Novavax CEO: End of U.S. vaccine trial could come 'earlier than we thought'

Novavax CEO Stanley Erck joins Yahoo Finance's Kristin Myers and Anjalee Khemlani to break down the latest on the company's COVID-19 vaccine trials.

Video Transcript

KRISTIN MYERS: But another vaccine is going to be available to fill that void left behind by that AstraZeneca vaccine, and that's from Novavax. It's found to be roughly 90% effective against the virus, and it also works against that UK variant of the virus. So we're joined now by Novavax CEO Stanley Erck, as well as Yahoo Finance's Anjalee Khemlani for this conversation.

So Stanley, I want to start with what happened with AstraZeneca. You've watched their roll-out, and it's been bumpy, to say the least. I'm wondering if you have concerns about the rollout of Novavax's vaccine.

STANLEY ERCK: Well, it's a good question. This just shows you that this is not an easy process. And it's got a lot of good companies trying to not only develop a vaccine, but then get it out. We're at the stage right now where we've gotten some really important clinical data that shows our vaccine, as you pointed out, works well, 96% efficacy against the original Wuhan strain, 86% against the UK variant. And that's important.

And so that is an important science. So we have to assemble all of the data from the trial, safety, efficacy, and all the manufacturing data that goes along with it to submit it to the UK regulatory agency. And that'll take a few more weeks. And so, hopefully, we will be able to have a relatively smooth rollout.

ANJALEE KHEMLANI: Stan, Anjalee here. Really good to have you back on. And to discuss, after you released the final data of phase three, looking forward to that rollout in the UK. Meanwhile, can you give us an update on sort of what you've thought of or what's happening with the doses on hand? You've clearly been you manufacturing ahead of time. Where do you stand right now with doses ready to go?

STANLEY ERCK: Well, you're right. We've started filling the doses that we make in the United States and elsewhere. And that starts a timetable. There's dating, six months or so of dating. And our expectation is, is that we will get licensed. And where we have a license, we'll be able to use those doses, whether it's in the UK first, which we expect it will be. But then where else? I think many regulatory agencies are going to be inclined to follow the NHRA very shortly so the doses could go to Canada or Australia or other places, where we have agreements, and ultimately in the US.

KRISTIN MYERS: So, Stan, I'm wondering. I know you're talking about how you've already started that production of the vaccine. But are there plans for Novavax to really ramp up that production to fill that void that's being left behind from the AstraZeneca vaccine, as more and more countries decide to suspend their use of that vaccine?

STANLEY ERCK: Yeah, excuse me. Absolutely. We have plants in eight different locations in seven countries and a partnership with a couple of important partners, Serum Institute of India, for one, the world's largest vaccine manufacturer. And I think we've said before, our expectation is, is that we will scale up between now, which is March. And by the end of the summer, we should be at an annual rate of over 150 million doses a month.

ANJALEE KHEMLANI: Stan, on that note, I know that you were talking about these partnerships and getting ready to roll out once you get that authorization with some partners that are willing to use that data. I know the discussions have been ongoing with the FDA. Any indication about whether or not they, too, will jump on board or whether or not they're still waiting for that phase three trial in the US?

STANLEY ERCK: Well, it's clear that they will look at-- they'll use the UK and South Africa data as part of their decision process. What's not clear is whether we also need the US data. But I think now at this point, the US trial has gone so well. We were able to recruit 30,000 people in a very short period of time, a record breaking period of time. And now we're counting what's called counting cases so that we can get enough cases before we unblind. And I think we're more optimistic that the unblinding process is going to occur earlier than we had originally thought. So those data may be available without a terrible amount of delay in FDA.

KRISTIN MYERS: Now as I mentioned, Stan, the Novavax vaccine is effective against that UK variant. And a lot of folks have been incredibly concerned about all of these variants, all of these mutations and strains. Are you guys anticipating that you'll have to further tweak your vaccine, or are you planning on creating booster shots possibly in order to fight against some of those variants and some of those other strains that we are seeing out there?

