Thank you for joining us today, Dr. Bourla.
MR. BOURLA: Thank you very much, Frances, and please call me Albert, if you don't mind.
MS. SELLERS: Okay. I'll call you Albert. Please call me Frances, of course.
So, you've started human trials in May but now moved into late-stage trials. What does that tell us about the safety and efficacy of your new vaccine?
MR. BOURLA: Well, this is exactly the trial that is going to tell us if the product is safe and effective. A large study started, as you said, a week ago, and it is progressing, actually, very, very nicely. Just to give you, for your viewers, also a sense of how things are working, we are going to vaccinate, to inject 30,000 people. Fifteen thousand will receive the vaccine. Fifteen thousand will receive placebo, basically saline. And no one will know if he received the vaccine, not the patients that received it nor the doctors that administer it. Not even us, because it is a coded in a database that only a special committee has access.
And then once we vaccinate all 30,000 people, we let them live their lives, and then we wait to see if they will get the disease. And that is what we are monitoring, every safety aspect that you can imagine, in terms of this vaccine.
So, when the study has enough people with the disease we will know if it works and we will know if it is safe.
MS. SELLERS: How many people have already signed up, and when do you expect to get to 30,000?
MR. BOURLA: We expect that we will get in early September, the 30,000. I think we will be--already, the vast majority of them will be by the end of August.
MS. SELLERS: And tell me, what are the risks to them and how are they compensated in the unlikely event that something does go wrong?
MR. BOURLA: Well, it depends. If it is a safe signal, that we will detect. Like with all the studies there is a Safety and Data Monitoring Committee. This is a committee from experts that are not part of Pfizer. They are key opinion leaders. They are academicians. But they have access to the data and they are monitoring specifically aspects of this study. If we have a sign that something is wrong, obviously we stop the study to see what is going wrong.
But so far, we are already in the first week and things are moving very, very nicely, and we are in excess of 2,000 people that have been vaccinated so far.
MS. SELLERS: Two thousand.
MR. BOURLA: We have enough sample of people that can tell us if something goes wrong.
MS. SELLERS: So, President Trump this morning suggested the vaccine could be ready as early as November, perhaps even by November 3rd. What is your timetable, given this very accelerated pace you're going at? What's your timetable for delivering the first available vaccines, and how many do you expect to deliver in 2021 to the United States?
MR. BOURLA: Yeah, both are great questions. There are things that we can control as we are planning, and things that we cannot control. What we cannot control, it is if the study will be effective. What we can control is to make sure that we stick to the study according to the plan.
So, if we execute the plan, the plan that we have right now, depending on the efficacy of the product we will have enough people that get diseased by the end of September, beginning of October, that will tell us if the product works or not. And if the product works, we already have started manufacturing, so that we will have available quantities that will be readily available if the FDA review--that is also the study--and they feel that the product needs to be approved.
So, from my perspective, October. It is a timeline that there is a high likelihood. But we will know if it works and we will have enough product to start distribution.
MS. SELLERS: You mean would go for FDA approval in October, or you would actually start distribution to governments around the world in October?
MR. BOURLA: We would go for regulatory approval in October, and we expect, given how fast the regulatory agencies all over the world are reviewing those applications, that we will do it very quickly. But ourselves, just to be on the safe side, we have started manufacturing at risk, so we will have already manufactured enough quantities--by the way, you asked the question. We believe that we will have this year approximately 100 million doses manufactured globally, for the entire world. And, of course, a big chunk of that will come to the U.S., and then, of course, we will also provide vaccines in the rest of the world.
MS. SELLERS: So, tell me about the proposed efficacy of a vaccine like this. Those of us who have had childhood vaccines know that a flu vaccine and a measles vaccine are very different things. Where do you think, given what we know about the coronavirus, your vaccine may stand in comparison with those sorts of vaccines?
MR. BOURLA: Look, I mean, I don't know how we'll stand in comparison with those vaccines, but FDA has already set some standards. They speak of a minimum of 50 percent efficacy for the product to be approvable. And we are hoping that we will get much more than that. Of course, we will wait to see how the results will go, but right now, what makes us cautiously optimistic that we should have good efficacy, it is that immunogenicity of the vaccine, and the neutralizing types of this vaccine, which means the ability of the vaccine to neutralize the virus are well ahead of those titers of people that have the disease. So, if you compare what someone who gets the disease and someone who gets vaccination, those that are getting vaccination, they have much higher protective titers.
