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Description

Andy brings you information directly from the source to let you know what to expect when the antivirals arrive: who will get them, how to get them, when to get yours, and the biggest question — will they change everything? In an exclusive interview with In the Bubble, Dr. David Kessler, Chief Science Officer of the White House COVID-19 Response Team, tells Andy how he is personally navigating Omicron and what the Biden Administration is doing to ensure that we have the capacity to respond quickly to the next pandemic.

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

Follow David @DavidAKesslerMD on Twitter.

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Check out these resources from today’s episode: 

• Learn more about the NIH’s COVID-19 treatment guidelines: https://www.covid19treatmentguidelines.nih.gov/
• Check out the New England Journal of Medicine article on Remdesivir that David mentions in today’s episode: https://www.nejm.org/doi/full/10.1056/NEJMoa2116846
• Find a COVID-19 vaccine site near you: https://www.vaccines.gov/
• Order Andy’s book, Preventable: The Inside Story of How Leadership Failures, Politics, and Selfishness Doomed the U.S. Coronavirus Response: https://us.macmillan.com/books/9781250770165

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For additional resources, information, and a transcript of the episode, visit lemonadamedia.com/show/inthebubble.

Transcript

SPEAKERS

Andy Slavitt, David Kessler

David Kessler  00:00

I mean, there’s a total of five products that work against Omicron. There’s a GlaxoSmithKline monoclonal for treatment. There’s the AZ monoclonal for immunocompromised, there’s a two anti virals and there’s an intravenous, antiviral remdesivir, the paper in the New England Journal, you know, two weeks ago, that showed as good results as any monoclonal, I mean, and the Pfizer drug. So, I mean, it’s not perfect, right? I mean, there’s still shortage of the GlaxoSmithKline and the AZ, I mean, and the Pfizer, right? But there’s a range of therapies, but I got to change medical practice, and everyone goes, where’s the Pfizer drug? Well, I can’t find the Pfizer drug, I have nothing but when there’s a range of therapies.

Andy Slavitt 

Welcome to IN THE BUBBLE, this is your host, Andy Slavitt. If you are new to IN THE BUBBLE, this is a great podcast for you. Because it’s all the things that we try to do in IN THE BUBBLE, which is, namely bring you an insider conversation on what’s happening in an area that’s of importance to you, where we all have a lot to learn. And, you know, we’ve been doing this show now for almost, it’ll be two years in April. And we generally try to bring you people who can tell you what’s going on in a level of detail that you might not otherwise hear it because these are people behind the scenes who generally tend to talk to me in one way or another, or are people inside driving what’s going on? David Kessler is on the show today. David, is the chief scientific officer of the United States. He’s the man who runs what used to be called Warp Speed. I don’t think they call it that any longer. And he is the man at the center of pretty much most of the things that the government’s doing right now to protect us. He’s a little bit more behind the scenes and some of the other people like Dr. Fauci. But he purchases, the antivirals. He has been accountable and responsible for making sure we have antiviral. So we have enough antivirals. And he’s going to talk to us about when they’re getting here, about what they’re going to do for us, about whether they’re going to change things about why we have purchased that we purchased.

Andy Slavitt  02:31

And we’re going to delve into some other topics, too, because he’s the chief scientific officer of the United States, you’ll see that I’ve taken the opportunity to ask him questions about his own family behavior. We’re gonna start with that. Around Omicron. We talked about masks, we talked about a bunch of other things. And he is a font of knowledge, you’ll see it’s a pretty classically intense IN THE BUBBLE conversation. Kessler was the guy who during the AIDS crisis was on FDA working on binding antivirals for HIV-AIDS. So he knows this area. Well. He’s the chief science advisor in the White House, he used to run the FDA. And he was formerly the Dean of Medicine at both Yale and UCSF. And I think you’ll hear a very interesting conversation. And probably, it’ll probably be the leading amount of information we have around the antivirals that are right around the corner. You know a little bit to tell you about this show, if you haven’t listened to before we have commercials, because we donate all of the proceeds that come in to me to COVID relief causes, we’ve donated just shy of $200,000, to date. So thank you for listening, thank you for making that happen. We cover the pandemic and other topics that are a bit scary to you and where you need to get inside knowledge. That’s what we’ve been doing. And we’ve been enjoying bringing it to you.

Andy Slavitt  04:02

So, if we get through Omicron. Let me just give you a sense of where we are. I’m not one to predict anything, but I will tell you my opinion is we have reached past the peak, we are very likely past the peak in Omicron. Now, you might not be able to tell it from looking at daily cases. But I will tell you the daily cases are misleading here. Because so many people go untested through official reported channels. That what will happen when cases go down, is that when total cases go down, is you’ll see more people get tests, you’ll see more people get tested. So case counts will continue to go up. Wow, test positives will flatten. And that’s what we’re seeing right now. We’re seeing particularly in different parts of the country. That’s starting to happen, the more telling sign of how much COVID there Is, is when you look at the sewage data, where they collect samples to look at how much COVID is in the sewage. And at least in two places, at least in Boston and San Francisco, you’re seeing a significant decrease in COVID by measured by that. So, you know, you could wonder like, well, gee, how can cases continue to go up while sewage count is going down. And that’s just because there’s this anomaly where more people are testing. The data on hospitalizations, I think continues to be rock solid in saying that if you are vaccinated, you’re not going to be in any risk of going to the hospital unless you have other illnesses.

