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President Trump, you have repeatedly either contradicted or been at odds with some of your government's own top scientists the week before last. The head of the Centers for Disease Control, Dr. Redfield, said it would be summer before the vaccine would become generally available to the public. You said that he was confused and mistaken. Those were your two words. But Dr. Sulloway, the head of your operation, warp speed, has said exactly the same thing. Are they both wrong?

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If you were listening to the debate on Tuesday and able to make out any of it amid all the terrible noise, you heard the moderator drop a name, Dr. Allawi as the left or I don't know if you're the head of your operation, works for the doctors.

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I disagree with it. No, I disagree with him. And he didn't say that. He said it could be there, but it could also be much. And I had him in my office today and he talked about the summer before it's generally available.

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Dr. Munsif Slaoui isn't a household name. He's not Dr. Anthony Fauci, who we all know as the cold guy. You can even buy a fancy bobblehead. I have one right in my kitchen.

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Zawi, on the other hand, is more of a behind the scenes guy, even though he's in charge of something very big, he's the head of Operation Warp Speed, the American government's 10 billion dollar effort to develop, manufacture and deliver a covid-19 vaccine as fast as possible.

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Slough is an experience vaccine researcher who came out of retirement to work for Trump in a moment of national crisis, and now there's a president who's been hospitalized for the virus. Sally is already in the Washington crosshairs, he's been criticized for not confirming the president's ambitious vaccine timeline and for his pharmaceutical industry ties. The question is, can Dr. Slaoui beat the virus before politics beats him?

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So you've been on my radar for a while, other people might not know it yet, but they definitely heard your name at Tuesday's presidential debate. I want to start talking about sort of going from the boardroom of a pharmaceutical company and working within the pharmaceutical industry and also as a venture capitalist to working in the executive branch. These are two different kinds of power. Can you compare and contrast these?

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Well, I mean, remember, I'm an adviser. I'm not a decision maker. But of course, there is significant influence.

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I think there is a in the context of the operation, there is a thirst for experience and knowledge of what it takes to make a product when in fact, this is not the mission of these organizations. So from that standpoint, there is a very high receptivity to knowledge, to information, to advice. Definitely there's really no need. I don't feel at any time that there is an exercise of power in the sense of authority, if you wish.

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But when you say you're just an adviser, come on, you're more than an adviser. You have great massive influence over this.

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Yes, there is. Of course, there is significant influence.

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But I mean, a lot of people that go into government from the business sector do complain about that. I've talked to dozens of tech people and been a venture capitalist. So, you know the difference in speed and this is called warp speed. Yes.

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Well, you know, I'm not working in the government. This is a mission. It's really interesting. And I think everybody is aware that this is a mission and we're all focused on that mission. We have adopted certain ways of working of the army that in the beginning it was really surprising to me. For instance, we have battle rhythm meetings, which in the beginning I was like, what are we talking about?

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Battle what battle? Rhythm, battle, rhythm.

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OK, so every morning at 8:00 in the morning, we review the projects that are vaccine projects. At 10:00 in the morning, we review updates on the therapeutic programs and that creates a rhythm that really create that sense of urgency. And at no point things are falling between the cracks. There is immediate follow up. You know, it takes five minutes or ten minutes for each project. And it's really incredibly effective.

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When I will go back to the private sector, I will definitely you're going to do battle introduce a certain type of battle rhythm on projects that require urgency and that requires immediate actions. I think it absolutely works because it keeps the whole organization on its toes, totally focused on the objective. There is no waste, but it is a mission I can see.

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Who do you talk to daily? Who do you talk to every day? General Purna? Secretary. Yes.

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Are so General Perner myself. If I talk about vaccines, Dr. Matt Hepburn, who looks specifically after the vaccines, or Dr. Janet Woodcock, who used to be one of the critical leaders in the FDA as regards therapeutic plus a number of four or five other individuals, we are kind of a leadership team that's really tied together. We are all every morning at those butlering, the meeting there in person. And we work together on an ongoing basis. And and then there are project teams that oversee each one of the vaccine programs that have a large number of individuals from the NIH, from the CDC, from BARDA, from the Department of Defense that interact with each one of the sponsor companies that own that particular vaccine several times a day.

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We have, you know, teleconferences, et cetera, et cetera.