So that tells me that we have a good sample, have a good efficacy. But again, October is coming, and October will be--the truth will be revealed.
MS. SELLERS: Help me understand a little better. Is this a vaccine you would expect people to get several doses of, or will it be a one-off vaccine, and how long do you expect it to be effective for? Even if you get very good results for the short term, how long do you expect it will be effective for?
MR. BOURLA: Again, excellent questions, both of them, Frances. The original vaccination schedule will be two doses. So, in our clinical trial we are using two doses for every person that we vaccinate, and we are administering them about three weeks. So, someone will get the first dose today and exactly 21 days later will get a second dose. And that's the vaccination schedule.
Now the question is for how durable this effectiveness, if we prove that the product is effective, will be. And that we will study. We will follow those patients for at least two years, so to know if they maintain the titers high and also if they have the disease later on.
But if we will need to have recurring vaccinations or not will depend on multiple things. One, it is how durable the vaccination protection would be, but also it depends also on the virus, if the virus will remain the same or if you will have mutations.
The good news in both scenarios is that the technology that we are using right now in mRNA technology is treatable for both scenarios. If the virus changes, this technology allows us to change the vaccine in weeks rather than in months, without changing multiple things on the elements of the vaccine, without changing the sequence of the mRNA, but it is part of the vaccine.
On the other hand, if we see that after a year, titers are going down and you need to boost, again, the mRNA technology allows you to do that. So, you can boost in a year from now with one dose, and we do not expect, given this technology, that this booster will not be effective and will not take the immunity out, which is not the case with all platforms. This is why we have chosen this platform when we started our clinical trials.
MS. SELLERS: So, two doses. How much will these cost, and potential boosters? How much will people expect to pay for a Pfizer vaccine?
MR. BOURLA: Given the agreement that we have done with the U.S. government, the people will pay nothing. The vaccine, we have now a contract with the U.S. government to provide them, if the vaccine is successful, 100 million doses, and we gave it to the U.S. government at, I believe, a very, very reasonable and low price, which is $19.50 a dose. But the U.S. government will give it to the Americans for free.
MS. SELLERS: This is part of the deal that you made, that the U.S. government gives the vaccine to people for free.
MR. BOURLA: Yes. The U.S. government will--t's part of their announcements, and we took that into consideration. That's why we provide them at price that will allow them to do so.
MS. SELLERS: So, do you expect to make a profit from this?
MR. BOURLA: Yes, we do expect to make a profit, and it's going to be, I think, reasonable and good. But the most important thing is that we didn't think about it when we started. In fact, many people were asking me what will be the price and what will be the return on the investment we are doing. And I said, it's irrelevant. We are not thinking about it right now. The main goal right now is to make sure that we have a vaccine.
And there are two enemies: the virus and time. We have reached a level but then government started asking, and that's why I start thinking about the price. And if we were to price, obviously the vaccine, based on the value that it brings to the society, the price would have been enormous, because as you know the economies are hurt by trillions right now, not by billions. So, if you can find a solution it's very valuable.
But, of course, I think it would have been unethical for us to try to do what we normally do. When we price a product, we try to see what is the value that it brings to society, and we price it accordingly. That was not the case right now. We are giving it at a very, very small fraction of what the value is. But this allows, also, everyone, basically, to access--every government, I mean. The product will be provided at very low cost, or no cost in the U.S., to the citizens of the world.
MS. SELLERS: So, some companies took money for recession development. You did not. You made this deal that you have described, which is an almost $2 billion deal. If your vaccine does not prove effective and you're already manufacturing, who foots the bill?
MR. BOURLA: We do. We do. And this is a very well-understood risk that we took when we started, the reason why we didn't want to take money from the U.S. government, or from any government for this purpose. And the reason, again, was that there was not a good consideration of return on investment. It was going to be, of course, much higher if someone could guarantee that if you failed the money is not paid by you.
