing here was the inability to deploy a diagnostic early, so we knew where it was spreading. Some cities absolutely needed to be shut down. I mean, New York was on the brink of collapse. We absolutely need to implement stay-at- home ordesr. Frankly, we implemented it too late. But did we need to shut down Houston and Bozeman, Montana? No, it wasn't spreading there yet. We could have used tracking and tracing to contain the spread. We didn't know that, because we had no diagnostics available.
Marc Thiessen: Jumping off of that, let me ask you a question. There's been a lot of criticism of Trump's handling of this, but how do you grade the response of our public health officials, the experts? Because as you pointed out, there was this delay in testing. That was a decision by the FDA not to allow all hands-on deck for testing, only to let the CDC develop a test. The CDC had... They had bad lab practices, screwed up the original test. So, we lost like six weeks just from there.
Marc Thiessen: Also, by the way, all these public health officials were saying, "Oh, don't wear a There's a lot of mistakes by the public health experts, and they seem to be so sainted. Well, we'll just listen to the scientists, but the scientists got a lot wrong, didn't they?
Dr. Scott Gottl...: Well, I mean, you're right that the FDA Commissioner made a deliberate decision not to get the clinical labs in the game early. We should have spun up LabCorp and Quest back in January. And then we would have had massive, well, much more massive testing capacity available by the end of February. It takes time to get those tests deployed. So, there were decisions made not to do certain things that left us without a backstop to what we were doing, which was trying to roll out that CDC test.
Dr. Scott Gottl...: Quite frankly, even if CDC hadn't botched the test and that test had rolled out on time, it still wouldn't have been enough testing. You always needed to get the clinical labs in the game. So that was really a decision by the FDA Chief. So, there were decisions made along the way that made this far more challenging. There's no question about that. That's not necessarily the White House. In fact, the White House staff was telling agencies to be doing these things. They just didn't do them. I mean, there was direction given to FDA about deploying the clinical lab tests earlier.
Dr. Scott Gottl...: So, I can't explain why certain things were done and not done, but you're right that not all of this is just the fault of one person. I mean, you need agencies to execute, make independent decisions. You need your experts to surface these kinds of things. People in the White House who are generalists aren't going to know that what we really should be doing is getting LabCorp and Quest and BioReference labs working on a diagnostic test to backstop ourselves. That has to come from the people who know that. That's the FDA Chief and maybe CDC,
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12 who also have proximity to that.
Danielle Pletka: My exit question, Scott, and it's something that isn't as much on our minds while we face up to the challenge of dealing with the virus itself. That is the aftereffects. We hear, although they're very anecdotal, stories about how lung damage, liver damage, heart damage, these things, cognitive decline. How worried are you about the long-term global impact of this disease, even once we get a vaccine?
Dr. Scott Gottl...: Look, I'm worried about it. I don't think we fully understand what these syndromes are. It's not unheard of to see post-viral syndromes where you have a virus that becomes epidemic in a population. You see a certain number of people presenting after resolution of the virus with certain unusual symptoms, particularly autoimmune type symptoms. We see it for example with Kawasaki. It can cause a dilated cardiomyopathy rarely in older individuals. So, when you see Kawasaki outbreaks in the summertime, you often see people present with myocarditis and cardiomyopathy.
Dr. Scott Gottl...: We see it with flu, people present with Guillain-Barré and other syndromes, encephalitis, other things related to flu. It's not entirely clear whether this is happening at a higher proportion with COVID, whether COVID is inducing more of these post-viral types of syndromes, not entirely clear what these post-viral syndromes are. Or is COVID just so epidemic that it's really not producing these kinds of rare events at a higher rate than another virus might, even if another coronavirus might?
Dr. Scott Gottl...: We're just seeing more of it, because so many people are getting infected with COVID. We've infected millions, tens of millions of people now with COVID in the United States. So, we don't know the answers to these questions. It does appear that there is a higher incidence of the serious post-viral syndromes associated with this virus, but we don't know that for sure. I think we're not going to know that for some time, because, quite frankly, we haven't even really accurately characterized what these post-viral syndromes are at this point.
Marc Thiessen: I have two closing questions for you. First, I just want to give you a chance to respond to this, because I know the President and quite a lot of people accused Pfizer of holding back information about the vaccine success until after the election. We talked about this offline. You actually pointed out to me that it was the FDA that pushed back on Pfizer and told them not to go with the first round of information. So, could you address the concern that why didn't we have this information before Election Day? And then second of all, can you just overall give us your assessment of Operation Warp Speed?
Marc Thiessen: We're talking about a matter of weeks in difference, but this is arguably the greatest public health achievement in modern times, the fastest development of a vaccine for a novel virus in history. The idea that we could have a virus hit our shores in February and March, and by the next February or March, have a vaccine in place that can basically immunize our population. That's never been done before. Give us your assessment of that entire effort.