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Yeah, you developed vaccines for malaria, cervical cancer, Ebola and many others. What was the one thing that drew you to this work? What drew you to it?

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So early in my youth, I learned about my young sister that out of a disease that later on I learned to be pertussis, disease, whooping cough. And I could see in my parents this was a trauma. And as you know, I was born in Morocco and raised and grew up there until I was 17. I went to college university in Belgium and I I had a fierce commitment to social justice and changing the government nature in Morocco that was quite authoritarian, let's say.

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So I engaged in very significant activities of politics that were against the government. And after three years, I ended up having significant challenges with the powers in Morocco to the extent that I couldn't go back and see my mom, who was very ill. So I decided I need to do this impact on society in a different way and decided to invest myself, frankly, in science. I loved immunology and I had a PhD in immunology. And then I came to the US in 1983, actually to Harvard Medical School, did a postdoc there and realized that the true.

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Effect on society would happen through designing developing vaccines. OK. When you were called from HHS this year to come work for them, what was the first thing that crossed your mind when you thought of working for the government?

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Well, frankly, the first thing that crossed my mind was the alignment or with the administration, which, as I have expressed, is not my alignment, but what do you mean by not my alignment?

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You're talking about you being a Democrat, correct? Or. Yeah, that's what I'm talking. You're talking about that. But that point was very quickly taken over by my commitment to public health and global health and really acknowledged that I could add value if I could impact. So my next point of focus was, will I be able to impact? And when I had the interview with the secretary and with the undersecretary of defense, the secretary of HHS and Jared Kushner, who were my interviewees, those were the two points that I said.

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I said, A, is this rule empowered to really drive? And second, can this rule just go through bureaucracy and not pay attention to it? And I told them, listen, I have no knowledge. I have never worked in government, and I'm certain I have huge allergy to bureaucracy and slowness. So I'm going to just ignore it and run through it. And they said, that's perfect. That's why you're the right person for the role.

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So that job also met. You have access to the president. Was that something that appealed to you or scared you? Neither.

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Frankly, what appealed to me is really the mission, the impact. I hope nobody ever has to do this again because there would be no other pandemic. But if there was, it's just an incredible mission. And it if you realize that you can really add value and make a difference, which has always been my motivation in my career and in my life, there was no more hesitation. And I had been to the White House before under the previous president, and I've been to it now.

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And that's not the appealing piece. Not the appealing piece.

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OK, so where are these stipulations you made to the White House that you needed in your contract before you said yes? It was really to be empowered with no interference and to not have to deal with the bureaucracy and is there anything that they didn't agree to?

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No, frankly, no, but I didn't. It was really at the level of the principals and the principal was totally agreed to.

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OK, so the name Operation Warp Speed, it's not a name you picked yourself. It's a Star Trek reference. Dr. Fauci said the name implies reckless speed. What would you name it instead if you had to pick it? I had one operation Open Nation get it rhymes. Is there any that you would call it if you could characterize it?

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Interesting. So first, let me confess. I didn't know what warp speed meant. I swear I discovered a of Star Trek, OK?

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No, I went back home from the interviews and I told my wife it's warp speed. My wife is American. She knows very well. And she told me, oh, this is what it is. I said, OK, all right. Thanks very much, I think.

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I like open nation, I would say something around saving the world, I say, yeah, something like that, but I think speed is essential. I have to say naming it warp speed gave us a focus on a sense of urgency that never disappears. And I have to say, every day I remember there's a thousand people dying every day, every day. We have to go faster, safe, but faster. All right.

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So give it to me straight. When do you really think we'll have the vaccine? I want to hear it from you directly.

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Yeah, listen, I am very confident there will be probably two vaccines between now and December. It's impossible to tell you the dates or even the month because there are two variables that drive that. One variable is what is the real efficacy of the vaccine?

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And I can explain that in a second. And the second one is how much transmission of the disease is happening in the study population. We recruit 30000 people that live their lives normally in their homes and work, et cetera, and they are just naturally exposed to the virus. There may be a lot of transmission or there may be limited transmission. We try to localize the clinical trial sites in areas where there was transmission at the time we started the trial.

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But we know that the virus comes and goes. If you look within the zip code, usually the duration of presence of the virus is six weeks or eight weeks or something like that. So we can't predict how much transmission there will be. That's number one. Number two, when we designed the trial, the mathematics behind all the statistics that allow us to confirm the data, tell us, OK, you have to assume a certain efficacy to help you sized the trial.

