STEVE INSKEEP, HOST:
We could soon see another COVID-19 vaccine. Novavax is running trials in multiple nations, and along the way, it's discovered some unsettling news. Novavax is running trials in the U.K. and South Africa, meaning the vaccine has been tested against new strains of the virus. CEO Stanley Erck says the vaccine is more than 90% effective against the original strain, 86% effective against the U.K. strain and considerably less effective against a strain originating in South Africa.
STANLEY ERCK: It's interesting. In South Africa, we also conducted the trial during the time period when the South African variant - it's called a triple variant - was circulating, and 95% of the people were infected by the South African variant and we got 60% efficacy. That drop was a result of the fact that the variant had changed sufficiently to try to escape the vaccine. And the other thing we showed in South Africa is that that people who had previously been infected who entered our trial, about a third of the people had previously been infected, and it showed that previous infection did not protect them from the South African strain. So there was no herd immunity. So what do you do about that? Turns out, we showed that it's important to vaccinate people, No. 1, because without our vaccine in South Africa, you would have no protection. But with our vaccine, you got 60%. And it says that it's going to be important to be flexible when you make your vaccine, so be able to change strains much like you do a flu strain every year.
INSKEEP: Do you believe that that is the case with your vaccine, that it can be tweaked the way that a flu vaccine is tweaked?
ERCK: Very easily, actually. So we're doing that now. We started doing that last month. We're testing it in animals right this minute. And our expectation is, is that we would be using this variant type of a vaccine both as a booster itself and as a bivalent vaccine. So we'll use the original Wuhan strain and the South African strain and test it in humans probably in the second quarter of this year. And that's what they do with flu vaccines, as you may know. There's quadrivalent flu vaccines now, so you get four strains. So our technology allows us to add strains very easily.
INSKEEP: So how far are you from federal approval of this vaccine? What do you need to do to get there?
ERCK: The equivalent of the FDA in the U.K. will probably be the first agency to approve it. But at the same time, in parallel, we're taking those same data from the U.K. and South Africa, we're submitting those data in what's called a rolling submission to the FDA, to the U.K., to the European Medicines Authority and other government authority. So it's going around the world. We're filing all at the same time. The trial's actually not officially over yet. We're still collecting data from some of the trial participants. And we expect to have that done sometime in the middle of March. And the final package would go to the U.K. Regulatory Authority, and it's up to them to determine when it would be approved.
INSKEEP: When the vaccine is approved - let's assume that it will be - what is your capacity to manufacture?
ERCK: We have now set up manufacturing sites in eight different locations in seven countries, and that gives us the ability to be able to produce maybe as many as 150 million doses per month sometime during that by the summer. So it is quite substantial. So we - and we've set up partnerships in Europe, in India, in Korea, Japan, U.S. and U.K. to produce this product.
INSKEEP: What would the capacity be in the United States?
ERCK: Hundreds of millions of doses.
INSKEEP: Over the course of a year, millions in a month. How would that vaccine, if it's out and being manufactured sometime this spring, how would it fit in with the vaccines that are already being distributed in the United States?
ERCK: Well, there are plenty of people yet to be vaccinated. And so we think there's a need for another vaccine globally and in the United States. And our vaccine will be one of them.
INSKEEP: If you get approval, are you prepared to move vaccine in - what? - days, weeks, months? How quickly?
ERCK: Quickly. I think that - let's say weeks would be - we're producing it now. I mean, we're producing it at risk, assuming that we're going to get approved. And we will be putting it into inventory until we get that approval.
INSKEEP: What, if anything, worries you about the days and weeks ahead?
ERCK: Can we keep up the pace? We've got a lot of people working 24/7, literally. I mean, I've never seen this in my entire life career, I guess, is that we've got people working 24/7 since January of last year. And so - but everybody's motivated. I mean, this is a noble cause.
INSKEEP: Mr. Erck, thank you very much, appreciate you taking the time.
ERCK: Good talking to you, Steve.
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