Novavax CEO and President Stanley Erck joined Yahoo Finance Live to review Novavax’s COVID-19 vaccine and how it will help the United States respond to the pandemic and the virus.
Video transcription
ADAM SHAPIRO: Lots of breaking news about the vaccine’s effectiveness. We are going to talk about this with Novavax CEO Stanley Erck, and also with Anjalee Khemlani, who is the correspondent here at Yahoo Finance. Very quickly, Mr Erck, congratulations, 89.3% effectiveness in the UK. What else can you tell us?
STANLEY ERCK: Well, actually, it’s an interesting number. We are doing three effectiveness tests now, one in South Africa, one in the UK and the third in the USA. And in the UK, that number is really a speck. But in reality, what we did was bring in 15,000 people. And during the trial, I found out – I don’t know if you’ve heard of the term “variants” – but one variant came out of the UK. And then half of our people were infected with a variant and the other half was infected with the original Wuhan virus. And we were able to separate the numbers after writing the press release, actually. And so it was, against the standard vaccine prototype that we all know and love, we had a 96% reduction in effectiveness rate. And against that variant, it was 86.
So it was obviously exceptional with Wuhan, but what we’ve learned is that variants matter. And then you had a small reduction in the effectiveness of the vaccine with the variant. And then, in South Africa, we face another variant called the triple mutation variant, which is thought to be – everyone feared it would be more resistant to vaccination. It turns out it was. And it turns out that in the group – the large part of the group, which was HIV negative – 92% of the group – we obtained 60% effectiveness of the vaccine. So it’s reduced, but it still works. And we’re learning a lot about what’s going on with the coronavirus now.
ANJALEE KHEMLANI: Certainly, and Stan, thank you very much for joining, because again, looking at this, obviously, with the worrying variants – B117 from the UK, B1351 from South Africa and P1 from Brazil, we know that all of these are now in the USA . What are you going to do to perhaps prepare for them to grow as strains here in the USA?
STANLEY ERCK: It is not what we will be doing. That’s what we’re doing. Now we started and made the South African variant, and it is in our research laboratory. And we are growing on that scale. And then, in the end, we’re going to grow and become a much bigger tank. But we did and we are going to purify the protein and marry it with our adjuvant and start animal studies very quickly.
We hope to enter human studies with the variant. And let’s look at this as a vaccine with just the variant. Let’s 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 then we’re going to look at that in humans starting next quarter, I think.
ANJALEE KHEMLANI: And from the point of view of the ramp-up and the production, obviously, you have to prepare a lot. You can tell us a little more about the schedule for the US – a clinical trial, as well as whether you plan to partner with someone. You know, last year, you were in a very different place as a company, but you definitely had to grow a lot. So, what are we seeing in terms of partnerships?
STANLEY ERCK: Well, the only thing we need is production capacity. Today, a year ago, we had zero. And now, we’ve brought together eight different large-scale commercial production plants, whether those we buy or those we’re partnering with other companies or what’s called contract manufacturing organizations.
So, we have them in India, Europe, the United States and Asia. And now we have the capability that I refer to as the beauty of our platform. The way we make our vaccine is that we develop proteins in vats, and purify them, and they form particles, and then we take an adjuvant – which is just a chemical solution – we put it in a vial – we mix it and we 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 do that using the same process. Therefore, it is not the months of extended learning that we have to do. We can just, instead of making a Wuhan batch, we can make a variant batch from the UK or a variant batch from South Africa. We could change it very quickly.
And we heard from the FDA that they will not require effectiveness. They probably won’t require effectiveness tests, but simply one, you know, an immunogenicity test with 400 people, just to show that the immune response you get for the new strain is the same level you get for the original strain and then put it on humans.
SEANA SMITH: Stan, what do we know about pricing? Have you considered this? Where are these conversations?
STANLEY ERCK: Yeah– we only received the data yesterday. Therefore, we have not discovered a pricing strategy. And I do not know. I just don’t know the answer to your question. I know where– you heard what the price of the COVID pandemic vaccines is, and if you have to put in a second antigen, it might be a little bit more, but I don’t know.
ADAM SHAPIRO: What are the benefits of perhaps approaching the FDA for an emergency use authorization based on UK data?
STANLEY ERCK: Well, that is exactly what we are planning to do. So, because the moment – that’s what you’d be interested in – is that we have to finish the test in the UK. What we reported was a provisional analysis. And it will probably take another two or three weeks to finish the study and get all the cases we need before we go to MHRA, which is the UK’s FDA. And this package – the same package – we will give to the WFP, which is Canada’s European equivalent, etc.
So, we are going to send a file to several regulatory agencies and, including, we are going to take the same package to the FDA because we will have this package much faster than we will have in the phase 3 test we are doing now. The phase 3 test we are doing in the United States has 30,000 people. 16,000 or 17,000 have been recruited to date. We will finish 30,000 in the first or second week of February. Then you have to collect the boxes, which takes six weeks. So, in March, you are thinking of ending testing in the United States and then analyzing the data. And we will be filing the lawsuit with the MHRA before that.
And I think the FDA will be open to that. I think it would have been – if we had much more confidence, given the excellent data we have from this study. And there will be a lot of enthusiasm to do this through the regulatory process. This is a great vaccine.
ANJALEE KHEMLANI: Stan, looking at it from that perspective, I’m so glad you mentioned the study in the United States, because I would love to know a little more about the timeline for that and if you could still end up launching the vaccine before it is completed, and what it means for the trial.
STANLEY ERCK: Well, we couldn’t launch the vaccine before the trial, because the trial will be over. It will end in March. We will not be able to approve and launch a vaccine before that. So, I know what you’re saying, but we can get the test data.
And I predict that an ideal situation would be if we used the UK data to get FDA approval. While we are going through the FDA approval process, we have completed testing in the United States. And while we’re launching this product to the US, we – now, remember, there’s a USA and then there’s a BLA – you know, a formal license. We will use US data. It is not in vain. We will use US data for the BLA.
SEANA SMITH: Stan, you mentioned earlier the eight large-scale production plans that you have in progress. I mean, this is extraordinary, because Novavax has never before brought a vaccine to the market. What do you see as some of the biggest logistical challenges that you think need to be solved, at least in the short term?
STANLEY ERCK: Well, I’ve been accused of never having launched a product on the market before, old man Novavax. It turns out – I’ll just comment on that – we have an incredible team of 700 people now, and many of those 700 people have many products for the market. So it’s not the company. It is the people who put it on the market.
That point aside, it’s incredibly complex. But we went through that complexity last year. I don’t think anyone has ever tried to put eight plants into operation at the same time for biological purposes, and this is unprecedented, but we did it. All eight – seven of the eight factories are currently producing on a commercial scale what is called GMP material. It is a material suitable for human use. And then, in January, we are making and stocking this material awaiting licensing.
ANJALEE KHEMLANI: And then, Stan, to continue this – with the releases, of course, we’ve seen how problematic this is now with the partnership with the U.S. government. Are you already working to ensure that the last kilometer is not damaged when your vaccine hits the market?
STANLEY ERCK: Yes, that is a great question. The last mile is not mine, however. I have to send it to the HHS or CDC distribution centers and my job is to get a vaccine approved, manufactured, packaged and sent to those distribution centers.