Andy Slavitt

And as I said, on Monday’s episode, that’s real. We got millions and 10s of millions of people in this country who have pre-existing conditions and illnesses. So we have to be very, very careful. And also that we don’t get dismissive about COVID and about the risks that exist to some people. But it is clear at least with Omicron, that for lots of people, these are lower risks. Interesting statistic I thought I mentioned, if you are vaccinated, your risk of ending up in the ICU at any age is .01%. .01% If you are vaccinated, and by the way, if you’re vaccinated and boosted your rate of likelihood of being hospitalized is cut in half. So that’s good. It’s really particularly important right now to our marvelous producer, Kryssy Pease, who, yes, has got a little bit of the case of COVID. Yes, nothing to be ashamed of. But she’s not feeling great. She’s been a real trooper going through the show. But she’s been vaccinated. She’s been boosted. And she’ll be getting better soon. And she claims that she got an opportunity to see a friend that she hadn’t seen in two years, which I don’t know. I mean, I have to tell you, it’s not an unreasonable risk, to go see someone you haven’t seen in two years, who you’ve put off seeing because of the pandemic. Just kind of risky to take with your eyes open. And Kryssy certainly does, and she’ll get better soon. But look, I think I mentioned that not to embarrass Kryssy who gave me permission to talk about this, but because it’s the story that’s happening to everybody, you know, to all over the country. People are in a variety of different stances, but I think for most people, I’d say they’re precautious, but not paranoid. And that’s what I’d recommend, be precautious, but not paranoid. Unless you have special reason to worry. I don’t think it’s healthy to be obsessing over the virus, I think it’s healthy to be mindful of it. Let me tell you to be precautious I think it’s important to be precautious about others. But I don’t think it means that it should rule our lives. We should rule our own lives, or, you know, let our spouses rule our lives or something like that. Okay. Now, we’re gonna get on to David Kessler, fascinating conversation, you’re gonna learn all about antivirals and some other stuff. And I think you’ll enjoy David’s character.

Andy Slavitt  08:30

Hey, David, how are you?

David Kessler 

I miss you.

Andy Slavitt 

I miss you, too, man. How are you?

David Kessler 

I’m good. I think I’m good. But I really do miss you. You know, I mean, every day, I mean, I wish you were here.

Andy Slavitt 

Well, that’s nice. Well, it’s so nice to be talking again. And, you know, I will view the work that we did together and the work that you’ve been leaving, it’s just extraordinary time. And I’m really excited for our listeners to get to know you. And some of the extraordinary work to do done. I probably have to start giving them we’re in the middle of Omicron by asking you, it’s sort of at a personal level. You’re the Chief Scientific Officer for the Department of HHS, but effectively for the country. Focusing on COVID You’ve been the commissioner of the FDA, there’s nobody with, I think a more respected set of experiences and backgrounds. From a personal standpoint, how are you advising your family in this very tricky, complicated time around Omicron? Are you advising your family that look be very, very careful, this is very contagious? Are you advising them? Look, this is very, very mild. And you know, you’re gonna get it anyway. So don’t worry about it. Are you somewhere in between? Can you help us help people who have been really trying to be very careful through this entire pandemic? Think through how they should be thinking about it by understanding how you’re thinking about it.

David Kessler 

So everything changed for me, it was Thanksgiving day. You know, I’m reading about South Africa, the new variant, just a few press reports. And I email my, you know, close colleague, going back to HIV days, you know, […] professor, the head of South African Medical Research Center, and I said, you know, what are you seeing? And I remember the email spike back around midnight. He said, it doesn’t look good. And it was the beginning of the spike in South Africa before, there was, you know, a lot of data, but just soar a variant that just transmissibility was clearly very different than anything we saw in the past. And I think from that day on, you know, I mean, this has been non-stop. I mean, it’s really been non-stop since March 2020, you know, that, but this is a different, different disease. I mean, it’s a different form of the disease. I mean, and I think we now have, you know, a number of weeks of, you know, experience in South Africa experience in the EU, experience in the UK, you know, and now we have experience in data from the United States. You know, my family has been listening to me for two years. And, you know, I mean, they’re terrific. They have kids, different ages, some vaccinated, some unvaccinated. So I think it all depends on the situation you find yourself in. I think we’re going to get through this. I think this is clearly the hospitals are crushed. Clearly, they are facing challenges, as severe as anything we saw in the first wave. But this is not, the problem is not where patients are on ventilators. This is a problem of staffing. And people being in testing positive, I think I’ll get to your answer in about 45 minutes. I mean, at this rate.

