Novavax CEO: We aim to complete the FDA filing for our COVID vaccine this year

Novavax CEO Stanley Erck joins Yahoo Finance's Anjalee Khemlani to discuss the pathway to FDA authorization for its COVID vaccine as well as scaling up its vaccine production.

Video transcript

ANJALEE KHEMLANI: Looking at the vaccine race, which has been going on for some time, we know we've heard of a couple of companies that have already made it to the finish line. But one that is getting closer here in the US is Novavax. And they've already started listing for emergency use authorization globally.

Here to speak with me about that and more is CEO Stanley Erck. Stan, thanks so much for joining us again. Pleasure to have you on. Let's get right to it. World Health Organization, the United Kingdom, and many other countries around the globe. You're finally starting to get those applications in. What can we expect in terms of a timeline?

STANLEY ERCK: Well, we've passed a major milestone, which is to get our first emergency use authorization in Indonesia, the fourth most populous country in the world. So that's a big breakthrough. And we've got seven or eight other regulatory filings in the UK, the European Union, and India and WHO. And so we've got just a ton of activity going on, on the regulatory side. And we're working with the FDA to hopefully get our filings in to them before the end of this calendar year.

ANJALEE KHEMLANI: I'd love to get an update on that. I know that we've talked previously about targeting that end of the year. Is that going to be the full package or the actual filing itself? And can you explain sort of what you anticipate the timeline to be after that?

STANLEY ERCK: Sure. It's-- we don't predict what the regulatory-- or the timing of the regulatory agencies. That's what's not in our control. What we can predict is the timing of our applications. And my guess is, is that following the Indonesia approval or authorization is that we'll start seeing as many as three or four or five EUAs approved in the coming six to eight weeks, and so this year.

And with the FDA, we can't predict until we have a meeting with them. We've asked for a meeting. I suspect that that'll happen very soon. And then we'll have an idea of what that pathway will be. But the hope is to get the complete filing based upon the results of that meeting and complete filing this year, this calendar year. And then, the FDA has to decide how quickly it'll review those data.

ANJALEE KHEMLANI: And of course, great news on Indonesia being the first market that you've actually entered. Looking at the supply that you have on hand, talk to me about, first of all, what's happening on the ground there and how much you expect to be able to distribute if all these other authorizations come in?

STANLEY ERCK: Sure. Yes, so it'll be the-- the distribution will be at the end of this year because we don't have the authorizations yet. So we do expect to be able to ship to Indonesia and perhaps one or two other places, countries, before the end of the year. But the majority of our production is scheduled for started in the first quarter. And we have publicly stated that we scaled up to the level that will be in the 2 plus billion dose range in the calendar year 2022. And that'll start in the first quarter. And so, we're going to go from 0 to a very large scale very quickly.

ANJALEE KHEMLANI: I know that we've heard today that the US government has created a deal with Johnson & Johnson. Largely looking at the global distribution through COVAX and waiving liabilities, do you anticipate being able to do something similar? I know that your vaccine specifically has been viewed as not only efficacious, but also possibly having a stronger safety profile and something that, you know, some individuals who are uncomfortable with M&A are looking forward to having come out.

STANLEY ERCK: Well, that's why we're going as fast as we possibly can. We have probably three things that stand out for us. The efficacy data is very strong, as you point out. The safety data is, I think, we have the most benign safety profile that is out there so far.

And we have another advantage, which is the stability of our product allows us to ship and store product at simple refrigerated temperatures. And so that can get us into parts of the world that are hard to get to. And we plan on targeting the low and middle income countries of the world with our COVAX agreement of 1.1 billion doses, along with our partner, Serum Institute.

ANJALEE KHEMLANI: And also going back to the US and by side by side, you also have that going on. But we know that largely speaking, you had really pivoted to looking at the global market, but also considering the booster market here in the US, with Pfizer being the only company, really, that looks to be able to get authorization by the end of the year possibly for all adults. Do you still see a market for boosters for Novavax here in the US?

STANLEY ERCK: Sure, but, you know, to be honest, we look at this as a global issue. And it's both getting the original first and second dose into as many people in the world as possible, but the booster market is a global issue. And so we expect to be boosted in the United States next year. And we're doing-- we've already completed a boosting study. We're in the middle of others. And so, we expect our authorization to include boosting throughout 2022 and beyond.