The Rush for a Covid-19 Vaccine

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0:51Hi, everyone, and welcome to this week's episode of HBR Quarantined. I'm Adi Ignatius, editor-in-chief of Harvard Business Review. My co-host is Josh Macht, who heads product and innovation for the company. Today, we're going to get back to the subject of COVID-19. Specifically, we're going to be checking in on the status of the race to develop a vaccine. Our special guest this week is Albert Bourla, who is the CEO and chairman of Pfizer, who in March challenged his company scientists to make the impossible possible by developing a vaccine in six months rather than on a more conventional 18-month time frame.

1:31So we're going to talk to him about where Pfizer is on that journey. But before we do that, we want to talk a little bit about the state of the pandemic. It is a very complicated picture these days. At this moment, coronavirus has infected more than 2.2 million people in the U.S. alone, killing more than 120 ,000. Worldwide, the estimate is more than 9 million cases, 470 ,000 deaths. Donald Trump, Vice President Mike Pence, and others in the U.S. are arguing that the pandemic is dying down, that the increases we're seeing in reported cases are mostly because we're testing more people. But there's hard data that would seem to refute that.

2:07The spikes in confirmed cases in many cases in South and the West clearly are not simply a result of increased testing. The percentage of tests that are positive are increasing as well. And in some states, we're seeing increased hospitalizations. The good news is deaths are down, but the rise in cases seems to be affecting more young people than before. And while many, if not most, are likely to stay healthy, they are, of course, carriers. Over the weekend, in a Meet the Press interview, Michael Osterholm, the director of the Center of Infectious Disease Research and Policy at the University of Minnesota, put it this way, I don't see this slowing down for the summer or into the fall.

2:43I think this is more like a forest fire. Wherever there's wood to burn, this fire is going to burn it. All of this, of course, heightens the need for a vaccine as soon as possible. And that's what we're going to talk about. But before we do, Josh, how are you processing all this conflicting information, I guess, as a consumer of news, but also as somebody who's mitigating risks in your own life? Yeah, that's the thing. I don't you feel as though I mean, this, this is constant game of figuring out what risks you're willing to take. I'm probably going to be going to Florida at the sometime in August, because my daughter is going to the University of Miami.

3:25Yay. But, you know, they're there, they're the cases are grown, right? That's a state. We're all we're all connected. And we're thinking, okay, I'm traveling. And then if I come back, I mean, how are you? are you starting to even think about travel? And then you have to look at some of these areas where the cases are on the rise and think twice. Yeah, I've turned down every kind of travel opportunity, conference opportunity. You know, we're doing them all remotely now. I have a son who's in college in California. He's thinking very seriously about not going this semester because it's going to be such a strange, you know, a lot of the, a lot of the classes will still be done remotely, and it's just not the same scene.

4:06So I don't know. I guess I'm not quite ready to reenter the world. I mean, that's, I guess, why we're excited to have this conversation today, because it feels as though between medicines and vaccines, we still have a distance to go of, you know, what we've been living through. Maybe not as severe, but we got quite a few more shows ahead of us, I think. So let's get to it. So it's our pleasure to introduce today's guest. Again, And Albert Bourla, the CEO and chairman of Pfizer. He's been Pfizer's CEO for about a year and a half. He's been with the company for 25 years. Again. This episode is brought to you by Google Chrome.

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5:18What propels you? Propel with Gatorade electrolytes. He challenged his scientific team to aim for a moonshot to have millions of doses of vaccine in the hands of the population before the end of the year. So we're going to talk about how that's going. So, Albert, welcome. And let me ask, where are you now and what has your life been during the pandemic?

5:39Albert Bourla:Thank you very much. I'm home. I have a small place that I used to be maybe once per week, and now I'm every day there. And this is from where I try to connect and run the company. My home is in Westchester in Scarborough, so I'm in New York. So that's Pfizer worldwide headquarters now. I don't know about that, but definitely it is an important part of Pfizer's management here. Adi was talking a little bit about the moonshot that you've called for, going to, can we do this in something like six months? But talk to us about, I mean, it's hard to get your head around when we hear that vaccines are so difficult to create.

6:26They take a lot of time. There's a lot of potential pitfalls. Talk to us a little bit about how you can put out such a bold, ambitious idea to shoot for.

