Status Update

Sep 21, 2021

Hello, everyone. I'm Jenny Ravello, Senior Global Health Reporter for DevEx. Thank you so much for tuning in to our series of events around the UN General Assembly. Access to COVID-nineteen vaccines continues to be a hot topic, and rightly so. Billions of people around the world still have not received at least one dose of the COVID vaccine. There continues to be a huge demand and despite estimates of vaccines being produced in over a 1,000,000,000 a month, access to them particularly in low and middle income countries remains a challenge. But there are more vaccines coming and one of them is actually a COVID-nineteen vaccine developed by Novavax, an American biotech company that has decades of experience developing vaccines for serious infectious diseases. In June, Novavax grabbed headlines after releasing efficacy data from a Phase 3 clinical trial in the U. S. Showing its 2 dose COVID-nineteen vaccine has 90% overall efficacy, including 100% protection against moderate and severe illness. And so I'm pleased to be joined today by Mr. John Trizzino, Novavax's Executive Vice President, Chief Commercial Officer and Chief Business Officer. John, thank you so much for being with us today. You're welcome, Jenny. Thanks for having me. Appreciate it. Well, there was a lot of excitement, as I mentioned, around June when Novavax released data from your efficacy trials. And also earlier in the year, we released Phase III clinical trials in the U. K. Showing the vaccine also has high efficacy at 89.3 percent. I'm curious about your reaction in the company. There must have been some kind of a celebration. Yes. As you can imagine, we were tremendously excited by the data both from the U. K. Trial as well as from the U. S. Trial. I think the data was compelling, not only in the efficacy against the original strain, but the efficacy against some of the variant strains as well. And so I think we ran especially our U. S. Trial during a period of time at which over 80% of the strains detected were of the variant strain. So I think there's a kind of robust cross reactivity and protection that we were very pleased with as well. It's a reflection of the hard work and dedication that the entire team here at Novavax has put forth both from a discovery standpoint, manufacturing, clinical, regulatory. We were thrilled as you can imagine. Now the question I guess on everyone's mind is when is the Novavax vaccine going to be made available to populations globally? Can you give us a sense of the timelines you're working on to get this to people's arms? Yes. Let me but let me just first just comment on just one or two quick things. The regulatory submissions, the final package that goes to these various regulatory authorities is a combination of a lot of activities that have taken place within the company from the Phase onetwo trials back in early last year to the Phase IIb in South Africa, the 2 Phase IIIs, 1 in U. K, 1 in U. S. And Mexico. And it's this collective effort that gets put into that final regulatory package. Along the way, there's a number of challenging things that have to be done from manufacturing scale up in addition to the great clinical data that we have and then a demonstration of kind of consistency of manufacturing across a network of manufacturing sites around the globe, not in the U. S, in the U. K. Facilities, owned facilities and contracted facilities in Europe are important and strategic partnership with Serum Institute, work that we're doing in South Korea with SK Bio and our partnership with Takeda in Japan. And so all of these interfaces create some regulatory challenges that we are making our way through. We're in been in constant communication with these authorities under rolling review and rolling submissions. And so therefore, we're now at a point in time at which all of that feedback and all that conversation has been incorporated into these documents. So we should be seeing a coordinated effort of getting these very similar regulatory filings being submitted within the next couple of months. Will we see it within the year? Well, we'll certainly see the filings within the year. It's impossible to difficult about how long the review time will take. Of course, we're optimistic that given the conversations we've had to date and given the rolling submissions that we'll see a quick review. Can you just quickly comment as well on the emergency use listing for the World Health Organization? How's that coming along? Yes. So there again, we've been in constant communication both from Serum's perspective, our partnership with them because of the COVAX doses that Serum will be supplying. Remember, there is 1,100,000,000 doses of product that has been committed through the CEPI collaboration and then into the COVAX facility, 350,000,000 doses of those coming from Novavax and 750,000,000 doses coming from serum. So that work is somewhat dependent upon the emergency use license with WHO both from the CRM perspective as well as from a Novavax perspective. I understand that you have several ongoing clinical trials at the moment. Can you give us a sense of what are these for? Yes. So these are all kind of an important kind of follow on to the primary trials that were conducted above 18 years of age. And so there are some adolescent trial, 12 to 18 trial in the U. S. That's now fully recruited and underway, hopefully data before the end of the year. There are some other studies that we're participating in that are not being sponsored by us. So there's several in the UK that are looking at heterologous primary regimen as well as heterologous boosting and homologous boosting. And we'll see some of that data readout coming soon. The booster strategy is kind of a hot topic across the globe on when that starts, what the duration of protection should be, whether it should be homologous or heterologous. I think we already have data that suggests that our boosting is significant to the first two primary doses and provides not only improved protection, but improved cross reactivity against the variant strain. So we're so far thrilled with the BOOST data that we've seen so far as well. You mentioned about booster shots. And as you know, the WHO Director General has called for a moratorium on booster shots until the end of the year because billions of people around the globe still have not received the vaccine. Do you see the Novavax vaccine being used more as a booster shot in countries, perhaps in countries with high vaccination coverage already? Or are you prioritizing for your vaccine to be used in places where doses are still very limited? Jenny, it's a great question. And we're the innovator, we're the manufacturer and so we're not the policymakers. And so what we have really with great effort put into place is manufacturing across the globe in order to create a robust capacity of our recombinant protein nanoparticle vaccine, also including our matrix M adjuvant. And so by virtue of that, we have been committed to an equitable allocation, in part because of our funding from CEPI that was critical to our quick acceleration early