MS. WINFIELD CUNNINGHAM: Well, good afternoon, and welcome to Washington Post Live. I am Paige Winfield Cunningham, a health policy reporter here at the Post and author of The Health 202 newsletter, and I’m really excited about our conversation today.

Novavax is a small biotech company in Maryland, but it's quickly becoming a formidable underdog in the race to get a coronavirus vaccine and vaccinate the world. Novavax recently demonstrated in a late-stage trial that it has clinical efficacy against several variants of the coronavirus and also has a trial that is ongoing in the U.S. and Mexico.

We have the president of Research and Development at Novavax, Dr. Gregory Glenn, with us. Thank you so much for being with us, Dr. Glenn.

DR. GLENN: Good to be here with you, Paige.

MS. WINFIELD CUNNINGHAM: So, of course, today we have great news about the Johnson & Johnson vaccine, which we know is going to be reviewed by the FDA on Friday, and that could potentially become our third vaccine.

DR. GLENN: Great. Great news.

MS. WINFIELD CUNNINGHAM: And then potentially next in line is your vaccine. Can you tell us a little bit about that vaccine and what differentiates it from the other ones that we've seen in the market so far?

DR. GLENN: So, our vaccine, we are making a vaccine that is called "recombinant protein." So, as you probably know, these viruses have a little spike on the surface, and the spike is critical for the virus to infect a cell. So, as you inhale virus, it binds to a lung or nose cell, and the spike is actually the lock, the landing piece, that allows it to attach to a cell. It's very critical. So, all the vaccines are targeting this spike by making immune response to it, and what we've seen now very clearly is that's a good strategy.

A year ago, we didn't know for sure if this would work, but it's working spectacularly, as you can see. And what we do is we actually make the spike. What's different from us, say, from the mRNAs and the now vectors, the Johnson & Johnson vectors, is we actually make the protein itself, and then we put this in a little particle. It's about the size of a virus, but it's just basically detergent or soap, if you will, where this particle is sitting.

Now, when the immune system sees it, it recognizes it as something foreign, and it mounts a very, very strong response. So, I would say the hallmark of this recombinant protein making the spike and the immune stimulant we add to it is that we make a very, very strong immune response to a really small amount of the protein, and that's important, really important. Because you get a very strong immune response, it should be highly protective, and that, we can talk later about our results. So that's been shown now.

And then, secondly, it allows you to make millions and millions of doses because it takes such a small amount of your protein to effectively immunize a person.

And, finally, the way we make it, it allows its use as a refrigeration project with product, which is the most common vaccines are simply bottles you find in a little white refrigerator at CVS, et cetera, and so we would be distributed in that very well established--we call it "cold chain," which is just refrigerated temperature. It's not frozen.

MS. WINFIELD CUNNINGHAM: Well, let's talk about results right now, actually. As you mentioned, of course, we've seen high levels of efficacy in the Pfizer and Moderna vaccines in the 90 percent range. Can you talk a little bit about the results that you've seen and whether they're in that same range?

DR. GLENN: So, it's good to explain a little bit about how we get to these trials. It usually takes a year to plan trials of these size and magnitude of importance. So, we're in a place where we don't have that time. So, these trials were conceived of and planned in kind of the May-June time frame, and one of the great risks we have in the trials is we don't know if we can collect enough cases to really statistically, soundly demonstrate that the vaccines are working.

So, everyone was trying to think about where best to test it, obviously looking at the world where there is disease. In the past, there's been many trials with, say, flu, for example, where people have had a very good vaccine, but they've gone out to do a trial. And they just couldn't get enough disease because it was a down year. So that was a risk.

So, we went out to South Africa, to the U.K. and the U.S., and we were not expecting this to the degree we saw it; that is, the virus we knew would undergo some changes. But while we were doing our trials, particularly in South Africa and the U.K., the virus evolved, and that could be a, potentially, very large problem for us to control the virus, like flu. It's a virus that has a lot of the same features of flu in terms of how it infects, how it can evolve.

