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Pfizer on Monday announced that its COVID-19 vaccine has proven effective in over 90% of previously uninfected people, and added that it could have 50 million doses available by year-end.
Axios Re:Cap talks to Pfizer CEO Albert Bourla about vaccine data, distribution, politics, and how he reacted upon receiving the news.
- Pfizer expects to release safety data next week.
- It plans to let public health officials, in the U.S. and other countries, determine who receives initial doses.
- Once Phase 3 trials are completed and analyzed, Pfizer will release its data for peer-reviewed publication.
- Pfizer did not accept government money for development, in order to better "liberate our scientists" and to "keep Pfizer out of politics."
- Pfizer's independent vaccine advisory committee began receiving data last Thursday or Friday, and met Sunday at 11am. Bourla was informed of the results around 2pm, and says that had the data been available before the election, he would have released it before the election.
Dan Primack: We're joined now by Dr. Albert Bourla, the CEO of Pfizer. So Dr. Bourla, can we just start with timeline here? The company today releases these efficacy results. When should we get kind of the other shoe to drop, which is safety.
Albert Bourla: I think the safety data will mature next week, the third week of November. As I've said, it's already preset, the day, because we want the median, two months from the median [NOTE: this refers to a median of two months of safety data], and we know when that is going to occur. And then soon after, we should be able to apply to FDA, with whom we are going to continue discussing the application and other authorities in Europe, Japan, Canada, etc., etc.
DP: You mentioned today or the company mentioned today that, if approved, there could be up to 50 million doses available by the end of 2020 — and I understand people ultimately require two doses, so that's 25 million patients. How soon after, if you were to get an EUA approval, would you actually be able to begin distributing the vaccine?
AB: I believe immediately because we have already a few million already produced and we hope that we will be able to make sure that all these batches are cleared by the FDA and that we continue producing as we speak. So we will have immediately some millions doses to be able to release after safety, after quality controls. And by the end of the year, we hope to be able to release up to 50 altogether, globally.
DP: The FDA obviously had this 50% threshold for efficacy kind of its baseline. Obviously everyone would like 100% efficacy because why wouldn't you in a vaccine? What was Pfizer's target? Or at least where did you think this was going to come in?
AB: We were hoping for the best. I have to admit that I never hoped that it would be — because it's not 90, I said it is more than 90 — so I never hoped that we'd be more than 90%. And that's a very, very strong, overwhelming indication of efficacy.
DP: Can I ask about that? You guys keep saying over 90%. Do we take that to mean like 90.02%? Or are you able to give us a more specific number?
AB: The reason why we're not giving a specific number is first of all, we are not even telling our teams what the specific number is. And also the number would change. So for example, if it is 91, it could become 92. If it is 94, it could become 95, or vice versa by 1 point. So we don't want to confuse people with different numbers, but it is more than 90 and I believe will remain more than 90. So we just have to say what would be the final number when you read the results.
DP: You know, over the past several months, when you talk to folks in the field on particularly the possible politicization of this, they all say the same thing, which is: So long as the company comes out and there is a vaccine and the data becomes publicly available and people outside the company and outside of even the independent review boards at the company can review it — at what point should outside physicians, outside virologists, etc., feel that they are going to be able to see your data?
AB: Yeah, I think there are two batches of data here. One: It is what we will submit to the FDA. And there's a question mark if the study will be fully completed by that time, because also this possibility exists. Those data, whatever they are at the time, will be given to FDA, and I'm sure that FDA based on what they have said, they will analyze them and they will give them to an external group of advisers. They are meeting publicly. So those data will become public knowledge.
The second is: Once we have ourselves completed the 164 [NOTE: this refers to 164 confirmed cases, Pfizer’s threshold to complete the clinical trial], which is the end of the study as per the protocol, those data we will publish in a peer review magazine, as we do always, which is a scientific magazine [where] high caliber scientists are reviewing the data before accepting for publication. And then the entire world will have visibility on those data.
DP: Pfizer didn’t take Operation Warp Speed money for the development of this vaccine. Just from a fiduciary standpoint, why not? It was kind of free money, or were there major strings attached from your perspective?
AB: There was free money, but always I think that there's never free lunch. When you take money from someone, there are always strings attached. But it was not an easy decision from a fiduciary point of view because the level of investment eventually is approaching or will exceed the $2 billion eventually. But the reason why I did that was because I wanted to liberate our scientists [from] any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together, etc.