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And the FDA helped us say, OK, we will not consider a vaccine that is less than 50 percent efficacious and where we have 95 percent certainty that it's at least 30 percent efficacious, that's what that law limits. But fifty percent I'm going to call that a moderately effective vaccine. I would expect the vaccine to be 75, 80, 90 percent effective. Right.

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So are these numbers aligned with other vaccines efficacy that you've worked on? Yes.

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On commercially, a vaccine is 50 percent efficacious, is not a great commercial vaccine, right? No, it's not. It's a toss of a coin. But in a pandemic where you have thousands of people dying every day. Yes, it is. If you can prevent 500 deaths a day, I think it is. Therefore, I think it was appropriate to set criteria that are I'm going to call them moderate. It doesn't mean that we expect the vaccine to have moderate efficacy.

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I was asked a number of times, what do I expect? Honestly, I expect it to be between 80 and 90 percent.

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OK, if it is 90 percent, we we need a few cases to show it. We need maybe 50 cases or 50, 60 cases. If it's 50 percent, we're going to need 150 cases in the city. And you can see immediately that, you know, we don't know how efficacious the vaccine really is and we don't know how quickly the cases are accumulating. All we know is they are accumulating. So we'll see.

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So when you say by December, does that mean a vaccine that works or a vaccine that is out there? How do you determine it? Because there's so many different words going on here by various people saying what you said and what you didn't say.

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You said extremely unlikely, but not impossible that the vaccine would be available by the end of October. I mean, I can say it's extremely likely that I'll grow three feet, but not impossible by any time soon.

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Yeah. Tell me what you meant by that.

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I meant by that, really what I meant by that. You know, I'm a facts and data driven person. If I was able to exclude that, it would never happen in October, I would have said it so that I can tell you, as I know we're able to manufacture vaccine and we are stockpiling doses of vaccines. The two vaccines where we have already recruited either very close to thirty thousand or more than thirty thousand subjects. And it's possible that in one or two zip codes there is an outbreak and all of a sudden there are fifty cases that happen, then we will have enough cases in the study to conclude it.

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It's impossible to predict so because it's impossible to predict. It would have been wrong of me to say it will never happen in October. That's why I said it's very unlikely but not impossible. And it's more likely to happen in November and it's even more likely to happen in December. And likewise, I know we will have a handful of million of those as in October 10 or 15 million doses by November and maybe 50 to 80 million doses of vaccine in December.

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And therefore, if efficacy is achieved and safety conditions are met, we will be able to have vaccines for, I would say, the highest risk population. That will be for the CDC A.S.A.P. to decide who those people are, right? And those are the reason why I say, yeah, I think it will happen. I think it's very likely to happen before the end of the year.

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And for the general public, getting the vaccine and getting a lot of Americans vaccinated. Do you have a timeline for that?

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So I can tell you my my current thinking and I think with all the team is that by the end of the year, we should be able to immunize 30, 40 million people who are likely to be, for instance, the very old, very frail people in the country and maybe the most exposed health care workers. By the month of January, we will have another capacity to immunize another 40 million people. So probably we would be able to cover all the elderly and all the health care workers.

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And then every month from there on, we are able to immunize between 80 and 90 million people. And that means we have enough doses to give them to vaccine shots for the vaccines that require two shots or one vaccine shots for the ones that require only one shot. This is assuming that the clinical trials will work, right?

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And the efficacy. Yes. So what happens here is that citizens get confused by this. And of course, there's a whole political overlay. You were mentioned in Tuesday's presidential debate by President Trump in several different ways. He said he'd spoken to a lot of companies. We can have it a lot sooner. It's a very political thing. And then he specifically referenced you when he said he disagreed with your timeline and then moments later said he agreed with. Now, I know you don't want to get I don't want you to be dragged into politics, but politics are here.

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You know, it feels like it's being rushed for the election for some political means. Everyone's confused about what is more important, speed or safety to you. And then how do you get citizens to feel trusting of the government and what you're trying to do?

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So speed and safety, frankly, in my view, are not contradictory. OK, if you are a racecar driver and you look at races that challenge you set yourself is to be very fast while being very safe. And those conditions happen in many settings. I think if you can find circumstances under which you can be very fast while being very safe in the context of a pandemic, that's what you should do. And what that takes is to be able to take very big, significant financial risk.

