With COVID-19 vaccine in Phase 1 trial, Novavax CEO says goal is to make 1B doses

Biotechnology company Novavax began phase one of its clinical trial for a coronavirus vaccine candidate. Novavax CEO & President Stanley Erck joins Yahoo Finance’s On The Move panel to address the company’s search for a vaccine.

Video Transcript

ADAM SHAPIRO: It was just the other day we were talking about Novavax and its phase I trial of its vaccine. We're expecting results in July and then their move into phase II. But now there's news that the company has purchased a Czech vaccine manufacturer which will allow it to produce up to 1 billion doses a year of the vaccine if-- and we hope it does-- if it works.

To talk more about all of this, let's invite into the program Stanley Erck-- he is Novavax CEO and president-- along with Anjalee Khemlani, our correspondent who covers COVID-19 and coronavirus for us.

This is a big undertaking, isn't it? We know companies are producing vaccine at risk. Will you do that as well?

STANLEY ERCK: We have been. Thank you for inviting me. We have been producing vaccine at risk already. We made the decision a few months ago when we started this program that we would do things in parallel and not in sequence. We recognized that when we showed that the vaccine was safe and had the potential for efficacy in animal models that if we waited until we got phase I human data we would lose six months. We think six months is too important in a pandemic.

So in parallel, we've started to manufacture material. We made what's called GMP material that's suitable for phase I studies. As you noted, we started our phase I trial on Tuesday of this week, and so the clock is ticking. And so we have to keep in parallel manufacturing.

So the vaccine has to be three things. It has to be safe because you're vaccinating healthy people. It has to be effective. You have to get a good immune response. We've crossed both of those hurdles in animals, at least, and now we're doing that in humans. But it has to be scalable. And so we found this facility, which is a fairly unique facility in the world. And it has the capacity, as you just mentioned, to produce perhaps more than a billion doses in 2021.

ANJALEE KHEMLANI: Stanley, it's Anjalee here. I know that you've partnered also with the Serum Institute, which previously owned that same facility. And you've also worked on coronavirus vaccines before. So how does this all pull together in helping your strategy and helping you meet that goal?

STANLEY ERCK: Well, so this is what-- this is what Novavax does. We have a vaccine platform from which we've made vaccines for Respiratory Syncytial Virus, RSV, the biggest cause of hospitalization of children under one. We've just unblinded phase III pivotal data for our flu vaccine. And everybody knows we need to get a better flu vaccine, and I think we have one.

And we've made vaccines for several emerging infectious diseases, including, as you mentioned, two coronavirus vaccines over the last five years, an Ebola vaccine, and pandemic-flu vaccines. And so this is right down our alley. This is what we do. This is what the platform does. We've shown safety in thousands of people, and this is just an extension of everything we've been doing for the past decade.

ADAM SHAPIRO: Mr. Erck, it would be helpful for a lot of us if we understood what effective truly means. Is it 100% of the people who get a vaccine are 100% protected? Is it 70%? What is that number?

STANLEY ERCK: It's a great question, and it is-- there are many vaccines in development. And we all-- I think the industry is rooting for one another. We need more than one vaccine because the demand is going to be--

ADAM SHAPIRO: Given-- I'm sorry to interrupt you, but we have vaccines for decades. What usually-- I mean so that we all understand, for instance, polio. Is the polio vaccine 80% effective? What is this number we should all be aiming for?

STANLEY ERCK: Many of the standard childhood vaccines have vaccine efficacy above 90%. And so they're usually very, very high. But there are many vaccines-- for instance, flu, a respiratory vaccine. Like coronavirus, it's a respiratory vaccine, and it ranges from year to year, depending upon which strain of flu comes around, the effectiveness of flu ranges anywhere from 10% to 50% or 60%, but that's better than zero. And so it's good. If you had a vaccine that worked 40% or 50% of the time versus nothing, you've got something that's really important.

So we don't know with coronavirus what's going to be effective or how effective a vaccine's going to be. There will different levels of effectiveness with different vaccine. Vaccines are going to be developed, and my guess is they'll range anywhere from 30% or 40% or 50%, and we hope that we can get above 70% or 80% or 90%. But, you know, we have to see the data. So there's a range.

JULIE HYMAN: Stan, it's Julie here. During this vaccine discussion, some people have treated it as sort of a panacea, that when we get the vaccine-- even, you know, say it's next year, for example-- that you're going to flip a switch and everything's going to be OK again. But, in fact, it's going to take-- it's going to take time to vaccinate people. Some people are going to be reluctant to get it. How long do you think it's actually going to take? Let's presume we get a successful vaccine from someone, you included, next year. What is then the time to actual herd immunity?

STANLEY ERCK: Well it's a question actually for an epidemiologist, not for me. My goal, my role is to make sure that we have a vaccine that is as high on the effectiveness ladder as we can possibly get it-- and higher means more of a panacea it's going to be-- and then to be able to make enough doses for everybody to potentially get a vaccine. So how long that takes for it to be actually distributed globally is an answer for the Tony Fauci's of the world.

ANJALEE KHEMLANI: Stanley, Anjalee here. We'll make sure to ask Dr. Fauci as well. So when you're looking at making the doses and providing that globally, I know that you clearly have that as part of the strategy with opening up that plant in the Czech Republic and looking at other-- and the partnerships. But what is the realistic timeline of getting that production to the point where we can have it available for, say, a regular person? And what is the timeline, realistically, for getting the first batch of doses out there?

STANLEY ERCK: Right. Well, so we have-- we have production going on in the United States right now. That production is intended to have vaccine available in this calendar year. And so we-- so there are a couple steps. We have to make the antigen, the protein that comprises the vaccine. We make an adjuvant, which is a chemical stimulant. On top of that, they have to be formulated, and then they have to be what's called fill and finish. They have to be packaged into a vial.

And those are all key steps. I think realistically we can make-- our goal is to make as many as 100 million doses by the end of this year, that by the time they're actually filled and finished and ready for warehouse distribution would probably be first quarter of next year. And our goal is to have the Czech Republic facility up and running by October of this year so that we could be-- we could be at a run rate of 100 million doses a month by January of next year. And then it takes-- you know, then it will take the 30 or 60 days to get it released and packaged for distribution in large scale.

And, of course, what's going to happen, or what everybody predicts is going to happen is that it will be used first-- there's going to be a priority, and it's going to use first by front-line health-care workers, people at high risk of-- have comorbidities and have higher risk of disease before it gets to the general population. And how long that's going to take is-- again, our goal is to make the product, and we have partnerships with people who distribute the product.

ANJALEE KHEMLANI: Right, absolutely. And I'm wondering if you've run into-- you know, there's been concerns about with this global race, this global-access question, concerns about nationalism and how politics are coming into play. What has been your experience, and are you running into any of that?

STANLEY ERCK: Well, not yet. I worry about it. So we have two big components, the adjuvant and the antigen. We are currently making both of those in Europe. We will be making those this year, both of those, in the US. We have discussions in China. We have discussions in India. So we're trying to make it in as many different places so that we are not-- we won't be contained by border closings or constrained, I guess.

ADAM SHAPIRO: All right, Stanley Erck is the CEO and president of Novavax, and thank you so much for answering these questions in a way that all of us can understand. I think you're one of the first who's answered that question we've had about efficacy in the last two months, and that's greatly appreciated.

All the best to you, sir. We're counting on you and your team.