And with that I unleashed the power of science, I think. And in retrospect, looking back, I'm very happy that I made this decision because we had the results I think much faster than otherwise if we were not unencumbered. And every day costs 1,000 lives only in the U.S. right now. So it's a very big toll that we’re paying. Also I wanted to keep Pfizer out of politics. I didn't take money, not only from the U.S. government, but then the other government in the world that they were offering.
DP: I want to come back to that in a second, but I'm just curious. You do, however, have an agreement with U.S. government and Operation Warp Speed in terms of production and distribution. On the distribution side, who decides — if there are, you know, 25 million patients who are able to get access to this year — who decides who those people are and who's in charge of the actual distribution? Is that you, or is that the feds?
AB: We are having agreements not only with the U.S. government, we have agreements with the European governments, with Japanese government, with Australia, with New Zealand, with Canada. With multiple governments in the world. I believe that it is not for Pfizer to decide who gets the vaccine. It is for the health authorities of its country. And I believe that in many cases, the health authorities should customize their recommendation based on different states, or in the U.S. for example, it could be based on the needs of the states, or the needs of the regions in some other countries.
Pfizer will work and is working already with all of these people, so that we can provide the scientific background and insight as to how our vaccine can be used as part of an overall program that will control the disease. In the beginning, it is clear that there will be more limited distribution. As you said, 50 million doses is 25 million people globally. Even if half goes to the U.S., that means that it's going to be 12 million people that we can protect in the next 1½ months. Very important protection, but still a small part of the population.
It needs to be strategically decided. I don't think it is for us. I think it is for the CDC or the authorities of the country, but they need to do it on a very equitable, only scientific basis.
DP: You said one of the reasons you didn't want to take the development money was to keep Pfizer out of politics. Judging by Twitter at least today, you have not completely succeeded in that. I'm curious, I guess, can you just walk me through a little bit when you knew that you were going to be able to release this data? And candidly, if it had been one week earlier, if you had had this report ready for Monday a week ago, would you have released it?
AB: Yes. In the, I think, one or two days after the first presidential debate, I wrote a letter to our employees and I said that some people want us to do it faster, some people want us to do it slower. I'm telling to all of you that we will move with the speed of science. So if it was before, I would have released it before. If it is now, I’ll release them now. I learned about those results yesterday, Sunday, at 2:00. And the independent experts’ committee, independent from Pfizer, that unblinded the data and reviewed, they met at 11 and they finished their meeting at 1:30.
DP: Was the 11:00 meeting, was that pre-scheduled for yesterday at 11? Or was that just “the data's in, everybody get around the table?”
AB: Sunday we knew that the data are in. So the data came in on Thursday or Friday. And on — but you know, from the time that the data comes in, before the committee meets, some people need to prepare for each case a very big and accurate narrative. And the physician should sign it. So there's a lot of work that needs to be done. But we did it with the speed of light. And once we had the 94 cases, they worked on the narratives, they worked on the tabulation of the results. So on Sunday morning, we didn't want to lose a day, right? They didn't do it Monday. They did it Sunday. The committee met and they reviewed the data.
DP: President-elect Biden said that he received late last night the information. Did the White House receive it also? The efficacy data.
AB: We are speaking with both parts of the administration and the campaign, both political leaders from both spectrums regularly. And so I don't know when exactly each one of them received it, but they all have been briefed.
DP: Final question for you. There is kind of a narrative starting to go around that Pfizer might've helped, candidly, save society, which isn't, you know, curing a certain number of people from a particular disease, which is what you guys are used to doing. How do you think about that? Just what you have done over the last eight months or so, and where you are today. It would seem to be something very hard to wrap your mind around.
AB: You're right. It was a great relief. I had the goosebumps and tears in my eyes. And I was cautiously optimistic, but I was nervous. Not because if we don't, if we're not successful, we are going to lose the billion dollars. But if we’re not successful, the world is losing hope. And I could feel this weight on my shoulders so I can tell you that I had the emotional reaction with everyone will have when they hear this news, exact same.
DP: Albert Bourla, CEO of Pfizer. Thank you so much for joining us.
AB: Thank you very, very much.