Roger Song: Understood. Thank you. Thank you for taking the question.
Andrew Guggenhime: Of course.
Operator: Thank you. We’ll go next now to Salim Syed at Mizuho.
Unidentified Analyst: Hey guys, this is [Eric Ladington] (ph) on for Salim. Thanks for taking our question. I’m curious what your take on possible outcomes for discussions for V116 of the upcoming ACIP meeting, by read-through to either your decision between VAX-24 and VAX-31. And what if I mean for the comparison on — in Phase 3s? Thank you.
Jim Wassil: Thanks, Eric. Jim Wassil here. So I’ll answer this by saying I think many of us know already, February 29, ACIP, Merck’s V116 will be on the agenda. I think at that meeting we’ll get a better idea of the current thinking of the ACIP pneumococcal working group. The pneumococcal working group will most likely present epidemiological data, health economic data, V116 clinical data. And then they’ll make a proposal to the ACIP regarding how to recommend V116, assuming they get FDA approval. So I don’t think I’d want to speculate on this, especially since we’ve got — going to have a much better idea by the end of this week what the ACIP position will be. I will say that I want to highlight V116 is only applicable in the adult population and it takes a different approach than our PCV program, in order for them to reach 21 strains.
Due to the limitations of their technology, they had to remove nine strains that have been traditionally included and approved PCVs. So with VAX-31, we do have a potential to further increase coverage to approximately 95% of invasive disease. And we’re doing this by adding additional strains and maintaining coverage of previously circulating strains. So we’ll wait and see, we’ll see what the outcomes are. I think VAX-24 will have a strong position regardless. Obviously, VAX-31, which contains for the most part, all the strains in both vaccines, will be in a strong position to increase coverage and really take a strong position if it gets approved.
Unidentified Analyst: Got it. Thank you.
Operator: Thank you. We go next now to Dave Risinger at Leerink Partners.
Dave Risinger: Yes, thanks very much. So, first I wanted to say congrats on the corporate progress. And I appreciate the updates. I guess, I have two questions for Grant and Jim. First, ACIP-preferred recommendations are rare but Vaxcyte to be particularly well-positioned for a potential preferential recommendation for VAX-31. Could you just comment on that notion and provide your perspectives? And then second, could you elaborate more, Jim, on your comment about potential prime boost opportunity in adults? Thanks very much.
Grant Pickering: Yes, thanks. Thanks for that Dave. Appreciate the acknowledgments and Jim is kind of our ACIP guru. So why don’t I hand it to Jim and see if he can respond to that question?
Jim Wassil: So, well — I — let me jump in. So yes, certainly the ACIP has within its purview the right to extend that preferred recommendation. They have been limited in those decisions in the past the most recent course was with Shingrix over Zostavax for the Shigella vaccines. It’s been more limited in the pneumococcal conjugate vaccine space, but it does occur and we even see that with Prevnar 20 in certain circumstances. So there are a lot of pundits out there, Dave, speculating on how the ACIP is going to react and the margin of improvement does need to be quite material from an efficacy perspective or coverage perspective. But when you have an opportunity to potentially extend the coverage with a singular vaccine to as high as 95% while continuing to maintain pressure on previously circulating strains.
To us, objectively, we think that is the kind of profile that would warrant a preferred recommendation. So we’ll have our day, if things stay on track, we’ll see how they react to the V116 profile. But certainly, from our perspective, we believe there is that possibility for us, but V116 will be another data point. I think what we had heard was there was hope at Merck that there was going to be an opportunity for a preferred recommendation. We’ll find out. I think that’s being walked back a bit from what we’re reading. But as Jim pointed out, before the week is out, we’ll have a leading indicator.
Grant Pickering: In terms of your question on the prime boost, in previous discussions at the ACIP, when both the 15-day and 20-day got approved, there was a debate over whether we should start immunizing starting at 50 years of age instead of the current recommendation of 65. I think there’s a lot of support for that. And the reason is the data says that almost, probably around 28% to 30% of adults right now are in an at-risk category or high-risk category for getting pneumococcal disease, in particularly pneumococcal pneumonia. And these are groups that it’s not just, you know, asplenics and malignancies and HIV and severe immunosuppression. These are a lot more common groups. You have severe asthma, COPD, you have diabetes, chronic lung — chronic liver disease.
And the belief is that that population in terms of percentage in that age group, is only going to grow. And historically, at risk recommendations haven’t really gotten penetration. So there’s been some debate about moving the recommendation down to 50, and then that would mean, most likely that you would need to get a booster at 65. So there could be a prime at 50 and a boost at 65. And we’ll also see some of that debate, I think, coming up in the upcoming ACIP.
David Risinger: That’s great. And just a follow-up if I may. Could you talk about your Phase 3 plans in adults? And your age strategy?