So, we have done a very valuable experiment for the world by testing the vaccine without knowing that it would happen, but it did happen. It evolved right in the middle of our trials. So that change allowed us to assess how well our vaccine works against the strain that was circulating mostly and still is in the world and a couple new strains.

So, in the U.K., we had--about 50 percent of the viruses that our volunteers encountered was sort of what we call the "prototype virus," very similar to what evolved from Wuhan. The other 50 percent had the new strain, which is big, now taking over in the U.S., a variant, and so that U.K. variant was about 50 percent of our vaccine.

So overall, if you look at the average vaccine efficacy, it was 89 percent, which I can tell you as a vaccinologist, these numbers are just spectacular. But we were able to further subdivide out how it worked against the prototype strain, which reflects the spike protein we have in our vaccine and then how it worked against the variant, and there, our vaccine had 96 percent efficacy against the--we call it the "match," which is very much what the Moderna and Pfizer vaccines were tested against the prototype strain.

So, we got into the camp of these extremely high efficacies with our vaccine, but we had the variant data also, and there, the variant data, we saw a slight decrease down to 86 percent, which is still very, very good. But it's showing us biologically that this evolution of the virus is important that we need to pay attention to.

Now, in South Africa, as we started the trial, there was a new variant, and it completely took over in South Africa. So more than 90 percent of the viruses we encountered there--or our subjects encountered were this new variant, and there, our vaccine efficacy was 60 percent. And so, this is really important to know that for the world. So, we have a vaccine that's working really as good as anything when it's matched, 96 percent efficacy. When we look at the evolution to this U.K. strain--and we understand a lot of this structurally--we see 86 percent, and when it really goes out on a limb, if you will, through viral evolution, it's 60 percent.

So, the other feature, the other big news in our trials, we look at the placebo groups and we can tell something about just the virus attack rate in the population as well, and there, what we were expecting in South Africa--they had a very large wave, very bad go with the COVID disease in sort of the June-July-August time frame, so much so, we thought there could be a very strong herd immunity. So, when we looked at the people who had established immunity from infection, it was quite high in our trial. When we looked at the people, we also had about half the people or more that did not have any evidence of previous infection. But what really jarred us was that the attack rate, that is, the amount of new virus infections, was no different, which means that the previous infection had no effect on protecting people against the new infection.

So that is the baseline against which our vaccine was being tested, and we still had 60 percent efficacy, so two messages. The variants are really important. It looks like infectious immunity may not cut it in terms of creating herd immunity, and secondly, our vaccine technology, as I described to you earlier, is in fact working, even though the virus has evolved from where we started with our spike protein.

So, these are really for the world, for the vaccine community, these are really important findings.

MS. WINFIELD CUNNINGHAM: Well, that is, indeed, good news about the efficacy, but can you walk us through the timeline here? I understand that you're undergoing the trial in the U.S., and potentially, you might apply to the FDA for emergency use authorization perhaps next month. But can you kind of lay out for us what you're looking at in terms of what happens over the next couple of months?

DR. GLENN: Yeah. So, as you noted, we've started a big U.S. trial, and again, it's going to be, I think, extremely informative, because the virus is changing. We've really done well in highlighting and recruiting people from minority populations where there might be some reluctance to take the vaccine. So, we're committed there to establishing a really good safety and convincing profile of our vaccine for Latinos, African Americans, Native Americans, et cetera.

So that trial, last week, we finished recruiting 30,000 people in the U.S. and Mexico, and we're expecting that result right at the beginning, maybe, of quarter two, so pretty soon. And shortly thereafter, we would be filing for what we call EUA, or emergency use authorization, in the U.S.

So, we're thinking quarter two, and then deployment can come fairly quickly. You may have seen that the FDA is really efficiently evaluating these packages of data and providing emergency use.

Now, I would like to talk about the globe. We've had a global view, and so that's going to be important to us as a company as well. But the U.S., I think that we're talking about a quarter-two application for the emergency use authorization.

MS. WINFIELD CUNNINGHAM: And then I know a question that many Americans have which is, did you observe any significant side effects from the vaccine in the trials that have been carried out so far?