6:36Albert Bourla:First of all, look, the vaccines, there are vaccines that are very difficult to make, and there are vaccines that are much easier to make. The truth is that from the known diseases, all the easy to make vaccines have already been made. And what remains right now are very difficult diseases that so far the technology wouldn't allow us to develop a solution. When it comes to COVID-19, we still don't know if it is easy or difficult to make a vaccine because this is the first time that we tried. But the truth is that to try to do something in six, nine months, which is if we can bring a vaccine by October, for example, will mean something like that.

7:12Albert Bourla:While it needs not 18 months, as you said before, but the typical needs many years to be done. Something has never been done before and you need to do things very differently to accomplish it. Let me invite our viewers to submit your questions as well for Albert. We'll try to take a bunch of questions from you. So put them into the comments box and we'll try to get to some of your questions. Albert, just to follow up on that, you know, it almost feels like the timeline for a vaccine is an article of faith. I mean, if you look at Ken Frazier of Merck, who's another smart pharma CEO, you know, he said publicly that even a 12 to 18 month outlook is probably too optimistic.

7:53So how do you account for the difference of opinion between between yourself and Ken? Is it is a personality or is it is it about science?

8:01Albert Bourla:Not at all. I know Ken, and he's a wonderful manager, and I'm sure he knows well what he's doing. In our case, I realize that it's going to be difficult, and I realize that it's going to be almost in the spectrum of impossible. That's why I said the famous phrase in this email that I sent to people, I know I'm asking you to do the impossible possible. But I will tell you something. When we started that, my question was if we are going to have a vaccine. And now, several months down the road, after I have seen a lot of data, my question is when we are going to have a vaccine. So I'm not sure we will have it in October.

8:38Albert Bourla:This is what we are shooting for. But I'm much more optimistic that we will have a vaccine by year end or around that. But I think October is the right time to expect. Wow. Okay, so talk to us a little bit about the safety issues, because we think of these things, too, or at least I do. I think of them as taking time because it just takes a while to usually go from high doses to figure out what's the right dosage and what's the safety and efficacy. And you learn over time. How are you ensuring that safety piece when we could be there in October? Well, the FDA has already made known their intentions, which is no.

9:23This episode is brought to you by Google Chrome. You think you know a browser, but Gemini and Chrome, that's new. It can help you with practically anything on the web, like restoring a vintage motorcycle from a 50-page restoration block, or finally break down that long article you've had open for weeks. Gemini and Chrome is here for it. Ready to make anything online make sense? There's no place like Chrome. Check responses set up required, compatibility and availability varies 18+. Propel Fitness Water. With Gatorade electrolytes, zero sugar, and vitamins, Propel hydrates better than water. to help you get the most out of your workout and get back to your best self.

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10:03Albert Bourla:This will be cut. And frankly, irrelevant what FDA or EMA was going to say, Pfizer was never going to cut corners because we are a company of 170 years of existence. I repeat, 170, and I plan to continue for many more. So our reputation is extremely important. The product, the vaccine, will be tested in thousands of people. Actually, it will be tested in the high end of what a vaccine will go through a testing to be approved. We are expecting that we will launch a phase three study pretty soon, in July, that will involve 30 ,000 people, 3-0. and there are not many studies nor vaccine studies that they are recruiting those many people in fact the reason why we are recruiting those many people 30 000 and not go to five six seven eight thousand but for safety reasons fda would be would be comfortable it is because we want by having a lot of people to be able to more quickly come to statistical significant result in the efficacy because we vaccinate those 30 people, 15 will get the vaccine, 1 ,000, 15 will get the placebo, and then eventually we are waiting to see events if those people are getting sick.

11:29Albert Bourla:And then at the same point, we will see that that many got sick in the vaccine and that many got sick in the placebo, and there's a significant difference between those two groups that is statistically significant. The more people you engage in the study, the quicker this result will come. That's the only reason why we do it. Gotcha. So in the testing, you know, my understanding is it's usually the young and the healthy who enrolled in trials, phase two, phase three. How do you design trials then to make sure you're going to have significant evidence about a vaccine's protection for the most vulnerable, you know, the elderly in this case?

