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Moderna (NASDAQ: MRNA) SARS-CoV-2 Vaccine Interim Phase 1 Data Call Transcript

MRNA COVID-19 Vaccine Trial Conference Call - Final Transcript

Moderna Inc (MRNA) Q1 2019 interim phase 1 data conference call dated May. 18, 2020

Corporate Participants:

Lavina Talukdar — Head of Investor Relations

Stephane Bancel — Chief Executive Officer

Tal Zaks — Chief Medical Officer

Juan Andres — Chief Technical Operations and Quality Officer

Analysts:

Matthew Harrison — Morgan Stanley — Analyst

Salveen Richter — Goldman Sachs — Analyst

Cory W. Kasimov — J.P. Morgan — Analyst

Alec Stranahan — Bank of America — Analyst

Hartaj Singh — Oppenheimer — Analyst

Yasmeen Rahimi — ROTH Capital Partners — Analyst

Alan Carr — Needham & Company — Analyst

Stephen Hoge — President

George Farmer — BMO Capital Markets — Analyst

Jonathan Miller — Evercore ISI — Analyst

Geoffrey Porges — SVB Leerink — Analyst

Jim Birchenough — Wells Fargo — Analyst

Presentation:

Operator

Good morning and welcome to the Moderna’s Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded. At this time, I’d like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna.

Lavina Talukdar — Head of Investor Relations

Thank you, operator. Good morning everyone and welcome to Moderna’s conference call to discuss the Interim Phase 1 Data for mRNA-1273, our vaccine against the novel coronavirus. You can access the press release issued this morning, as well as the slides that we’ll be reviewing by going at Investors section of our website.

Speaking on today’s call are Stephane Bancel, our Chief Executive Officer; Tal Zaks, our Chief Medical Officer; Stephen Hoge, our President; and Lorence Kim, our Chief Financial Officer.

Before we begin, please note that this conference call will include forward-looking statements. Please see Slide 2 of the accompanying presentation and our SEC [Technical Issues]. Before we begin, please note that this conference call will include forward-looking statements. [Technical Issues] for important risk factors, that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments. With that, I will now turn the call over to Stephane.

Stephane Bancel — Chief Executive Officer

Thank you. Lavina. Good morning or good afternoon everyone and thank you for joining our call. One hour ago, we reported positive interim Phase 1 data for mRNA-1273, our development candidate against the novel coronavirus, as well as, mouse challenge data. We believe that these two datasets will present an important step forward towards the development of a vaccine candidate against SARS-CoV-2. We are encouraged by these interim data and it confirms our strategy to develop mRNA-1273 as fast as safely possible.

Let me briefly summarize the key takeaways from this morning’s press release. We talked on new investment [Indecipherable] data. After two doses, a prime and a boost, all participants across the 25 microgram and the 100 microgram dose cohorts seroconverted with binding antibodies levels at or above levels seen in convalescent sera, which is the level of antibody in human blood after being infected by SARS-CoV-2 and recovered from SARS-CoV-2 disease. mRNA-1273 elicited neutralizing antibodies titer levels in all eight initial participants across the 25 microgram and the 100 microgram dose cohort, reaching or exceeding levels generally seen in convalescent sera. mRNA-1273 was generally well tolerated. We anticipated [Technical Issues].

We also announced between 25 [Phonetic] for pre-clinical mouse challenge study and with a successful vaccine candidate, we’re entering one for several animal challenge models. This consists of vaccination of animals with the same dose regimens as that’s used in clinical [Technical Issues], in this case a prime and a boost. These are placebo controlled studies. After vaccination, the animals are exposed to high levels of the SARS-CoV-2 virus in order to mimic a natural infection. In this mouse challenge study, we showed that mRNA-1273 provided full protection to 100% of the mice against viral replication in the lungs of the mice. The totality of the data released today, the interim Phase 1 data and the preclinical mouse challenge model gives us confidence that mRNA-1273 has a high probability to provide protection from COVID-19 disease in humans. We’ll know how much protection from the efficacy performance of a Phase 3 study. Currently, our plan is to start the Phase 3 study in July 2020. We could not be happier about these interim data.

On Slide 4, you will see the progression of mRNA-1273 program. The sequence of the virus was made available to the world only four months ago. It is humbling to already have this positive data and to be finalizing, as we speak, our Phase 3 protocol will begin to start dosing in July. With this, let me now turn to Tal.

Tal Zaks — Chief Medical Officer

Thank you, Stephane, and good morning everybody. Before I review the interim data, let me start with a reminder of the Phase 1 trial design, which as you know was run — is being run by the NIH. The study initially enrolled a total of 45 participants between the ages of 18 to 55 for the 3-dose cohorts, 15 participants each in the 25, 100 and 250 microgram dose levels. The study was also recently expanded to include two additional age cohorts – 55 to 70 year-olds and 71 and above. Enrollment into these cohorts is ongoing. And the vaccination regimen is a prime boost regimen, a month apart totaling two vaccinations per participants. The first injection was given at day 1 and the second vaccination was given at day 29. The primary endpoints of the trial are safety and reactogenicity and tolerability and immunogenicity at day 57, although immunogenicity or titer levels were evaluated more frequently starting at day 15, day 29, day 36 and day 43.

Today, we’re sharing the top-line interim analysis from the trial. Safety and immunogenicity data from the 25 and 100 microgram dose levels are available after two vaccinations and safety and immunogenicity data for one vaccination at day 29 for the 250 microgram dose level.

So let me start with the safety and tolerability profile. Overall mRNA-1273 was generally safe and well tolerated with the safety profile that’s consistent with what we’ve seen in prior Moderna infectious disease vaccines in clinical studies. One incidence of a grade 3 adverse events of erythema or redness around the injection site was reported in the 100 microgram dose cohort. But the most notable adverse events were three participants with grade 3 — systemic grade 3 symptoms at the 250 microgram level that followed the second vaccination at that dose. We do not see any of these after the first dose and so I believe these flu-like symptoms are really an indirect measure of a strong immune response. That said, all adverse events have been transient and self resolving, no grade 4 adverse events — no serious adverse events have been reported.