DR. GLENN: Yeah. So that, I think, is another hallmark of our vaccine is the safety profile is very good. So, it's recombinant protein. It's an adjuvant. These things traditionally have been used widely in licensed vaccine. So that gives us a really good sense of how well it would perform that way.

So, look, all vaccines are going to give some local arm soreness. When you may get immune response, you can feel off. So, we see that, but I think compared to some of the other vaccines, it's much more muted with our vaccine, and especially in older adults really very quiet, and that's important. So, you should know, people should know how much scrutiny we give these vaccines. These are--the data collected around them are extensive. If you happen to enroll in a trial, which I would encourage you to try to do, you get interrogated daily and frequent visits, and a lot of the visits are about collection of symptoms, anything that you have, so a really strong dataset around people to prove that this is safe.

Of course, things like hospitalization and medical care, all that data is collected as well, and of course, we're blinded. We don't know, but again, another thing I think should reassure people is that these trials are supervised by people that are outside the company, have no interest except the public good. And they evaluate in an unblinded fashion. They see everything we can't see. So, they know whether or not these events are in the vaccinees or placeboes, and that should be reassuring because they're looking for patterns that might be associated with safety.

Now, that being said, you never get into a clinical trial without extensive evaluation and a sense of whether or not it would be safe. So, we wouldn't even approach a human trial unless we thought these were very safe.

If you looked at a vaccine vial, you'd be amazed. It's a little bottle of what looks like clear water. The amount of material we're talking about is 5 micrograms in our case, which is exceptionally low dose. If you dried it out on the table, you couldn't see it. It's just an exceptionally small amount of material we're injecting, but it's very potent. It targets the immune system, and we get a strong response with a small amount of material.

MS. WINFIELD CUNNINGHAM: Also, what about the distribution? We know there have been some challenges with the Pfizer and Moderna vaccines in terms of having to be stored in very cold temperatures and then, of course, the shots being spaced out. Can you walk us through what you kind of see the distribution looking like?

And then, also, have you found that there is--or do you believe there's a particular population of people for whom this vaccine would be particularly--work particularly well?

DR. GLENN: So, yes, I think that, as you have seen, the logistics involved in vaccinating a national population are really daunting, and my opinion is a good job is being done. But it's just a huge task, never been done. Nothing has been done like this across the globe, if you will. So, anything that can make that go smoother, easier, et cetera--and it's really obvious that if you have a vaccine that uses normal refrigeration that that will smooth things out. So, I think we have really something important to add there.

We're evaluating our vaccine in all these special populations. I expect that the vaccine will work well in old people and other populations. We have people with a lot of what we call "comorbidities" in the trial. So, we'll be able to make statements about that. We're expecting the vaccine will work really well throughout all those populations.

MS. WINFIELD CUNNINGHAM: Well, I know that you all had some hurdles, some obstacles as you were trying to get this U.S. trial together, but now you've actually been able to reach your enrollment goals in a quick amount of time. How were you able to do that?

DR. GLENN: Well, thanks for asking that. I mean, we have a collaboration with the U.S. government, which has been really fruitful, and also collaboration with the NIAID, the National Institute of--the NIH, essentially. And they had a network of trial sites, of investigators. These are people that have extensive knowledge in terms of how to do a vaccine, vaccine trials, and frankly, they have to be convinced that you've got a good product for them to even join in.

We have morning calls every day at 8:30 with the U.S. government managers, who are fantastic people, with our contract research group, with people executing on the trials. I cannot tell you how much, how frequent we talk to everyone involved. We had great dashboards of how the sites--we're working at 118 sites in the U.S. and Mexico, extremely complicated implementation and with strictures on recruitment that were really actually quite challenging. We'll say that we were able to collaborate with people like Howard University and University of Maryland locally, just to kind of illustrate the types of groups that were involved in this and that. That allows us to achieve our goals, our recruitment goals of really strong diversity in the Latino population, the African American population, Native American, Asian American.

I think we have a super representation of the kind of people that will want to take the vaccine, and I would say that collaboration with the NIH, the U.S. government, and the company has been very fruitful.

