Go Pharma!
Pfizer CEO Albert Bourla Raises Expectations That the Pharmaceutical Giant Can Deliver a COVID-19 Vaccine by Fall
https://time.com/5864690/pfizer-vaccine-coronavirus/
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.
Some of the Q&A:
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?
No, never.
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?
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.