Now let me talk about the immunogenicity. Similar to our other infectious disease vaccines, we observed a dose-dependent increase in titer levels both across dose levels and between the prime and boost injections within a dose level. All participants in the 18 to 55 age cohort across all dose levels seroconverted by day 15 of the single vaccination such that we could see antibodies in their blood. For the 25 microgram dose, at day 43 or two weeks after the second vaccination, the level of these binding antibodies that the vaccine generated reached level seen in convalescent sera from people who have recovered from COVID-19 disease. In fact, if you look closely, they’re already above the median or the halfway point of the levels induced by or seen in convalescent sera.

At the 100 microgram dose, also at day 43 or two weeks after the second vaccination, the level of binding antibodies now significantly exceeded the level seen in convalescent sera. I should say that convalescent sera used to benchmark these results were obtained within a month or two after the disease. Neutralizing antibody data are available only for the first four participants in each of the 25 and 100 microgram dose cohorts. Consistent with the binding antibody titers, mRNA-1273 vaccination elicited neutralizing titers in all eight participants as measured by plaque reduction neutralization assays against live SARS-CoV-2 virus. The levels of these neutralizing titers at day 43 were at or above levels generally seen in convalescent sera.

Now, I should say this is a difficult assay to perform for a live dangerous virus and we are really indebted to NIAID and its academic partners for setting these up and running them. The important element here is that, in general, neutralization correlates with total binding antibodies once you’re above a certain threshold. So the relevance of these results for us is not just the direct confirmation that in these first eight subjects, indeed, we see neutralizing activity, but they really allow us to extrapolate but we expect to be achieving in all 45 subjects.

Let me touch on the preclinical results from the viral challenge in mice that was conducted also in collaboration with NIAID and the institute’s academic partners. The results from the challenge study in mice show that mRNA-1273 completely prevented viral replication in the lungs of animals challenged with SARS-CoV-2. Importantly, the neutralizing titers that we see in Phase 1 clinical trial participants at the 25 and 100 microgram dose levels are consistent with the titers that were protective in the mouse challenge model. So since early this year and in rapid succession, we along with our collaborators at the NIH went from selecting the antigen for mRNA-1273 on January 13, to vaccinating the first participant on March 16, a mere 63 days later. The FDA has given us clearance to proceed to Phase 2 on May 6 and the top-line interim results today boosts our confidence to move into Phase 2 shortly. NIAID plans to have these and full data from the Phase 1 trial in the public domain prior to the start of the Phase 3, which we now anticipate will start in July of this year.

As mentioned previously, we will start the Phase 2 study in this quarter and it will be evaluating the safety reactogenicity and immunogenicity of two vaccination, the prime and boost regimen of mRNA-1273 at 50 and 100 microgram. Based on the data that I’ve described, the study protocol is being amended and will no longer include the 250 microgram dose. Since we are already potentially there, the lowest dose of 25 microgram, there really is no need to go to 10 times that level and especially when in the context of a pandemic, we expect demand to far outstrip supply and the lower the dose, the more people we expect to be able to protect. We intend to enroll 600 participants in two age cohorts, 300 participants in adults aged 18 to 55-year-olds, 300 in older adults aged older than 55-year-olds.

Finalization of the Phase 3 protocol is ongoing and we expect to begin the trial, as I said, in July. We’ll come back and update once we have complete alignment on that protocol between us, our collaborators at the NIH and of course the FDA. Let me now turn it over to Stephane for closing remarks.

Stephane Bancel — Chief Executive Officer

Thank you, Tal. We are excited and humbled by the opportunity to bring forward the vaccine against SARS-CoV-2. The development of mRNA-1273 potentially accelerates our overall mission to develop a new class of medicines for patients. I would like to thank the entire Moderna team who have been working seven days a week, literally, for four months now and the NIAID team who have [Indecipherable] to this place and all of our partners and suppliers. I would like to especially thank the many people who participate in our clinical studies, including patients, healthy volunteers, the physicians and nurses who have worked tirelessly to continue this important clinical study in a very competitive environment with the pandemic going on. With that, we’re now happy to take your questions.

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from the line of Matthew Harrison from Morgan Stanley. Your line is now open.

Matthew Harrison — Morgan Stanley — Analyst

Good morning, everybody. Thanks for sharing these data and thanks for taking my question. I guess two parts from me. First, if you’re willing, could you provide us maybe a little bit more specificity around the specific titers you were seeing, whether that’s what the titers you were getting with the vaccine or maybe specifically what the titers are that you’re thinking about when you compare against convalescent sera? And then second, can you maybe talk a little bit more in detail about the longitudinal results here, where you’re seeing clear increase in titers after the boost? And how do you think about the need for a boost versus being able to use one vaccination? Thanks.

Tal Zaks — Chief Medical Officer

Thanks, Matthew. This is Tal. Let me take these two questions. I don’t think we’re being specific yet about the actual titers. I think we are going to defer to NIAID and it’s academic partners to publish these results and I think, of course, the relevant part here is not the absolute level of the titers, but actually how they correlate across between what we see convalescent serum and any data in animal models. I think the other point that is worth noting is that these are still relatively early days, both for characterizing and standardizing clinical assays, as well as, for characterizing and standardizing what one sees in convalescent serum. So many people and many groups across the world are busy working at this. I think there is a concerted effort by NIAID that we are supportive in part of to standardize and qualify these assays. And I think all of that should emerge in the coming weeks and months. So I don’t think it’d be appropriate to just give a number out there because what’s relevant is not the number, it’s our confidence in context of what that number means in terms of standardization and assays.

In terms of longitudinal results, thank you for that question. Indeed, as one would expect from basic immunology of applying boost, the prime is clearly seroconverting people and getting antibody levels that you can clearly see that are real and there is a clear dose response among the doses. When you come in with a boost, that’s where you really see an additional significant increase in those titers. The early data that we have for neutralizing activities — these are the first four in each of the dose cohort that we have and so we focused obviously on the end game here which is two weeks after the boost. And at that level, if you look at what you get with a 25 micrograms, as I said, you’re already above the median and at the 100 micrograms, there is no overlap in the confidence intervals. If your question is what you get after just one dose, I think you’re starting to get antibodies — at a dose of 100 micrograms, you’re starting to get to the level that you can see in convalescent serum. But I think we anticipate, going forward, at least at the doses that we’re talking about today, with the prime boost regimen into Phase 3.

