Novavax CEO: FDA filing for COVID-19 vaccine is ‘probably going to be next week’

Novavax CEO Stanley Erck speaks with Yahoo Finance Live about the efficacy of Novavax vaccines and the path to FDA authorization amid a surge of the Omicron variant.

Video Transcript

JULIE HYMAN: We also have to talk about of course, the latest developments when it comes to coronavirus. And one of them has to do with the vaccine developer Novavax. The company releasing data that says that its- like many of its competitors, its booster shot as part of a three dose regimen, increased effectiveness against omicron. It doesn't sound like they're ruling out though developing a separate vaccine entirely to address the variant.

Stanley Erck, the Novavax CEO, is joining us once again now, along with our health care reporter Anjalee Khemlani. Stan, thanks for being here. Really appreciate it. So as you look at this data, we should be clear, you guys just got emergency approval in the EU, so you're going to begin shipping there. You've begun shipping I believe, in Indonesia. When are the first people going to get Novavax shots? What are we going to start to see that wave?

STANLEY ERCK: Well, actually we have our first shot in Indonesia. We shipped 10 million doses to Indonesia. They were the first country to approve and we have shots in arms as we speak. And so that's exciting.

We have, as you pointed out, we got emergency use authorization in the UK on Monday of this week and we'll start shipping doses to them in January and that'll be going into arms later in the quarter. And the same for WHO. And WHO gives us worldwide authorization and that gets us into a host of low and middle income countries around the globe. And all of that's happening as we speak.

ANJALEE KHEMLANI: Stan, Anjalee here. Let's talk about the rest of the world. I know that already you've gotten a World Health Organization emergency use listing. So how quickly are you starting to see everything go through COVAX and really supply that system, so that we see sort of a global market that you've anticipated come to fruition?

STANLEY ERCK: Well, it's happened. COVAX had to wait until we had the WHO listing, which we've got. They've got to do their thing by putting together purchase orders to guide us specifically to where our vaccine gets shipped. And we are prepared to do that. And so that'll happen this coming quarter.

ANJALEE KHEMLANI: OK, and what about the omicron? I know that now that you have this data, how are you thinking about that in terms of will you be applying essentially for a three-dose vaccine when you get to the point of filing for the US or others around the globe, or are you looking at it as you really just a booster and the two does is the core?

STANLEY ERCK: Could go either way. We're a data-driven company and we'll see what the data look like. What we just announced yesterday was really interesting data. Is what we had hoped for and expected, which was that we took our sera from vaccines that we've vaccinated previously and showed that after and analyzed it after two doses and then compared that with after three doses, with the hope that we would be able to measure the stimulation of neutralizing antibodies.

And we did. We were successful, even after two doses, to get a good immune response. A response that may well be protective. And that's boosted many fold when you get into a third dose. And so our vaccine-- our platform is-- one of the benefits of our platform is, is that we get broadly neutralizing antibodies. We've done this in the past with our flu vaccine so that we're protected against variant strains and flu. And now in coronavirus we've shown really good response against both the alpha and beta and delta variant, and now the omicron variant.

So why don't we make-- we are in fact making a new omicron vaccine variant strain right now. That'll go into GMP production in the next week or two. And we'll make a determination, along with the health authorities as to whether we want to shift strains or stick with the original strain that works pretty well with omicron right now.

ANJALEE KHEMLANI: I know I asked you this a couple of days ago, but update us Stan, when are we looking to see that filing in the US? He said a few days a few days ago. So will it be by the end of the week or are you targeting next week?

STANLEY ERCK: It's probably going to be next week but I'm sticking with the claim that we'll be doing this by the end of this year. The last of the paperwork is going in.

BRIAN SOZZI: Stan, we've seen the market react very favorably to this news, sending your stock higher. Just from if someone is holding your stock here, how big a financial tailwind is news like this to your business?

STANLEY ERCK: Well, I think it's an accumulation of finance-- of news. We started out, the first thing you show is that you saw very good efficacy profile, which we did. I think our efficacy data from a couple of phase III trials showed that both against the ancestral strain is the Wuhan strain, it's now called, and the alpha beta variants, we've got efficacy data in the 90, 96, 100% against moderate and severe disease. So that's excellent data that moves stock.

Safety data has to be there. Everybody knows something a little more subtle, but very important is that we can get our vaccine distributed globally at refrigerated temperatures. It's good for storage, long-term storage at refrigerated temperatures and room temperature, for that matter. And one after the other, now that we're showing the omicron.

So it's just accumulation of data. And I think we're going to end up with a best in class vaccine. We haven't been in the marketplace yet and we're just starting to get there. In 2022 I think you'll see a lot of conversion to our vaccine in all countries, including the US.

ANJALEE KHEMLANI: I know definitely we've talked about that, especially as the CDC just preferred away from Johnson & Johnson AstraZeneca, which have sort of been the bulk of global distribution. So it certainly opens the market for you there. I want to pivot though to the adolescents really quickly. I know that you had the data as well in the news yesterday. So with this sort of shift in what is preferred generally speaking, as well as sort of the pressure on the mRNA vaccines, what do you see in terms of continuing trials for the adolescent group and whether or not that market really is there?

STANLEY ERCK: Well, the market is there. I mean, kids have to get vaccinated. We've got a ways to go to turn this pandemic off, or at least turn it into a flu like epidemic where you have annual seasonal vaccination. And that's got to include kids. And we announced some of the data in kids. It showed what you would expect, is they get a better immune response, I think of something like two to four-fold better response than in older adults. And we'll keep marching down the age group sp that we get all kids vaccinated.

JULIE HYMAN: Fingers crossed. Stan, thanks for being with us. Stanley Erck is the CEO of Novavax and our Anjalee Khemlani as well. Happy holidays, Stan. Be well.