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Novavax CEO: The headline of delaying our vaccine filing in the U.S. is not accurate

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Stanley Erck, Novavax CEO, joins Yahoo Finance to discuss Novavax’s earnings, delaying the Covid vaccine emergency authorization submission to FDA until Q4, and outlook on global vaccination.

Video Transcript

KRISTIN MYERS: Welcome back. Let's talk about Novavax now-- the pharmaceutical company reporting their quarterly earnings and also announcing that they would delay seeking that emergency use authorization from the FDA until their fourth quarter. So let's bring in Stanley Erck, CEO of Novavax, and Health Reporter Anjalee Khemlani now.

Stanley, I do want to ask you about that delay in seeking that FDA emergency approval. This is not the first time the company has had that delay. Why, again, this delay in seeking that emergency use authorization?

STANLEY ERCK: Yeah, actually, it's an interesting characterization, because what the announcement was that we have actually made our first regulatory filing in three different countries, which is a major advance forward for our company. And we filed with the DCGI, which is the Indian FDA in India, and Indonesia, and Philippines, places where they desperately need our vaccine. And we've gone over a major hurdle to get to that point.

The headline of we've delayed our filing in the US is not accurate. What it is, we are going to take longer to file than we hoped by several weeks because we are in the process of validating assays. And because we don't have control over all the timelines with the outside firms we use to do that, we decided that September is not the most likely date and it would have to be in October, sometime around then. So we haven't lost-- you know, it wasn't a decision to delay, it was reflecting on the timetable.

And so it actually has no impact on our ability to commercialize our product globally, which is what we're on the pathway to do. With the filing that we did in India, and Indonesia, and Philippines, we set the pathway for our first commercial shipment of product to people in low and middle income countries. We're following that with a filing in the UK. We have a timetable for that in September. And then we think we're going to follow that with a multitude of regulatory filings, including the FDA, and Australia, and Canada, and other places. So it's not as dire as the headlines seem.

ANJALEE KHEMLANI: Stan, great to have you back-- Anjalee here. I'm going to get to India and the UK in just a second, but I want to focus on that FDA notice to Novavax. I know that part of it was the analytical method, the testing of the drug product. And I know that from the beginning, our conversations, you talked about building out that manufacturing capacity. So while they're pausing the funding for manufacturing, what are the steps that need to be taken in order to meet that criteria and restart that whole process?

STANLEY ERCK: It's a good question. And it's not the FDA that delayed us, we have an intermediary, which is what we now refer to as the US government-- what used to be referred to as Operation Warp Speed. And they are managing-- they're doing project management on this. And so we are guided by their instructions about when to go to the FDA. So it wasn't the FDA that caused the partial shutdown of funding, not the partial shutdown of work.

What was going on in the Texas facility that we were we were directed toward a long time ago by Operation Warp Speed is that the facility has been stopped because of quality problems. They've been working on bringing their quality system up to our standards and the government standards. There's inspections going on. And as soon as we get through those inspections and then get reviewed by the FDA, that'll be up and running again.

ANJALEE KHEMLANI: And then looking forward from-- I know that you're talking about all the different avenues that you're applying for emergency use authorization and all the various regulatory bodies that you're in touch with, knowing that you've largely targeted not just the global market but also here in the US the booster market, what are your thoughts about how you might end up being able to assess ahead of time, especially now that you're able to test with the Delta variants and we've seen all these concerns about some other vaccines-- have you looked at some of those instances and how to address that right now?

STANLEY ERCK: Well, we have. And so there are two concerns. One is we've got to get the world vaccinated. We have to get through the primary dose one and dose two and get people the primary vaccination. And there's a lot to go. For instance, in Indonesia, just look up the problem in Indonesia right now. It's dire.

They have raging spread of virus and they don't have enough vaccine there. And we need to get them their primary vaccination. And that's true in a lot of countries. And even in the United States, we're trying to get the last 20% or whatever vaccinated. And so our vaccine is perfect for that.

You know, we've demonstrated, you know, the efficacy of 100-- as much as 100% efficacy against the original strain and 90-some odd percent protection against the various variants. So we know our vaccine works well in that situation. But we also know, and we showed data yesterday, that we have done some booster work. We took our people that we vaccinated six months ago or six to nine months ago in the US and Australia in our phase I/II trial, and we gave them a six-month booster dose.

And that's what we announced yesterday is the results from that trial that showed that, in fact, just like true immune responses and vaccinology of lore, you get vaccinated, you get a boost in antibody response, that antibody response wanes over time. And so it did in ours, it's done it in every study-- Moderna and Pfizer have seen the same thing. And you start waning. And what you want to do is boost that.

And so we did. We took a six-month boost. And what we found was is we got tremendous boosting response to well above, far above what we got after the first two doses. And that's classic immunology. That's what happens in pediatric vaccines when we vaccinate our kids in two doses and then give them a boost six months or 12 months later. So there's nothing surprising, it's just good that it works the way it always does.

But what we found in addition is that our vaccine boosted the response to the Delta variant four times what it was after the first two doses, and also the alpha and beta. So we know that our vaccine can be effective as a booster. We know that our plan is, that, particularly next year as we're giving vaccine out for all the primary vaccination in all the countries that need it, we're also going to have a booster dose-- or a booster vaccine that has a really very good, if not the best at least it's very good, and probably the best, package of safety, efficacy, and combined with its stability that we can ship at refrigerated temperatures. So we're very happy with where we're going on this.

ANJALEE KHEMLANI: Right. And I know you've talked about sort of the different technology that you're using in order to achieve that, but now you're targeting India, right, where the largest need is right now in the world. So walk us through the timeline for that. Do you expect to get it out on the market pretty soon there?

STANLEY ERCK: Yeah. You know, so every regulatory agency is going to-- we've done what we can in where we filed. And so what we can't predict is the timetable that the regulatory agency is going to take to review the data. And so the good news is that we've been giving them data for months now-- you know, with they have all the clinical efficacy, and the safety data, and it's the last pieces of data that we've now submitted, which is the manufacturing data.

And so we'll see how long it takes them to do that. I think India, the regulatory agency, is very sensitive to what we've been giving them. I don't know if their timetable is. We've submitted now in August-- whether that's going to be sooner, or September, or October. But I think it's going to be relatively fast.

And I don't know-- I think it's possible that Indonesia and the Philippines may even move faster because of the great need for the vaccine. And we have product that we can actually ship once we get the regulatory process approved.