Matthew Harrison — Morgan Stanley — Analyst

Great, thanks very much.

Operator

Thank you. Our next question comes from the line of Salveen Richter from Goldman Sachs. Your line is now open.

Salveen Richter — Goldman Sachs — Analyst

Good morning. Nice to see this data. So two questions for me. How do you get confidence here as to what is protective for the binding and neutralizing antibody levels seen in convalescent serum? And then secondly, based on everything you’ve seen to date, what do you see as the risks and the forward as you look to the Phase 2 and Phase 3?

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Tal Zaks — Chief Medical Officer

Thank you, Salveen. So what is — how do we get confidence as to what is protective? I think it is a measure of really two elements. One is understanding the

— how these correlate with convalescent serum and I think while these data give us great confidence that we’ve got now the right dose range for Phase 3, just being at convalescent sera could be enough, we know or at least we believe and I think most experts would agree that once you’ve had disease, at least as we know it in the past five months, with relatively short follow-up, but once you’ve had disease, we’ve not seen really a case that describe of getting disease again and I suspect we would have seen those descriptions if that were a real problem.

So we anticipate, I think like most experts, that having disease is protective and therefore having antibodies by extrapolation is likely protective. And so if you get to the level of people who had disease, that should be enough, that the other point that I think is going to give us confidence is the various animal models. Were describing just the first one here today. I should qualify and say that the virus here is actually a virus that had been slightly altered so that it binds to the mouse Phase 2 receptor, but it’s a valid model in the sense that you see the full gamut of replication and the organs you care about, which in this case is lung and to the degree that you can correlate generating antibodies to the same level and consistent with that, you then challenge animals and they do not get replication of the virus in their lung. I think that all increases our confidence.

I think what you’ll see in the weeks and months ahead is more data, both in terms of animal models and in terms of the validity and standardization of these assays that would allow this confidence to continue to increase. Ultimately, we’re going to have to pick a dose for Phase 3, and as I said, we believe that it’s going to be somewhere between 25 micrograms and 100 micrograms. I think whenever you’re a vaccine developer, you always want to make sure that you’ve got a margin and that you’ve got a higher immune response in what you absolutely need because you expect to see some variability in the population there and inevitably ours is. But here, we’re going to have a very difficult math because the higher the dose, the fewer people we’re going to be able to immunize. So I hope I’ve answered that.

The risks going forward? Well, it’s a good question. I think the biggest risk as I see it is actually in being able to see enough cases. So what do I mean by that? The success of the Phase 3 trial depends on only three factors. Number one, can we — or two factors, can you get enough cases in the placebo arm such that in the vaccinated arms, if you avoid those cases, you can actually speak to it statistically, and that’s a function of how good is the vaccine and how protective is it to immunize against this spike protein. I think the totality of science tells us that this is the right antigen and that we should be protective. The challenge for me then shifts to how do I ensure I have enough cases to be able to demonstrate that as quick as possible? And I think that’s a function of being able to conduct a Phase 3 trial that’s large enough, but more importantly, that actually goes and vaccinates people who are then at risk for getting disease in the ensuing months because if I vaccinate a whole bunch of people, doesn’t matter how many, if there is no circulating virus in the places that I chose to vaccinate, then we won’t have the cases and it will be a long time before we know.

So I think really, as I look forward, I think these data today take off the table the risk of not being immunogenic or the risk of the antibody type being wrong. No, it works and it’s — you’d see demonstration of neutralizing activity. So I think the major risks, as I look ahead, is just operationally being able to demonstrate clearly that there is safety and efficacy in a large randomized trial. So we’ll get there, it’s just — it’s really a question of time.

Salveen Richter — Goldman Sachs — Analyst

Thank you.

Operator

Thank you. Our next question comes from the line of Cory Kasimov from J.P. Morgan. Your line is now open.

Cory W. Kasimov — J.P. Morgan — Analyst

Hey, good morning, guys and really great to see this latest very encouraging step. So two questions from me as well. First, can you provide additional details around the systemic grade 3 safety events that were seen at the 250 micrograms dose and was there any evidence of this in lower dose cohorts even sub-grade 3? And then secondly, how much do you want to see to select for that go-forward dose in Phase 3? Will this be coming from — will this information come from Phase 1, since you’ve now included the 50 microgram dose or is it going to be based on preliminary Phase 2 data as well? I guess, what else is left to finalize that decision? Thank you.

Tal Zaks — Chief Medical Officer

Hi, Cory, it’s Tal. Thanks for the questions. The systemic grade 3 were sort of your typical solicited adverse events, I think it was a case of fever, we had some muscle pains, a headache, fatigue, among those symptoms is what you see. They were all gone by the next day and they’re sort of typical solicited adverse reactions for vaccines. We didn’t see anything that we didn’t expect frankly. You do see some grade 1’s and 2’s. We haven’t reported the exact numbers. You’ll see that all come out in the table but nothing surprising and nothing that we believe would prevent one from fully developing and deploying a vaccine.

What additional data do we expect prior to Phase 3? I think it’s — they’re going to be the totality of the data from the Phase 1. It’s going to be the emerging safety — the very initial safety profile from Phase 2 to just confirm safety profile. And I think that it’s — we’re talking a matter really of weeks before we hope to be launching the Phase 3. There will continuously be data coming out of this Phase 1 and of course we’ll do our best to accelerate any learnings we have from the emerging Phase 2. I also think it’s important to continuously look at the assay per performance in continuing to characterizing and standardize what convalescent sera is, so that we’re all comfortable with the choices that we’re making here.

Cory W. Kasimov — J.P. Morgan — Analyst

Okay, great. Thank you and good luck with the ongoing work.

Tal Zaks — Chief Medical Officer

Thank you.

Operator

Thank you. Our next question comes from the line of Geoff Meacham from Bank of America. Your line is now open.