STANLEY ERCK: Well, the answer is sort of yes to both of your questions. Since the UK variant works so well, and it is the variant that is moving most rapidly into the United States, our vaccine should work quite well against that. But in the meantime and, you know, in parallel, we've, of course, got a variation of the South African variant. And we are testing that in animal studies. Now we expect to test it in humans.

It shouldn't be a very long process because I think the FDA and all regulatory agencies will see it as merely a strain change, not a new vaccine that requires all of the efficacy trials. It merely has to show that you can get an immune response that's equivalent to what our current vaccine is. So that changeover process should happen in the early fall.

ANJALEE KHEMLANI: Stan, I want to pivot back to manufacturing for a quick second. I know that, you know, with looking at what has really happened globally, we're seeing such different stories, some issues popping up in some plans, the US government sort of stepping in, in some cases, to help out, and then some partnerships globally that you yourself have with some makers. So, walk us through what that's been like. Where have the hurdles been for Novavax right now? And what have you been able to sort of iron out?

STANLEY ERCK: Well, you know, we all-- and when I say we all, the industry are all trying to scale up very large scale, unprecedented scale across the globe. And some of our processes used the same raw materials. So you've got media that grows ourselves. And you've got things that sound simple like filters that are very short supply that everybody uses the same filter, and it takes time to scale up filter production. There's just a variety of these things that are in short supply.

So what we have to do is, if you have eight plants, you can't have one plant have six or 12 months' worth of inventory, which they would normally keep. You have to start-- do just in time inventory that we're doing. I think all the industry is using techniques like that to be able to keep their plants from shutting down. It's touch and go. And it's not all solved yet, but that's what everybody's doing.

KRISTIN MYERS: Now I hear what you're saying about some of the difficulties really in ramping up all of this production of the vaccine. Now we have an incredibly ambitious timeline here in the United States. Biden essentially ordering all states to make the vaccine eligible for all adults by the beginning of May. He's already indicated Independence Day holiday as a time when Americans will be able to at least gather in small groups.

Now we know that globally, when it comes to vaccine distribution, it has not been as fast, generally speaking. Are you hearing from other countries how they're also trying to push up deadlines to reach herd immunity in their countries? And if so, is there a concern for you that there will be a strain, at least, on the manufacturing line and that you guys won't be able to meet some of those deadlines?

STANLEY ERCK: We don't see the day anytime soon where there's not going to be a strain on our manufacturing capacity. We hear from the global leaders of the countries, and not just in US and Europe, but across the globe in low and middle income countries. And we partnered so that we can address all of those countries at the same time. So it's equal access across the globe. And to do that, we need to have our plants running at full speed for quite some time.

KRISTIN MYERS: Stan, I want to lastly ask you about the safety of the vaccine and I kind of just want to pivot back to what we've been seeing going on with AstraZeneca. I think we already have a lot of folks that have so much vaccine hesitancy, even just here at home in the United States. What are you doing to really reassure folks that once they take your vaccine, that they're not going to be experiencing further medical complications?

STANLEY ERCK: Yeah, good question. So we in the vaccine industry deal with a product where safety has always come first. The reason for that is, is that in the drug industry, when you're treating life threatening diseases, cancer, et cetera, and you've got drugs that have complicated side effects, if it works, the side effects you can live with.

In a vaccine, you're giving it to billions of people potentially, millions of people and billions of people who are completely healthy. And so, you have to have a much different safety profile. So what we do is, we collect every possible types of safety data during the vaccination process. And we follow people for up to a couple of years. And so, that's a way to give people comfort that the vaccine is going to be safe.

Another way is education. You know, this pandemic is turning into a big education process on vaccines themselves. And the industry is trying to try to put together communications from experts in all kinds of fields to discuss the issues about why people are hesitant and whether they should be or not. So there's a communication issue as well.

KRISTIN MYERS: All right, Novavax CEO Stanley Erck, Yahoo Finance's Anjalee, Khemlani, thanks to you both-- thanks so much to you both for joining us for this conversation.