MS. WINFIELD CUNNINGHAM: So, I know that you said quarter two is sort of the aim for when you would apply to FDA for emergency use authorization, but can you be a little more specific about that? And I ask because there was a lot of talk last fall about how much time needs to lapse between the time when the trial is fully enrolled and how much time the recipients of either the placebo or the vaccine are observed and how many cases you need to--of coronavirus you need to see. Can you talk about that a little bit in terms of, I guess, the timing or the number of cases you need to see and when you'll be able to know that, okay, now we can go ahead and apply to FDA?

DR. GLENN: That's a great question. So, let me just walk you through how to works.

We give people the vaccine regimen, and then we start looking for whether or not they have infections a week after their second dose, so Day 28. And then, essentially, we're waiting to see--people are out living their lives--waiting to see who gets infected and counting cases. So, we don't really control the timing.

We are in a situation where there's a lot of disease, and also, we're in a situation where the net, if you will, for capturing disease is very big. So, 30,000 people is what we call "overpowered." I would say in South Africa and the U.K., once we started into that period where people could be a case, had gotten their doses, and now were in the right time frame, it took us about six weeks to actually get--accrue the number of cases we needed.

So then once you know that--and so we don't know that. We get told by somebody who could--because we don't want to be unblinded in any way. Once we're told that, then--in the case of the U.S., 72 cases we're looking for--then they will push a button, and that will start to--they'll look at the data in a big database, clean it up, push a button, and we will know. So, the timing is, frankly, uncertain, and it's one of the issues we're facing with all the trials. But one thing I would say is the U.K. data is very good. We expect to propose to the FDA that this data could be used as a basis for licensure. We'll see. That trial and the South African trial are all conducted in a way that the FDA will take that data seriously and the U.K. potentially as what we call the "pivotal data." That is, we lined up--FDA gave advice on how to do a trial, what success means, and that really was accepted by the world, if you will, and so we're aligned up with those success criteria in all of our trials.

MS. WINFIELD CUNNINGHAM: So, would it be fair to say that April is a fair timeline for when we might be expecting you guys to file for EUA?

DR. GLENN: Yeah. I think we're--look, quarter two--I can't really venture much beyond that.

What I would say is you ought to think about this as not a sprint, but it's a marathon. This virus is not going to go away. We're going to need to boost. We're going to need to have a strategy like we do with flu, where the virus changes, and we need to be able to make that change in our vaccine.

You may know this--we've already begun to work on a virus that does--a vaccine that reflects the virus seen in South Africa. I think that's really important. We expect to begin testing that shortly as well, and at some point, the strategy is going to require boosting. And so, I think that all together, you have to see this as a marathon, and we're at a critical juncture in implementation of vaccination. And it's just not going to go away.

So, globally speaking, this vaccine will be--we expect it to be deployed widely because this is really affecting every country, and it's going to persist.

MS. WINFIELD CUNNINGHAM: Novavax's vaccine is expected to be considerably cheaper than the one we've seen from Moderna. Why is that? Are the materials cheaper? Walk us through that.

DR. GLENN: Yeah. I mean, cost is something that it depends on who you're talking to, but just remember people are going to get this vaccine for free. So, it's really about the cost of goods.

We use a very small amount of antigen. That's one of the great things about our technology is it's really potent. So, the amount of material that goes into our vaccine is really small.

This is just as important to think about the world. We, as you may know, have commitments to global supply. We've stood up manufacturing in the U.S. for the U.S. We also have manufacturers in the U.K., in Spain. We have a very large plant which we were able to purchase in Czechoslovakia. We have a huge operation in India, in Korea, and Japan. So those other sites in the world are making vaccine for the world, and there's a very good strategy for helping to implement the distribution in the poorest countries, which I'm very proud of, my company is, because we've always had a global view. We knew this was going to be a problem, and places like South Africa where we work, this is completely ruining the economy.

