So yeah, I think we feel like we’re tracking. And then last week, the pediatric data for PCV20 was released. And once again, we saw that they could go down as low as 0.6, which they are at for a few strains. I know one in particular, they got 0.6 in the number that were closed. And again, that was adequate to exceed the non-inferiority threshold. So, I think we’re seeing that sort of consistency across adults and pediatrics that has been a bit of a hallmark in this space. And then, Jim, why don’t you take the second part about superiority?
Jim Wassil: Sure. I think that what you’re seeing with our data from the 50 to 64, is that’s reproducible in the 65-plus. We feel comfortable with the Phase 3 side that we can repeat the statistical superior in that we had seen in the 50 to 64. But we could, in fact, if we — again, repeat what we’ve seen in the 50 to 64 in the Phase 3 goes to as high as many as eight or nine, depending upon what the FDA says, would be the requirement for the lower bound to demonstrate superiority. If it’s a lower bound of 1.0 or greater, we think that we can hit seven or eight of those.
Roger Song: That’s great. Thank you.
Grant Pickering: Thanks Roger.
Operator: Thank you. One moment while we prepare for the next question. Our next question will be coming from David Risinger of SVB. Your line is open.
David Risinger: Thanks very much. And thank you for the updates. So, I have two questions. First, obviously, you’re planning Phase 2 in infants with Vaxneuvance as the comparator. But assuming Prevnar 20 is approved in infants in April, and it’s given an equal recommendation to Vaxneuvance by the ACIP this summer, should we just assume that down the line in a couple of years, you would ultimately run a Phase 3 in infants versus Prevnar 20? And then second, just to follow up on Jim’s comment a moment ago. Why would the lower bound be different for your Phase 3 in adults? I think you had said if the lower bound was 1.0 or greater, you might be able to hit seven to eight of those or something? I just wanted to understand that a little bit better. Thank you.
Grant Pickering: Hey, David. Thank you for the question. Yeah. So, the ACIP conversation last week would suggest that PCV20 is on a path toward approval. We’ll find out soon enough when the FDA decides in April. But looking forward to our own Phase 2 clinical study that we’ve already guided to beginning in the second quarter of this year, we have two different stages for that study. The first stage is a safety look, for which we have been planning to compare to PCV15. And as you say, if they give a joint recommendation, starting out against PCV-15 will be more than adequate. But to your point, there is a precedent where the agency has asked to compare to the broadest spectrum standard-of-care vaccine that’s out there. So, we will be making preparations in order to potentially switch from PCV15 to PCV20 for that stage two portion of that study, and that would be a core we strike with each of the investigators who’d be participating in the study.
But given the interactions that we’ve had with the FDA, although we could theoretically have the alternative, I think the preference would be that the FDA would want us to compare to the broadest spectrum one, and we’ll do it — we’ll be doing what we can to potentially alter that original plan, but that will be a bit of a work in progress as things unfold with the FDA and then ACIP. And then you had a second question with regard to the lower bound. I hope that wasn’t something that I confused the issue around. The technical lower bound threshold in order to show the non-inferiority standard is still to exceed 0.5, but that’s where the lower limit of the 95th confidence interval needs to exceed. And what we were saying was the point estimate, if it’s at 0.6, that’s usually not for that lower limit to exceed 0.5. But was that more related to the superiority?
