A Potential COVID-19 Vaccine Begins Clinical Trial
MARY LOUISE KELLY, HOST:
Where does the effort to develop a vaccine against the coronavirus stand? This week, Monday marked the first testing in humans of an experimental vaccine. Eight patients have received it so far, all of them in Washington state. The company that is developing the vaccine is Moderna, and their chief medical officer joins me now via Skype, Dr. Tal Zaks.
TAL ZAKS: Thank you, Mary Louise. Good afternoon.
KELLY: I'm glad to have you with us. So we - I mean, we all just learned about this new virus in January. How unusual is it to have a trial vaccine developed and being tested by March?
ZAKS: Well, I think it's very unusual. In fact, I think we've set a new record here. We've been able to do that based on the fact that our technology starts with the digital information. So we did not need to have the physical virus, just the information. And we used that and leveraged our platform and the experience we've had with the platform, as well as our pre-existing relationship with the NIH and National Institutes of Health, to be able to move so quickly.
KELLY: And am I right in saying the goal for this first set of tests is to learn, is it safe, and then we'll follow the tests to determine, does it work?
ZAKS: Well, so this first trial will actually accomplish two things for us. First, of course, we anticipate it will demonstrate the safety and tolerability profile. But second, we will be collecting blood from these volunteers to measure the ability of the vaccine to immunize them, to generate antibody levels that should be able to protect against it. So its both safety and immunogenicity are the endpoints of this trial.
KELLY: And I mentioned eight patients have gotten it so far. How many will get it in this first trial? And how are you going to monitor them to make sure it is proving safe?
ZAKS: So that is correct. The trial in total will have 45 patients, 15 each at three different dose levels. They are monitored, as you do - routine volunteers in vaccine trials. This is not the first trial we're doing. In fact, we have already run - this is the 10th Phase 1 trial that we've run with our platform. And to date, we've dosed over a thousand volunteers across different applications - not against this corona, this obviously is new.
ZAKS: But for the past several years, we've been developing vaccine against numerous other viruses. And so using that as a backdrop, we'll be monitoring these patients, as is routine for just, you know, flu-like symptoms and local reactogenicity.
KELLY: The goal, of course, is to get a vaccine rolled out to the general public. And the estimates that we keep being given are that that is somewhere in the year to 18 months timeframe. Let me put to you the question that's on so many people's minds, which is, why? Why does it take so long?
ZAKS: Yeah. So it's a great question. The reason it takes so long is before we can start and immunize millions of people, we need to know that our vaccine is safe and effective. And in order to demonstrate that, what one does is you successfully vaccinate or immunize more and more people. And you collect information to demonstrate that, indeed, it is safe and effective.
And so before we know that our vaccine has an expectation of being beneficial, it would not be warranted to go and make it more widely available. Now, I would say that we as a company, our belief based on the history of what we've shown in the clinic is that this should work. And so we've already begun the scale-up activity in our manufacturing site to be able to scale up and produce the vaccine that is going to be required.
KELLY: Oh, I see. So that once you land on what you think is the right vaccine, you'll be able to roll it out in vast quantities as quickly as possible.
KELLY: And just very quickly, I wonder, are you coming under pressure from political officials or others to speed up testing?
ZAKS: Look. The biggest pressure we come is under ourselves. We feel to be fortunate to have this platform, but a tremendous sense of responsibility and obligation to do this as fast as we can. All of us see what's happening around us, and this is why we come to work every day.
KELLY: Dr. Tal Zaks. He's chief medical officer with Moderna, talking about the effort underway to develop a coronavirus vaccine.
Dr. Zaks, thank you.
ZAKS: Thank you.
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