12:05Albert Bourla:In the original phases, in the very early stages of our program, which we call it phase one, we started with the younger people. and then the people was 18 to 55. And then after we've proven that the vaccine is safe for them, then we moved to, not proven, but we saw that we didn't have any side effects, then we moved to a group of 60 to 85 years old. So now already we are in both groups. In terms of, just to understand, side effects, you can have multiple side effects, but the most common for vaccines are headaches, or pain in the injection site or redness, could be fever. And we want to make sure that all of these are minimal.

12:50And usually younger people, they are much more expressing those symptoms

12:56Albert Bourla:much more profound way than older people because their immune system, it is less active and robust as the younger people typically. But of course we want that also the product works. So we want to make sure that it gives enough immunity that will prevent the disease or the symptoms of the disease to the degree possible also for older people. But we are doing both. Albert, can you explain? It seems to me, at least from what I've been seeing, that there are varying approaches to this vaccine. But in general, some, and I think Merck, are trying to use things like the measles vaccine or older technologies.

13:41It seems as though in the idea that they maybe know more about it, even in terms of manufacturing. So when you get all the way to that point, you can move quickly. It seems that others like Moderna and I think Pfizer as well are working with newer technologies. Is that, how is that, does that roughly break out that way?

13:59Albert Bourla:I think that America is a very good platform. This episode is brought to you by Google Chrome. You think you know a browser, but Gemini and Chrome, that's new. It can help you with practically anything on the web, like restoring a vintage motorcycle from a 50-page restoration block, or finally break down that long article you've had open for weeks. Gemini and Chrome is here for it. Ready to make anything online make sense? There's no place like Chrome. Check responses set up required. Compatibility and availability varies 18+. Propel Fitness Water with Gatorade Electrolytes, zero sugar, and vitamins.

14:34Propel hydrates better than water to help you get the most out of your workout and get back to your best self. What propels you? Propel with Gatorade Electrolytes.

14:44Albert Bourla:I think they announced that they will engage their platform to see if they can create a COVID-19 vaccine. And it is important that when you embark into a study that you need results, strong results, and you need them quickly, a lot of things can go wrong in manufacturing. It's not simple to manufacture a vaccine. So you need to have end-to-end capabilities from early research to mid-research to all the way to manufacturing and distributing because vaccines distribution is a very different type of animal that will allow you to feel comfortable. Ourselves, for example, you are right that the mRNA technology, but also you're right, Moderna is using, is a technology that hasn't produced yet a vaccine, but it is a technology that is not unfamiliar to us.

15:30Albert Bourla:With BioNTech, we are collaborating in this technology since 2018. So we had two years' experience with this technology. And our collaboration was not to develop a COVID-19 vaccine, but was to develop a flu vaccine. A flu vaccine that could disrupt basically the flu market because this technology has the benefit that you can very quickly, from the time that you sequence the virus, move into production. So if you know the sequence of the virus, you can move very quickly to the production. This is not the same with other technologies. It could take months or what you can do now in weeks. So we felt comfortable that this is the right technology, and we jumped.

16:13Albert Bourla:But there is no doubt I had a lot of anxiety that we are taking significant risk because it has never been done. That's why I said that if the stars are aligned, we could have, if the plan is executed without the surprises, we could have data in October timeframe that we will feel comfortable that we have a good vaccine, safe, efficacious, and FDA will feel comfortable. and I'm surprised to tell you the truth but still the stars are aligned so so far we have already we are let's say one third half the way between one third and half the way and things are still on plan let me take a couple questions from our audience we're getting a lot of good questions this is from well alright let's take this one from Charles from Toronto so if a vaccine you know if this is achieved in six months, could it eliminate a second and possible third wave of corona infections?

17:13Albert Bourla:I don't know. First of all, we need to see what would be the level of efficacy of the vaccine. No vaccine or very few vaccines are 100 % efficacious. Flu vaccines are 40%, for example, typically. But there are other vaccines that we are having that could be 90 plus percent efficacious. We need to see how efficacious it is. We need to see also what will be the strategy of vaccinating. But the hope is, yes, that you can vaccinate very big parts of the population so you can create herd immunity so that your population is immune. And when a very big part of your population is immune, you can break down the transmission circle.