Alec Stranahan — Bank of America — Analyst

Hey, guys. this is Alec on for Geoff. Thanks for taking our questions. One question from me, in the Phase 1 study for CMV neutralizing antibody titers were around 10 to 40 times that of seropositive patients and for the COVID-19 Phase 1, it seems to be much lower. So, could you provide some color around this and what it means in terms of conferring protection, particularly since the patients facing an active immune response may yield higher titers than what can be assayed in convalescent plasma? Thanks.

Tal Zaks — Chief Medical Officer

Thanks, Alec. Let me try and answer that. I think, the salient comparator, as we look at the data is that at the 100 microgram after the boost, we far exceed what you see in convalescent serum, the confidence intervals do not overlap. I think at the 25 microgram, as I described, we’re already at that level. I think the relevance for me here is the convalescent sera, we’re still only with a few months of history from this disease. So we’re talking about convalescent serum that were obtained at one to two months after disease, which is sort of their peak. So I think it’s an appropriate benchmark.

I think CMV is a different story because CMV you’re talking about a chronic latent infection and these are antibodies that people live with them constantly. So I don’t — I think you’re comparing apples-to-oranges here.

Your second question, I think is the one that everybody is sort of wrestling with which is, okay, what level are you shooting for and what is protective. And as I said, I think that determination is going to be a function of a full quantitation and standardization of the assays in convalescent serum and seeing more data as it relates to the preclinical models. What do I mean by that? Well, if you look at this mouse study that we described, so after a prime and a boost as a dose that completely protect the animal, we see neutralizing activity that is the same as what we’ve described here after a prime and a boost. But one of the salient points is that at that dose in the mouse, after just the prime, the mouse was already protected. And so I think we’re getting a comfortable margin here to know that we’re at the right level that one needs to be in to protect people. I think the question is going to be, okay, how much higher above that do you want to have a margin of safety.

Alec Stranahan — Bank of America — Analyst

Great, thanks and congrats on the progress.

Tal Zaks — Chief Medical Officer

Thank you, Alec.

Operator

Thank you. Our next question comes from the line of Hartaj Singh from Oppenheimer. Your line is now open.

Hartaj Singh — Oppenheimer — Analyst

Great, thank you for the questions. And on the progress, really kudos there Tal and Stephane. Just taking a step back, one of the things that I think some investors are struggling with is how quickly Moderna has moved. I think Moderna has been pretty transparent about how they’re moving — you’re moving quickly. Stephane, if you can take a step back and maybe talk a little bit about how the platform, all of the manufacturing investments you’ve made, the personnel there have — that you’ve — that you have, have got you to a point where you could essentially do in one year that normally takes 5, 10 years, of course, the pandemic and regulatory authorities are being more helpful. And then secondly, how this new sort of approach using this platform approach with this investments in all the preclinical work you’ve done across all the modalities could also help in different modalities in there. Thank you for the question.

Stephane Bancel — Chief Executive Officer

Hey, good morning and thank you for the good question. If I think about kind of how did we get there, how could we go from the sequence in January to our interim Phase 1 data in May, the green light from the FDA in May and saying that we believe our current path is to start the pivotal Phase 3 in July. I think there are maybe five things that come to mind. The first one is of course the platform. Messenger RNA being an information molecule, we could not have done that if we were lacking a recombinant, like [Indecipherable] virus technology always. The fact that we are really dealing with an information platform that we can work directly from the genetic information of a virus and literally drop that into our vaccine cassette from the sequence of a virus I think is really a unique feature that creates extraordinary leverage and network effect.

The second piece for me is that this was not our first vaccine. I think there has been a lot of question we have asked ourselves, a lot of sensitive unknown process, unknown during manufacturing that I think one of the place where we got lucky but we were prepared for it is the progress of the nine vaccine in clinical trials before that. And so we have been actually doing vaccines first in humans of our H10 flu by December 2015. That’s more than four years ago before we started 1273. I think we’ve been working on couple of years on the science and CMC readiness for manufacturing on the vaccine and we always keep on running, we keep on working. The teams in the science have developed new lipids, more constant mRNA construct. And on the process side, Juan and his team keep on inventing new processes, they’re keeping the process — better yield, more potent mRNA. And as you know, we will never stop. We still believe we’re in the early days of mRNA science. We still believe we have a lot to learn and we still believe we are the best company positioned in this space to keep growing and keep running and keep making better and better products.

The third thing that enabled us to move very quickly, is that we were prepared because we have been working with NIAID, with Tony Fauci, the government on the Middle East Respiratory Syndrome which is another corona, which as you can imagine, in those few hours, when we saw the sequence of SARS-CoV-2 and the team had to really kind of analyze and understand which protein to pick, how to go at developing the vaccine, those are of course fundamental to serums, because if you get these wrong, then the vaccine is not going to work. We were also was massively informed by all the work that has been done by our teams and NIAID over the last couple of years. So they’re also very important. I think it might have been a very different situation, you could never work on the coronavirus before.

The fourth one is Norwood. As I’ve said many times, and I won’t stop repeating because I believe it is a competitive strategy [Indecipherable] company, having our own manufacturing facility from raw materials to shipping a virus to clinical trials, having our own teams who understands the process, who can make judgment about decisions is really fundamental. If we are not with contract manufacturers, we could never have moved so fast because, when we’ve had to call, four, five CMOs around the world and the chance they all had an empty slot for us waiting was of course very slim. And so being in Norwood, with our own team, own equipment, own facility allow us to tell the team, this is very important. This one is to move through the system much faster than usual and people knew the importance of these and as the virus was spreading, our determination just grew stronger with the days.

And the last thing for me is the team. We have been very fortunate over the years to assemble a team across the company, I’m not talking only about the executive, the entire company, a team of scientists, engineers, clinicians, women and men, who I think believe in the mission of the company. This is once in a lifetime opportunity that we have in our career to be able to collectively together figure out how to be the new technology that could help so many people. And I think today the company is nine years old, is we’re getting to a place where all those pieces are coming together. So it’s more of a network effect of all the investments we’ve made, of the science, of what we have done before that helped us prepare for this moment. Now, many of us wished we already had a big manufacturing plant where we could have been able to make 20 million or 50 million doses across them all from January, that would have been amazing. Unfortunately, this capacity is a bit too early in company history. But this is what I think has made this opportunity unique.

