But at this point, we’re trying hard to make sure that we can do both products across all of our major markets, if the data is filed this year. And so we’ll go more on that as we move forward. But for now, we are proceeding without independent sorry for the confusion in your model. On the question of CMV and seropositivity. So it’s a really important point. Thank you for raising it. But while the majority — well, the risk of vertical transmission of CMV to pregnancy to the fetus is highest in seronegative. It does happen in seropositives as well. So congenital CMV is a disease that’s seen in — particularly in reactivation or sometimes reinfection, even in the seropositive context. And so we do believe that there’s a potential for benefit for a vaccine even in the seropositive population.
We are evaluating the study right now in seronegative because the rate of that transmission and obviously, the potential to prevent against infection is more enriched and therefore the study primarily are focused on seronegatives. But we are looking. We have studied the vaccine from a safety perspective in seropositives. And we are looking at things like shank [ph] if you draw a little bit of an analogy to correlate to the EBV data that we’ve already put out there in a different virus, but we’ve been able to show that we can really control the rate of setting even in seropositive is the simpolovirus [ph]. And so we have some reasons for optimism and believe that when we pull together the totality of the data, there will both be the obvious potential benefit, which is that there is still vertical transmission in seropositives and some — potentially some data on the rate of — that would be supportive to that.
Ultimately, though, we’re studying all the way down to 16 year olds. And our goal will be a label that 16 plus, with the goal going into a population that is not as highly seropositive as it is later in life and therefore, we see a very large opportunity, and primary infection in CMV with the vaccine and the potential for [Technical Difficulty].
Jessica Fye: Thank you.
Operator: Our next question comes from Jeff [indiscernible]. Your line is open.
Unidentified Analyst: Hi, this is Alex coming in on for Jeff Mitchem. Thanks for taking our questions. So on your zoster vaccine candidate, when should we receive updates on your pivotal strategy and is there any color you can provide today in terms of your current thinking on the Phase 3 design? And then our second question is on the PA and MMA programs that are advancing into pivotal trials, can you provide any thoughts on the nature of editorial and the comments on safety? Thank you.
Stephen Hoge: Yes. Could you describe about the first part of the question was on which program? The booster?
Unidentified Analyst: The zoster, the shingles.
Stephen Hoge: Shingle booster, thank you. So on the VZV program, we have — we’re obviously very excited by the Phase 1 data which was compared against a licensed product, and we saw really strong T cell response in immunogenicity. And generally, we’ve been seeing that across our programs. But in that one, it was very encouraging. We’re in the process right now of trying to find the pivotal strategy that will include, obviously, dose selection, the number of doses in that study and then how we’re going to expect that study. We do not have an update today on what that will look like in addition to our own thoughts on it, we obviously want to consult with regulators before we finalize that. But we are moving towards a pivotal study in VZV.
We do not have any more update yet. As it relates to MMA and PA, the clinical data that we have continues to show a compelling benefit risk profile, good safety profile. In fact, in the PA studies, we have many folks who’ve been in those study on drug for well over a year. And over 30 years, I think, from our last update in overall patient dosing experience. So we are starting to get a very clear perspective on the safety profile. The editorial question, I don’t have a view on editorials or opinions based on the preclinical data. I think we stand behind the clinical data that we have and are quite encouraged by that profile, and we’ll continue to watch it closely in our ongoing Phase 1 studies, but we do not have any specific or new concerns based on the clinical data today.
Unidentified Analyst: Thanks.
Operator: Our next question comes from Evan Wang with Guggenheim Securities. Your line is open. One moment.
Evan Wang: Great, two from me. First, on the combo 1083 program, so data, it sounds like this quarter, I believe enrollment was completed a few months ago. So I guess how comprehensive will the top line update be in terms of follow-up? And then with submission, is longer-term vault needed there and are there parallels from 1010 that we can take in terms of regulatory filing speed for 1083 or is that more impacted by the decision for buying one or the other first? And then second, on RSV, it’s kind of early ahead of approval, but with some international markets, it seems that’s more nascent in terms of establishing some reimbursement there. So I guess how are you thinking about positioning internationally? Thanks.
Stephen Hoge: Great, thank you. So for the 1083 data, yes, on this quarter, and I would say that we’re — we enrolled the majority of the 1083 studies you know last fall. And the 1010 second-generation study. So we talked about the P303 study. The first part of that enrolled over last summer, just a few months before the combo study. And the second part of it, there was a part B and C, as you know, looking head-to-head against Fluzone HD, that actually enrolled the same time as the 1083 study last fall. And so they’ve been actually kind of tracking right on top of each other. I think we’re going to wait to see the data before we can provide growth guidance on timing. But obviously, we’re — we’ve been working towards that flu COVID combination product for a while, and we will want to make sure that we get that filed, if it is positive as fast as possible.
I wouldn’t draw too many, because of the difference in the structures of the study between the P303 study, which has a part A and the B and a C, and the 1083 study, which was done very quickly. I wouldn’t too many correlations between — reading out and the timing for submission on either one. Stéphane, do you want to take the RSV question?
