Novavax CEO and President Stanley Erck joined Yahoo Finance Live to break down Novavax’s COVID-19 vaccine and how it will help the United States’ response to the pandemic and virus.
Video transcription
ADAM SHAPIRO: Lots of news about vaccine effectiveness. We talk about it with Novavax CEO Stanley Erck, as well as Anjalee Khemlani, who is the correspondent here at Yahoo Finance. Very fast, Mr Erck, good luck, 89.3% efficiency in the UK. What else can you tell us?
STANLEY ERCK: Well, that’s actually an interesting number. We are currently conducting three efficiency tests, one in South Africa, one in the United Kingdom and the third in the USA. And in the UK, the number is actually a blip. But actually we brought in 15,000 people. And during the trial it appears – I do not know if you have heard of the term “variant” – but a variant came from the United Kingdom. And so half of our people became infected by a variant and the other half became infected by the original Wuhan virus. And we were able to break out the numbers after we wrote the press release. And so it turns out that compared to the standard prototype vaccine we all know and love, it had a 96% reduction efficacy rate. And against this variant it was 86.
So, of course, it was extraordinary with the Wuhan, but what we learned is that the variants matter. And so you got a slight decrease in vaccine efficacy with the variant. And then in South Africa, we faced another variant called the triple mutation variant – everyone is worried that it is more resistant to vaccination. It turns out it was. And it turns out that in the group – the largest part of the group, which was an HIV-negative group – 92% of the group – we had an effective vaccination of 60%. So it’s reduced, but it’s still working. And so we learn a lot about what is currently happening with the coronavirus.
ANJALEE KHEMLANI: Absolutely, and Stan, thank you very much for joining, because if we look at it, of course, with the variants involved – B117 from the UK, B1351 in South Africa and P1 from Brazil, we know that all of this is now in the US . What are you going to do to perhaps prepare yourself for them growing in the US as tribes?
STANLEY ERCK: That’s not what we’re going to do. This is what we do. Now we have started and we have made the South African variant, and it is in our research laboratory. And we enlarge it to this scale. And then we’ll finally build it up to a much bigger barrel. But we got it right, and we’re going to purify the protein and help it with our tool and start animal studies quickly.
We hope to do with the variant human studies. And we’ll consider it a vaccine with just the variant. We look at the vaccine with the variant and our current vaccine and make it a dual vaccine, which our platform allows us to do so. And so we’ll look at it in people starting next term, I think.
ANJALEE KHEMLANI: And if you look at it from the start-up and production point of view, you obviously have to prepare a lot. Can you tell us a little more about the timeline for the US – a clinical trial as well as whether you plan to work with someone. You know, this time last year you were in a very different place than a business, but you definitely had to grow a lot. What are we looking at then in terms of partnerships?
STANLEY ERCK: Well, the one thing we need is the manufacturing capability. Today we had zero a year ago. And today we have put together eight different large-scale commercial production plants, one that we bought, or one that we have with other companies, or a contract production organization.
So we have it in India, in Europe, in the USA and in Asia. And so we now have the capability I refer to as the beauty of our platform. How we make our vaccine is that we grow proteins in barrels and purify them, and that they form particles, and then we take an adjuvant – which is just a chemical solution – we put it in a vial – mix it and put it in a vial. This is your vaccine.
Well, all we have to do with these variants – they are basically the same entity, and we can make it with the same process. So these are not the months of upscaling that we need to do. Instead of making a Wuhan bundle, we can just make a British variety group or a series of South Africa. We can switch it very quickly.
And we’ve heard from the FDA that they are not going to need efficiency. They are probably not going to need efficiency tests, but simply a 400-person called an immunogenicity test, just to show that the immune response you get on the new strain is the same level as you have on the original strain. and then put it in man.
SEANA SMITH: Stan, what do we know about prices? Have you considered it? Where are those conversations?
STANLEY ERCK: That’s– we only got the data yesterday. So we did not invent a pricing strategy. And I do not know. I just do not know what the answer to your question is. I know where – you heard what the price of the COVID vaccines is, and if you have to insert a second antigen, it might be a little more, but I do not know.
ADAM SHAPIRO: What benefits could there be to approaching the FDA for an emergency permit based on the UK data?
STANLEY ERCK: Well, that’s exactly what we’re planning to do. So because the timing – that’s what you’re interested in – we need to complete the UK trial. What we reported on was an interim analysis. And it will probably take another two or three weeks to complete the study and get all the cases we need before filing with the MHRA, the UK FDA. And that package – the same package – will give us to PMA, which is the European equivalent of Canada, and so on.
So we are going to serve at several regulatory agencies, and we will take the same package to the FDA because we will have the package much faster than we will do from the phase 3 trial we are currently doing. The Phase 3 trial we are doing in the United States is 30,000 people. As of today, 16,000 or 17,000 have been recruited. We will complete the 30,000 by the first or second week of February. Then you have to collect cases, which take six weeks. So you look in March to close the US trials and then analyze the data. And we will be submitted to the MHRA before then.
And I think the FDA will be open to this. I think it would have been – if there had been a lot more confidence, given the good data we have from this study. And there will be a lot of enthusiasm to get it through the regulatory process. It is an excellent vaccine.
ANJALEE KHEMLANI: Stan, if I look at it from that perspective, I’m so glad you filed the U.S. trial, because I’d like to know a little bit more about the timeline for it and if you can still roll out the vaccine before it’s done, and what it then does for the trial.
STANLEY ERCK: Well, we will 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 approve and roll out a vaccine until then. So I know what you’re saying, but we’ll be able to get the data out of the trial.
And I expect that would be an ideal situation if we used the UK data to get FDA approval. While we are going through the FDA approval, we are busy with the US trial. And as we roll that product to the US, we remember: there’s an EUA and then there’s a BLA – you know, a formal license. We will use the US data. It’s not for nothing. We will use the US data for the BLA.
SEANA SMITH: Stan, you mentioned earlier the eight large-scale production plans you have underway. I mean, it’s extraordinary because Novavax has never brought a vaccine to market. What do you think are some of the biggest logistical challenges that you think should be addressed, at least in the short term?
STANLEY ERCK: Well, I’m accused of never putting a product on the market, little old Novavax. It turns out – I’ll just make one comment on that – we have an incredible staff of 700 people now, and many of the 700 people have many products to market. So this is not the company. These are the people who bring it to market.
So it’s incredibly complicated. But we’ve been through the complexity over the last year. I think no one has ever tried to get eight plants going at once for biologics, and it’s unprecedented, but we did. All eight to seven of the eight plants currently produce on a commercial scale called GMP materials. These are materials suitable for human consumption. And in January we make up the material and wait for license.
ANJALEE KHEMLANI: And then, Stan, to follow up on that – with the rollout, of course, we saw how difficult it is now to partner with the US government. Are you already working to ensure that the last mile does not break when your vaccine hits the market?
STANLEY ERCK: Yes, that’s a great question. The last mile, however, is not mine. I need to get it from HHS or CDC distribution centers, and my job is to get a vaccine approved, manufactured, packaged and shipped to these distribution centers.