Andy Slavitt  12:31

This is great. I love to listen to how you think.

David Kessler

So the answer is, you know, we’re lucky everyone’s healthy. Everybody’s vaccinated. Everyone’s been boosted. So I don’t think anyone is sitting in fear. One caveat. Right? It’s for parents who have kids who are under five, right? Or if you have someone at home, who’s immunocompromised or elderly, those are the ones who have to take greater precautions. But I’m not of the school yet where if you’re healthy, vaccinated and boosted, just throw up your hands, take off your mask and go out there if you’re positive. Just not there. Right, because I just don’t know enough. Right? I mean, maybe in you know, in 6 months, 3 months, 6 months, 12 months, we’ll understand more about long, you know, long COVID. Maybe I’ll be able to sit here and say, you don’t, you know, look, if you’re vaccinated and boosted and you get infected with Delta. And no problem, you know, there’s no real long-term sequelae this virus is not going to, you know, attached to your heart or your liver, you know, I mean, elsewhere. And you really know, we just don’t have great deal of experience with immigrants. So I’m not of the school, where, you know, take off your masks, if you’re healthy and just if your doctor and who cares treat this like the comical, just not that smart? Maybe ultimately, you know, we get enough data. So we’re there. So I’m probably the answer to your questions after what 15 minutes of the going on? I’m probably middle ground. I think we’re gonna get through this. I don’t think I mean; I think it’s great. This is less severe. I think for everybody. I think this is highly much more protected, certainly vaccinated and boosted. We have to figure out what we’re vaccinating for ultimately, you know, is this when vaccinating for you know, against infection, are we vaccinating for serious disease. But, you know, I think we’re gonna get through this. I’m telling everyone to be cautious. But no one should be in fear, except for those who are really most risk.

Andy Slavitt  14:55

I actually think that was a pretty mesmerizing takedown of the issues and I think I suspect a lot of Americans are kind of close to where you are. Which is, you know, they’re willing to take reasonable risks, to live their lives and experience the joy, that it’s a part of being with each other, and attending events that matter. But they’re still don’t want to take stupid risks. And if all things considered, they don’t want to get it, I think maybe people are less fearful that they’ll die if they get it, which is great. But I’d still think most people would prefer not to get it in part, because as you say, there’s uncertainty.

David Kessler 

Just to that point. I mean, the motto in the family from the beginning And again, we’re fortunate, right? I mean, everyone has jobs, where they can sit in front of a screen, that they can, you know, communicate, they have access. I mean, not everyone’s just fortunate, I mean, to have jobs like that. But, you know, most of the kids and family, you know, have jobs like that. And, you know, what I’ve always say is look, for now, you just have to choose, choose which risks, you know, you want to entertain, right? I mean, if something’s really important, you do it. I mean, if it’s not so important, you know, I mean, just give me a just give me a couple more weeks, Andy, let me get this down. I don’t know about you; I don’t know what time you look at their graphs every day. Yeah, I tend to look, I mean, you know, there’s documents that came in around 11:30 at night, I tend to look at those. And you know, I’m starting to see if I, you know, you’re close one, you can start to see this peak. It’s coming crashing down in London, it’s down in South Africa. It’s somewhat of a plateau. Just let’s get through the, you know, give me another couple of weeks. And then maybe we can breathe a sigh of relief until, until the next one.

Andy Slavitt 

Well, let’s talk about the future in a minute. But let me just finish up with what you’re doing for the next few weeks. What kind of masks do you wear? What kind of masks you wear if you are, you’re going indoors to be around other people outside of your home?

David Kessler

I mean, I will wear when I’m in tight quarters I wear an N95. It’s non-medical.

Andy Slavitt

And what do you recommend for your family members? So they all wear N95 so that we’re different types of asks, and then if you’ve got kids or grandkids in school, what do you recommend for them?

David Kessler  18:07

So I have actually, I mean, depends on how long people are in this. If somebody is in this all day, I find an N95 very hard to wear all day. And I’m concerned, you know, so procedure mask, surgical mask, it depends on the setting. Keep on going. I mean, you’re so you’re asking about masking policy?

Andy Slavitt 

No, not about policy. I really, look, I think everyone in the world knows that N95 masks are the most protective.

David Kessler 

So let’s see if we can agree on this. I think there’s a lot of confusion. Let’s see if we can make this simple. So no doubt, most protective with regard to filtration. It goes N95, KN95. Right? Surgical mask, cloth mask. And there’s different gradations of each one of those. So you go from most protective, to least protective. Now, not everybody can tolerate, and N95 or has access, you know, right. So I think that, in general, it makes sense, you know, to, for people, as I understand what’s being said, is to choose that mask, right, the highest quality mask that you can tolerate and that you will wear.