So, we need to have a strategy for getting our vaccine out to the rest of the world. It helps that we use a very small dose. That makes the cost of the goods really low, and that's going to be important for a lot of the countries. But we expect that the vaccine is going to be essentially provided by government, funded by donors, and distributed to the whole world, and that's going to be a really gratifying thing to see. I think we announced some of the actual mechanisms by which that would be distributed to the rest of the world called COVAX.

And Serum Institute of India, which was last year, heretofore, the only vaccine maker in the world that was making billions of doses, they actually built a plant dedicated to the manufacturing of the Novavax vaccine, and they see this. I mean, they are very experienced in providing cost-effective vaccines to the world. They see that our vaccine with its really small dose can do that. So, I think that's important to us as well.

MS. WINFIELD CUNNINGHAM: You mention the Serum Institute of India. I know your company is set to produce 2 billion doses a year starting the middle of this year. Who do you think will see most of those vaccines? Where are the doses going to be going?

DR. GLENN: Oh, that's a great question. Yes. I'm not sure I'm the best one to answer that, because how it gets distributed is pretty important. But it's global. So COVAX is a mechanism that both caters to lower middle income, lower income, and high-income countries, but the vast majority are targeted for the other communities. So that's a big topic, how the vaccine gets distributed. I'm not probably the best person to talk about that, but it is in place, the COVAX mechanism. There is a--that's taking advantage of an infrastructure that exists, something called Gavi, which has been very effective in distributing vaccines throughout the world. So, it's a super complicated topic. There's a lot of countries, but I'm confident we're going to make enough. That's sort of in my arena to distribute about 2 billion doses.

MS. WINFIELD CUNNINGHAM: Well, I know your company has looked at combining the coronavirus vaccine with the seasonal flu vaccine. NanoFlu, I think it's called. Do you think coronavirus vaccines will become a regular part of yearly flu boosters?

DR. GLENN: Yeah, I do. I think as we see in our data, the virus will evolve. That evolution is going to be important. It's going to be important to try to match that up with the vaccines, and we have the technology to do that, very agilely. So, our particular technology is suited for that.

Last year when the COVID started, the COVID epidemic started, we had just completed a pivotal trial with a flu vaccine, and this topic of virus evolution away from vaccines to the point where the vaccines were not working well, the flu vaccines, was exactly what we were focused on. So, our technology is uniquely suited to address that by creating a broad immune response.

Last year in March, we finished. We announced a Phase 3 pivotal trial with our new flu vaccine. It was fantastic. We met all of our endpoints, and no one cared because the COVID tsunami was approaching. So, we have a basis for combining these two very good vaccines into an annual seasonal flu vaccine, and we've begun work on that already. But our flu product is very advanced. Now our COVID vaccine has caught up to it, and it really makes sense to combine them as an annual seasonal vaccine to cover these viruses that really are just not going to go away.

MS. WINFIELD CUNNINGHAM: Well, our time is drawing short, but I do want to ask you. We're under a new administration, and they've continued some of the vaccine strategies started under the prior administration. They're also trying to do some new things in terms of distribution using DPA, et cetera, but any thoughts on what would be most helpful to your company in terms of what the Biden administration can do to help you get these vaccines, get through the trial, get approval, get them distributed?

DR. GLENN: Well, to their credit, they reached out very early to us. We've met with their team. They have been supportive, and I actually have seen no blip in the very strong support we've had throughout the program. So that's been great.

I think, they also have a global view. So that's also really a good thing. So, we're seeing every bit of the kind of support we had, which was good at the beginning, and it's still there. It was really great to meet with their team. They brought in some great people. So, I'm expecting that to just have been a smooth transition to the next year for us.

MS. WINFIELD CUNNINGHAM: Well, unfortunately, we're out of time, but this has been a great conversation. Thank you so much for joining us, Dr. Glenn.

DR. GLENN: Good. Really good to talk to you. Thank you for your time.

MS. WINFIELD CUNNINGHAM: Well, stay tuned to today because at 2:00 p.m. Eastern, my colleague Christina Passariello will host an important program called "Transformers: Recovery," exploring the impact of the pandemic on digital integration, on education, and manufacturing. You won't want to miss that.

Thanks so much for joining us this afternoon.

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