Study Result

Jun 14, 2021

Press Release

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Prevent 19 Phase 3 Final Data Announcement Conference Call. By pressing on a touch tone phone. Please be advised that today's conference is being recorded. Call. I would now like to turn the conference over to your speaker today, Sylvia Taylor. You may begin. Good morning, and thank you to Everyone who has joined today's call to discuss our PREVENT-nineteen Phase 3 final data results. A press call. This release announcing our results is currently available on our website at novavax.com and an audio archive of this conference call will be available on our website later today. Please also note that we have posted the slides that we are using during this morning's call at novavaxdot com/events. Joining me today for discussion and a Q and A period are Stan Erck, President and CEO Call. Doctor. Gregory Glenn, President of Research and Development Doctor. Philip Dubovsky, EVP and Chief Medical Officer Call and John Trevino, EVP, Chief Commercial Officer, Chief Business Officer and Interim Chief Financial Officer. Call. Before we begin with prepared remarks, I need to remind you that we will be making forward looking statements during this teleconference that could include financial, clinical or commercial projections. Call. Statements related to future financial or business performance conditions or strategy and other financial and business related matters, including expectations regarding revenue, operating expenses, cash usage and clinical development and anticipated milestones are forward looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward looking statements are Call subject to numerous assumptions, risks and uncertainties, which change over time. I'd now like to hand the call over to Call. Stan, for those of you following on the accompanying slides, please turn to Slide 3. Stan? Thank you, Sylvia. So today is a great day for Novavax. This morning, we were talking about the exciting results of our PREVENT-nineteen Phase 3 study in the U. S. And Mexico. But this work follows a successful Phase 3 trial in the UK, a successful Phase 2 trial in South Africa and a successful Phase onetwo trial in the U. S. And Australia. These trials taught us a lot about our vaccine and from the early clinical data and even the preclinical work before that. We were encouraged by the potential of NVX COV-two thousand three hundred and seventy three to play a significant role in combating the global COVID pandemic. Call. With each analysis, our trials prove that we are on the right track. And today, the safety and efficacy that are consistent across all studies, Our PREVENT-nineteen results reaffirm our strong belief in 2,173. All this work has been made possible by the participants who volunteered for our trials and the research and clinical staff who conducted the studies. We are grateful for all of these contributions. We're also thankful for the support of the U. S. Government and CEPI. Call. For more on these results, I'll turn it over to Doctor. Philip Daboski. Thanks, Dan. So maybe we can go to next slide. I'm really pleased to present these results to you today. And I think we're all going to be excited when we see these results. So Slide 4 has the design of the study. As you remember, this study included 30,000 adults greater than 18 years of age and it was randomized 2 to 1. Where we are with the current study is we've crossed over the adults to the people who received placebo got active vaccine and the people who got active vaccine got placebo. Additionally, we've expanded this study to include adolescents 12 to 17 years of age. Complete enrollment of that age group. The data we'll be describing today is data in the adults only and that's from when they were randomized to when they crossed over to receive their crossover vaccine. And this will include both safety and efficacy data. Next slide, Slide 5. Call. On this slide, what you see is the time course of the variance that occurred in the U. S. In the color diagram on top. Call. You can see that we gave dose 1 from December 27 to February 18 and dose 2 from January 18 to March 26. Call. The blue box indicates that window in pre captured efficacy endpoints. And what you can see in the bright orange is that there was an emergence of B117, which was first identified and described in the UK as a large portion of the strains in the U. S. There's a very small sliver in bright red in the bottom, which accounts for 1% to 2%, and that includes cases from 3 51 variant, which was first described in South Africa. So we conducted the study, the efficacy evaluation period during a time when emergence variants emerged in the U. S. Next slide. Now we're talking about Slide 6. And so just to remind you that one of the features of this study is we had a big push to enroll high risk populations and included previously underrepresented racial and ethnic subgroups. And you can see in the chart that we did fared well in enrolling Latinos, African Americans, Native Americans as well as Asian Americans, and we had a broad location of the trial sites in the U. S. In a handful in Mexico. Next slide. Now we're on Slide 7. Call. Slide 