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And the second thing that it takes is that you are able to have incredibly disciplined project management. So you understand every step where you are and what's the next step. And thirdly, frankly, it was visionary to put together HHS and the DOD to bring in the logistical dimension. General Perna, who is my colleague there, you know, we are one team. We are one team.

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We literally work like hand in glove or glove in hand, whether it was ever we say it and it's incredibly effective. We are able to go very fast because, a, we made I'm going to call them experience based judgment call on selecting vaccines that are using platform technologies that we understood and we could predict their behavior. We sped up every step except actually the size of the clinical trials, if you look into the clinical trials, the phase one face to face with studies are all way bigger than the size of normal phase one face to face, three studies because we knew if we put the logistics behind and the money behind it, we can recruit more subjects in the trial, which allows us to actually conclude the trial faster because we may accrue cases faster or we can demonstrate immunogenicity with, you know, narrow statistics around them to very quickly move to the next step.

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We also manufacture the vaccine and we continue to do it at risk. So we didn't cut any corner that has to do with quality or safety.

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And so at the debate, when the president saying he's spoken to the companies and we can have it a lot sooner, it's very political thing. Does he have information that you don't? And do you disagree because it was confusing? I mean, is it just that people are talking about possibilities and hope?

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Listen, first, as I said before, I don't want to get into the politics. Second, frankly, it was difficult to understand who is talking what because it was everybody was talking at once.

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Well, thirdly, the I would say it is possible, as I said earlier, that efficacy could be demonstrated during the month of October. Yet it is extremely unlikely. But it is possible. So possible, but extremely unlikely.

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Go ahead. I can tell you that letter size and likewise. Yeah, it fits with what I was saying. And likewise, it will be in the second quarter of 2021 when we will have enough vaccine doses to have. Right. Immunized the whole population. So I do think that was a political debate. I just want to say the numbers. We will have enough vaccine doses by April, May 2021 to immunize 330 million people, which is the population of the United States.

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Now, will we be rolling out month by month and immunizing that number or will it happen differently? I think will depend on the efficacy of the vaccines. Right.

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And that meeting he spoke of in that particular meeting, you said exactly what you're saying here to me.

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Yes. That's what was said. That's what I consistently say, absolutely, and I have been saying it for quite a while and I have been asked the question many times, I'd like this to say, frankly, I have never felt pressured. I have always expressed my independence of thinking and whether it's from the president or his entourage or the secretary here in HSW, I have never heard you feel heard in these meetings with leaders and especially President Trump.

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Do you feel like you're being clear or you know, there's a thing called selective listening. I do it all the time with my kids. But do you think you're being heard? Because what you're talking about is something very sophisticated. The idea that that there's a possibility doesn't mean it's a probability.

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Well, I expressed myself very clearly. I apologize if I have an accent and that is what I control. The rest I can't control.

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And what I'm trying to get at is a consistent message. How do we get a consistent message? Because it's not just I mean, Robert Redfield and he had a back and forth. I just want to get to the idea that our citizens deserve a consistent message. Yes.

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And I want I want to suggest a different name to the consistent message and I'll explain why. I would like to suggest that we say a transparent message. And the reason I make a difference between the two is the following. See, when you want to build a bridge, you know how to build a bridge and you can predict everything. It's physics here. We're talking about biology. In order to produce the vaccine, we need to grow cells. Some days you look at them the wrong way.

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They don't like it and you have a two thousand little fermenter that dies and or gets infected with the bacterium and you have to do it all over again. And it takes three weeks to regrow that amount of cells in order to produce the vaccine groups. You just lost three weeks, right? Or you want to recruit 30000 subjects in your clinical trial and you say, I'm going to do it super fast. But those are human beings with their life, their volunteers.

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They may come and be recruited in eight weeks, as you planned, or it may take you seven weeks or it may take you 15 weeks. Then you plan. You know, I'm going to have a certain transmission of virus that's going to be, let's say, four to one percent per week in the city. And it turns out to be three percent. You're going to go much faster or it's going to turn out to be point zero five percent and you're going to go slower.

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So when people think that we don't want to be transparent about the message because it may be evolving, it's evolving because we learn as we go and we can't predict the behavior of biology. I would say, frankly, please, let's talk about transparent message. Every time there's a change, we'll talk about it and explain it.