But the concern was speed, and when you take money from anyone, the one that gives the money needs also to monitor where you spend it, how do you spend it, what are you going to do, how is your development program, and I wanted to liberate our scientists from all this bureaucracy. I told them, "You have an open checkbook. Just go and find the solution," and they did. And I'm very happy that I did that, retrospectively, because we started, in May, as you said, and a week ago we were the first ones--no, we were together with another company, the same day we went [audio distortion] Moderna, into Phase 3 clinical trials. I don't think we will be able to catch up if we wouldn't do that.
MS. SELLERS: So, I have a viewer question that I'd like to read to you from Steve Abramson in New York, who says, "Has the financial guarantee from the U.S. government allowed Pfizer to begin manufacturing before FDA approval?"
MR. BOURLA: No. We have started manufacturing before FDA approval, but this is at our own dime. So, if the product doesn't work, if we fail in manufacturing, or if the clinical trial will fail to produce a safe and effective vaccine, we will have to destroy the inventory and write it off at our own cost. Unlike other companies, we haven't received a single dollar or a single guarantee for our vaccine.
MS. SELLERS: So, a number of other companies are obviously producing vaccines also at huge speed. Without getting too much into the scientific weeds here, why focus on messenger RNA. What sets your vaccine apart? I know Moderna's is the same, but why this technology?
MR. BOURLA: Yeah. First of all, let me just start by saying I'm very happy that there are multiple technologies being tested out there. And also, I wish to all of the companies that they are trying right now, diligently and with a lot of effort to bring a vaccine, that we will all be successful. Because this is not a race between us, as I said. It is a competition with the virus, and the race will start.
Our search, we did have access to basically all the technologies. We have worked with adenovirus technology, for example, in our cancer vaccines. We have worked with polysaccharides. We have worked with conjugate vaccines. We have worked with protein vaccines [audio distortion] mRNA for two reasons.
One it is that the speed with which you can follow variations or mutations of the virus. You can develop it very fast. And then if the virus changes, once you have developed it you can very quickly tweak it. This is a big characteristic of influenza vaccines. As you know, every year the influenza vaccines are different, because the virus every year is different. With an RNA technology, which also we tried to implement in an influenza vaccine, allowed you to do that in weeks rather than in months. That's one.
The second is that with this technology you can boost very effectively, which means that once you give an additional dose the immune response goes very, very high up, because the vaccine doesn't create antibodies to the vaccine. It creates only antibodies against the virus.
So, these were the two main reasons why we selected this technology. But of course, nobody knows if eventually we took the right path. Until we have the final study results, we don't know. And I'm happy that other people are taking different paths, because that gives multiple chances to beat the virus.
MS. SELLERS: So, this vaccine will be delivered to a world that's polarized and fraught with differing ideas about who should receive the vaccine first. What are your thoughts on this? Should the vaccine go to medical workers? Older people? How should it be distributed?
MR. BOURLA: I will tell you something. I think that first of all the decision needs to be made by the health authorities of each country. I think we know well our vaccine and our data, and who should be part of the consultation, as those decisions will be made. The decision should be made not by us but by those that have the health policy as their responsibility.
What I want to emphasize is that we must let scientists decide who should get it first and who should it second. They know how they make these decisions. They will get all the information about our vaccine, and they should leave all other factors, including socioeconomic factors or politics out of this decision.
MS. SELLERS: So, my colleague, Carolyn Johnson, wrote a piece recently saying that a vaccine won't be a magic bullet. We'll be living with this virus for a while. What are your thoughts about that, and in terms of that, how it should be deployed, and what the best use of it will be going ahead, in the immediacy of this crisis?
MR. BOURLA: I tend to agree. I don't think it will be the silver bullet but it will be a significant, significant advancement. I think from what we know so far, likely the most effective tool that we can implement.
Secondly, in the beginning, when fewer of the population is vaccinated, we should not, I think, relax, and I'm sure the authorities will not relax all the other measures that are needed, like social distancing, masks, et cetera. But the more we vaccinate, and the more we create herd immunity, and the more we create the majority of the population being protected, then the less, I think, the other measures will have to be implemented, and as a result the economy will open.
MS. SELLERS: So, you mentioned the issue of putting science first and trusting science. How do we make sure that people get vaccinated, particularly with a new vaccine, and for an illness we know so little about?
MR. BOURLA: Can you repeat the question? I'm not sure I--
MS. SELLERS: Yes. You mentioned the importance of trust in science. How do we make sure that people will get vaccinated, and particularly with a vaccine, a new vaccine, for an illness we know so little about?