Andy Slavitt 

Right, look, I’m trying that I’m not even going to wear it with the CDC should or shouldn’t say when they should or shouldn’t say it, because I think that people want to just be very want to be told what the best protection is. And then, as we’ve said earlier, people are willing to take..

David Kessler  20:00

What I put somebody, you know, who’s sending, you know, huffing and puffing in a N95. No, I mean, I gotta use, you got to use clinical judgment. So it’s very important what people are comfortable in, what they will tolerate, how long? I mean, they will be in, right. I mean, I think there is some judgment here, what is the range of protection? We got to get away from the using of what’s the best mask?

Andy Slavitt 

And I think the other piece of this that it’s important to say it I think you’ve been implying this is none of these are necessarily forever.

David Kessler 

You know, I don’t do masking.

Andy Slavitt 

Yeah, no, I think people want to know what we all do personally, as much as they do, because I think it helps explain it in real human terms, but it’s better than necessarily, than anything else. But I guess the other part I want to make sure that people hear is, I kind of hear you saying none of this is necessarily forever. And if you find it unpleasant to wear a mask. And if you find it unpleasant to take certain precautions, or avoiding a restaurant or a ballgame or something that no one can predict the future. But the decisions that we’re making our decisions for what’s right, right now, and there is reasonable, you can be an optimistic or you can be a pessimist. But there are reasons to believe that you do it when you need to. And there will hopefully be long periods of time in the near term, even when we’ll be able to take fewer precautions. Is that fair?

David Kessler

Absolutely. I mean, as I said, do me a favor, just coming through the next couple of weeks here. I mean, I recognize that I recognize that, you know, different places in the country are gonna peek in different places. You know, I’m sitting in Washington, DC, I use that timeframe for DC, you know, but I recognize, you know, I mean, this is gonna roll through.

Andy Slavitt  22:02

And to kick off the next part of the conversation. I want to just orient people a little bit. You’re the chief scientific officer, you’ve come in and taken over what the prior administration had called warp speed. I don’t know if we still call it that. But you’re, you’re basically you’re a public servant with a tremendous amount of expertise, and a central role that you play in helping us fight the pandemic. Can you just explain what you’re accountable to the public? What are the key things that you do as part of the overall effort? And I think we warrant that you and a couple of other people are leading the entire effort. But there’s very specific things that you have on your plate.

David Kessler 

Yeah, I mean, I’m sure everything is we. As you know, there’s a team of us. So everything we do is us, right, and we make all decisions really together. And none of us is smart enough to get all these right. But I, I really am responsible. If there’s a vaccine issue, if there’s a therapeutic issue, I’m there. I’m helping drive those issues again with the team, but vaccines and therapeutics from day one, you know, I mean, I did that you were there. You know, the story. Man, I was doing that. In some ways, you know, even before we got here for then, Vice President and you know, during transition, I mean, I remember saying to the then Vice President, you worry about becoming president, we’ll take care of the vaccine side. Well, you know, we’ll get the vaccine, we get people vaccinated. And I think he delivered on that, and he helped us deliver on the vaccinations.

Andy Slavitt 

So I’m going to want to I will come back and talk a bit about vaccines and the future of vaccines and what we’re planning for, but I do want to talk about therapeutics, well in your mind, in your opinion, are therapeutics, if vaccines are called an eight or nine on a scale of 1 to 10, in terms of how great a tool they are. And the reason they don’t give them a 10 is because, you know, if we never got to Delta, we’d be dealing with a vaccine that prevented us from being contagious, and that’d be wonderful. But let’s give it an 8 or 9, maybe you may not agree with that assessment. But if a vaccine was an 8 or 9, how important are the therapeutics

David Kessler

The therapeutics are very, very, very important, and will become more important. I mean, I would give it a 7-8, right behind vaccines. I think vaccines have the great benefit of really prevention. You know, I mean, again, we have this problem, you know, it prevents against serious disease. I’d much rather the virus not attack to the receptors, I mean, the different organs and avoid that attachments or I’d rather avoid, you know, disease from setting in and prevent it always, I mean as a doc, than having to treat it, because whenever I’m treating it, I’m always somewhat behind the ball even if it’s early. But I think this is soon as we have enough, especially of the Pfizer drug, and it’s going to change how we look at this disease. I mean, first of all, one of the advantages of the oral anti viral is, you know, we’re gonna need several oral anti virals, as my view, I mean, we can’t stop with just, you know, I mean, having one, the Pfizer and Merck, we need to in 2022, we need to develop other antivirals. I mean, I come out, you know, I mean, I spent the 1990s, doing antivirals, you know, with Dr. Fauci with Tony, for HIV. I mean, that’s what I, you know, did a large part when I was at FDA, right? It took us six years to develop the antivirals. And to be able to, you know, change the course of HIV, we didn’t have a vaccine, we still don’t have a vaccine. And yet we were able to change the course of that disease.

