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Novavax files first COVID-19 vaccine authorization in UK

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Novavax CEO Stanley Erck joins Yahoo Finance to discuss the company's filing for vaccine authorization in the UK, plans to seek approval from the FDA, and how supply chain disruption has affected the ramp-up of vaccine production.

Video Transcript

- Novavax is out news on the COVID-19 vaccine front. Yahoo Finance senior health care reporter Anjalee Khemlani talked exclusively with the company's CEO, Stanley Erck.

ANJALEE KHEMLANI: Novavax has exciting news-- it is applying for a conditional use authorization in the UK, the first filing ever for the company's COVID-19 vaccine. Joining me to talk about all of that and more is Stanley Erck, CEO of Novavax.

STANLEY ERCK: Thanks for having me on. We are-- we reached a very big milestone for the company, and hopefully for global health, by preparing a package of-- a complete package that is going to be filed with the UK today. And it represents just an enormous amount of work, particularly on the last remaining manufacturing data that we put together. And it allows us to prepare for not only this filing, but also for global filings with various regulatory agencies in Europe and Australia and Canada and other places, and the US. And so this is a-- it's a big day for the company.

ANJALEE KHEMLANI: Very exciting. And of course, the schedule of when that goes forward is-- we'll know in some time. Meanwhile, let's pivot to the US, where I just want to know the updated timeline for that. Do you still anticipate filing with the FDA before the end of this year?

STANLEY ERCK: We do. In fact, we've harmonized all of our-- part of the problem, we've been a very complex company because we're manufacturing in seven or eight different countries, and you have to harmonize all of the processes. And so we have been able to do that. And so the filings with the manufacturing data will be harmonized in the US, and similarly to what we're filing today with the MHRA. So we stick to that goal of filing in the US this year.

ANJALEE KHEMLANI: Great. OK. So we'll follow up on that for sure. But meanwhile, let's talk about how this moves forward. Obviously, we've been waiting to hear from the company about what your plans are in terms of rolling out the-- a ramp-up of production, as well. Earlier on in the year, we had a conversation about how supply constraints were an issue. And has that cleared up? And what is left now to move forward with production of doses?

STANLEY ERCK: It is. Well, the supply chain issue has cleared up a lot compared to what it was 6 and 12 months ago. So it's never perfect, but it's much, much better than it was. And so we are actually manufacturing product that can be used in humans in all of our plants now, and putting it in stockpile. And so we're doing that in Europe, in our Czech Republic site, to a large degree in Pune, in India, with our partnership with Serum Institute, and globally with-- so we're building up inventory now in anticipation of getting regulatory approvals. And when we get regulatory approvals, we'll be able to ship product.

ANJALEE KHEMLANI: So you're-- and all of that that you just mentioned is the manufacturing that's going to go into the doses for delivery in Europe, and as well as the UK, once you get all of that approved. Tell-- talk to me about the conversations with the Serum Institute, because that is something that I think the entire world was watching. You know, last time-- last year around this time, it was certainly a different landscape that we were looking at, and Serum Institute was supposed to be sort of the heavy-- heavyweight of the world in providing doses. But the Delta surge seemed to have disrupt that, and they had to pivot to domestic distribution. So are they in play right now to be able to support global distribution for Novavax?

STANLEY ERCK: They are. And so, you know, the strategy-- well, now well over a year ago, we knew this would be a global problem and it needed a global solution. We were a small biotech company, and we needed to find a partner. We couldn't possibly have figured out how to distribute and get through regulatory processes in all of the low and middle income parts of the world. And that's what Serum Institute does. You know, they distribute vaccines to 2/3 of the world's children every year. And so they're really experts at that.

So we partnered with them. And that partnership has really paid off. They've built capacity such that we can have as much as 200 million doses a month being produced starting in January. And we're ramping up to that level right now. And you know, and to Serum's credit, speaking of India, Serum has made-- I think they just announced I think this week that they shipped their one billionth dose of vaccine to India. And so they're making AstraZeneca's vaccine for India, and now they're shifting their production to Novavax.

ANJALEE KHEMLANI: That's great. And I'm sure we're going to hear more about the global distribution. Do you have ideas about working with COVAX, or do you feel like bilateral agreements are the better option?

STANLEY ERCK: Well, the answer is yes, both. So we did announce earlier this year that we and Serum together pledged to provide COVAX with 1.1 billion doses. And so we are-- much of our early production is going to go to low and middle income countries through COVAX. And I think that's going to be a big help to the part of the world that's been lagging in getting supplies. So-- but we also have important APAs, advance purchase agreements in Canada and Australia and a few other places, as well, so.

ANJALEE KHEMLANI: Great. OK. One of the other things I know that we have to talk about is what-- the report that came out in the past week that talked about the setbacks that you're facing here in the US. Can you clarify and give us an update on what specifically has been an issue? Because I know there have been multiple reasons along the way why you've had to delay the EUA filing. And the report talked about impurity levels. Can you give us some clarity?

STANLEY ERCK: Sure. The report was largely inaccurate. So-- and I think that the only way we can address that and the answer to that report is by doing what we did today. You don't file for emergency use approval if you haven't solved all of your manufacturing issues. And so we feel that the filing today and the other regulatory agencies this week should largely put to bed any of those concerns.

ANJALEE KHEMLANI: Moving forward, looking at the global distribution, that's been a really big concern, obviously. There are other companies that have been under a significant amount of pressure to share their technology and talk about sharing the secret sauce, if you will. And with you coming into the play, coming onto the stage now, do you feel like maybe that will also help put to bed some of these conversations? Or do you support the idea of maybe sharing technology in order to expand what the globe has?

STANLEY ERCK: No, I think that it's just too complicated of a manufacturing process to expect to be able to share the secret sauce, the ingredients, and expect it to have any impact in the next couple of years. It just is impractical to do that. So the way to solve this problem is to do what we and Pfizer and along with Serum and Moderna and all those companies are doing, which is to scale up production as fast as you can. It's much more efficient to do it if you know how to-- if you have the experience. And so that's-- we're going to go from-- we're the new guy on the block, and we're going to be going from zero production to a production of over-- you know, an annual rate of 2 billion doses next year. So that takes care a lot of that issue.

ANJALEE KHEMLANI: And looking forward, as well, it's going to be the first product that you bring to the market. Talk to me about what the plans are after that. Obviously, you have other things in the pipeline, as well. What are some of the things that you see immediately, especially considering we're still going to be dealing with COVID probably within a year from now?

STANLEY ERCK: Absolutely. COVID is not going away. We're going to be dealing with COVID for a long time. And so what do we do about that? Well, we also, before COVID, were developing a flu vaccine, because flu is a-- remains a big problem, a significant problem that is-- we need a better vaccine for. So what-- so we completed actually last year a phase III trial with a flu vaccine that showed that we had potentially the best flu vaccine that can be introduced. And so we decided, since flu is given annually and COVID is likely to be given annually, that we'd put those two together. And we actually started a clinical trial too months-- in early September. We have co-formulated a COVID vaccine and a flu vaccine that could be used on an annual basis, just like the annual flu shot.

ANJALEE KHEMLANI: Great. And so finally, on this COVID vaccine, we're obviously talking about the adult population. What are the plans for younger than 18 years old? Or do you feel like that market is pretty much already saturated?

STANLEY ERCK: Oh, I don't think it's saturated. First of all, we are completing a trial in under-- 12 to 18-year-olds, and we'll also explore it in younger kids. Kids need to get vaccinated globally, and so that's why we're doing it.