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OK, China's developing a vaccine operation. Warp speed has already said that anything developed by China's out of the question. Top of that, we're not involved in the Kovács, the World Health Organization's Global Initiative. Could you just explain why not cooperate with these other countries?

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So, first of all, we do talk to Kovács. I have a number of conference calls, et cetera. There is no specific formal collaboration, but there is a lot of exchange and discussions. Absolutely. Some of the vaccines that they are working on and we are working on are the same and we exchange information. The comments I personally made around the Chinese vaccine are more relating to the technology used, which is to grow the virus, kill it.

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And that's the vaccine. I personally think in today's age where we have technologies that allow us to not having to grow trillions of a deadly virus and then kill it because we could have a leak, we could have a terrorist attack, we could have something where enormous amount of virus are let go into nature. I think we should avoid it. And that's the reason I was advocating that. That's not a technology I would go after.

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We'll be right back. This episode of Hsueh is brought to you by sales force these days, the office isn't always in office and a work from anywhere solution is more important than ever. That's why sales force Customer 360 helps everyone go digital faster. We'll give you teams all the tools they need to connect and collaborate on a single customer relationship management platform, giving you a unified view of your customer and helping to deliver the seamless experiences they've come to expect. To learn more, head to Salesforce.com.

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Slash 360.

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This is Sam Dolnick. I'm an assistant managing editor at the New York Times. Our newsroom has been empty since March, but we've been busier than ever before. The pandemic has changed how we work, but it hasn't changed what we do. We are living through history. Every single one of our journalists is trying to match the moment. We have political reporters analyzing every development of this historic election. We have data journalists tracking every single virus case in America.

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We've national reporters braving wildfires and floods to witness and understand the effects of climate change. And then there are food writers offering advice for what to cook during these many nights at home. This is why we became journalists to bring to light real verified information when the stakes couldn't be higher. We can't do this work without our subscribers. If you'd like to subscribe, please go to NY Times dot com slash. Subscribe and thanks. On May 15th, the day Dr.

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Montse Slaoui started his job at Operation Warp Speed, he stepped down from his seat on the board of Maidana, a developer of one of the lead vaccine candidates. But he took a lot of heat for keeping his pharma stock. Senator Elizabeth Warren tweeted, quote, It is a huge conflict of interest. Dr. Slaoui should divest immediately. Slaoui sold his Madrona stock soon after. But that wasn't the only company in his portfolio that was awarded in Operation Warp Speed contract.

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So was GlaxoSmithKline. And Sławik kept his shares there about 10 million dollars worth, although Slowes contract technically allows it. Some critics, like Senator Warren, see it as an ethical violation. The first person to be fired should be Dr. Slaoui.

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The American people deserve to know that covid-19 vaccine decisions are based on science and not on personal greed.

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I'd like to hear your position on this, so make a case why your pharma holdings don't amount to a conflict of interest. And I'd love to hear it was said that you had an ethics disclosure. I'd love to know what was in that. Yeah. Or an addendum.

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Yes. So first of all, I completely agree that there could be a conflict of interest and it should be investigated. And I'm absolutely transparent about it. I have been from day one, you know, as I was discussing, I didn't ask for this role. I was called to do it and I said, here is what I have. And regarding GSK, I explained that's really my retirement because this case has paid dividends and I want to use that dividend.

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I'm not somebody who deals in the market. So for me, a steady income is important. And second and I know this is my point of view, but, you know, every morning when I wake up, I look at myself in the mirror and I have to agree with what I see. That's my personal values. I know I am doing this to help people, not to enrich myself. And therefore, I said anything I can do to make sure I don't enrich myself in any way, shape or form, I will do.

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Moderna is really an obvious conflict of interest. I cannot be sitting on the board of the company and because I knew Moderna would be one of the key vaccines to take forward for sure. And it is one, as we can see, the most advanced vaccine with the Fizer vaccine, which, by the way, uses the same technology.

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So I. I. Thoughts and I continue to think that I have done everything that can be done other than divesting my GSK shares.

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OK, why do I say we're selected? Also, I am explaining because I think that if I commit to give any accrued value on those shares to research, once I finish the role, any accrued value that is above the average of the industry. And frankly, if people would like it, any accrued value that is above the value. On day one when I started, I'm fine with that. I am not about the money. I'll give it to the research I want to make a decision around GSK, GSK, frankly, is a small player in the equation.

