Graham Parry: So it’s going back to RSV vaccine. I think you sort of referred to this requiring a lot of education, obviously, having more than one player in the market can help there. We’ve also referred to probably a launch trajectory below Shingrix. I was just wondering if there’s a lower bound analog for launch that you could point to that you would think is appropriate, whether it’s pneumococcal vaccines or perhaps one of the older pediatric vaccines. And any thoughts you’ve got on the recent Moderna interim data and the level of competitive threat that you see from having 3 vaccines in the market just from a contracting and pricing point of view more than anything else.
Emma Walmsley: Thanks. Luke?
Luke Miels: Yes, Graham. I mean, I think lower bound pneumococcal, again, it’s not a perfect comparator but I think that’s a fair one. I think you’ll get more information with the pricing being presented at the Feb ACIP by ourselves and Pfizer on the 23rd, 24th of February. Look, I think that having 3 companies there, you’re definitely going to drive awareness and a more rapid uptake. So the pie will be larger but obviously shared 3 ways. Our expectation is that it will only be Pfizer and ourselves at the June ACIP and that remains the same. I think from a strategy point of view, as always, you need to anchor in your own evidence base. And I think the 94% efficacy that we have in adults with comorbidity is impressive and the similar range that we have in the 70 to 79 year-old group who obviously bear the brunt of RSV infections.
I mentioned earlier from Kerry’s question, the 50 to 59 year population that will also have evidence of that for the 2024 cycle. So all of these things help contracting. And I think there’s just 2 big variables that remain unknown. One is the final label that people ultimately get. Again, we’ve only seen headline data at this point. And then secondly, ourselves and Pfizer are likely to have that second year of exposure data just before the June ACIP, and that’s a variable that remains unfactored at this point. But net-net, I think it’s still a very exciting opportunity. And what is striking is just the level of awareness and just the depth of the RSV infections that we’ve seen this year post-COVID.
Emma Walmsley: Exactly. And our co-admin on flu is another big umbrella to retail. That’s where semi distribution will be here.
Operator: You have a question coming from James Gordon from JPMorgan.
Emma Walmsley: James? James, are you there?
James Gordon: James Gordon from JPMorgan. Can you hear me now?
Emma Walmsley: Yes.
Luke Miels: Yes, we can hear you, James.
James Gordon: You’ve hear me. Brilliant. Lovely. Two questions, please, both on vaccines. One was on RSV. So just in terms of multiyear protection, based on what you’ve seen so far, have you seen things that are encouraging just in terms of the efficacies you’ve seen through the year that suggest you are likely to get multiyear protection? And if you do, is that something that would actually be upside to the share assumptions you already had? Or was multiyear protection somewhat baked into the projections you’ve already given for this vaccine? That was the first question, please. And the second one was on Shingrix. So there was the potential need for a booster mentioned. What data would you actually need for that? Do you have some data that’s already telling you when you think you might need revaccination?
And would you have to do a study that actually showed a statistically significant benefit on symptoms from revaccination? Or would it be more just about antibody titers? Is there like a quicker route to get such a recommendation?
Emma Walmsley: Right. Well, I’ll give both of those to Tony. But just as a reminder on Shingrix, we launched it in 2018, I think. So — or ’17. So — and we’ve got good data for 10 years. So the cohorts coming through, the boosting is more for later in the decade, as Luke alluded to. But definitely something that we’ll look at. But Tony, do you want to respond on both the RSV durability and Shingrix.
Tony Wood: Yes, sure. So first of all, in terms of duration for RSV, obviously, we have solid coverage across single-season vaccine efficacy with our existing data package. And James, you may remember, we also have titers that are elevated above baseline as measured at the end of first year. As Luke indicated, we’re planning — and indeed the study was designed with this purpose in mind, to be able to bring second season data to ACIP in June. Obviously, that is depending on the dynamics of the second season. And so we’ll be able to report more on that when we get to the June date. Can you just remind me — in terms of was it incorporated, second season data was not incorporated in the baseline model, so it would be an upside. And then can you just — sorry, what was the second question?
Emma Walmsley: Shingrix.
Tony Wood: Shingrix booster, yes. Okay. So obviously, we have 10-year data from Study 049 and that shows outstanding duration of protection. That’s cumulative vaccine efficacy of greater than 82% over the 6- to 10-year period of follow-up, 89% vaccine efficacy over the 10-year period. Study 049 was designed to continue to generate data in order to answer the booster question. Remember that the vaccine was launched in 2018. And so we’re reaching a point now with 10 years subsequent to that, we’ll be looking to later in the decade. It’s reasonable to expect that we will see some waning in vaccine efficacy associated with an aging population. But to your point, James, we’re also engaging in ongoing conversations with the regulators to understand what the design of a study required to show the need of a booster would look like and for whom. But I don’t want to go into any greater detail about that at this stage.
Emma Walmsley: Great. Thank you. So maybe one or two more questions and we’ll try and speak through those. Next one, please.
Operator: Next one is coming from Emily Field from Barclays.
Emily Field: The level of detail provided on the ongoing Zantac litigation release was very helpful and particularly following the MDL update in December. And the time lines on California were also helpful. I was just wondering if perhaps you could put in context how you’re thinking about the rest of the state cases and just for — on our side, it’s been tough to follow kind of what follows the dower standard and what doesn’t. But just outside of California, if there’s any states where cases could be moving to trial in the near future that we should be mindful of?
Emma Walmsley: Right. Thanks, Emily. Obviously, we were delighted with the outcome in December. We’ve got some things to navigate through this year. But Iain, perhaps you could update on the different state situation?
Iain Mackay: Yes, absolutely. Emily. So obviously, MDL was incredibly impactful. That took out the equation, 46,000 claims within the suits filed at the federal level. So I’m delighted with that decision, as Emma said. You reflect on the bulk of claims in State Court, they sit in Delaware with more than 70,000. And although it’s clearly for the courts and Delaware to decide there is a pattern of behavior where they tended to follow federal precedent in that regard. So that is probably an encouraging indicator. Then across the other states, we’ve got a little bit less than 6,000 claims out there, which about 3,000 are in California and the rest are spread across sort of half a dozen other states. We’ve got 4 bell weathers that will — that we expect to take place in California this year, the first of which will kick off a little bit later this month or early March.
The Sargon hearing for that trial has actually been pushed back another week to the 16th of February as the judge reflects on input from both plaintiff and defense attorney. So look, again, the really important thing here, the MDL decision, the diverse decision was incredibly helpful. It was informed by the strength of the epidemiological independent studies of which that are now 13, the consensus of which is there’s no causality between the consumption of ranitidine in any form of cancer. And it’s clear from Judge Rosenberg’s decision that was the significant factor in informing our decisions. So we’ll continue to defend vigorously and first up or a couple of trials in California, we’ll keep you posted.