Dr. Scott Gottl...: Well, with respect to the data and Pfizer, Pfizer found out about these results Sunday morning, I believe, at 2:00. The company had a board meeting at 6:00
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13 to inform the board. They put out a press release 6:45 AM the next day. The question is, "Could there have been a result before the election?" That's what people were speculating in the press. Well, what you would have potentially had would have been an interim analysis based on 32 cases. So, the results that were eventually put out were 94 cases. So, could you have had an interim result, the first interim result based on 32 cases at some point before the election? It's not clear that you could have. That data wasn't available as late as end of October, if I recall correctly.
Dr. Scott Gottl...: So, it's not clear that it would have accrued in the next three days and been out before November 3rd if it wasn't available on October 28th or whatever the day was when Pfizer had its earnings call. So, they hadn't yet reached the first interim. But even if you did have it out and you showed a good result on 32 patients, it would not have had the impact of that showing a good result on 94 cases did. The reason why that data when it accrued, when it was divulged was so impactful was because it was 94 cases. It was a big cohort.
Dr. Scott Gottl...: Thirty-two probably wouldn't have driven the same, I think, consciousness about the potential benefits. The reason why we didn't have the interim analysis with the 32 was the feedback from the advisory panel was very clear that they didn't think that an analysis of 32 cases was going to be meaningful. It certainly wasn't actionable. Once FDA changed their guidance, actually, you couldn't seek authorization based on 32 cases.
Dr. Scott Gottl...: So, what you're doing by taking an interim analysis of 32 cases is you're risking the trial. You're reducing the statistical rigor of the trial by doing an interim analysis for no benefit. You're not going to have any public health benefits. You're potentially confounding the trial for no benefit, because you know you're not going to be able to file on 32 cases. So, what is the availability of data actually going to do? It's not going to do anything from public health standpoint.
Dr. Scott Gottl...: So, when you're judging this from a public health standpoint, the right thing to do in terms of trying to drive developing the vaccine, once you knew that 32 cases wasn't actionable and the feedback was very clearly that you shouldn't do an interim based on a cohort that isn't actionable, the company made the decision to take the first interim analysis at 64 cases instead.
Dr. Scott Gottl...: What happened was they blew past the 64 cases. They waited a period of time for more cases to accrue. By the time they unblinded the data or started to process samples to look, because infections were accruing so fast, they didn't have 64 cases, they had 94. The same thing happened with Moderna. They were supposed to take their interim analysis at something like 60 cases or there about. When they actually went and took it, I think they also had around 90 cases. So, it's just a function of the fact that we have a raging epidemic now. So, the cases are accruing very quickly.
Dr. Scott Gottl...: As far as Operation Warp Speed, yeah, I think that this is a tremendous achievement. It's not just the vaccines. We have to look at the monoclonal antibodies. We have to look at the scale-up of manufacturing. I mean, there's many parts to this. There's a lot of therapeutics that had been advanced simultaneously. I mean, we've never really had this level of development work
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14 undertaken over such a short period of time with so many successes. This is a singular achievement. I can't think of any historic proxy.
Dr. Scott Gottl...: I mean, you need to look at technology development for military purposes to find situations where we've had a concerted undertaking by the federal government to develop simultaneous technological solutions to challenges at the same time. This is certainly the first time I think we've ever done this in a public health context with this level of success.
Marc Thiessen: Does the President deserve credit for that because a lot of people are going out and saying, "Yeah, yeah, but Pfizer really wasn't part of Operation Warp Speed. This happened despite Donald Trump and his administration"?
Dr. Scott Gottl...: This is an administration achievement. I mean, there's no question that the White House helped lead this. Obviously, there's a lot of people part of this. The ideas came out of the agencies and the departments. Peter Marks at FDA had a big hand to play here. But the White House supported this. They got behind it. They helped galvanize the support to this. So, they deserve a lot of credit for driving this over the finish line.
Danielle Pletka: We can tot it up against all the stupid things they did, Marc, that made fighting the virus much harder. There's a balance sheet here.
Marc Thiessen: Okay. I'm not questioning that. I'm just saying that somebody can mess up the overall response but then you give the President credit where credit is due. That's not that hard.
Danielle Pletka: Yeah. That's what Scott did. Scott, as usual, you are clear, you are well informed, and you're so generous with your time. Thank you so much for being on with us.
Marc Thiessen: Thanks, Scott.
Danielle Pletka: We really are grateful.
Dr. Scott Gottl...: Thanks for having me.
Marc Thiessen: Operation Warp Speed, which the Trump administration implemented, has proven to be the greatest public health success in modern times. I'm just mystified by the reluctance of so many people to give the Trump administration credit. You don't have to say you approve of Donald Trump's presidency or his handling of COVID or the way he handled his briefings. You don't have to approve of all that to say, "Yeah, in this case, home run. Good for you, good for the President, good for America." Why are people so reluctant to give him credit for what really is what's going to end this pandemic?
Danielle Pletka: Well, I think people are reluctant to give Donald Trump credit because he has been, first of all, unbelievably divisive on this question, because he has done a lot of foolish things that he shouldn't have done. For many people, especially people who've been directly impacted, the good things he's done don't mitigate the bad things he's done. Everybody has a different perspective, but
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15 political mania has been a feature of the Trump presidency for four years. That's not going to stop.