17:52Albert Bourla:But all of that needs to be proved. You need to prove the efficacy, and then we need to make sure that we don't have any surprises in the well-known theory that when you create herd immunity, then the transmission is breaking down. So here's a follow-up. This is from Sourav in Miami. So what's the plan for vaccination after virus mutations take place? How do you respond to that? Yeah. I don't know if this virus is subject to a lot of mutations. From information that we have will mutate that's for sure but i don't know how how fast could take a few years but this is exactly why this technology the mrna technology is ideal you don't need to redesign the vaccine all you need to do it is if there is a new mutation you take the sequence of the new the i mean the dna sequence of the new this episode is brought to you by google chrome You think you know a browser, but Gemini and Chrome, that's new.

18:51It can help you with practically anything on the web, like restoring a vintage motorcycle from a 50-page restoration block, or finally break down that long article you've had open for weeks. Gemini and Chrome is here for it. Ready to make anything online make sense? There's no place like Chrome. Check responses set up required, compatibility and availability varies 18+. Propel Fitness Water. With Gatorade electrolytes, zero sugar, and vitamins, Propel hydrates better than water. to help you get the most out of your workout and get back to your best self. What propels you? Propel with Gatorade Electrolytes.

19:26Albert Bourla:Vaccine, and within days, you can prepare new templates that could replace the core of your vaccine. So this is why we wanted to do it with flu, because flu mutates very often, actually every year. Every year is a very different strain. And that's why we thought it is ideal for that. So if this will be the case and the virus mutates, this technology will be able to follow up very quickly. But I'm not sure that will be the case. Are you, Albert, with, you know, you talked a little bit about manufacturing, and it seems as though the major players that are in this game are setting up, prepared to manufacture at scale.

20:03But does that mean rewriting the rules between how you go from the lab to manufacturing? Are you doing things in just a very different way that could change the game permanently going forward?

20:13Albert Bourla:Completely different game. Completely different way of doing things. we have let me start from the day one we started with Moderna for example with excuse me with BioNTech for example we didn't sign a contract we called them you want to be yes they called us yes we want to be we started exchanging information confidential we started putting plans together we started spending money without contract and then as we were doing that we signed a letter of intent and then only after that we signed a contract so So that's untypical, right? You don't want before you spend to be safe. Then we started doing things in parallel, non-sequential.

20:53Albert Bourla:I will tell you the biggest risk element. It is that you prepare your manufacturing and you're going to manufacture tens of millions or hundreds of millions of doses or prepare to manufacture hundreds of millions of doses, which means you buy all the materials and you set up the lines in your manufacturing site without knowing if the vaccine works. What this risk-taking gives you is if the vaccine works and it is approved, then you have already the quantities manufactured so that you can immediately jump and vaccinate people. But if it doesn't work, it means you need to write off all this investment.

21:32Albert Bourla:And this is big money. But that was the only way that you can do it. And I don't think that a company of our size will break if we lose$1 or$2 billion. But if we are successful, I think it is absolutely the right thing to do, and people will remember it. So we've all seen the statistics that seem to show that a large percentage of the U.S. population, and maybe 30 percent according to one study, say they won't take the vaccine even when it's developed, which is incredible to me. So how do you anticipate that problem? How do we reassure the public and improve messaging, you know, to make sure there's a significant eventual uptake when there is a vaccine?

22:18Albert Bourla:I think that the key opinion leaders of this country, which is prominent scientists, the CDC, Dr. Fauci, multiple other people, they need to basically to make a campaign. they've been to make an educational campaign to explain to people why they should get vaccination and that it is safe and what you should expect and that it is going to protect them because otherwise there will be a percentage of people that either will think that if it is done so quickly likely they don't know if it is safe so let me be not the first one to get vaccinated or they will say that it was pressed by political reasons to get the vaccine out there.

23:05Albert Bourla:So there will be a lot of that. Now, from my perspective, I know that I will, no matter what pressures, we will not put out a vaccine unless Pfizer scientists feel that it is safe and efficacious. And from all my interactions with FDA, I don't think they intend to cut corners as well. But still, there will be people that will doubt. Hey, it's Kelly Rowland. You may not know this, but I have eczema, so I get how it can steal your time. But why let eczema take over when you can talk to your doctor about ebglis? Ebglis, Lubrikizumab LBKZ, a 250 milligram per two milliliter injection, is a prescription medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds or 40 kilograms with moderate to severe eczema, also called atopic dermatitis that is not well controlled with prescription therapies used on the skin or topicals or who cannot use topical therapies.