I wanted to point out an interesting interview given by Pfizer’s CEO Albert Bourla to Time. I have made some pointed remarks about Pfizer over the years, but this is one of the better Q&A pieces like this that I have seen – you’ll see why in some of the answers below.
Bourla is actually quite optimistic about the Pfizer/BioNTech vaccine program (four different mRNA attempts, as fans will recall). He says that they should have enough data “in the September time frame” to submit to the FDA, with approval, he hopes, in October if the data are strong enough. Is that realistic? Well, if the data are strong enough, yes. But as with all these timelines, that’s what can happen if everything works right the first time (and with enough vaccines being tried, one or more of them could indeed come through like this). What we’ll have are short-term efficacy and safety data: real-world data on protection against coronavirus infection and on adverse reactions on dosing. What we won’t have are the data on duration of that protection, nor a read on long-term safety. But we’re not going to know those for *any* of the vaccine candidates – those are the big corners that the world is going to cut, and I agree that it’s the right move.
He goes on to say that
“. . .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. . .We have a lot of indications that make me feel that really it should make it.”
Remember that earlier this month the company published Phase I data on one of the four vaccine candidates; I very much look forward to more information of this kind. This is where I should mention that (at least as I write this) we still don’t have such information about the competing mRNA vaccine from Moderna, and it has now been eight weeks since they press-released their first results. (Update: they just published this afternoon! Blog post on the way). Meanwhile, on Monday morning Pfizer announced that the candidate they published on (BNT162b1) and one of the other three (BNT162b2) have been fast-tracked by the FDA for development. The former is one of the two base-modified RNA candidates, and despite some digging around this evening I have been unable to figure out which is the other one. From the looks of the number code, it might be the other base-modified one? We shall see. At any rate, they apparently have enough convincing data on that one to show the agency as well.
Bourla goes on to say that they will be starting manufacturing soon on a risk basis (something they’ve never done with a vaccine candidate), and that the company plans to be ready with up to 100 million doses by the end of the year – and over a billion doses next year. When the Time reporter asked what they’ll do if the vaccine doesn’t turn out to work in Phase II/Phase III, Bourla responded “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.” More in this vein:
. . .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. . .The vaccine should be free to all people. 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.
He makes the point, as others have, that this is a chance for the drug industry to show what it can deliver for the world. And he’s right: no one else can do the things that the biopharma industry of the industrialized countries are doing right now. If there’s going to be a cure, it’s going to come from us. No one’s going to combine two things from the grocery store and find the wonder drug – that’s what you get from lazy screenwriters cranking out a cheap movie. “My God, that’s it! Nutmeg and anchovies! Under our noses all along!” Nope. It’s going to be the result of a lot of hard work and a lot of expertise in immunology, molecular biology, formulations, pharmacokinetics, protein science, clinical trial design, statistics, toxicology, manufacturing logistics and a whole lot of other subjects that many people would rather break rocks all day than have to pass an exam on. Oh, and a lot of money, too: Pfizer (just one company in the race) is apparently spending about $2 billion this year on this program, and as many have noted, in their case none of it has come from the US government. The folks who claim that new drugs only cost a few million and that they all come from the NIH anyway are going to have to make an exception this time, looks like.
So good luck to Bourla and to the Pfizer/BioNTech collaboration as they push on in the clinic. Those Phase II/III trials are where all of this is going to be settled, because there is simply no other way to find out what works. Not everything will. We’re heading into an immense, unprecedented, and incredibly expensive and nerve-shredding pile-up in the clinic later this summer and fall, and I’ve said it before – we’ve never seen anything like this, and I hope we never have to again. Hold on tight.