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And to your second question, I think the width across the platform is going to be extremely valuable both internally in how we think about study design, how we think about translating in our products from preclinical to clinical. There are a lot of learnings, as you can imagine, this is a very special moment for the company. And if you look at it at a more global basis, assuming we start in July as planned in our Phase 3 for 1273, we have not yet shared the size of the study because we have to discuss and align with the FDA as you already can appreciate. But it is going to be a large study, because as Tal said the biggest risk of a study is the attack rate, and how quickly are we going to get enough people infected to get to efficacy data. Well, one of the way to solve for that is, you just have a lot of people enrolled in the study because [Indecipherable]. And so that is going to enable us to get a very big safety that are going to benefit all of our vaccine programs. And then the question because of that, if you look at it, we have said, we are in 18 to 55 years old, 55 and 70, 71 and above. There are still a lot of population that we’ve not talked about yet that might be accelerated through our Phase 3 study, and this would be of course extremely valuable across the platform. So I think, I hope this answers your bulk of your question.

Hartaj Singh — Oppenheimer — Analyst

Great, thank you, Stephane.

Operator

Thank you. Our next question comes from the line of Yasmeen Rahimi from ROTH Capital Partners. Your line is now open.

Yasmeen Rahimi — ROTH Capital Partners — Analyst

Congrats team on the amazing progress and thank you for your tremendous dedication for working on this incredibly urgent matter. I had two questions for you. The first question is, can you share with us what was the median age of the cohort that just read out? Did you look at each dependency on neutralizing antibodies and immunogenicity data? And maybe some color on reasons for moving forward with the 50 microgram dose group and the new cohorts add of the Phase 1 study, and then I have a follow-up. And thank you for taking my questions.

Tal Zaks — Chief Medical Officer

Hi, Yasmeen. Thanks for the question. It’s, Tal. I don’t have data yet on the median age or any of those other analysis. These I think are things that we’ll be looking at in due course. I think the salient point for age is going to be very deliberately testing the immunogenicity in older and elderly adults, which is part of the Phase 1 as has been amended by the NIH. You asked about reasons for moving forward in the 50 micrograms. I think as we described, we think the Phase 3 dose is going to be somewhere between 25 micrograms and 100 micrograms. The question is how much of a margin do you want above already exceeding the median of convalescent serum. And with that in mind, the Phase 2 is really meant to expand the safety database and enable us to start the Phase 3. So that’s why we have amended the Phase 2 instead of 100 micrograms and 250 micrograms to be 100 micrograms and 50 micrograms. There’s no reason to go higher. But it is important to continuously expand our understanding both of safety, tolerability and eventually immunogenicity of the dose range that we think is the relevant one for Phase 3 and eventual deployment.

Yasmeen Rahimi — ROTH Capital Partners — Analyst

Thank you. And then another question is, can you shed some lights in regards to maybe the level of viral load reduction you saw on the challenge model or to an extent to the T-cell responses in that mouse model? And thank you again for taking your questions.

Tal Zaks — Chief Medical Officer

Yeah. So when you look in the mouse models, I think the relevant organ where you want to see decrease in viral replication is the lungs, right. That’s where the virus causes it’s pathology and there we see complete elimination of viral replication at the dose that we described that has the same level of neutralizing antibodies. I don’t have any T-cell data yet to share. I would make two observations. One, whenever we look across our platform, whether it’s preclinical or in clinical trials, we do see strong T-cell activity and you would expect that based on the fundamental scientific principles of how an mRNA vaccine works because it teaches the body — our body’s own cells to make the protein from within the cell and that’s how you stimulate T-cell responses as well. It is not a recombinant protein.

The other element is, when you see such a strong, what we call, anamnestic response with the boost, that is, you’re mounting immune response faster and stronger when you boost to that, tells you that you’ve got T-cell, that’s how the immune system works. You have a collaboration between T-cells and B-cells to stimulate the second response to happen quicker. So I think based on places where we have other data, based on the fundamental science and based on the magnitude and kinetics of the immune response we see here, I have little doubt that we are listed in T-cells. Measuring T-cells is a tricky thing especially in clinical trials and often is not very useful as a way to either predict immunity or find a corridor of protection. And so we’re really focusing here on the antibody assays as the relevant measures of what we’re achieving.

Yasmeen Rahimi — ROTH Capital Partners — Analyst

Thank you again.

Tal Zaks — Chief Medical Officer

Thank you for your questions, Yasmeen.

Operator

Thank you. Our next question comes from the line of Alan Carr from Needham & Company. Your line is now open.

Alan Carr — Needham & Company — Analyst

Hi, thanks for taking my questions and congratulations on your progress. Tal, can you go into a little more detail about your target group to be enrolled in Phase 2 and Phase 3? You mentioned that risk, and have you and government agencies come to any conclusions on which groups? Maybe it’s by age. And then also, can you give us an update on manufacturing capacity? Do you think you’ll be entering into more production agreements and then what sort of production capacity do you think you’ll have towards the end of the year? Thanks.

Tal Zaks — Chief Medical Officer

Thanks, Alan. Let me take the first question then I’ll defer to Stephane or Juan to take the second one. The Phase 2 is still subjects that we anticipate not being at risk, at least, as far as the local epidemiology of the centers although that’s of course very hard to predict these days in the U.S., and it will have both old adults and older adults. The expectation for the Phase 3 is that we will enroll people at risk. We will enroll people at risk, both based on their age, based on their co-morbidities and based on their occupations and other sort of parameters that put people at risk. I think the goal here is to have a fairly large trial that will look across different ways of how one defines that risk and leave some of that decision-making to the local investigators, who understand their local population better. But the exact discussion on what that would look like from a protocol perspective and then in real life I think is still ongoing between us and the NIH and FDA. I think FDA has an expectation that the Phase 3 trial will indeed include people at risk and will include a population that would be representative of the population where we ultimately expect to apply this vaccine and of course that should include everybody.