7 highlights the demographics of the population we actually enrolled and you can see the randomization worked well. Call. All of the key categories were well balanced between the vaccine and placebo group. I want to call your attention to the bottom line, which is medical comorbidities of 37% call. And these are high risk medical conditions that we have tried to enroll to make sure that we had a public group representative, including people who would most benefit from the vaccine. Call. Next slide. This slide is a very high level review of the safety that we saw. Call. And you can see both serious adverse events and SAEs were infrequent and they were balanced between the 2 age groups. The graph didn't project well. For the bottom three lines with adverse events of special interests and deaths, those all had a rate of less than onetenth of 1% were also balanced. No adverse event was reported more frequently than in 1% of the participants. And this is very consistent with the previous call data we've captured in the UK as well as South Africa. Next slide. Call. We're on Slide 9. And Slide 9 shows the reactogenicity profile of the vaccine. And let me orient you to this slide a little bit. On the left hand side, we have the local react symptoms, dose 1 and dose 2. And on the right hand side, the systemic dose 1 and dose 2. In gray is the placebo group call. And in blue is the vaccine group. And you can see if we focus first on the local side that we had an increase of local reactivancy events after dose 2, which was completely expected. And the most common ones were pain and tenderness, and these were all short lived occurring both median and mean less than 3 days. And you can see the grade 3 response in the gray bar was very, very low indeed. On the right hand side are the systemic side effects. Once again, a few more after dose 2, once again expected. The terms that are most common were fatigue, headache and muscle pain. These were also short lived, within 2 days median and mean, and the number of Grade 3s was low. And this is very consistent with There are previous studies. I think it may be important to look at fever rates, which were very low, including break fees. And the safety profile we just discussed was reviewed with the NIH DSMB and they agree with our evaluation of this data. Call. So let's turn to the next slide, Slide 10. Slide 10 shows the primary efficacy endpoint. Call. You can see that in the vaccine group, we had 14 cases. In the placebo group, we had 63 cases. And I want to remind you once again, this is 2 to 1 randomization. So this resulted in a vaccine efficacy of over 90% with a lower bound of 82.9%. As a primary efficacy endpoint, this had a statistical success criteria, which we achieved handily. This was about 30% with a lower bound. It's important to note that 82% of these cases were caused by variants of interest and variants of concern and that these are the definitions defined by the U. S. CDC. Call. I think another notable feature is that all the cases in the vaccine group that broke through were in the mild category. And we have a secondary endpoint, which looks in moderate and severe later in the deck and getting the focus on that. So next slide, now we're on to Slide 11. Call. So Slide 11 is a detail about the variance that we were able to identify in the study. As you saw previously, we have a total of 77 cases in the per protocol population. We have sequence data available on 54 of those cases. We may get some subsequent further sequencing, but these are the ones we had in hand for the primary analysis. What you can see is that as far as variance is concerned, 65% of all the cases found in the category, vast majority were 117, which was first identified in the UK. You can also see 49, which is California, 351, which is South Africa and P1, which is Japan and Brazil. 17% of the cases were variants of interest. These include from the top going down, USA, New York, USA, New York. You have the India delta variant, but that's 6.7.1, so now the more severe one as well as Brazil. And finally, in the Sweden category, you can see that 19% of the cases were variants not of concern and interest. And these are cases that have not been identified as worrisome by the CDC. And in this category, things that will be more like prototype, including Wuhan strain would fall into this group. So let's turn to Slide number 12, please. Call. So we identified as a key secondary endpoint efficacy against variants not considered variants of interest and concern. Call. And the reason we did this is that this most resembles the matched strains that the vaccine is built against. So the prototype of pittance category, as with the virus per site invite in Wuhan. And as you can see, we had 10 cases in the placebo group and 0 cases in the vaccine group, yielding efficacy of 100%, a little longer than 80. And as a key secondary endpoint, we also pre established a success criteria in the statistical analysis plan and we view that handily. Call. So there are a number of cases that we were not able to sequence, in fact, 23 in all. Of those, 21 were mild, call. 1 was moderate and one was severe. You can see that all the cases in the footnote that occurred