David Kessler  26:15

I mean, when we got here, I mean, you will remember, when we wrote, as part of the AARP, we wrote for funding for antivirals, we set up an anti virals, in essence, the Warp Speed teams, we picked three antivirals in 2021. And we carry them forward, you know, there was the Pfizer and Merck, you know, there was a third, you know, the […]. But, you know, two hit, you know, companies deserve enormous credit here. I mean, it’s not us, but those were the three we followed, you know, and one had, you know, has marked efficacy, again, not a perfect drug, but there are always issues. But, you know, we did that in 2021. And I think that it’s gonna change. We don’t have an I mean, by April, we’ll have millions of doses a month. And if I told you, okay, you’re vaccinated, and you’re boosted, but you still can have a breakthrough case. And if you have asthma or something, you still have a risk of getting hospitalized. I mean, we’re gonna take the, you know, the death and you’re not gonna end up on the ventilator, and you’re not going to end up, you know, I mean, dying, and you can still end up in the hospital. But I told you, hey, you can go down to the CVS. And you can get your doctor write a script, and you take, you know, a pill for five days. And that’s going to reduce your risk even further, of any hospitalization or death. I mean, you may not even go to the CVS if you got infected and pick that prescription up. The fact that you know, there’s a treatment. Right, and this is a treatable condition. I’m not going to end up on a mental I’m not going to end up you know, I mean, in the ICU, you go, oh, well, maybe I can go to the movies.

David Kessler 

Yeah. Different category. Different category.

David Kessler  28:01

I mean, yeah. And I think that’s, I think we’re very close to getting.

Andy Slavitt 

Interesting. So in layman’s term, […] references a couple times that he will have, you know, we have a couple 100,000 coming in January, you refer to we’ll have millions and starting in April, where they can get 10 million coming in September,

David Kessler

20 million in September, but who’s counting?

Andy Slavitt 

T 20 million will be by September?

David Kessler 

20 million cumulative by September, 10 million by June.

Andy Slavitt

So if you think about that, is that enough? When will it have enough? What do we have enough for today like today, do we just have enough for immunocompromised? How should we think about it?

David Kessler 

I gotta get you to change. Here’s where we are. Up until now we had three monoclonal treatment, right? We have three monoclonal. We had a literally Regeneron GlaxoSmithKline. We have three monoclonal and, you know, one was, you know, sub q, others IV, and with Omicron we lost two of them. So we still have the GSK one, right. But we’ve added this four other I mean, there’s a total of five products that work against Omicron. There’s a GlaxoSmithKline monoclonal for treatment. There’s the AZ monoclonal for immunocompromised, there the two anti-virus, and there’s an intravenous antiviral remdesivir, the paper in the New England Journal, you know, two weeks ago, that showed as good results as any monoclonal and the Pfizer drug. So it’s not perfect, right? I mean, there’s still shortage of the GlaxoSmithKline and the AZ, I mean, and the Pfizer, but there’s a range of therapies, but I got to change medical practice. You know, everyone goes, where’s the Pfizer drug? But I can’t find the Pfizer drug. I have nothing but when there’s a range of therapies. I mean, and in fact, I mean, if you look, I think we will allocate some 2 million plus I think we, you know, we’re getting in deliveries of, you know, million, several million up to 4 million over the next number of weeks. So we actually have more therapies in January than we ever had before, but they’re different. And yet, you know, what it takes to change medical?

Andy Slavitt  30:16

It’s a good clarification. You know, I think the torture a little bit of the show, probably hundreds of 1000s of users, most of our guests, all the Washington crowd probably listens. And there’s influencers, but these are mostly regular Americans, regular folks, who I think, here the assessment that you just made about the therapeutic, the oral therapeutic, which, you know, for people who don’t want to subcutaneous shatter intravenous, or don’t have access to it, it just as you say, it sounds simple. You can march down to the CVS and so forth. And my guess is..

David Kessler

We’re not there yet. We’ll be there in April. And the thing we have to recognize right now, is we got to save these, for those who are most aggressive.

Andy Slavitt

That’s the first thing I wanted to hear is for now, you know, we still have a couple 1000ish people dying a day. And those are the people, many of them are unvaccinated. Many of them are people who are immunocompromised or older, or have risk factors. But that’s who you’re saying we should be targeting. Ideally, we should be..

David Kessler

What we did, NIH colleagues did something extraordinary, they put out right, in record time. Before you know, the new year, as soon as these may understand that four of these therapies hit in latter part of December, right, either they were EUA or the NIH recommended them. So there’s four new therapies, in the end of December, NIH puts out treatment guidelines, right? And everybody I mean, every doc, every healthcare provider should look at those treatment guidelines, because they do two things, they prioritize. Very rarely do we talk about, use this first, use this second, use this third line, use this fourth one, NIH did that. It’s laid out in the treatment guidelines. Right. I mean, it goes use Pfizer, if you can’t use Pfizer, you know, it’s not going to work because there’s drug interactions, and you can’t use Pfizer use the GlaxoSmithKline monoclonal if you can’t use that use IV remdesivir. If you can’t use that, use Merck. I mean, it was an extraordinary accomplishment.