Stephane Bancel — Chief Executive Officer

Thanks, Tal. This is Stephane. Let me maybe take a stab at the manufacturing capacity question and whatever I miss, I’m sure Juan will add to it. As we’ve said in the past, we are currently scaling up our manufacturing capacity as fast as we can. Partnership with Lonza help us to be able, assuming the 50 microgram dose, to potentially get to 1 billion dose per year. And as you understand, we are basically expanding from the Norwood plant, which was our only manufacturing capacity with our Lonza partnership. To enabling GMP suite at Lonza, we have new capex, new teams and so on and so the way to think about it is a ramp. It’s a ramp between Norwood which was not kind of fully staffed and with all the process of the largest scale that we think we can get to, that the teams are working on as we speak. And so the way to really think about it I think is that in terms of multi-outputs. And so as we’ve said in the past years, now the multi-output is going to start obviously making millions of vials — doses, sorry, per month going into tens of millions of doses per month and just keep ramping that number up until we get to around 1 billion annual run rate on a multi-basis. That’s how you want to think about it.

So it’s going to take several quarters, obviously to get there. But the team is already working really hard, both in Norwood, as we said, Juan is transferring the process to Lonza plants in the U.S. as a first step. We can go to start making product there in July. So we’ll give you more update as time goes by. There are so many moving pieces right now. Just be assured that Juan and his team are highly aware that every additional million doses will make a big difference in many people’s lives. And so we’ll make sure while not compromising quality. Because of the product that we’ll be injecting people, so quality is priority number one, while not compromising quality. The team knows the role we have to play to protect a lot of people. So we get as much as we can out of the system.

Alan Carr — Needham & Company — Analyst

Thanks. One last one, Tal, with respect to animal models, what do you think is — is there a best animal model for respiratory infections? You’ve used a mouse one here. But, what are your thoughts on that? Is there — might we get — you mentioned there is more animal models in progress.

Tal Zaks — Chief Medical Officer

Sure. [Speech Overlap] Please go ahead, Stephen. Thanks.

Stephen Hoge — President

Yeah. So, Alan, thanks for the question. I think the answer is always virus specific and because this is such a new virus we just don’t know. We don’t have enough information to say which particular models are most predictive. There are several under development. Obviously you start with rodents. And there are also primate models that have been put in place. Our intention is to test in a pretty broad set of models, so eventually across most of them just to confirm the activity of the vaccine and its potential to generate protective immunity in those models. But I don’t think we have a clear sense of which one is going to be more or less predictive. Obviously, the most encouraging thing to find will be that across any model, across primate and rodent models, that we’re able to show this sort of protective immunity that we showed today or that we announced today, in just the rodent.

Alan Carr — Needham & Company — Analyst

Thanks.

Operator

Thank you. Our next question comes from the line of George Farmer from BMO Capital Markets. Your line is now open.

George Farmer — BMO Capital Markets — Analyst

Hi, good morning. Thanks for taking my questions. Wanted to talk about the difference between immunogenicity and neutralizing antibodies. I guess the two aren’t necessarily the same. At what point do you get comfortable with whether immunogenicity is actually predictive of the generation of neutralizing antibodies? Are we there yet? And is it necessary to keep on doing these kinds of high-risk assays on patients to determine such?

Tal Zaks — Chief Medical Officer

Hi, George. It’s Tal. Thank you. The short answer is yes. I think we’re there. In other words, there is, in people who are looking at it, there is a clear linear correlation between total binding antibodies and neutralizing activities. I think that’s true once you cross a threshold where clearly here at or beyond that threshold, with the data that we’ve described, I think the one caveat is that these assays need a certain level of qualification and standardization before we can just use binding as the correlate. So there are several assay formats that are being developed. There is the neutralization assay, there’s print which is looking at reduction of plaques that is the one that’s most complicated, but it is the gold standard, because it’s a live virus and it’s the full power lifecycle. There is, on the other end of the spectrum, just measuring antibodies, which is what we are describing here. In the middle, there is something called as pseudo-neutralization assay, which is where you develop a pseudo virus, one that has all the components necessary to bind and get into a cell but don’t have a replication cycle that are not dangerous to work with, and you can adapt these to high throughput.

There’s work ongoing by many labs to correlate all of these assays so that the simplest one are the ones that’s most high throughput can be put to use to develop a correlate of protection, a surrogate of protection, a way to actually be able to say, yeah, if you achieve this, then you should be protected and make vaccine development ultimately easier.

So, I think to summarize my question, I think we’re there in terms of the confidence we have that the antibodies we’re eliciting are the right ones. I think there is work to be done to standardize these correlations so that the simpler assays can be adopted for more high throughput use.

George Farmer — BMO Capital Markets — Analyst

Great. And then a couple more. Recognizing the urgency of developing a vaccine, what is the rationale for layering Phase 2 and Phase 3 so close together? I mean, do you need — don’t you need to get some sufficient information out in the Phase 2 trial before comfortably starting the Phase 3? And then also, how do these — how does the potency of this vaccine compare to what you’ve seen with the CMV vaccine?

Tal Zaks — Chief Medical Officer

Yeah. So, two good questions. I think the Phase 2 was envisioned with two goals in mind. Number one was to substantiate the safety, at least, in the initial month or two. Of what we are proposing to take into Phase 3 in the larger number than just 15 subjects per dose level before you go and vaccinate thousands, I think that’s a reasonable expectation from the agency and that was always the number one driver to do this Phase 2, even if the timeline is abridged, it is still some information that’s relevant that I think makes us all more comfortable.

I think the second reason to do the Phase 2 is that it will allow us to substantiate and better quantify the immune response. And in the world where our understanding of the immune response continues to evolve as to what is relevant and how much is relevant, there is a potential down the road that the Phase 2 with 100 subjects now per arm with very tight error bars will give us confidence as to the level of antibodies that has been relevant as measured both by standardized assays on standardized convalescent serum and animal models that the scientific world is developing and we feel is predictive of what’s likely to happen in people. And so the Phase 2 continues to increase our data. Even as the Phase 3 is launching and ongoing, I think the Phase 3 — the Phase 2 will generate data that is relevant for our continuously increasing understanding of what it is we’re trying to achieve here.

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George Farmer — BMO Capital Markets — Analyst

And relative to CMV vaccine?