on last year and the funding mechanism we received from them for $400,000,000 to do early stage large scale manufacturing as well as Phase III trial. But also because we think it's the right thing to do. Our partnership with Serum is an additional reflection of that knowing that CRM's expertise is in large scale manufacturing and moving product logistically into low and middle income countries. So we've taken our responsibility seriously and making doses available across the globe. Now it's up to a variety of policymakers to decide where and how those are prioritized, but we're doing our part in making them available. There's a lot of concerns around transparency on the part of manufacturers. COVAX has recently raised this issue. And there have been reports that Novavax, and please correct me if I'm wrong, your production capacity for 2022 is around 2,000,000,000 doses. But the question is, are all of those doses been allocated for already in advance? So it's another good question, right? This transparency is important and we've been extremely transparent across multiple fronts. All of our clinical data has been shared very quickly. As you can imagine being in the spotlight under a pandemic as a manufacturer and innovator that has a highly effective vaccine, Everybody wants to know when it's coming. So we're doing the best we can to keep everybody informed in an up to date fashion. We've talked about a global supply run rate of about 100,000,000 doses before the end of this quarter and 150,000,000 dose run rate capacity before the end of the year. Your number of 2,000,000,000 doses for next year is about right based upon what we would expect to be able to manufacture across the globe. In May, the company released a statement opposing the TRIPS waiver, which is another, again, another hotly debated topic in the middle of this pandemic. We've seen countries and some organizations having changed their stance on this issue. I wonder, has Novavax position changed 3 to 4 months since that statement? Why or why not? It hasn't changed. We do oppose the TRIPS waiver and specifically for this reason, not because we're not in support of equitable allocation and not because we don't believe that doses need to go into low income countries with some priority. But because manufacturing a complicated biological like we have is not like making aspirin. You just don't give the recipe to somebody and they turn around and it can easily manufacture that complicated tech transfer. We've now done it at 8 facilities in 7 different countries. So in effect, we are implementing what the trips waiver is intending for us to implement, but we're doing it under our control and under our supervision in order to be sure that the quality product that we've seen in our clinical trials is the quality product that's manufactured across multiple manufacturing facilities. You mentioned earlier around your agreements with companies in India, in Japan, in South Korea. Are there plans to do more of that perhaps in a little bit less developed countries that may have capacities in Latin America or South East Asia or maybe in Africa? Yes. We are continuously looking at other opportunities to expand our manufacturing capacity. As you said earlier in the interview, armed with this great clinical data, which we're very proud of, we're eager to manufacture as much product as we can. But again, as we go and kind of do our due diligence around the globe, we're being very selective about where that manufacturing is being done, the experience of that facility or the ability to bring up a new facility and build that out over time. But now you're talking about a function of time and quality and those two things have to converge. You mentioned about your agreement with your deal with Covavax earlier and part of that's coming from Novavax and then part of that is coming from the Serum Institute of India. SII has been challenged in delivering some of its doses for another COVID vaccine to COVAX. Do you anticipate to face any similar challenges? There's always challenges, right? And that's part of what we do every day is identify them, resolve them and move on. But I think fundamentally, the relationship with Serum is such a strong solid relationship. We've tech transferred to them. They're manufacturing in multiple suites within their facilities. We're monitoring the quality of that product. They are a very well experienced role recognized, the largest manufacturer of vaccines by dose in the world. And so we have a high degree of confidence in our ability to maximize that relationship. And we feel comfortable in the commitments that we've made to COVAX. And then this is a kind of a collaboration between CEPI and Gavi and are confident in our ability to deliver those doses. Recently, there was an announcement from Novavax starting a new clinical trial on a combination vaccine. Can you tell us a little bit more about that? Yes. I'm glad you brought that up. It's an exciting opportunity. I think many people may recall that we took an influenza, a quadrivalent influenza vaccine on the same platform or the recombinant protein nanoparticle into a Phase 3 trial back in 2019 and then over into 2020 just before the pandemic. And we received the Phase III results, which were successful. We met all of our primary objectives for that trial. And we were just thrilled at the data coming from our NanoFlu Phase 3 trial and we're getting to roll that out or intended to roll it out commercially and then hit by the pandemic and appropriately so it needed to take a little bit of a back burner. But now faced with what might be an annual seasonal vaccination for COVID, which may align with influenza, it makes perfect sense to combine these 2 vaccines that are on the same exact platform. Again, the recombinant protein nanoparticle, both adjuvanted with Matrix M. And so bringing those two together makes perfect sense. And we're excited to have that trial started and look forward to having the data from that trial mid next year. 2022 looks like it's going to be a very busy year for you at Novavax. But I wonder what's next for Novavax? Is also eyeing to develop other vaccines for other diseases other than what we've discussed? Yes, of course. The success in clinical data that we've seen with our COVID vaccine gives us renewed confidence about our technology platform. The Phase 3 data for NanoFlu also gives us confidence. I think the combination vaccine is an important next step. We also have tremendous amount of experience in RSV, respiratory syncytial virus. And I think that we've learned some things from our COVID experience that will help us with going back into the clinic with RSV, 2 dose vaccinations, the use of adjuvant are all kind of important lessons learned. In addition to a variety of other things that we're considering and evaluating as to where the future takes Novavax. Well, I think that answers all my questions. Thank you so much, John, for sharing your insights and your time with us. And thank you, everyone, for tuning in. Please stay tuned because we have more events coming. Jenny, thank you. My pleasure.