in the vaccine group were in fact mild. And this makes some scientific sense. The mild disease likely had lower viral loads, so it was harder to get enough virus to sequence the data. So this all holds together from a scientific perspective. So, let's move to the next slide, Slide 13. Slide 13 is the flip of that analysis, and that's looking at efficacy efficacy against vaccine variants of interest and variants of concern. And this is an exploratory endpoint. But you can see that we had a total of 6 cases in the vaccine group, 38 in the placebo group yielding a vaccine efficacy of 93% with a lower bound greater than 80. Call. So, this is this I think is remarkable. It shows that if you generate antibodies of a very high quality, they are actually able to impact both variants of concern and variants of interest. Next slide, please. So one of the predefined secondary endpoints was efficacy against moderate and severe disease. In this analysis, you can see that we had no cases in vaccine group, fourteen cases in placebo group, giving a vaccine efficacy of 100%, level bound of 87%. We additionally did a post hoc analysis looking just at severe disease. And you can see once again we had 100% case against severe disease with a 95% confidence interval starting at 35%. And remember, this is 2 to 1 amortization, so this is really you think it is more like 0 versus 8 cases. Call. I think there were additionally, we had 6 hospitalizations with COVID and this included 1 patient who's suffering from a COVID disease. And these all occurred in placebo group. These were not included in the efficacy analysis because by the strict rules of the protocol, the PCR had to be done by the central lab and because these patients were hospitalized, We're unable to submit samples. So, Ed, we're going to be conducting a post hoc analysis, which includes all severity, including sessions announced should be coming up in the near future. Next slide, please. Now we're on Slide 15. Another predefined secondary endpoint was efficacy in the high risk population. And this is defined in the protocol as those who are greater than 65 years of age and those who had medical conditions such as obesity, chronic kidney disease, chronic lung disease, cardiovascular disease and type 2 diabetes or we're living under life consensus, which increase our risk to severe disease or getting COVID. It's included things like hard lifting conditions as well as working in packing plants. Call. And you can see in this analysis, we had 13 cases in the COVID group, 62 in placebo group, yielding AVE of 91% lower bound, once again, greater than 80 So I'll go to the last slide and look at some of the results. This is now Slide 16. So overall, the primary efficacy evaluation yielded a vaccine efficacy of over 90%, and this was in the face of a predominance of various of interest and concern. Over 83% were VOIs or VOCs. Additionally, when we just looked at those that were variants of concern or interest, we had a vaccine efficacy of 92%, call. Once again showing if you generate high levels of quality antibody with this vaccine, you're able to impact disease caused by variants. We had 100% protection in this analysis against moderate and severe disease. And furthermore, we had 100% protection against variants not considered variants of concern and interest. And once again, this is where the original prototype strains will fall into. So it's a good benchmark about how this vaccine technology could perform against my Train. All the hospitalizations occurred in the placebo group and all the severe cases, including deaths, occurred in the placebo group. So with this, I'm going to conclude my remarks and we can go back to Sam. Well, thank you very much. Great day, Adam. Call. Absolutely. All right. So we're going to open up to Q and A. And operator, if you could organize that for us, that'd be great. Call. We will now begin the question and answer session. Call. Call. And the first question comes from Charles Duncan with Cantor Fitzgerald. Please go ahead. Yes. Good morning, Stan and team. Thank you for taking our question and congratulations on these very good data. Call. So, quick question regarding the number of infections. So, I think the data speak for themselves, but call. I'm wondering if you could provide a perspective on how to interpret the data relative to data sets that may have higher numbers. Do you believe that the numbers that you have here in the stats have clear predictive value for efficacy of the vaccine when more patients or more people have taken it? Call? So I'm not 100% sure specifically what you're asking. So let me answer 2 questions. One of them is if we think about the high numbers for the match vaccine strain. That's why we pre specified the efficacy analysis against variants not of concern and So this is a number which would most likely which we think would be similar to results we would get if we were doing this just against Wuhan or the other type strain. As far as the broader analysis, the primary efficacy analysis, call. That actually included vaccine efficacy against all variants, and 82% of those cases were variants. So I think this very much is going to represent what we can hope to