Tal Zaks

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.