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The vaccine that was selected is the Sanofi vaccine that's associated with an adjuvant, which is an addition that's added into the vaccine to make it stronger from GSK. That has been discovered. It's like a booster to the vaccine that you add into the vaccine, too. So I don't think there has been any untoward behavior or any enrichment of GSK or of myself.

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May I give your own words? Do you want to just make it transparent? Why not just list all the things your AVC at this company?

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Mataji is that I did I did list them. In fact, my contract. I have signed a contract to a committee of Congress with the addendum sites, the companies of which I was a board members and the VCI that I am a partner into. It's also listed the companies, the boards from which I resigned and the date at which I will resign. And they are all around me 15 or May 17, because when the company is public, I couldn't resign before my new role was announced.

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And the last company from which I effectively resigned is called Calzado, which is a product for GeoEye. Discomfort that the consumer product has nothing to do with covid. I told them I will resign in May. They asked me to look for a new chairman and be hired before I effectively resign, and that happened early in September.

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I mean, getting business people into government is critical. So how do you imagine solving this problem?

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Frankly, by being again, by being transparent and by being in agreement with investigation. I have never been in disagreement with investigation. The fact that Senator Warren on her own decides that I am a corrupt person and that I am greedy, et cetera, is an accusation. It's not an investigation. And, you know, if people want to come and see what I'm doing, what I have, it's an open book. And I can tell you people can come and look at everything they want.

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I feel very comfortable. I know I have not done anything wrong and I know I'm not here to enrich myself. I know I have knowledge, expertise and experience that can help. I'm passionate about helping.

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And what would you say to Senator Warren? I would say to Senator Warren that people deserve the opportunity to explain that it's inappropriate to prejudge that prejudging is something that carries a different name. That's much more difficult to say to a senator. It's wrong. So if somebody asks that we investigate, please investigate, if somebody asked me a question, I'll give you the answer. Just ask me the question and be fair and, you know, publish or take into account the totality of my question.

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OK, but you have this influence on major government decisions. You have the ability to persuade people to direct money in ways that might benefit you. I'm presuming you are honest, like let's start with that presumption. But there are dishonest people and there's billions and billions and billions of dollars here running through this government.

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So how do we make sure this doesn't happen?

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I think it's really by having two things. One is transparency, and then a team is making a decision. See, one of the other things that I would say to Senator Warren is, you know, there are NIH leaders, great scientists, there are CDC leaders, there are army generals, four stars, one star, two star, three star. There are, you know, Bardell leaders all together with me. We're sitting together and we're making these decisions, these choices, their principal investigators.

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This is not something happening in a black box by Monsef Slowey who says, OK, this the choice, go execute. That's not how it works. We discuss that scientists. We have rational decisions. We listen to each other. We come to a common view. We make that decision. We progress. I do influence those decisions. Otherwise, honestly, I wouldn't be here. Why would I be here? I bring my experience. I've been doing this for 30 years.

[00:35:11]

And in a humble way, I was fortunate to I have been involved directly in 14 vaccines that became approved. It's an experience that I feel passionate about sharing it to help our country and the world deal with the coronavirus.

[00:35:29]

I think the issue is some people expertise and ethics shouldn't be mutually exclusive. I think that's what happens in that regard.

[00:35:35]

And they are not. And frankly, people should look into my track record and my reputation. I was in a large company. I drove the company to invest for 27 years in a malaria vaccine that is designed to save the life of babies in sub-Saharan Africa. Zero return. I worked very hard to make the company make a vaccine against Ebola. Zero return. I worked very hard to create a proposal that was called the Bio Preparedness Organization, by the way, which I shared with the U.S. government to offer a facility that the company had to prepare for.

[00:36:09]

And fortunately, what's happening now, I have a long track record and people should go and look.

[00:36:14]

I mean, have I been a slimy, sleazy, greedy person or have I been with high integrity across my career? I think I have. And people can go and ask. It's very simple.

[00:36:27]

OK, that's a fair answer. Now, vaccines are only used for people. Take them. I'm sure you're aware there's a growing number of anti vaccines in this country pushed by social media and other things. New polling suggests only 51 percent of U.S. adults say they would get the covid-19 vaccine if one became available. And I just had Elon Musk on my podcast and he said he's not going to take the vaccine because he doesn't need it. How do you get people to take it?