see when this vaccine gets deployed. I guess I'd like to point out that the overall vaccine efficacy was only different by about 0.5 percentage point from what we saw in the U. K. So we're getting very consistent results against both variance as well as with non variance. Call. Okay. Thank you, Phil. Did I ask a question? Yes, it did. I was just referring To 77 infections versus say something like 150, do you have confidence in this data? And then the second thing is, Was there any geographic grouping in the observation of infections? So we for the latter question, we don't have that data yet. Call. As far as the robustness of the data, I think it speaks for itself. Our lower bounds in all these analysis were above 80%. Call. So that shows a very consistent and very robust response. In the ITT analysis, which we don't have in hand yet, we have well over 250 cases. Call. And as you remember, what happened is the epidemic slowed down just as we were entering the efficacy evaluation period. So where we lost the ability to have many cases, what it gave us was the ability to have many variant cases. And I think in the context of what's happening globally, efficacy against variants is going to be a very key feature. Call. Okay. Len's clinical question is regarding the side effect profile. You mentioned fever. And I guess I'm wondering if you can speculate on, call it, the technology platform versus some others that are out there. How do you interpret the fever observation as being fairly low? Call. I think your notion is right. I mean, each technology is going to have a different safety profile. We've tested this obviously with many different antigens, including our NanoFlu product, conference call. In this case, we have extremely low levels of antigen, 5 micrograms, right? That's just a tiny bit. And it's really in conjunction with adjuvant that we get Such high levels of efficacy, high levels of neutralizing antibody with a very broad spread of epitope identification. So I think those do matter. We are aware that there's going to be some data coming out soon from the U. K. Where they're doing mix and match studies that will continue to build our efficacy profile. Okay. Last question for Stan, probably your favorite question, question and that is how do you feel about being able to produce vaccine and can you provide some, call it, quantification if that's Court or other measures of success that you anticipate in the near term? Sure. And I think that We're not changing guidance that we gave a few weeks ago at the end of the Q1 earnings report. We are filing this on a global basis and we'll clouding all of the data now that the rest of the remaining CMC data, which is the long pole intent is being put together now and we expect to file with the U. S. FDA, with the UK NHRA, with the EU, EMA and also importantly, I think in India and Korea. And all of these filings are we intend to have those filings done in the Q3. And the different agencies will take Different times to evaluate it, but a lot of them are working on it right now because we've had global submissions. And our goal is to manufacture all of the plants. We have been successful at all the plants globally, these 8 manufacturing sites to produce product at commercial scale. We haven't had The raw materials to produce in the commercial scale consistently throughout the first half of this year, but we expect to be able to do that starting in the Q3. So Our goal is to have to be up at a capacity of around 100,000,000 doses per month by the end of the 3rd quarter and 150,000,000 doses per month call in the Q4. Perfect. Thanks for taking my question. Congrats on the data. Thank you. Call. The next question comes from Khachi Chekari with Jefferies. Please go ahead. Good morning and congratulations on the much anticipated data here. These data clearly position Novavax in 2,173 as one of the premier players in the space. I guess my first question is, call. Where are you at in the process of completing your CMC requirements versus where you were in early May? And I guess more importantly, How much risk would you say is there with you actually completing that seeing those sequencing requirements in before your Q3 filing? And I guess my Second question is just similar to Charles. Just if you could help us put into context your level of confidence in reaching your vaccine production goals in Q3. Is there a particular supplier coming online, the Biden administration lifting, the embargoes? Any data points that you can cite to conference call. Yes. So it's a process and the process involves Developing assays for your products. So we make products in 8 different plants in 8 different countries. And we have to make sure that the process allows us to have make the same product. We make a batch in the Czech Republic that looks exactly the same as career in the United States. So to do that, you have to develop a set of comparability assays, potency assays, purity assays, which show the product is the same. And that's what takes time. And we're in the middle of that validation process. We've taken one of the most important assays and qualified it. Now you validate it. And that basically just means you have to run it in