Tal Zaks — Chief Medical Officer

Oh, yes. So I think the dose here — if you do the math of the CMV vaccine, remember CMV has six different mRNAs in every construct. So if you take a look at 180-microgram of our CMV vaccine, which was near the top end of the dose, I mean the highest dose we’ve tested was 300-microgram, and you divide that the mass by six, then you realize that the per antigen level in any one of those constructs was between 30 microgram and 50 microgram at the highest doses that we’ve tested. And here we’re talking about 25 microgram to 250 microgram of just one antigen. So that’s one way of thinking about it.

Of course, that is not all of biology. Every construct is going to get translated and expressed depending on the biology of that construct in that mRNA and it’s the sequence, the promoter, everything else that goes into it. So it’s not a one-to-one, but at least it gives you sort of a rough sense of a ballpark estimate of what we think — where we think the potency of this vaccine lands relative to others that we have been developing.

George Farmer — BMO Capital Markets — Analyst

Great. Thanks again.

Tal Zaks — Chief Medical Officer

Thank you.

Operator

Thank you. Our next question comes from the line of Jonathan Miller from Evercore ISI. Your line is now open.

Jonathan Miller — Evercore ISI — Analyst

Hey, guys. Thanks for squeezing me in here. I guess I wanted to ask more about neutralizing antibody levels in convalescent sera. And I understand that you’re not giving numbers here, but when we look at convalescent sera, we see huge variability in the reported levels of neutralizing antibodies. You’ve spoken a little bit about the need for standardization of those assays. But I just wanted to clarify, when you say you’re at or above those median levels, are you using a particular reference or particular source that’s already been published or is that internal data taken from patients that hasn’t been published yet?

Tal Zaks — Chief Medical Officer

Yes. Thanks, Jonathan. That’s an excellent question. These are internal data that have been generated by our collaborators at NIAID.

Jonathan Miller — Evercore ISI — Analyst

And you’re just looking at convalescent sera broadly speaking, you’re not thinking about, for instance, I know the FDA and NIAID has put out guidelines for the use of convalescent sera as a therapeutic, which has minimum bars for expected neutralizing antibody titers. Sometimes that seem much higher than what we see in the broader population, but you are just talking about observed in the broader population of recovered patients.

Tal Zaks — Chief Medical Officer

That is correct. Although I would note that NIAID does put that bar of sort of their monoclonal antibody control, and if you look at where we get to at the 100 microgram post-boost or well above that level as well.

Jonathan Miller — Evercore ISI — Analyst

Okay. Well, I will be looking forward to seeing…

Tal Zaks — Chief Medical Officer

[Indecipherable] so if that helps you visualize the graphs, then we’re above there.

Jonathan Miller — Evercore ISI — Analyst

No, absolutely. And we look forward to seeing that published. I was also going to ask a little bit more about cellular responses. You said you haven’t gotten that data. I think I was confused. Have you not gotten that data from the animal models, or do you have any data of cellular responses in patients yet, or are we still waiting for that?

Tal Zaks — Chief Medical Officer

We’re still waiting for that.

Jonathan Miller — Evercore ISI — Analyst

Okay, fair enough.

Tal Zaks — Chief Medical Officer

I’m not sure to what degree we actually expect to see similar responses in the clinical data. It’s easier to play around with that in the non-clinical models. I personally find in the clinical trials that these are complicated finicky assays that really for an antigen like this, in a disease like this, I don’t expect them to add that much of a significant information as it relates to vaccine development. They are always reassuring to see, but you can deduce their presence based on the first principles that I alluded to and I struggle to see how that data is actually informative to concrete vaccine development cycle.

Jonathan Miller — Evercore ISI — Analyst

Makes sense. And one final one. As you talk about the amendment to the Phase 2 with the new doses being 50 microgram and 100 microgram as opposed to going up to 250 microgram, you’ve spoken a little bit about wanting to get as many doses as possible out of the manufacturable stock, and that makes perfect sense to me. But you’ve also said that there was dose dependency in effect observed across those doses. Do you see a delta in first-dose efficacy. Obviously, you don’t have boost data. But in prime efficacy between 100 micrograms and 250 micrograms, and how big is that of [Phonetic]?

Tal Zaks — Chief Medical Officer

It’s a very astute observation. The answer is, yes, we still see a delta to the 250 micrograms. I think that delta pales in comparison to the bump you get with the boost and that’s why we’re comfortable with the prime boost, we should be able to go much lower.

Jonathan Miller — Evercore ISI — Analyst

All right, thank you very much.

Operator

Thank you. Our next question comes from the line of Geoffrey Porges from SVB Leerink. Your line is now open.

Geoffrey Porges — SVB Leerink — Analyst

Thank you very much for taking my questions and congratulations on getting so far so fast, really remarkable in the history of vaccine. A few short questions. First, could you talk about — do you have any information about the number of episodes that you’re seeing antibodies developed to and a little bit about the isotopes [Indecipherable] IgG?

Secondly, in your conversations with regulators, could you give us a sense of what duration of safety you will need to see in vaccine subjects, both in the Phase 2, obviously, you’re moving quickly to Phase 3, but particularly in Phase 3?

And do you envisage needing to give longer term re-boosting, particularly if the viruses isn’t circulating and providing any natural boosting?

And then lastly, Stephane, could you give us a sense of whether your expectations are that this vaccine will be profitable for Moderna, because a number of your competitors are talking about giving product away, but, obviously, if you’re at the 1 billion dose level. Just wondering how you’re talking to investors about about what that profitability might look or whether it should be profitable?

Tal Zaks — Chief Medical Officer

So, Geoffrey, this is Tal. Let me take your first three questions. A number of epitopes we haven’t mapped it yet. Isotopes, this is total IgG we’re talking about. Duration of safety, I think in Phase 2 we expect just the preliminary client boost to get a sense of the tolerability as enabling to get into Phase 3. I think the duration of safety for Phase 3 will be your typical vaccines. It will be a total follow-up of our expected a year or two.

I would make a distinction between safety and tolerability. You get a good sense of the tolerability. Just up to seven days after the dose, you don’t expect anything after that. Safety is, of course, I think that you monitor for a longer duration. I think I expect the agency is interested in seeing as long the safety as is reasonable to follow these people given the size of the trial that we anticipate to launch, and the fact that it will be the largest and first such experiment for our platform.

