But to your point, what we’ve seen, at least in adults with VAX-24 data, is that we are — for the most part, getting higher immune responses relative to Prevnar 20. And if that’s the case, it could widen the advantage, certainly in a three-dose regimen versus a four-dose regimen. So, yes, we’ll have to see how some of this plays out with regard to how the European authorities handle that. The study that we’re running that we’ll read out in 2025 with VAX-24 in infants is the conventional three-plus-one approach. So that’s the data we’ll start with. But to the extent, we see higher immune responses, potentially once again after that primary series, that could set us up for a potentially better outcome to create even further competitive advantage relative to Prevnar 20 in Europe.
But we’ll see what that data looks like next year. And then, Seamus, you were also asking about the potential V116 comparisons, I thought you were first talking about VAX-24 versus VAX-31 impedes. But obviously, you must be talking about adults only, given that V116 will be restricted to the adult population to the extent it gets approved. So, yes, I think we’re going to see — we’re going to get the benefit of having seen not only how the conversation is progressing with the ACIP later this week, but by the time we will expect to get our VAX-31 data, we’ll know for sure if the vaccine is approved. And if so, how it’s sequenced or recommended relative to Prevnar 20? So, yes, I think armed with that information, we’ll have a much better sense of what the appropriate comparison would be for either VAX-24 or VAX-31, VAX-31 in particular.
So I think that’s a bit of a wait-and-see. Jim, anything to add?
Jim Wassil: No, I think that is there. I think that if there is a non-preferential recommendation, then I think it will be at up to us to choose which of the competitor we can choose to use in the Phase 3.
Seamus Fernandez: Great. Thank you guys. Appreciate it.
Andrew Guggenhime: Yes. Thanks, Seamus.
Operator: Thank you. We’ll go next now to Louise Chen at Cantor Fitzgerald.
Louise Chen: Hi, thanks for taking my question. Wanted to ask you on your global manufacturing capacity and how this gives you a competitive advantage. And then what kind of capacity will you have once you complete this buildout? And second question I wanted to ask you was, just on the infants. Are you going to also choose either VAX-24 or VAX-31 for infants? What are you thinking here? And what is your VAX -31 adult data are going to give you as you think about the instant opportunity?
Grant Pickering: Yes, thanks for the questions, Louise. Yes, so as it relates to the manufacturing buildout from a competitive perspective, it’s really table stakes, if you will, if you can supply these vaccines at the appropriate capacity then how can you expect the ACIP among others, to make a broad recommendation for your vaccine? So, for us, it’s been fundamental to unlocking the full value of these vaccines, is to stay ahead of that sort of capacity so as to have not only the ability to deliver but the sort of profile that would warrant a preferred recommendation ideally. And so that’s been absolutely crucial to this whole story. And I think we’ve been able to stay ahead of that. We’re in a position to launch out of existing Lonza infrastructure where we’ve been making these materials to study clinically.
And then late last year, as you all know, we made the strategic decision to invest in a dedicated facility at Lonza. And as you requested, the way we’re thinking about that dedicated facility is one that would be able to satisfy the global demand from the developed world for either VAX-24 or VAX-31 in both of the adult and infant indications. So we do really expect that one to really deliver for us to maximize the sort of opportunity that we think is at hand. And then to your question about VAX-24 versus VAX-31 going forward, I think it’s really an indication dependent conversation. So for us, we find ourselves in a position where both VAX-24 and VAX-31 have an opportunity to reach the market on the same timeline. So with the right VAX-31 data later this year, naturally, it would make sense for us to move to deliver the most broadly protective vaccine that we can and ideally that would be VAX-31.
If not, we know VAX-24, it looks really good as well and so we’ll see that data before anointing which one to advance. That said, in the infant market, we’re already well ahead with VAX-24. And so for us, we’re contemplating either or both of VAX-24 or VAX-31 in the infant indication, just because we know we can bring VAX-24 to market faster based on the path we’re on today. So it’s a little more nuanced in the infant indication because of that sequencing.
Louise Chen: Thank you.
Operator: Thank you. We’ll go next now to Joseph Stringer at Needham.
Joseph Stringer: Hi, thanks for taking our question. Just a couple of quick ones on the preclinical programs. You briefly mentioned those, but could you just give us a quick sense for which one you think could enter the clinic first? And in particular on Strep A, curious if you’d give us a quick outline of a competitive landscape there and what you think the commercial opportunity in that indication is?
Jim Wassil: Sure. Thanks, Joe. So, as we stated, we’ve three other pipeline projects, we’ve got Group A Strep periodontitis and Shigella, all three are moving forward in early-stage preclinical development. We haven’t guided to when they would go in the clinic. But yes, the one that I believe is most advanced at this point is the one that you mentioned, which is Group A Strep. The Group A Strep vaccine, I think has a very important role, I think it’s one of the most underappreciated diseases. There are over 500,000 deaths due to Group A Strep that occur every year due to rheumatic heart disease. But it’s a ubiquitous disease causing pharyngitis, mainly in school entry kids as well as young toddlers. If not treated aggressively with antibiotics, which means that there’s a significant amount of antibiotic prescriptions associated with this disease.
And also subsequently, you would expect growing levels of antimicrobial resistance have led to increasing importance of finding a vaccine to prevent against this. And there is recent economic studies that say that medical and indirect costs are around $5 billion a year. So a vaccine that can have some degree of efficacy, a reasonable amount of efficacy, could significantly have direct medical cost to offset. So I think you’ll see a commercial opportunity here in school entry kids, potentially toddlers. And then the one area I haven’t mentioned is there is high rates of invasive disease in older adults as well. So we could see a very similar type of recommendation, in fact, a little bit more because you’re immunizing school entry kids as well, that you see with the PCV.