every in just a ton of times with every varying condition And show that it works the same way. So we're doing that and it takes time. But we're I think we're going to be successful call in meeting our timelines. With respect to the one of my concerns about being able to scale up that requires Call. Raw materials, I think that the one of the things that's constrained us in the past is not be able to ship materials across certain borders. And now the borders are opening up and all the manufacturers have been trying to increase their capacity, whether it's for filters, whether it's for 2,000 liter bags Well, media, they're all trying to they've been working with this is an industry wide problem and we're getting better availability of product. Still tight. If you look in normal times, you'd want 6 months worth of raw material inventory in the production plant, And we don't have that, but we have weeks at least and before we had a week and so it's getting better. That's helpful. Thank you. Call. The next question comes from Mayank Mamtani with B. Riley FBR. Please go ahead. Good morning, team. Congrats on the seller data here and thanks for taking our questions. So two quick ones on the data. So, Philip, on the dropout rate, call. Just a brief comment on what you had what you sort of reported here relative to what you had expected. And then in terms of follow-up, call. How much you have in terms from a safety standpoint and what more you think you need to if you had to file for an EUA putting the assay requirements aside, like how much safety follow-up you have at this point? Call. Yes. So maybe the second question first. So we timed the closing of the database and the efficacy evaluation to match was required by the FDA to seek EUA. And that was the median of safety data for 2 months after the So that's captured and that is the data that you got a brief glimpse of now. This is ongoing process. We just have top line results, but we'll be getting rest of the safety data, which we'll be summarizing, writing it up into a clinical study report and submitting it to all the global regulatory agencies, including the U. S. R and D. As far as dropouts, we had, at the end, approximately 5,000 people drop out of the study in all, And they dropped out at different rates, slightly higher in the older people who had easier access to EWAY vaccine early on call and slightly less so in the younger folks. So, be that as it may, as you saw, we obviously had adequate cases to evaluate efficacy of the vaccine, and We're going to have more than enough cases in the city database as well. Great. And then on the unsequenced 23 cases, Is there a reason to believe that there's a higher proportion of delta and beta variance in there, just given the relatively again, everything's relative, call. So a low BE number there? Yes. It's that would be really speculative. I think one thing you can feel conference. If there are some hiding in the vaccine group, they're mild disease. So when we run with the primary analysis included even those we couldn't sequence and all the disease that did breakthrough was mild. We hope to have some additional sequencing. Based on that, we're taking different approaches to sequence it and that will be cooked into a post hoc analysis We could evaluate that as well. So we may be getting some more information. We just don't have it in hand right now. Awesome. And then You obviously have had a lot of other publications come out since Friday, the 3 preclinical studies and then also The co administration study with flu, a sub study part of your U. K. Cohort. Maybe just Call. Kind of just touch on like what how you are thinking about variant specific versus a single booster given that you're seeing such strong efficacy here against the VOI, VOCs? Call? And also just maybe comment on what we should be watching out for the COM COV study data coming out later this I guess in July at some point? Call. Yes. So, first of all, as far as the variant work, the real question I believe you're asking is, Do we really need a variant specific vaccine or if we give just this vaccine or this vaccine as a booster, would that be adequate to achieve very high levels of protection against their variance. And right now, the data we have from this study are quite reassuring. As you know, in our Phase 2 study, we are giving 6 month boost dose. So we'll be able to quantify the level of immunity and we can try to in the lab see those can neutralize conference, whatever variant is emerged at that time, including delta. So that's call. One feature. And of course, we're also working on constructing our variants of vaccines and maybe Greg can touch base on what they just published. Yes. Hi, Monique. As you know, this Friday, we put out a manuscript on the beta variant we made and we tested that in call. Three different animal models. It was very effective at preventing matched virus as well as drifted virus B117, the original prototype stream. So I think Phil's right. At this data, it's really encouraging, call suggesting that our vaccine against the various we see in the U. S. Works extremely well. We're still on track to evaluate call. The South African variant strain in the trial because