MR. BOURLA: Yes. Thank you. I think that the number one is we need to leave the politics out of it. I think they create a very big, dangerous situation because they create the perception that maybe political reasons will advance the vaccine and not the scientists. And that makes, obviously, understandable, people uncomfortable about that.
So what I have to say to those people, that I understand very well at this, first of all, we should all leave FDA to make it work, and we should leave also the EMA in Europe and the Japanese authorities and the Canadian authorities and all the other authorities that right now can sign deals and agreements with us. And they will review the results of our vaccines and I'm sure will review the results of all the other vaccines before they give approval.
They are very, very competent people, and they are using very, very high standards. So as long as people know that the approval or not of a vaccine, it is subject to strict scientific criteria that only the staff of FDA is recommending, I think that will be a very big win for creating the right sentiment.
Also, I want to send a second message to those that are reluctant, maybe, to do a vaccine. And they need to understand that this decision, unfortunately in this case, does not affect only their health. Unfortunately, by making this decision, they will become the weak links in the way that the virus is transmitted, and they will enable the virus to [audio distortion] and they will risk society's health rather than their own health. It's also something that they need to take into consideration.
MS. SELLERS: Is Pfizer also involved with the production of treatments? We have remdesivir and also some steroids. Nothing curative as yet. Are you involved in developing treatments?
MR. BOURLA: We are. Actually, we are, and we are quite advanced with a protease inhibitor, which is a viricide. So, it's a medicine that will kill the virus. We are starting clinical trials in the U.S. in several week, I believe this month or maybe the beginning of September. So far, the preclinical data are looking very, very, very promising, but again, it's much earlier than the vaccine.
MS. SELLERS: So, you've been running a lot of ads about putting science first. Do you really feel that around the world, and in American in particular, people have given up on their trust in science? Why did you need to put out all those ads?
MR. BOURLA: No, I think people have not lost trust in science, and I believe that this disaster, the COVID-19 pandemic, likely will enhance. And this is what we see also in polls and research of opinions of people, that it is enhancing the image of scientists and scientific organizations, including pharmaceutical companies, which are scientific organizations in the private sector. It's just affecting the life of everyone in a profound way, and this is why politics is getting around it. And then we have politicians speaking if one medicine is effective or not, which means, of course, it is not the job of politicians to do that. It is the job of the scientists.
MS. SELLERS: So, one last question for you. I'm afraid that's all we have time for. It is a divided question. This political pressure, are you worried about it in terms of your own manufacturing process or that of other companies, and what has the pressure been like for you, personally, running a company like Pfizer?
MR. BOURLA: Look, the political pressure doesn't worry me at all, because I don't feel it. No one is politically pressuring me right now. And also, we have made it very, very clear that we are a company that last year celebrated 170th anniversary of existence, 170 years ago the company was founded in Brooklyn. We have a legacy that we respect, and we are not going to put out there any product that ourselves do not feel, our scientists do not feel that it is safe and effective, even before FDA speaks.
Now, it's a different story how I feel. I'm a new CEO. I came on board last year, in 2019, and obviously, in my second year we've had to deal with this crisis. And when billions of people around the world, millions of businesses, and hundreds of governments are investing their whole in the pharmaceutical industry to find a solution, and you are the CEO of one of the leading companies, I can assure you, Frances, that you feel the weight on your shoulders, and I do feel it.
But in this case, I think what is the best to do is just follow the purpose of your company. That's following the purpose of existence of Pfizer, which is breakthroughs that change patients' lives. I mean, I can't think of a breakthrough that would change more patients' lives than a vaccine against COVID-19 right now.
MS. SELLERS: Dr. Albert Bourla, thank you so much for joining me today, and for that personal note on which we ended our conversation.
Later on today--thank you for joining us.
MR. BOURLA: Thank you very, very much for that.
MS. SELLERS: Later on today, my colleague, Jonathan Capehart--sorry, at noon tomorrow my colleague, Jonathan Capehart, will be back on Washington Post Live. He will be speaking with former New Orleans mayor Mitch Landrieu, and also jazz icon, Wynton Marsalis. As always, you can go to WashingtonPostLive.com for further details.
I'm Frances Stead Sellers. Thank you again to Dr. Albert Bourla. Thank you all in the audience for joining us.
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