Novavax CEO and President Stanley Erck joined Yahoo Finance Live to break down Novavax's COVID-19 vaccine and how it'll help the United States' response to the pandemic and virus.
ADAM SHAPIRO: A lot of breaking news regarding vaccine efficacy. We're gonna talk about that with the CEO from Novavax, Stanley Erck, as well as Anjalee Khemlani, who is the correspondent here at Yahoo Finance. Very quickly, Mr. Erck, congratulations, 89.3% efficacy in the UK. What else can you tell us?
STANLEY ERCK: Well, it's actually, it's an interesting number. We're doing three efficacy trials right now, one in South Africa, one in the UK, and the third one in the US. And in the UK, that number is actually a blip. But actually, what we did was we brought in 15,000 people. And during the trial, it turns out-- I don't know if you've heard of the term "variants"-- but a variant came out of the UK. And so half of our people got infected by a variant and the other half got infected by the original Wuhan virus. And we were able to break out the numbers after we wrote the press release, actually. And so it turns out, against the standard prototype vaccine that we all know and love, we had a 96% reduction efficacy rate. And against this variant, it was 86.
So it was obviously exceptional with the Wuhan, but what we learned is that the variants matter. And so you got a bit of a decrease of vaccine efficacy with the variant. And then in South Africa, we went up against another variant that's called the triple mutation variant, which is thought to be-- everybody worried that it would be more resistant to vaccination. It turns out it was. And it turns out that in the group-- the big part of the group, which was HIV-negative group-- 92% of the group-- we got a 60% vaccine efficacy. So it's reduced, but it still works. And so we're learning a lot about what's happening with the coronavirus right now.
ANJALEE KHEMLANI: Absolutely, and Stan, thanks so much for joining, because, again, looking at that, obviously, with the concerning variants-- B117 out of the UK, B1351 out in South Africa and P1 out of Brazil, we know that all of these are now in the US. What are you gonna be doing in order to maybe prepare for them growing as strains here in the US?
STANLEY ERCK: It's not what we will be doing. It's what we are doing. Now we started and we made the South African variant, and it's in our research lab. And we're growing it up into this scale. And then ultimately, we'll grow it up into a much larger vat. But we've made it, and we're going to purify the protein and marry it up with our adjuvant and start animal studies very quickly.
We hope to get into human studies with the variant. And we'll look at it as a vaccine with just the variant. We'll look at the vaccine with the variant and our current vaccine and make it a bivalent vaccine, which our platform allows us to do it. And so we'll look at it in humans starting next quarter, I think.
ANJALEE KHEMLANI: And looking at it from the ramp-up and production standpoint, obviously, you have to prepare a lot. Can you tell us a little bit more about the timeline for the US-- a clinical trial as well as if you plan to partner with anyone. You know, this time last year, you were in a much different place as a company but definitely have had to grow a lot. So what are we looking at in terms of partnerships?
STANLEY ERCK: Well, the one thing that we need is manufacturing capacity. One year ago today, we had zero. And now today, we've put together eight different large-scale commercial production plants, either ones that we bought or ones we're partnering with other companies or what's called contract manufacturing organizations.
So we've got them in India, in Europe, in the US, and in Asia. And so we have now the capacity that I refer to as the beauty of our platform. How we make our vaccine is we grow up proteins in vats, and we purify them out, and they form particles, and then we take an adjuvant-- which is just a chemical solution-- we put them in a vial-- mix them and put them in a vial. That's your vaccine.
Well, all we have to do with these variants-- they're basically the same entity, and we can make it using the same process. So it's not the months of scale-up learning that we have to do. We can just, instead of making a Wuhan batch, we can make a UK variant batch or a South Africa variant batch. We very quickly could switch it.
And we've heard from the FDA that they're not gonna require efficacy. They're probably not gonna require efficacy trials, but simply a, you know, a 400-person what's called an immunogenicity trial just to show that the immune response you get to the new strain is the same level that you get to the original strain and then put it into humans.
SEANA SMITH: Stan, what do we know about pricing? Have you considered that? Where do those talks stand?
STANLEY ERCK: It's-- we only got the data yesterday. So we haven't figured out a pricing strategy. And I don't know. I just don't know the answer to your question. I know where-- you've heard what the pricing of the pandemic COVID vaccines are, and if you have to put a second antigen in, it may be a little bit more, but I don't know.
ADAM SHAPIRO: What benefits might there be to perhaps approaching the FDA for an emergency use authorization based upon the UK data?
STANLEY ERCK: Well, that's exactly what we're planning on doing. So because the timing-- this is what you would be interested in-- is we have to finish the UK trial. What we reported on was an interim analysis. And it's gonna take probably two or three more weeks to finish the study and get all the cases that we need before we file with the MHRA, which is the UK FDA. And that package-- that same package-- we will give to PMA, which is the European equivalent to Canada, et cetera.
So we're gonna file to multiple regulatory agencies, and including, we'll take the same package to the FDA because we'll have that package much faster than we'll have from the phase 3 trial we're doing right now. The phase 3 trial we're doing in the US is 30,000 people. 16,000 or 17,000 have been recruited as of today. We'll finish the 30,000 by the first or second week of February. Then you have to collect cases, which takes six weeks. So you're looking at way off in March to get the US trials closed and then analyze the data. And we will be filing with the MHRA before then.
And I think the FDA will be open to this. I think it would have been-- had lots more confidence given the great data we have from this study. And there's gonna be a lot of enthusiasm to get this through the regulatory process. This is a great vaccine.
ANJALEE KHEMLANI: Stan, looking at it from that perspective, I'm so glad you brought up the US trial, because I would love to know a little bit more about the timeline for that and if you could still end up rolling out the vaccine before it's complete, and what that does then for the trial.
STANLEY ERCK: Well, we would not be able to roll out the vaccine before the trial, because the trial will be over. It will be over by March. We will not be able to get a vaccine approved and rolled out before then. So I know what you're saying, but we'll be able to get the data from the trial.
And I anticipate an ideal situation would be is if we used the UK data to get FDA approval. While we're going through the process of FDA approval, we finish the US trial. And while we're rolling that product to the US, we-- now, remember, there's an EUA and then there's a BLA-- you know, a formal license. We'll use the US data. It's not for naught. We'll use the US data for the BLA.
SEANA SMITH: Stan, you mentioned earlier the eight large-scale production plans that you have underway. I mean, this is extraordinary, because Novavax has never before brought a vaccine to the market. What do you foresee as being some of the biggest logistical challenges that you think need to be addressed, at least in the short term?
STANLEY ERCK: Well, I've been accused of never having brought a product to market before, little old Novavax. It turns out-- I'll just make one comment to that-- we have an incredible staff of now 700 people, and many of those 700 people many products to market. So it's not the company. It's the people that bring it to market.
So that point aside, it is incredibly complex. But we've been through the complexity for the last year. I don't think anybody's ever tried to get eight plants up and running at the same time for biologic, and it's unprecedented, but we've done it. All eight-- seven of the eight plants right now are producing at commercial scale what's called GMP material. That's material that's suitable for human use. And so January, we're making and stockpiling that material waiting for licensure.
ANJALEE KHEMLANI: And then, Stan, to follow up on that-- with the rollouts, of course, we've seen how troublesome that is right now with the partnership with the US government. Are you already working on ensuring that that last mile doesn't break down when your vaccine comes to the market?
STANLEY ERCK: Yeah, that's a great question. The last mile is not mine, though. I have to get it to HHS or CDC distribution centers, and my job is to get a vaccine approved, made, packaged, and shipped to these distribution centers.