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Stanley Erck, CEO of Novavax, joins Yahoo Finance to discuss Novavax revenue, delay submission of emergency Covid vaccine clearance to the FDA until Q4, and global vaccination outlook.
Video transcript
KRISTIN MYERS: Happy to see you again. Now let’s talk about Novavax – the drug company reporting quarterly profits and also announcing that it will delay the emergency use clearance application with the FDA until the fourth quarter. Now let’s take a look at Stanley Erck, CEO of Novavax, and health journalist Anjalee Khemlani.
Stanley, I want to ask you a question about this delay in seeking this emergency FDA approval. This is not the first time that the company has suffered this delay. Why, once again, the delay in the search for this authorization for emergency use?
STANLEY ERCK: Yes, actually that’s an interesting characterization, as the announcement was that we actually made our first regulatory filing in three different countries, which is a major step forward for our business. And we have applied to DCGI, which is the Indian FDA in India, Indonesia, and the Philippines, places where they desperately need our vaccine. And we crossed a major hurdle to get there.
The title of We Delayed Our US Filing is not accurate. What is it, we are going to take longer to deposit than we hoped for several weeks as we are in the process of validating the assays. And because we don’t have control over all the timelines with the outside companies we use to do it, we decided that September was not the most likely date and that it should be October, roughly. to this date. So we didn’t lose – you know, it wasn’t a decision to delay, it was a reflection on the schedule.
And so, it actually has no impact on our ability to market our product globally, which we are in the process of doing. With the deposit we made in India, Indonesia and the Philippines, we paved the way for our first commercial shipment of products to people in low and middle income countries. We are tracking this with a UK deposit. We have a schedule for this in September. And then we think we’re going to follow that up with a multitude of regulatory filings, including the FDA, and Australia, and Canada, and other places. So it’s not as bad as the headlines seem.
ANJALEE KHEMLANI: Stan, nice to have you back– Anjalee here. I’ll be heading to India and UK in a second, but I want to focus on this FDA notice to Novavax. I know part of it was the analytical method, the drug product analysis. And I know early on in our conversations, you talked about developing that manufacturing capability. So, while they suspend manufacturing funding, what are the steps to meet those criteria and restart the whole process?
STANLEY ERCK: It’s a good question. And it wasn’t the FDA that delayed us, we have a middleman, which is what we now call the US government – what used to be called Operation Warp Speed. And they manage … they manage projects on it. And so we are guided by their instructions on when to go to the FDA. It was therefore not the FDA that caused the partial stoppage of funding, not the partial stoppage of work.
What was happening in the Texas facility that we were directed to by Operation Warp Speed a long time ago is that the facility was shut down due to quality issues. They have worked to bring their quality system up to our standards and government standards. There are ongoing inspections. And as soon as we complete these inspections and then go to the FDA for review, it will be up and running again.
ANJALEE KHEMLANI: And then looking into the future of – I know you’re talking about all the different avenues that you’re asking for for emergency use authorization and all the various regulatory bodies that you’re in contact with, knowing that you have largely targeted not just the global market but also here in the United States the boosters market, what do you think of how you might end up being able to assess ahead of time, especially now that you are in able to test with the Delta variants and we’ve seen all these concerns about other vaccines – have you looked at some of these cases and how to fix them right now?
STANLEY ERCK: Well we have. And so there are two concerns. One is that we have to get the world vaccinated. We need to skip the first and second doses and get people vaccinated. And there is a lot to do. For example, in Indonesia, just research the problem in Indonesia right now. It’s horrible.
They have a raging virus spread and they don’t have enough vaccines there. And we have to give them their first vaccination. And this is true in many countries. And even in the United States, we’re trying to get the other 20% vaccinated or whatever. And so our vaccine is perfect for that.
You know, we’ve shown, you know, the effectiveness of 100 – up to 100% effectiveness against the original strain and 90% protection against the different variants. So we know that our vaccine works well in this situation. But we also know, and we showed data yesterday, that we did recall work. We took our people that we vaccinated six months or six to nine months ago in the United States and Australia in our phase I / II trial, and we gave them a six-month booster dose.
And that’s what we announced yesterday, it was the results of this trial that showed that in fact, just like real immune responses and traditional vaccinology, you get vaccinated, you get an increase in response. in antibodies, this antibody response decreases over time. And that’s what happened in ours, that’s what happened in all the studies – Moderna and Pfizer saw the same thing. And you start to decline. And what you want to do is increase that.
And that’s what we’ve done. We took a six month boost. And what we found was that we got a huge uplifting response way above, far above what we got after the first two doses. And that’s classical immunology. This is what happens in pediatric vaccines when we vaccinate our children in two doses and then give them a boost six months or 12 months later. So there is nothing surprising, it’s just that it works as always.
But what we found in addition was that our vaccine boosted the response to the Delta variant four times more than it did after the first two doses, as well as alpha and beta. So we know that our vaccine can be effective as a booster. We know our plan is that, especially next year, as we distribute the vaccine for all the primary vaccines in all the countries that need it, we are also going to have a booster dose – or a booster vaccine that has a really very good, if not the best at least it is very good, and probably the best, set of safety, efficiency and combined with its stability that we can ship at refrigerated temperatures. We are therefore very satisfied with the direction we are taking on this subject.
ANJALEE KHEMLANI: Right. And I know you talked about the different technologies you use to achieve this, but now you are targeting India, precisely, where the need is greatest right now in the world. So, give us the timeline for that. Do you expect to release it on the market very soon there?
STANLEY ERCK: Yes. You know, so every regulator goes … we did what we could where we deposited. And so what we can’t predict is what timeframe the regulatory agency is going to take to review the data. And so the good news is we’ve been giving them data for months now – you know, with they’ve got all the clinical efficacy and safety data, and that’s the latest data we’ve now submitted. , which are the manufacturing data.
And so we’ll see how long it will take them to do that. I think India, the regulatory agency, is very sensitive to what we’ve given them. I don’t know if this is their schedule. We have submitted now in August – whether it’s going to be earlier, or September, or October. But I think it’s going to be relatively quick.
And I don’t know … I think it is possible that Indonesia and the Philippines are moving even faster because of the great need for vaccine. And we have a product that we can actually ship once the regulatory process is approved.
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