Andy Slavitt  32:37

We’ll put a link to that document on this.

David Kessler

But it also did something else there was absolutely essential. It talked about who the priority was to talk about that. And you saw right up there were immunocompromised over 75. And then there were, you know, people over 65 with risk factors, and then there was unvaccinated with risk factors. And then there was I mean, so it actually laid out a four tier, maybe because you can’t just put these medicines out in short supply and say, to our colleagues mean, in the medical profession, good luck administering this. I mean, you got to give them some kind of guidelines. I mean, this is really very hard.

Andy Slavitt

So the answer, if I came in, in March, positive for COVID-19, and the sniffles, and there was day two, and I said, hey, Doc, and Adam, and not any of those lists, I’m 55. I’m not on this list fortunately, for me, and I said, hey, Doc, I’d love a prescription for Pfizer, for this, this great anti-viral, what should they say? They’ll say to me, no, it’s March. This is our guidelines. You don’t need it, go home.

David Kessler 

Now by April. You understand right now, I don’t want to get wonky on you.

Andy Slavitt 

Oh, come on. Let’s get wonky.

David Kessler 

Okay. So what’s the FDA label? There’s no FDA label if you really want to be wonky, because it’s an EUA authorization. But if you look at the EUA authorization, it’s for people at high risk of progression. So it’s not standard. Right. So basically, even today, or even an April until after he changes the label. Right. It’s for high-risk individuals. But in fact, there is a, you know, the Pfizer did two studies, they did a higher study in high-risk individuals that the pivotal endpoint was positive. Right? It worked. It was successful trial, that the standard risk trial actually was a negative trial, primary endpoint didn’t meet. The central did not meet its primary endpoint. But the secondary endpoint is always issues. You can’t really look at a secondary endpoint if you fail the primary, but it’s still important. This was for standard risk people. It prevented hospitalizations and death and that was statistically significant. So I mean, I think FDA has to look at it so  by April, hopefully there’s enough supply, we’re in the millions, we’ll see what the efficacy is in high risk versus standard risk, bottom line, lose certainly in the face of Omicron. I mean, if you’re healthy to me, just get make sure you’re vaccinated and boosted and you’re going to do fine. If you have risk factors, right, then we need to talk.

Andy Slavitt 

So you don’t see the antiviral is sort of necessarily playing a role, where it provides a sort of ring vaccination effect, where you give it to people prophylactically to prevent, you’ll give it to healthier people or people with lower risks?

David Kessler  36:08

But you’re switching a little of me, because you’re talking about prevent, should I assume you mean, prevent hospitalization, after you’ve infected as opposed to prevent even before there’s pre-exposure? There’s post exposure, there’s treatment. So you know, so I mean, I think that right now, the drug is mean, the oral antivirals are for people who are at high risk of exposure. Right. And because of the short supply, I just would ask, January, February, we really got to be recognized. This is for the high risk of the high risk. So immunocompromised over 75, unvaccinated over 75, etc. We crashed on these. I mean, you have to understand, we took a Warp Speed. I know that, we you know, we didn’t cut any corners. But we really, these trials are not supposed to be done till mid this year 2022, we moved, because of what we did. I mean, what Pfizer did to their credit, they move the this all the way up to get the results seven months earlier. But you know, saying that I still got this other study, there’s other data, I mean, that we will want to come in, I think this is gonna, these oral antivirals is going to change how we all perceive this. But am I going to get you a healthy, you know, 50-year-old to go take this. And maybe not, I mean, ultimately, but you’re going to know what’s available. And if you know how risk factor, I think it’s going to change how I think it’s gonna affect everybody. But I don’t think in the end of the day, I mean, everybody’s gonna end up taking an oral antiviral. Let’s see what the data shows.

Andy Slavitt  38:02

You don’t see it like a Tamiflu where, you know, it’s very accessible. And it’s kind of a common part of, you know, what you do on day two or day three of illness after you get tested?

David Kessler 

Yeah, but how many people really take Tamiflu? I mean if you look at the uptake of Tamiflu but you know, by the time you’re diagnosed.

Andy Slavitt 

I think people are more scared of COVID, so they are the flu. And so I don’t know whether it’ll meet reality. I think people anticipate there being high demand for this.

David Kessler 

When’s the last time you took? I mean, right now, great drug, nothing against it. When’s the last time you took 30 tablets in five days? And that actually, what compliant with it? I mean, so I think once we get this down to one once a day, right? I think if we can make it easier, I think we could get more compliance. Let’s see how the data ended up being in the non-standard risk group. I mean, I think it’s gonna I think it’s going to be available. Let’s see how severe the disease is. Well, I mean, if there’s no, if you don’t have a significant chance of pneumonia, this is going to end up being primarily upper airway in you. I mean, you know, what do you know, what you got, again, what are we treating? But look, let’s keep an open mind. I mean, let’s keep an open mind, it’s great that we have these, I mean, we really can prevent, just by having, you know, hundreds of 1000s of courses of treatment. I mean, we’re gonna have a real impact in January, February, not enough, we got to get more, right? Let’s keep these for the most at risk. Right now. Let’s see the kind of disease we’re facing, you know, in March and April. And let’s see what the data show and I’m open minded. Maybe this will be for everybody. Maybe this will be just for high risk.

