Novavax launches COVID-19 vaccine trial

Yahoo Finance’s Brian Sozzi, Alexis Christoforous, and Anjalee Khemlani speak with Novavax R&D President Dr. Gregory Glenn about the company’s coronavirus vaccine candidate.

Video Transcript

ALEXIS CHRISTOFOROUS: Welcome back to "The First Trade." The US reported 600 deaths Sunday. That is actually the fewest since mid-April according to data from Johns Hopkins University. Even so, the US death toll from COVID-19 remains poised to surpass 100,000 this week, with more than 1.6 million cases.

Globally, nearly 350,000 people have died. Total infections have now top 5 and 1/2 million. But this morning, there is renewed hope for a vaccine. US biotech company Novavax began injecting a coronavirus vaccine candidate into 131 volunteers in Australia with hopes of releasing a working vaccine later this year.

Joining us now is the president of R&D at Novavax, Gregory Glenn. We're also joined by Yahoo Finance's Anjalee Khemlani. Good morning, everyone. Doctor, I'm going to start with you. Thanks for making time for us this morning. We're all curious. How is that a human trial going, and when do you hope to have some results that you can share with the public?

GREGORY GLENN: Yeah, this is a big day for us to start human testing. It's going well. You know, people want a vaccine, so obviously, we have to rely on volunteers who are willing to have a vaccine tested. And we're very grateful for that. We expect to see the result in July. And now, normally-- you may know this-- but the development of vaccine could take many years. You go from phase one to phase two to phase three.

This trial is designed to be very compressed. We'll look at the results from this trial and move right into the next phase in August timeframe. And the hope would be that during that second phase that we would determine that the vaccine is working well enough that it could be deployed.

ANJALEE KHEMLANI: Dr. Glenn, Anjalee here. So when you're looking at the manufacturing of this-- I know you're doing it at risk as well, like many others. Is that in part sort of the strategy right now-- looking to having many other candidates out there as well as yours in order to respond to this unprecedented pandemic?

GREGORY GLENN: Yeah, I think, you know, with respect to us, you know, the normal-- again, the normal train of development is, do the early testing in animals. Then go into humans. And once you've established the vaccine's working, then you go into the very expensive process to scale it up and manufacture.

I can't tell you what a big thing it would be to claim you could make a hundred million doses. So to do that, we're doing everything in parallel. So the manufacturing piece is scaling up multiple sites on the assumption that the vaccine is going to work.

And you may have seen-- a few weeks ago, we had a $400 million grant, approximately, given to us by CEPI. And what that does is enable us to do that scale-up of the vaccine in anticipation that there'll be a large demand globally for our vaccine.

BRIAN SOZZI: Doctor, 100 million vaccines-- that's a lot of doses. I understand that you have gotten funding. But how much more funding would you need to reach them the estimates I've seen out there for next year-- if this does go through-- potentially 300 million doses by the end of 2021?

GREGORY GLENN: Yeah, I think the donors are there. You know, I think you can see the US government is there. So as they see progress, they'll be there for the scale-up. So right now, you know, we are, I think, safely operating on those assumptions. You know, the plans for that grant-- the requirements for the grant-- were to demonstrate-- you know, obviously, it's still a plan with some feet on it-- But. To demonstrate to funders that we could actually do that.

And I think our technology very much lends itself to that. So we can use a very small dose of vaccine. And so, therefore, a run and a manufacture goes a long way. So if we're using five micrograms-- and this-- I can just tell you, if you were to drop a drop of our vaccine on the table and let it dry out on a clear glass table, you couldn't see it. It's such a small amount.

So the point being dose very matters. That allows you to scale. So if you took 1,000 liters, and you had to use a very small dose, that can go a long way. So we're quite confident that our vaccine allows dose fair-- needs small doses. And then out of the manufacturing facilities are at the scale that we can make the kinds of doses we're talking about.

It's going to take a monumental effort, and the funders like CEPI know that. The found-- the Gates Foundation is very interested. They want to see global access. So we are fanned out across the world and different sites, you know, either making or planning to make the vaccine. And that's the way to do it-- is to have multiple sites, a dose-sparing technology like we have, a lot of confidence based on our historical experience that we can scale up.

ANJALEE KHEMLANI: What about the type of vaccine itself? It's a different technology. We know that some others are working on a traditional vaccine routes, and others are working on messenger RNA. So what is different about your vaccine?

GREGORY GLENN: Yeah, we're kind of in between, aren't we? We're a recombinant vaccine. So we are able to look at the gene sequence of the virus. We can take the sequence of interest-- the spike protein is the main target for everyone. The spike protein binds to the surface of a cell, kind of like a spacecraft docking.

And that allows the injection of the genetic material of the virus into the host cell. And then your lung cell becomes a virus factory, causing lots of inflammation and disease. Let's block that. If you can make the spike protein as a vaccine, you can make antibodies to the spike protein. You block that process. So we can make the spike protein.

