Pfizer is increasingly confident that its efforts to develop a coronavirus vaccine will be successful. In a July 7 interview with TIME, Pfizer CEO Albert Bourla said he believes that Food and Drug Administration approval could come as soon as October. On the basis of promising results in an early-stage trial released on July 1, Pfizer has dramatically increased the projections for the number of doses it will produce this year, from tens of millions to 100 million. Bourla also disclosed that the company has begun commercial talks with governments around the world about how many doses they will receive.
Bourla is so convinced his $52 billion global pharmaceutical giant is on the right track that he has decided Pfizer will start producing the vaccine before receiving approval from the FDA. It’s a move as risky as it is unorthodox. Pfizer’s vaccine, being developed with its German biotech partner BioNTech, uses a novel genetics-based approach called messenger RNA; Bourla acknowledges that no messenger-RNA vaccine has ever been approved to prevent infectious disease to date.
The race to develop a vaccine is one of the most consequential and urgent scientific challenges of our time, and there are 180 vaccines in development, according to the Milken Institute. Other pharma CEOs have been less aggressive in their projections about when vaccines will be available, suggesting that any vaccine is at least a year away.
Pfizer is set to launch a large-scale clinical trial later in July, which will involve 30,000 people at 150 locations by the end of the test period. Bourla, 58, who was born in Greece and trained to be a veterinarian before working his way up the ranks at Pfizer, plans to price the vaccine to make a profit, but believes governments should distribute the first doses to the most vulnerable, at no cost.
(This interview with Pfizer CEO Albert Bourla has been condensed and edited for clarity)
What did the data that Pfizer and BioNTech released on July 1 show?
That the vaccine in humans created the very robust immune responses in all individuals that received the vaccine. And those responses were also able to kill the virus. What we learned is that this vaccine can neutralize the virus.
So it was a big moment?
For me, it was the moment when I saw the data, plus many other data that we haven’t published yet, [that] made me say that until now I was thinking if we have a vaccine. Now I’m discussing when we’re going to have a vaccine.
Let’s talk timing. You said your reaction was not if but when. So when?
Well, let me be accurate and factual here. One, we will only know if the vaccine works when we have the final study. We have a lot of indications that make me feel that really it should make it … We should be able in the September time frame to have enough data to say if the vaccine works or not. And to submit that to the FDA. So for a potential approval in October, if we are lucky. It’s feasible.
And when will it be ready to be distributed?
The most interesting and important thing is that if the vaccine is successful, which means that if we are convinced about it, effective and safe, and the FDA is convinced about it, effective and safe, we will have already manufactured doses that will be readily available.
So have you ever done that before, started manufacturing pre–FDA approval to get it ready to ship?
Are you currently manufacturing the possible vaccine itself or just the bottles and the containers it will go in?
Pretty soon we will start manufacturing actual vaccine. We may not bottle it yet because we are waiting, but there are a lot of stages.
You’ve invested more than $1 billion in this. What if the FDA rejects the vaccine?
We will just have to write it off and call it a day. We will throw it away. It’s only money we’re going to lose.
In terms of scale, if you got FDA approval in October, what kind of shipments do you anticipate?
Now I’m discussing <i>when</i> we’re going to have a vaccine.We are planning to have up to a hundred million doses for this year. We’ll be fewer in October, a bit more in November, a bit more in December. And then we will have approximately 1.1-1.3 billion doses in 2021.
With a B or with an M in 2021?
With a B like my name.
How does your CFO feel about this plan, potentially writing off the investment in the vaccine development?
He’s also responsible for manufacturing. So he’s on the hot seat right now. But from day one, it was very clear that this is not business as usual. So yes, if you were calculating return on investment, we would never do these things. We were discussing that back in March, what that means to human lives, to the economy of the world. So it was a must, that we must take those measures.
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How did the board respond?
When they heard the plans, they were extremely supportive. And I think this is what our investors want to hear, that Pfizer can use their resources and can distinguish itself by bringing a solution to the world that very few can bring. That creates a significant value proposition for this industry and for us specifically. I can’t measure that with the cost of, let’s say, $2 billion that we may lose on this thing.
That’s your total investment, $2 billion?
I think that in total, and most of that will be this year.
Are you in regular touch with Dr. Fauci about this?
He’s aware of our progress. I don’t want to speak for him, but I know that he’s cautiously optimistic. I’m using the exact expression that he used, cautiously optimistic.
What kind of conversations are you having with various governments around the world?
Everyone has reached out to place preorders. And we are in the first discussions with all of them trying to see how much they need and how can we allocate the quantities to them in a fair way.
If you look at who’s dying of COVID now, and the broader discussion on inequity which in many respects is really about who gets to jump to the front of the line, getting vaccinated is going to be the ultimate line to jump. But many of the people that are dying are poor, of color, working on the front lines. What steps are being taken to ensure equitable distribution of the vaccine?