Andy Slavitt 

Well, let me ask you, let me put to you this way, come September, we will have had 20 million produced will we, A, have had demand under 20 million, so we’ll have plenty of excess doses, B, we will have no excess doses because people will be keeping up with demand or C, where there’ll be millions of people still feeling like, they want more, because this is such a wonderful thing. And we’re going to have to keep ramping to catch up.

David Kessler  40:29

I mean, all I know, I mean, not to be flip is I’m going to get yelled at one way or the other. Either I bought, or I didn’t buy enough. One of those is gonna happen.

Andy Slavitt

That is so true. I’d say FDA, you’re either too fast or too slow. It’s never just right. CDC, you’re either too cautious or you’re too aggressive. It’s never just right. But which are you more worried about it? Which are you planning on because I do think this is a different take around, at least for my perception going in, that it would be more commonly used, more commonly in demand.

David Kessler 

But you’re just focused on Pfizer. Here’s my goals. Let’s talk about what our goal should be. I want two or three additional antivirals by the end of the year. Because I really want to look at an armamentarium. I just, I don’t know what the one thing we know. Is every time we get this curve down, what happens, comes back up. And so we you know, again, I want to be optimistic, right? But I got to be prepared for the next one. And what’s the next one gonna be?

Andy Slavitt

You and I could both predicted New York Times headline in June, when just like it is for testing. Now, when people or  maybe it’s in March, or maybe it’s April, where whenever we get to a point where people wanted the virus to go to the doctors that can’t get them. And people say, gee, you guys did a good thing. And your reward is you didn’t do enough of a good thing, we don’t have enough.

David Kessler  42:09

I got to make sure, I don’t know what the next variants gonna hit us. And I got to make sure that the antivirals that I can use either combination, or make sure it’s on resistant, so I gotta have a medicine cabinet that can handle what I don’t know is coming at me, I gotta be prepared.

Andy Slavitt

That’s right, you’re right, you are gonna do that no matter what scenario is, if you’re not prepared for it, I think that is just part of the service. But help us understand like, these things don’t ramp as quickly and from production standpoint, it appears because the chemical process as the mRNA vaccines appear to or are way beyond tell me I’m wrong. And in terms of like, being able to open up factories and scale like, I had one guest on the show who God loved them said, you know, if something’s good, why can’t we instantly have 100 million of it? Why can’t we take every scientist that every factory in the country? And I’d like spoken like someone who’s never been and had to make these decisions to move through this? So I’m not asking that question. What I’m asking to give a perception is, this is a complex chemical process. It doesn’t scale overnight; you can’t just have 10 million tomorrow. And then as you think ahead to proving FDA approving two or three more, as you say, how do you address that? Are you starting in production now? Even before they’re approved? Do you wait until they’re approved? How does it work?

David Kessler

That was exactly what we were focused on in the prior hour. We were looking at certain candidates not only on getting the clinical trial done, but how to jumpstart the manufacturing, before we even have the clinical trial results when we sort of guarantee well, when we said to Pfizer, we’re in for a billion dollars on this antiviral, all we had was mass data.

Andy Slavitt

Got it. I want to talk about something very cool as we finish up, that you’ve been working on that I think the public has less perception now even though you’ve started to talk about it, but it’s kind of in the middle of the pandemic, people don’t pay enough attention to it. At some point, people will, which is the preparation that you’ve been leading and doing for the future, around vaccines, probably I rounded antivirals as well. That was after my time, but around making sure that going forward, we have the capacity as a nation, and as a planet, to respond quickly to the next pandemic to the next virus that we are as quick out of the gates as humanly possible on vaccines or vaccinations. And the really reason is that this is cool, David and I really want to just go with me here and your imagination. And this is a little bit strange construct. But 50 years from now, 75 years from now, 100 years from now, sometime long after you and I are gone. Nothing’s going to happen and somebody is going to take, they’re going to have to respond in a crisis. And something about the work that that you did, that you led here, will have paid off in some future time. Now, I’m hoping it’s far off in the future, it could be five years from now. But I think it’d be very cool to talk to the audience a little bit about the preparedness that’s going on to make sure that we don’t go through this again, and that we’re better prepared, that we’ve got our ducks in a row. And you did some amazing things there. And I think it’d be great for people to hear a little bit about it.

