Tal Zaks
speaker
203 appearances
1 recordings
1 series
first heard Jan 2025
last heard Jan 2025
Tal Zaks’s voice in public audio — every appearance, attributed to the second.
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That same size batch is exactly what you need to run a phase one trial with just two doses because the cancer patient is going to get doses for six months every three weeks. And so that served us well to be prepared to move so quickly. So that's what enabled us to start quickly. But how did we get to the end point quickly? Well, that was two factors, really. The first was the private partnership.
And this had to do with the NIH and the CDC and the FDA under Operation Warp Speed actually getting the government's act together and giving us guidance and working with us to be able to move quickly. So what usually take weeks and months of back and forth with the agency was literally a week. agreeing on a protocol, agreeing on endpoints, agreeing on trial design, etc.
That was all done very expediently, in fact, at a pace that it takes a global pandemic to get done. And that also enabled the investment in manufacturing and the scale up in manufacturing that usually is done later in a much more circumspect environment.
By the time we had to scale up the investment in manufacturing, there was a period of several months that it was challenging and the company had to actually foot the bill, go raise money in the capital market. People think the government funded it. No, it was private companies.
If you go back and look at the history that actually funded the commercial expansion, what the government did at a certain time point was backstop the investment and said, OK, we'll pay for these doses. But the capital actually came from the private sector.
And then the final factor was actually, well, to test a vaccine or any medical intervention in a phase three trial, you need a certain amount of events to happen. So you give half a population your vaccine and half don't, and then you see, well, what are the event rates? And this is where modern technology actually helped us.
So we were looking at the spread of the pandemic as we were rolling out the phase three trial. And We could predict weeks ahead where hotspots would be. And we use those prediction to go and open clinical trial sites in places where we knew that event rates would be high.
And if you look at the original design of the trial, the event rates that was expected to take up to a year actually occurred within three months. So because we were able to target the trial to where the events were happening, we could get the answer quicker and be ready with the vaccine. So all those elements, I think, are what enabled that unusual success.
Now, I do have to mention one word about safety here, and we'll come back to the public perception question. These mRNA vaccines... have been the most well-studied medical intervention in the history of mankind. Full stop.
I can tell you as the one responsible for setting up the collection and analysis of the adverse events data that we had thousands of people pouring over tens of thousands of adverse event reports. We had... Given this vaccine to probably at the time it was millions and counting as we were rolling it out, it ended up being billions.
We collected the safety data with a rigor and breadth that has never been done before in human history using tools that have never been available before in human history. The event rates in terms of side effects that people were reporting was about 10 to 20-fold higher than had ever been reported before with even prior vaccines. And the reason was, A, the public was fearful. It was a pandemic.
B, this was all quick. Nobody had heard of mRNA. And C, all the government entities were pushing out tools to report safety. So, this was a real concern, and we had to stand up systems to capture all of that. Now, the proof is in the pudding.
If you remember some of the other vaccines that ended up getting on the market and then getting pulled and people don't use them anymore, the adenovector vaccines, whether it was J&J vaccine or the AstraZeneca one, we discovered event rates that happened at one in 150,000 cases. and they were discovered within weeks to months.
They were assessed as true and relevant, and they were quickly added to the label. Even we discovered this rare myocarditis finding in young adults. It was reported and appropriately put on the label. Still, by the way, the risk of getting the virus is much higher, even just for that side effect of myocarditis, but it appeared to be related to vaccine, and It went on the label.
And so I've never been as sure of anything in my life as I am of the safety profile of these vaccines because the data and the way it's been collected and analyzed. And look, when you're the executive on the other side of it, A, this is your life's mission to get it right. But B, if you don't, you go to jail. Yeah. I mean, this is as important as it gets in terms of getting it right.
And believe me, all of us sitting on that side of the table, we're super conscious of the responsibility and making sure we got that safety profile right now. Where did we miss a beat? It was probably in terms of the public backlash. And as I stand back to look at that success, and again, both on the efficacy side, I mean, people have done the math.
These vaccines have saved millions of lives, full stop. Anybody who believes in reason and science will agree that that's incontroversial. But where did we fail? Because obviously the sentiments I'm expressing here are not uniformly shared by the public. I even have people in my own family who refuse to take the vaccine. So I think it's a question of trust in institutions.
And I think it's also a question of probably scientists, myself included, overstepping our boundary in a sense. And it goes back to the point I started with. of the misguided philosophical framework that we operate under, which assumes that because it is science, it is good. Science per se is not an ethical framework of the force for good.
People who deploy it for good have the obligation to explain why their moral framework is what it is, and that abuts in other ethical and moral considerations having to do with people's autonomy, freedom, and other aspects that have also ethical and moral perspectives to them. And our society is a balance of these different forces.
And as a democracy, and I'm very proud of our democracy, and I'm a proud immigrant into this country for both the opportunity and the democratic processes we have, I also have to recognize that that means that the public gets to say and vote on the things that have ethical and moral frameworks.
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