we want to be ready. Also in that paper you saw we boosted Nonhuman primates who have been primed with original strain with our South African variant strain, we've got extremely high immunity So reaching back and reaching forward. So our goal right now is to generate the data. We're watching the very ominous 3rd wave, for example, in South Africa. And we want to be ready if there's a decision made or need to go to the variant. Right now, I think this data speaks for itself very strong against the variance we've seen circulating certainly in the U. S. Call. And just back to the COM COV data, that immunogenicity data will be available at a later date. But as you know for the COM COV, the initial On their initial study where we did not participate, they published their adjacency profile as a letter and we're hopeful that we're going to have a similar treatment to COMCOP 2 where we did participate. So perhaps that data will be available in the near future as well. And just to touch base on the study that perhaps you were referring to in your question, We have a manuscript which is available on medRxiv now, which included the influenza substudy in the UK study. Call. And there we demonstrated that we had excess flow reactogenicity when we co administered our vaccine with influenza. We did not impact call. In response to flu at all for all four strains in the main group. And most importantly, we maintained a trend toward efficacy of 87.5 percent in the people who received flu vaccine at the same time as our vaccine. And this really compares favorably with the overall endpoint, which was 89.8 event. So I think we at least have a path forward now to thinking about vaccinating people in the wintertime when they need both influenza as well as COVID call. Great. Thanks for the comprehensive answer and appreciate you taking our questions. Congrats again. Call. Call. The next question comes from Eric Joseph with David Weiss. Please go ahead. Call. It's Eric Joseph with JPMorgan. Thanks for taking the questions. Just one on sort of the timing of the data Call. Elyse, this morning and congrats on the repeat high efficacy rate. Just given that you basically had accrued all the events by the end of April, call. Can you just sort of help us understand sort of the lag in timing between having those essentially those cases in hand and the fuller dataset detail today. And then on the regulatory front, if I remember correctly, call. The demonstration of probability with large scale manufacturing with 2,173 was needed to start this Phase 3 trial. Can you just clarify how call. The CMC requirements for submission of EU differ from those to start with that 'nineteen and should be or can we anticipate a relatively more swift process with respect to in the UA package here in the U. S? Call. I'm not 100% sure I understood the first part of your question, but I'll take a crack at it anyway. So yes, we finished accruing cases at the end of April. And I think your question was why did it take so long to get the results? And in that regard, we had many steps we had to take, including cleaning call data for 30,000 people since we need to have a clean safety database as well as the efficacy database. We also need to sequence of the strains. And finally, all the severe cases were adjudicated by external adjudication committee. So they had a lot of work to do to make sure that they all lined call. All the patients of mild, modern, and severe disease lined up. So essentially, that's the process we undertook call. And we just got the results now. Did that answer your question? I wasn't sure if I comment right there. Maybe there's one piece also. So now we have strong efficacy data with a scaled up manufacturing process. So during comparability of our other processes, we will anchor a lot of the work to this to the capability to this lot. So it provides a very good anchor for the CMC to have a lot that's gone through efficacy. So I think that's what you were referring to. Call. Yes. Derek, this is Stan. I apologize, but could you redo your question about CMC issues? Call. Yes, sure. It was my understanding that comparability with this call. Large scale manufacturing, large scale lot is what you need to demonstrate or satisfy with OWS to start with that 19. Call. Is there other requirements for CMC call meaningfully different to satisfy new regulators compared to what was required to start call Phase 3 trial here. I guess given that you essentially use large scale used products, manufacturers under large scale process here for 'nineteen, so do you anticipate a relatively sort of more swift? Do you basically have the validation assays already in hand support, the CMC requirements for EUA and the U. S? Yes. I think the answer to this is that we The process of getting these assays in place requires qualification, developing them and then qualifying them and then validating them. And so we have gone through the qualification process, in particular, and are In the middle of or hopefully the tailwind of validating, which is a time consuming process. And then you run all the assays in the various lots And show comparability. So it's just a time consuming process. We've got lots of people working