We get the gene. We read the gene off the internet. We can make a full-length spike protein so it looks just like it does in the virus. And we add an adjuvant, which increases the immune response. So I think of all the technologies out there. What I like about what we're doing is, we can actually see the vaccine. We can characterize this exquisitely because the three-dimensional structure is very important.

And then, you know, we can make a lot of it. So we know that-- and we were talking about this before we got on-- the immune responses we are seeing are well in excess of what we see in people who have infection. So I think that that's going to be now the standard we need to show because that-- right now, we don't have evidence in humans that it's going to work.

But if it's as immunogenic-- or it gets an immune response-- as good as a human who's had an infection, we'd have to have a lot of optimism that that's actually going to protect people who have not had any infections obviously-- so prophylactically given in advance can't protect them against the virus.

ALEXIS CHRISTOFOROUS: Doctor, the speed with which your vaccine and others would potentially come to market is wonderful on the one hand and very scary on the other. There are some folks out there who say, you know, how can I trust a vaccine that's been rushed to market like that? What would you say to those people who have those concerns? And is there any way to know what possible side effects of this vaccine might be?

GREGORY GLENN: So I can speak to ours first maybe. So we are a mature technology. We just completed a Phase III flu trial. So that's a very advanced trial and several thousand subjects. So it's-- you know, from the immune standpoint, the vaccine looks the same. It's just a nanoparticle with this protein and out adjuvant.

So those kind of side effects we see there, which look about like licensed vaccines, are what we would expect with our vaccine. Now, when you talk about side effects, there's maybe two categories-- sort of short-term and long-term. And so, you know, the vaccines can often give a sore arm or, you know, you feel a little off while you develop the immune response.

But that's going to last for a short period of time. And then you're well. So we know these types of vaccines are very, very safe in terms of any adverse health outcomes. And that's always-- you know, the thing that's important to explain to people is that, you know, the of somebody getting COVID and having a sore arm are what you balance.

And you know, I can tell you as a doctor-- this is a very bad disease. We talk-- you talked early on about deaths. I've got a daughter who works in the nursing facility of a hospital. The people who are sick are very, very ill. They may recover. It can take them months, maybe years, to restore their life back to normal or they never get back to normal.

So this is a very, very bad disease. We need to keep that in mind. It's not just deaths. It's the people who are getting this disease. They're debilitated. They're in the hospital. They suffer. And so, you weigh those things against some side effects. In our case, it's a sore arm.

You know, other vaccines less proven-- I think that is-- you know, the less proven, the earlier the technology, the more you need to pay attention to their side effects because they have to find the right dose that is a balance between a good immune response and a side effect. And I think we know that about our technology.

So we anticipate-- and that's, of course, one of the things we're defining in this trial-- is safety and immunogenicity. We need to monitor safety throughout the trials. I can assure you that every safety aspect of these vaccines in the development phase are looked at extremely carefully. And if it were to be deployed, there's also a very robust reporting system. So we know if something's really gone wrong. So that's important for people to know. There's a lot of care given to the safety of the vaccine and monitoring that throughout trials.

ANJALEE KHEMLANI: And Dr. Glenn, you are a pediatrician, you said. So you know the importance of vaccines but also their value. What can you tell us about, you know, the things-- the metrics, the, you know, qualities that are going really quickly about what are going into the pricing of it and thoughts about the pricing of it and access globally, because there are concerns about, you know, global access and where it'll be distributed first and how companies like yourself-- smaller ones-- will be able to profit off of this?

GREGORY GLENN: Yeah, so just going back to your first point, I am a pediatrician. I went into vaccine development because I saw a couple of vaccines licenses. They are miracles. They just-- I saw a couple of very bad diseases-- childhood diseases-- go away when the vaccine became licensed. They really work. They've changed human history.

So they're going to change the history here. I mean, this is a very bad situation, both from a health standpoint, economic standpoint. We're at a standstill. We need to get out of that. We need to keep people from suffering as they are. So we signed a contract with CEPI-- Coalition for Epidemic Preparedness Innovation. They are really thinking ahead.

So part of that is global access. And you know, from my standpoint, being the technical guy, I want to have a vaccine I can make a lot of doses. That will solve many ills, right? We want to have equitable distribution. We want to cover our own country, make sure our own citizens and our own families are immunized. So we've spread out our manufacturing strategy to cover that.

So I don't know. I think there's going to be some, you know, forward-looking debate on pricing. It isn't-- it's not a cheap process. You know, it takes a lot of investment. But right now, I think that's, you know, a complete unknown. It's a really good question. Don't press me on it. You can press other people. I think that, you know, it can be made in equitable access. We're A global health company. We want to see the poorest of the poor get a vaccine as well as our fellow citizens of the United States.

BRIAN SOZZI: All right, let's leave it there. Novavax President of R&D Dr. Gregory Glenn, important work that you guys are doing over there. Good luck with it, and we'll touch base-- we'll catch up with you shortly. Thank you to our very own Anjalee Khemlani as well.

GREGORY GLENN: Thank you for your interest.