Longer term re-boosting I think is a good question. I don’t think we have any idea of today either what natural infection give you in terms of long-term immunity, let alone what a vaccine would do and how relevant waning immunity over the course of months and years is to a pandemic that may or may not circulate. So great questions, but our entire history on the relevance of anything having to do with durability here is no longer than four months since we started following subjects, certainly in the US, maybe five months in China.

So these are all good questions that we will need to collect data on, but I think our — your prediction here is as good as mine. Let me transfer your last question over to Stephane.

Stephane Bancel — Chief Executive Officer

Thank you, Tal, and good morning. Thanks for your question. So as we’ve said in the past, we have not finalized our analysis on pricing. As you said, we’ve moved so fast since January. We have been literally focusing on the clinical plan and telling this team have done a remarkable drug. And on the manufacturing plan, because, trust me, it was not part of the business plan to be having a line of sight of how we’re going to make given a 100 million dose for ’21. We are not even talking about the 1 billion. So that has really been our focus and will remain for the coming weeks.

But, we want to do a detailed analysis of value. When you think about the healthcare cost and the healthcare system, we want to understand the value of this vaccine. And when we have detailed analysis done and better output, we’ll of course share it. We’re only in the starting line, obviously.

Geoffrey Porges — SVB Leerink — Analyst

Great. Thanks for the answers. Appreciate it.

Operator

Thank you. Our next question comes from the line of Jim Birchenough from Wells Fargo. Your line is now open.

Jim Birchenough — Wells Fargo — Analyst

Yeah, hi, guys. Congrats on all the progress. A few questions, maybe just starting with the preclinical data, the mouse model. So SARS-CoV-2 doesn’t bind very well to the ACE2 receptor and I know you referenced a modified virus, but could you speak to the binding affinity to ACE2 with the modified virus?

And then, did you look for any other areas of infectivity, upper airway as an example? And then I’ve kind of follow-up. Thanks.

Stephane Bancel — Chief Executive Officer

Juan, do you want to take that one?

Juan Andres — Chief Technical Operations and Quality Officer

Yeah, sure. So this is done with an academic collaborator with the NIAID. The work we’re describing is theirs. They have modified the SARS-CoV-2 virus, particularly the receptor binding domain, so there is good infection of mouse ACE2 receptors and have demonstrated that, and so there is a negative control in the study. You obviously have a viral infection, both in the lower respiratory tract and the upper respiratory tract. I think we looked at a range of dose levels across that study and await for the data to come out. But we didn’t see suppression in viral replication, both in the upper airway and lower respiratory tract. Our primary focus though, as Tal described, is what’s happening in the lower respiratory tract. That’s the disease that causes COVID-19 as opposed to sort of just measle replication and things like that. So, the assay, at least the negative controls, give us a high degree of confidence that it’s replicating a good productive infection in the mice and that the vaccine is able to completely eliminate viral replication in the lower respiratory tract in the lungs.

Jim Birchenough — Wells Fargo — Analyst

And then maybe just on the clinical side, just in terms of confidence in these results being replicated in older adults. Is there anything to reference in your CMV experience that would suggest you can get to immunogenicity that’s comparable in older adults to younger? And just wondering, a bit of a controversial area, but challenge studies, is it your sense that that’s going to be difficult to pursue and you feel there’s enough infection out there to really conduct an appropriate Phase 3 study? Thanks.

Tal Zaks — Chief Medical Officer

Yes. So the older adults, let me just say that where we have experience, which was I think our first RSV program, we did not see a difference between older adults and adults. So we look forward to carefully seeing the results here. I’m sorry, your second question, could you please repeat that?

Jim Birchenough — Wells Fargo — Analyst

Just in terms of regulator appetite for a challenge study…

Tal Zaks — Chief Medical Officer

Oh, the challenge study, yes, yes.

Jim Birchenough — Wells Fargo — Analyst

Yeah. And just whether there is enough infection out there to do an appropriate Phase 3?

Tal Zaks — Chief Medical Officer

Yeah. I guess what you’re seeing me is having a bit of a Freudian block there. The issue with the challenge study as I see it is threefold. Number one, for us, by the time it ever gets established, it would likely be irrelevant. I mean, we’re about to launch a Phase 2, and we will be in an efficacy trial I think before anybody is able to launch a challenge study. Number two, on the fundamentals of the challenge study, if you read sort of the expert opinions and people are continually looking at this, it’s not going to replace our ability or — the need, I’m sorry, to do a safety and efficacy trial for a very simple reason. A challenge study is not going to give a good enough sense of the efficacy, because you’ll be measuring a vaccine’s ability to limit very minimal disease in relatively healthy people where what you really want to know is that the vaccine can eliminate really severe disease in older people and people with co-morbidities. That’s really the benefit that we hope for a vaccine to do.

And so you’re confident that the vaccine can do it, let alone, you’re confident that you have the right dose, I think, is going to be very hard to extrapolate from a challenge study. And your sense of safety of the vaccine is also going to be very hard to extrapolate from a limited number of subjects in a challenge study. So, I don’t think it’s really possible to get the full assurance of safety and efficacy from a challenge study. And if it doesn’t eliminate the need to do an efficacy trial, then at least for us, the benefit that our development would obtain from putting people in harm’s way, I don’t think outweighs the risk for those individuals.

Now, all that being said, if the right institutions develop and qualify and set up the ability to do such a challenge study and regulators believe that such information would be materially useful to an understanding of our vaccine, then of course, we would consider it, but I don’t think that is the case today.

Jim Birchenough — Wells Fargo — Analyst

Great. Thanks for taking the questions.

Operator

Thank you. At this time, I’m showing no further questions. I would like to turn the call back over to Stephane Bancel for closing remarks.

Stephane Bancel — Chief Executive Officer

Well, thank you very much everybody for being with us today on the quick notice and for your excellent questions. We look forward to talking to you in the coming days. And just to remind you, our next big rendezvous is on June 2, where Stephen, Marissa [Phonetic] and the team will share with you all the new things they’ve been working on the science. It will be a very exciting day. Speak to you soon and stay safe. Thank you.

Operator

[Operator Closing Remarks]

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