David Kessler

Sure, you know, a lot of people have written about this and thought about this in terms of pandemic preparedness. And, you know, some of this is, you know, overlapping, you know, COVID is not over by any means. So, you know, this is going to be a continuum. But, you know, it took us from Genome identification, to vaccinating through, you know, to have enough doses for 300 million Americans about 18 months. And, I mean, that included all the clinical trials, and the production. And the question is, can you do the construct? Do the phase one, have the vaccine ready to go? And can you reserve capacity? So you can shorten that time period down from Genome identification. I mean, to about six months. to have enough vaccines for everybody.

Andy Slavitt  46:22

So from 18 months to 6 months?

David Kessler

I mean, can you do can, in essence, can you plan and carry out some of the phase one, you know, what works against a range of virus families? Do the phase one, find out what the best construct is, right? And figure out and be ready? Yes, obviously, when you have the exact strain, you got to swap that out, you’re gonna have to do some basic immunogenicity, but you’ll have done the safety, right? And you can just swap that exact strain in and you can produce manufacturing, with, you know, more abbreviated clinical results in a short order, because you’ve done that planning.

Andy Slavitt 

So you’re talking about getting that stuff in advance done. So that the minute you spot, an outbreak, within six months, have scoped out tested and produced a vaccine that’s available to at least this country. Is that what you’re saying?

David Kessler

Exactly. It’s not only having the capacity; it’s also having the capability and the human talent to do that. I mean, I think, you know, we have the world class Vaccine Research Center, John Mascola, you know, in […], you know, the most talented people, I mean, in the world, you know, and BARDA, but it’s having a whole team that has the resources. And really, to have that kind of vaccine manufacturing hubs, where manufacturers who have a great deal of experience can put this into practice, you know, in between pandemics, and people don’t like to fund this kind of stuff, you know that, it’s hard to get dollars. And I think that’s always been the problem.

Andy Slavitt  48:14

Okay. One final question for you, David. You probably have a perch, this unique among everybody that I know, and I talk to a lot of people, you both see the pandemic, and the epidemiology and the virology as it goes on. You also see the science side and what’s developing around vaccines and antivirals, etc. I guess the overall question is, is all of this, all that you see, leave you net optimistic, over the long run, that ultimately, science wins against this virus? Or does it leave you uncertain? Or does it leave you pessimistic that we got something that’s very wily, and we’re going to be dealing with a lot of time and you’re not sure whether science catches up with it?

David Kessler 

You know, I’m humbled by how much we don’t know, mean every day and how much we learn every day, just what Omicron is teaching us I mean, that we didn’t say, so. I mean, I that is always, you know, you talk about, you know, the big kind of, you know, the kinds of things that they put you in awe, right, it’s how much we don’t know. I mean, saying that, I spent six years trying to do the protease inhibitors back in the 1990s. This got done in two and a half months. We have mRNA vaccines, they’re built on five years, you know, plus of experience that had you know, still holding 90% against serious disease and that science is remarkable. Right. But the problem is, when you’re in it, it’s so dynamic. It’s changing so, and you just don’t know the next thing that’s gonna be thrown at you. Can you in the end optimistic? Absolutely. But it’s daunting, Andy. I mean, […], this is daunting. Yeah.

Andy Slavitt  50:23

Yeah. Well look too big to be through what you’ve been through. And be optimistic. I think she’d give a lot of people a sense of optimism, because you’re nothing if not grounded, in fact, based, and you’ve been carrying a lot of this burden. So it’s not easy. I think a lot of the things that happen, well, that we take for granted, were a lot of things that you and others have been a part of. So thank you, David. Well, thanks for all the time, I think explaining how you look at the world, to people was immensely valuable. And anyone where we started, I miss you, it’s great to talk again.

David Kessler 

Come on back, Andy.

Andy Slavitt 

Thank you for sticking with me in the conversation. I think if you want to hear longer edition ever, we’ll put one up for some kind of special subscriber, folks. Okay, let me tell you what’s coming up next week. On Monday, we have our episode on another crisis, that I think we’re all getting increasingly worried about where many of us are. And that’s what’s happening with our democracy and what we’re doing about it. Jon Favreau, from Pod Save America will be on the show, I think you will enjoy that, he is a great guest a lot of fun, has his own podcast, as it turns out. Then on Wednesday, we’re gonna be taking you inside the walls, where you can’t go, we’re gonna go inside another bubble. We’re going inside hospitals. And we’re gonna go inside a shift at a hospital in Rhode Island for just to hear what’s happening and what’s different about Omicron than in prior waves inside the walls of the hospitals. Megan Ranney, an ER doc is a terrific, terrific commentator. And I think she’s been kind enough to take us through her shift there. And then the final show I want to tell you about is the one coming up the following Monday. And that is a show about the topic that Americans claim to be their number one healthcare issue. See if you can guess what that is, America’s number one health care issue. And it turns out, it’s none of the things that people think it is. It’s none of the things that people in Washington thinking is. Your number one healthcare issue according to Deep Survey and polls is caregiving. How you provide caregiver support to your family. So we’re gonna go really deep into that conversation. Okay, that’s all I got a lot of tape. Bye for now.

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.