[00:36:50]

Yeah, so first, I'm very worried, really very worried by what's going on here. And I think it's extremely unfortunate that politics got involved in this vaccine development in this period because it has created that level of anxiety. I mean, we're really like in a fishbowl where everybody is looking and everybody is simply looking to critique or to support 100 percent, but nobody to have, in a way, a more balanced perspective.

[00:37:23]

It's starting to happen. I have to say, I've seen the media we went from. How could this possible is impossible to do. It has to be something bizarre and weird and to now saying, well, we need to make sure the data are transparent. Yes, of course, transparency is going to be number one, continuous communication and engagement is going to be number two. And just telling people the fact as they are, that's why I come back to transparent plans of communication, rather consistent communication, because if I say something and I change it, please don't take it that it's a lie because we learn as we go.

[00:38:01]

There are specifics that we cannot plan to the day or to the week. So I think that's what we need to do. The other thing that I would like to say to Elon Musk and many others who elected not to take vaccines is right.

[00:38:13]

I think in most cases he's saying he doesn't need it because he's not going to. If he gets sick from it, he'll be fine. I don't think he's saying, you know what I mean?

[00:38:20]

I'm not talking frankly specifically about Elon Musk, but the unintended consequences. He may have a lot of followers that take that point of I don't want to. Take the vaccine right as a general statement versus as I feel protected. I don't need to take it. The other point I'll make to him is he may get infected without knowing it. He may be asymptomatic. He may be infecting other people. So taking a vaccine is not only about protecting yourself, it's also about protecting the society around you and our life.

[00:38:48]

If there were no vaccines, would be like it has been in the last several months with masks, with lockdowns, and there would be much fewer of us and in general will end up dying anyway of one of the many vaccine preventable diseases that were disseminating the populations. The problem is, frankly, is one of danger isn't here and now we forget it. Many physicians even here don't know a number of diseases because we don't see them anymore. And guess why we don't see them is because we are vaccinated.

[00:39:19]

If we stop taking vaccines, all of these bugs are going to come back to us because they're there.

[00:39:25]

So take them because because they protect us. They allow us to live a better life and a longer life. And frankly, the biggest challenge that vaccines have is that you take them and then anything that happens going forward from there on, you chronologically associate the vaccine. So if I take a vaccine and I have a car accident a week later. I may not say, you know what, I had the car accident because I took the vaccine because in our brain we don't associate car accident and vaccine.

[00:39:57]

But if I take a vaccine and a week later I am diagnosed with some disease, I almost automatically and I should do the hypothesis, OK, maybe it could be associated with it. I think the mistake is to conclude it's associated just because it was chronologically happening at that moment, because, you know, somebody unfortunately may have a heart attack one day if it happens that that heart attack took place one week or two weeks or a month after vaccination, it doesn't mean it was caused by the vaccination.

[00:40:27]

All right. So there's a lot of concern about the emergency use authorization and the general rush to get the vaccine out. President Trump really said he might reject the FDA's new plan for having outside experts weigh in as a political move. I'd love to know what your perspective on this, because you said very clearly I would immediately resign if there was undue interference in this process. Would this tempt you to quit?

[00:40:49]

I only believe in actions, not in words. So, frankly, if the action took place, I would do it immediately and I will raise my hand to explain why I'm doing it. I think in this case, the issue is really I describe it as a pit stop on a journey, the end of which is a full licenser bill is going to be any and it's really close to it. Sure.

[00:41:13]

But in the instance of hydroxy chloroquine, it got in Iowa after Trump Tower it and then the EPA was revoked. How do you make sure there isn't political interference? You yourself, what is your power to do this and make and assure citizens of this country that we're getting a vaccine that is both safe and speedy? Yes.

[00:41:32]

Here's why I feel confident and frankly, it's almost impossible to do. And if it was to happen, it would be blatantly obvious. These vaccines are being tested in placebo controlled prospective clinical trials, the highest standards that exist to demonstrate whether something works or doesn't work. For the Hydroxycut organ, for instance, there was no clinical trial that's placebo controlled, right. Etc. So that was made on a basis of a different standard of science. I would say here we took the high standards so it would be impossible to say, oh, it works if it doesn't work or or there is no side effect.