There’s no doubt that several minorities are disproportionately impacted by COVID-19, and African Americans for example is one of these groups that have many, many more victims in their population. We will make sure that in our studies will have a fair representation of the people who are getting sick. I believe that the government should define the priorities, but the priorities should be the most vulnerable people.
You’re a businessman and a scientist, not a politician and a moral philosopher. But there’s so much social unrest in this country now, it seems that if the vaccine is out there and elites get it before the frontline workers, it could set off a new level of outrage in the streets.
I think that if something like what you describe happens, it’s going to be a big shame. That would put the credibility of our institutions at complete risk. How you start, it’s a very tricky situation but needs to clearly follow some different criteria, and nothing that has to do with either who has money or who is in power right now.
And what about pricing?
The vaccine should be free to all people.
It should be free? So are you giving it away?
We are not giving it away to governments. We are going to charge governments … a very, very nominal value. But our intent is to ask governments that they should, for these prices, they should provide it free of charge to all citizens.
So are you essentially selling it to governments at cost?
No, I think we will make profit, but we will make a very, very marginal profit at this stage. And also keep in mind that we didn’t take—and I think we are so far we are the only ones that I know—but we didn’t take any money from the U.S. government or any other government in the world.
Given the aggressive price increases on Prevnar 13, the pneumonia vaccine which is one of your top-selling products, some consumer health advocates are worried about your pricing plans for this vaccine.
You are right that if we were to price our vaccine based on the value that it brings, business as usual, we could go to that level and much higher. But what I’m telling you right now is that we do not plan to do that. Because we understand that right now the No. 1 consideration is to facilitate that everyone will get it very fast.
In the not-too-distant past, the pharma industry was reviled for its role in the opioid crisis and predatory pricing. Do you see this as an opportunity for the industry to redeem itself? During the Democratic primaries, Big Pharma was referred to like Big Tobacco.
My company provided medicines that are saving the lives of 500 million people. And I don’t think that any other industry in the world can claim that it is producing so much good for humanity. Think how many fathers or mothers will live long enough to see the graduation of their daughters. That’s because of us. So I am extremely proud of the value that this industry is bringing to the world. It is a completely unfair perception, and it is used by politicians because it’s scoring very, very well. I believe that COVID-19 really offers an opportunity to reset the perception. Not reset the value, because the value was there. Right now we represent the hope for billions of people, millions of businesses and hundreds of governments to find a solution to this mess.
You’re quite passionate about that point.
I’m sure you would be as well if you are thinking that your job brings good service to the world and someone was saying you’re like tobacco. You would be very passionate as well.
You have a PSA that says “Science will win.” I know the political situation isn’t something you want to wade into, but that feels like a direct comment on an Administration that has in many respects abandoned science.
It is not my intention. But it’s very clear that science is everything to us. And it is very clear that the only solution that we see right now is science. And we are expressing our confidence that science will win.
I feel like I should ask a question about Pfizer’s Viagra. What does the current relative importance of Viagra, now that it is off patent, say about the nature of the pharmaceutical industry?
Viagra is a very big part of our rich innovation history because it was one of a kind. I know that there were jokes about this product, but for people that were suffering from a true medical condition, that was not a joke. But we are proud about it, as we are proud about Lipitor (a medicine that lowers cholesterol and is also now off patent protection), which was much bigger than Viagra and likely prevented the deaths of hundreds of millions of people. And it costs pennies right now. And that’s the same with every product that we have right now. Pretty soon they are going to lose patent and they will cost pennies. That’s the name of the game.
I understand one of the first things you did when you took over as CEO was redesign your office and place patients’ pictures either on your desk or on your wall.
The only way that a pharmaceutical company can be successful, it is if we create value for patients. There’s no other way.It’s a symbolic move that’s helping to build the culture of what every pharmaceutical company should be having. A patient-centric culture. That’s all about patients. The only way that a pharmaceutical company can be successful, it is if we create value for patients. There’s no other way.
You trained as a vet. Did you have an actual veterinary practice?
I practiced in the university hospital. I was a specialist in obstetrics. I was practicing in the obstetric clinic. And my Ph.D. was in biology—biotechnology of reproduction. I was doing embryo transfer, in vivo fertilization. Insemination, artificial, etc.
You were born and educated in Greece. Did you read Homer in the original as a schoolkid?
And do you like The Iliad or The Odyssey better?
I like The Iliad better. Although The Odyssey is much more adventurous in its way.
What is it about The Iliad that drew you to it?
Because it’s politics, love [laughs] and power. In one book. Sex and power and war. And politics. Unbelievable.
— with reporting by Alice Park
BUSINESS BOOK: What Brought You Here Won’t Get You There by Marshall Goldsmith. I found myself in it. All the things that he was describing about what people do when they go to higher positions. The mistakes, I discovered that I was doing them.
AUTHOR. I read Greek authors. The latest English book that I’m reading right now is Bad Blood.
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