Danielle Pletka: So, yes, he deserves credit as the big boss for the things we did right, but he also deserves a lot of demerits for the mistakes that were made, for the bad signals that were sent. Frankly, he should have shown better leadership and I understand people's unwillingness to forgive him.
Marc Thiessen: First of all, that's like saying, "Well, yeah, he won the war, but we didn't like the way he handled a lot of things." This is what will end the pandemic. This is the greatest public health achievement in our lifetime. He literally is responsible for stopping this virus cold, even if the effects will be after his presidency. So, yeah, I don't defend a lot of the stuff he said, but he beat the virus through the Operation Warp Speed and he deserves credit.
Marc Thiessen: Okay, let's turn to your topic of China, because we spent the last months of the campaign saying, "The virus is Donald Trump's fault." I think you and I both agree that no, the virus is China's fault. So, is China going to get the blame for this? How are we going to deal with China going forward?
Danielle Pletka: Well, the first thing is that and I didn't want to start arguing with Scott about this, because I don't think it's worth it, but I don't believe China's numbers.
Marc Thiessen: Oh, I don't either.
Danielle Pletka: This is a country of 1.4 billion people. They don't tell the truth about anything. We don't know how many people died at the beginning. We have not heard one true statement from the Communist Party of China. So, I don't know what their numbers are. They could be low; they could be high. They might have beaten this, but they may not have.
Danielle Pletka: One thing though that we cannot forget and here I will 100% agree with you is that the country that is responsible, the country that lied to the World Health Organization, the country that installed their puppet at the head of the World Health Organization in order to front for them and then didn't tell the world about this, causing us to react too late to this, was the People's Republic of China and the Communist Party that heads it. There's got to be an accounting. Once we have the vaccine, there's got to be an accounting.
Marc Thiessen: I agree with you 100%. What I worry about and we talked about this a little bit in the last podcast with Jack is that the Biden operation is so invested... Blaming China became... Reflexively people rejected it, because it was seen as deflecting responsibility from Trump and his mishandling of the virus, right? So, the Biden team just basically... Anytime you said China is to blame, they'd say, "No, Donald Trump is to blame." So, how do you pivot from that, because they're so invested in the lie? Do you really think there's a chance that the Biden administration is going to turn around and say, "Actually, it is China's fault. Here's how we're going to punish them for it"?
Danielle Pletka: I don't know, the honest answer to that question. I would hope that an
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16 administration that is coming in and trying to draw a contrast between itself and its predecessors would strenuously do its best to be honest and truthful and to look for some accountability. The government of Australia is looking for accountability. The government of the United Kingdom is looking for accountability. We have allies who we should be standing with in forcing the Beijing government to come to account. I really worry about this. The last tiny thing I want to just put a footnote on our conversation, because we got to come back and talk about this, because Scott brought it up as well and that is the bioweapons.
Marc Thiessen: Yeah.
Danielle Pletka: This is something we've got to come back to, because there's a lesson learned for every bad guy in the world right now.
Marc Thiessen: Oh, we've just had a demonstration effect of how a respiratory virus can absolutely cripple a society. The terrorists sitting in caves in Afghanistan, in Pakistan, in Yemen are looking at this and they're looking at it with bitter jealousy there, because this is the kind of destruction they want to wreak on our country. I mean, they're looking at this and saying, "Bioweapons are the way of the future." As Scott said, particularly respiratory virus, it's harder to do than one might think, because you got to get just the right kind of virus.
Marc Thiessen: I remember when Ebola struck, I did a column about how terrorists are willing to put suicide vests on, why wouldn't somebody infect themselves with Ebola and come over here and spread it? The reality is, is that one of the reasons why is because Ebola is so deadly. The reason why we didn't have a huge outbreak of Ebola in the United States partly is because it kills its hosts too efficiently, right?
Marc Thiessen: What made COVID so deadly is that it's got just the right mix of deadliness, but not so deadly that it kills people before they can spread it. They got to get the right virus, but yes, absolutely, they would happily infect themselves with smallpox, infect themselves with some other virus and come over here and spread it. I think that's probably the next front in the battle against the terrorists, is that it's making sure that they cannot weaponize the virus to get to wreak havoc in this country.
Danielle Pletka: On that happy note, everybody's going to have an amazing Thanksgiving, food for thought. At least, now you have something to talk to your appropriately distanced and masked family members about.
Marc Thiessen: Just remember, this is the darkness before the dawn. We're in a very dark winter, as Joe Biden likes to say, but the dawn is coming. We've got a vaccine. It's only a matter of time before we're immune and we can go back to life. So, wear your masks, socially distance. It's only going to be for a little longer.
Danielle Pletka: Amen to that. Thanks, everybody. Complaints to Marc, compliments to me, tech to Alexa.
Marc Thiessen: Do you ever get any of those compliments? I don't think you do. You keep
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17 begging for them at the end of every podcast, the emails... It's just I don't hear your email going beep during the podcast with people saying, "Dany, you're so wonderful."
Danielle Pletka: No, because they're too irritated with you and they can't tune in for that long. Bye, everybody.
Marc Thiessen: Take care.
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