[00:42:13]

If there were side effects, by the way, I am very satisfied. Unfortunately, there is a serious adverse event in one of the AstraZeneca vaccines trial. But, you know, the trial was stopped instantly, regardless of the consequences until we understand what happened. And then the FDA and the data safety monitoring board, once they are satisfied, they may allow the trial to start again or not, they will make their decision. So things are being used to the highest scientific standards.

[00:42:43]

You cannot come back from that. And if you try to come back from that, it would be visible to everybody. And I'll be the first one to say it.

[00:42:50]

When you say be the first one to say so, do you believe that the president's standards for efficacy and safety match your very own high bar? You're talking about a very high bar here.

[00:42:58]

I really don't want to comment on on the politics. I'm just telling you, we set the bar very high, very clear, a very high in the sense of scientific standard quality. We didn't set the bar very high in terms of expected efficacy. As I said earlier, it's at 50 percent. I hope it will be much higher. But, you know, we set the bar very high in terms of quality of the science, safety of the vaccines.

[00:43:24]

If these vaccines are approved, I feel very comfortable they will be approved on the basis of full knowledge of their efficacy and of their safety. And I would like to offer there is a limitation in what we will know about this vaccine, which is because of the urgency of the pandemic, the follow up time of vaccine is in. The clinical trial is going to be limited, more limited than usual. It's going to be at the time of the approval if there is one four months or five months or something like that, usually you wait a year or something.

[00:43:57]

However, 90 percent of adverse events associated with vaccines happen within 40 to 60 days from completion of immunization. And the FDA is proposing that at least 50 percent of the individuals in the study population have at least two months of follow up on safety before the vaccines are approved. And secondly, we are working really hard with the FDA and the CDC to make sure we have a very active pharmacovigilance surveillance system to allow us to continue to assess the safety of the vaccines as they are being used in the high risk population.

[00:44:34]

OK, I wasn't talking about politics, actually. I'm talking about the standards and you're talking about extraordinarily high standards.

[00:44:40]

Let me first say, if I may correct, I think they are the appropriate standards. They are not incredibly high standards. Vaccines are given to healthy people they need. To be safe and they need to provide a benefit and that benefit needs to be certain, which is what the clinical trial as we design them will show if they show it. OK, we will be transparent about the data, and I cannot guarantee that decisions will not be made by people who have the power to make them.

[00:45:07]

I can guarantee that I will say what I think and I am saying what I think.

[00:45:12]

OK, do you regret doing this or do you feel I do not this interview. Is this the last last less. Yes. No, no. I'm saying do you regret coming into the government and doing this?

[00:45:22]

Do you feel when you look back on it?

[00:45:24]

No, I mean, honestly, like, honestly, this is the best time of my professional career in terms of the content and the work and the team and the impact. This is the worst in my professional career in terms of being. Trashed. Frankly, I can't believe that somebody stands up that I have never met and say I'm a corrupt person. Welcome to Washington. Yes, but I am not I am not a political person. And this is why I felt compelled to go and make interviews.

[00:45:56]

And I will I will do it again and again if I feel I'm being unfairly treated.

[00:46:01]

OK, I want to give you one last chance to name the vaccine effort. Do you have any others?

[00:46:07]

Honestly, I like warp speed. I'm used to it. I love it. I love the process that we're doing. We're all working super hard. And, you know, I, I would feel almost like doing something wrong for it. I love the name. Fine. I'm going to watch after when I have time. When I'm done with this, I'll watch Star Trek.

[00:46:27]

OK, thank you so much. Thank you very much. I really appreciate and good luck. We all I really want a vaccine. I'm going to make you take it. I promise. Right. Thank you.

[00:46:37]

Thank you. Bye. Hsueh is a production of New York Times opinion is produced by name Arreaza, Hiba Urbani, Matt Kwong and Vishakha Darba, edited by Adam Schulz and Paula Shumann with Music and Sound Design by Isaac Jones.

[00:47:05]

Fact checking by Kate Sinclair. Special thanks to Janine Winterland, Larry Higa and Cathy too. If you're in the podcast app already, keep on your masks and hit subscribe. If you're listening on the Times website and want to get a new episode of Hsueh delivered to you at warp speed. Of course, download a podcast app like Stitcher or Google podcast, Search for Hsueh and Subscribe. We release every Monday and Thursday.