on it. We've got 8 different plants that we're trying to get demonstrates comparability on it. But having said that, the work is going on and we'll get there. Call. Okay. Maybe just a final question, if I could. A lot of questions from investors on how you're thinking about pricing, particularly, sort of whether the pricing call. The anticipated pricing model differs for a vaccine that is used sort of in this pandemic period versus call. One that's used more as a booster in an endemic setting looking conference call next year's following? Yes. And that's a great question. And the answer in the short run is The pandemic, we have a pricing scheme that's got a tier for the low income and upper middle income and high income countries And it's pretty much in line with some of the other manufacturers. And in fact, it should be noted and I think this is a good thing, it should be noted that Given that we've got a commitment of 1,100,000,000 doses with COVAX along with our partners here in the institute, a lot of our first dose We're going to go into low and middle income countries as it should. And then but in parallel, we have call. Advanced purchase agreements with 4 or 5 high income countries that we will be supplying those as well. And so But in the very early days, it's going to be low, middle income countries. And throughout 2022, I think it's going to transition from satisfying The $1,100,000,000 dose commitment, all of our APAs and eventually it's going to transition into a booster. Call. We haven't determined what the pricing scheme for that would be, but I wouldn't be surprised if it didn't follow a tiered pricing again By country that we sell it to. So I think particularly in the United States, Our vaccine is going to be probably most important to use as a booster, but that's going to be true. We've got a lot of actually United States, we've got a lot of prime boost doses to get out there. There's a lot of people that haven't been vaccinated yet. But You mean as we work our way through those, there's going to be a need for booster. We know there's a need for boosting and I think that's pretty well accepted in the industry. And the studies that are going on right now are going to show how our vaccine is effective at boosting and has a safety profile that's available. Call. Okay, great. Thanks for taking the questions and congrats again. Okay. Call. This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks. Call. I'm sorry, was there one more question? There appears to be one more question. Yes. We actually had somebody just join in as I was saying that. We have Vernon Bernardino with H. C. Wainwright. Please go ahead. Hey Vernon. Call. Hey, Stan. Thanks for squeezing me in and congratulations on the whole process and the Successful positive results. It's been a long journey and glad to have been there with you. Thanks for squeezing this question. The comments you just Pad. I brought a question that I didn't think of until then, and that is what have you looked at so far as far as Conference Call. Like a market study that you could perhaps expect in the future? And How are you looking at it as far as market share when you get to the vaccine being participant or having a role in a market where it's all booster shots in the U. Call? Yes. So we have been looking at it and I think that what we see is not a pandemic vaccine that just queue goes away once we get everybody vaccinated. I think we look at this as an ongoing large market, call. Much like characterized maybe by the flu where you have a changing virus and has to have a booster, whether the booster has Should be an annual shot or something different from an annual shot, time will tell, but we see this as an ongoing market. So When you transition from pandemic to the more commercial aspects of the market, then you have to look at product advantages more carefully and market share and pricing will probably follow those characteristics. We're confident In our vaccine, the characteristics we have, the safety profile, the stability and ability to ship at that standard refrigerated temperatures going to be an advantage of ours. And so that's how we see that play out. There's going to be also call. An opportunity to combine our vaccine with our NanoFlu vaccine. You know the results that we have from our Phase 3 pivotal study earlier last year. And we've already we just published actually a paper showing that in animals now that are combination nano flu COVID vaccine does very well that the combination doesn't Adding COVID to flu or flu to COVID doesn't change the immune response that you get to either. And we actually challenged the animals with COVID and got 100% protection against COVID challenge. So we're optimistic that we could bring this along as well. Call. Perfect. That's an environment I'm looking forward to. And congratulations again, and thanks for squeezing in my question. Call. You're welcome. Okay. So now I think we're done. And I'd like to thank everybody for listening in. We've This is a huge milestone for the company and hopefully for the world of vaccination. And so we expect to bring our platform forward into people's Call. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.