CEO of Novavax on the COVID-19 virus

Novavax CEO and Chairman Stanley Erck has joined Yahoo Finance Live to break down Novavax’s COVID-19 vaccine and how it will contribute to the United States’ response to the pandemic and virus.

Video transcript

ADAM SHAPIRO: Lots of latest news regarding the effectiveness of vaccines. We’ll talk about it with Novavax CEO Stanley Erck, as well as Anjalee Khemlani, who is the correspondent here at Yahoo Finance. Very quickly, Mr Erck, congratulations, 89.3% efficiency in the UK. What else can you tell us?

STANLEY ERCK: Well, that’s actually, it’s an interesting number. We are currently conducting three efficacy trials, one in South Africa, one in the UK and the third in the US. And in the UK that figure is actually a failure. But in reality, 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 with some variant and the other half got infected with the original Wuhan virus. And we were able to split the numbers after writing the press release, actually. And it turns out that compared to the standard vaccine prototype 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 Wuhan, but what we learned is that variants matter. And so, you reduced the effectiveness of the vaccine a bit with the variant. And then in South Africa we ran into another variant called the triple mutation, which is believed to be – everyone was worried that it was 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 the HIV negative group – 92% of the group – we got 60% vaccine efficacy. So it’s reduced, but it still works. And so we’re learning a lot about what’s going on with the coronavirus right now.

ANJALEE KHEMLANI: Absolutely, and Stan, thank you very much for participating, because, again, looking at this, obviously, with the variants involved – B117 in UK, B1351 in South Africa and P1 in Brazil, we know that all of these are now in the United States. What are you going to do to maybe prepare for their growth as varieties here in the United States?

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STANLEY ERCK: This is not what we are going to do. This is what we do. Now, we’ve started and we’ve made the South African variant, and it’s in our research lab. And we make it grow to this scale. And then, finally, we’ll turn it into a much bigger tub. But we did, and we’re going to purify the protein and marry it with our adjuvant and start animal studies very quickly.

We hope to get into human studies with the variant. And we’re going to think of it as a vaccine with just the variant. We’re going to look at the vaccine with the variant and our current vaccine and make it a bivalent vaccine, which our platform allows us to do. And so we’re going to be looking at it in humans from the next quarter, I think.

ANJALEE KHEMLANI: And looking at it from a ramp-up and production perspective, there’s obviously a lot to be prepared for. Can you tell us a 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 very different place as a business, but you must have grown a lot. So what are we looking for in terms of partnerships?

STANLEY ERCK: Well, the only thing we need is the manufacturing capacity. A year ago today, we had none. And today we have set up eight different large-scale commercial production plants, whether they are the ones we bought or the ones we collaborate with other companies or what are called contract manufacturing organizations. .

So we have them in India, Europe, the United States and Asia. And so we now have the ability that I call the beauty of our platform. The way we make our vaccine is that we grow proteins in vats, and we purify them, 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 bottle. It’s your vaccine.

Well, all we have to do with these variants – they’re basically the same entity, and we can do it using the same process. So these are not the months of large-scale learning that we need to do. We can just, instead of doing a batch from Wuhan, we can do a batch of UK variants or a batch of variants in South Africa. We could change that very quickly.

And the FDA told us it wouldn’t require efficacy. They probably won’t require efficacy trials, but just a, you know, an immunogenicity trial of 400 people just to show that the immune response you get to the new strain is on the same level as you get. for the original strain. then put it in humans.

SEANA SMITH: Stan, what do we know about the prices? Have you thought about this? Where are these discussions at?

STANLEY ERCK: That’s – we only got the data yesterday. We have therefore not defined a pricing strategy. And I don’t know. I just don’t know the answer to your question. I know where – you heard how much the COVID pandemic vaccines cost, and if you need to put in a second antigen, there may be a few more, but I don’t know.

ADAM SHAPIRO: What advantages could there be in possibly approaching the FDA for an emergency use clearance based on UK data?

STANLEY ERCK: Well that’s exactly what we plan to do. So, because the moment – that’s what you would be interested in – is that we have to finish the trial in the UK. What we reported was an interim analysis. And it’s going to take probably two or three more weeks to complete the study and get all the cases we need before filing with the MHRA, which is the UK FDA. And this package – this same package – we will give to PMA, which is the European equivalent of Canada, et cetera.

So we’re going to file a case with multiple regulatory agencies, and including, we will bring the same package to the FDA because we will have this package much faster than what we will have from the phase 3 trial that we are currently doing. . Our phase 3 trial in the United States has 30,000 people. 16,000 or 17,000 have been recruited to date. We will complete the 30,000 by the first or second week of February. Then you need to collect the cases, which takes six weeks. So in March you plan to close the trials in the United States and then analyze the data. And we will file with the MHRA before that date.

And I think the FDA will be open to that. I think it would have been – if we had a lot more confidence given the great data that we got from this study. And there will be a lot of enthusiasm to get that through the regulatory process. It is an excellent vaccine.

ANJALEE KHEMLANI: Stan, looking at it from that point of view I’m so glad you brought up the US trial because I’d like to know a bit more about the timeline for this and if you could still end up rolling out the vaccine before. let it be finished. , and what that does then for the trial.

STANLEY ERCK: Well, we wouldn’t be able to deploy the vaccine before the trial because the trial will be over. It will be over in March. We will not be able to get a vaccine approved and launched before that date. So I know what you’re saying, but we can get the trial data.

And I predict an ideal situation would be if we used the UK data to get FDA approval. While we go through the FDA approval process, we are finishing the US trial. And while we’re rolling this product in the United States, we – now, remember, there’s an EUA and then there’s a BLA – you know, a formal license. We will use US data. It’s not for nothing. We will use US data for the BLA.

SEANA SMITH: Stan, earlier you mentioned the eight large-scale production plans that you have going on. I mean, it’s amazing, because Novavax has never put a vaccine on the market before. What do you think are 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 putting a product on the market before, little old Novavax. It turns out – I’ll just comment on that – that we now have an incredible staff of 700 people, and a lot of those 700 people have many products in the market. So it is not the company. These are the people who market it.

So that point aside, it’s incredibly complex. But we have been going through complexity for a year. I don’t think anyone has ever tried to get eight factories up and running at the same time for organic products, and it’s unprecedented, but we have. Currently, all eight to seven of the eight factories produce what is known as GMP equipment on a commercial scale. It is a material suitable for human use. And so in January, we manufacture and store this material awaiting approval.

ANJALEE KHEMLANI: And then, Stan, to follow up on that – with deployments, of course, we’ve seen how awkward it is right now with the partnership with the US government. Are you already working to make sure that last mile doesn’t break down when your vaccine hits the market?

STANLEY ERCK: Yeah, that’s a great question. The last mile is not mine, however. I have to get it to the HHS or CDC distribution centers, and my job is to have a vaccine approved, manufactured, packaged, and shipped to those distribution centers.