Arpa, would you like to add anything in terms of your perception of the market going forward?
Arpa Garay: Sure. So, I would say we do anticipate it being at least the 3-player market with Moderna, Pfizer and GSK. There is a possibility of a 4-player market if J&J has a regulatory path forward with their adenovector virus vaccine. Nothing more to add there.
Operator: Thank you. Our next question comes from Jessica Fye with JPMorgan. Your line is open.
Jessica Fye: Great. Good morning. Thanks for taking the question. Following up on flu or mRNA-1010, just to be very clear, if you hit on non-inferiority in the efficacy Northern Hemisphere study, do you think that mRNA-1010 would be approvable in spite of missing on non-inferiority on the B strains? And related to that, would you envision the approval only being for older adults? And on RSV, can you comment on the expectation for dosing frequency for your RSV vaccine? And how do you think about the value and potential pricing of that vaccine, maybe benchmarking off of other vaccines for that age group? Thank you.
Stephen Hoge: Yes. Thanks for those questions. So, let me take the flu stuff first. So again, the full approval of standard is a head-to-head efficacy study. And so if we demonstrate non-inferior efficacy against an approved vaccine in the population which we are studying and which in this case in P302 is 50-plus adults. We do believe that could form the basis of an approval. At the end of the day, immunogenicity results, and in particular, are only surrogates for efficacy, and ultimately, efficacy is the gold standard. That’s what’s required for traditional approval, and that’s why we are running the P302 study. So, it will depend upon how a conversation with regulators around that data package, but it is certainly plausible.
And in fact, one might say likely that if we meet efficacy in the efficacy study that that would be sufficient to move forward for a full approval. It doesn’t mean that there may not be questions about demonstrating non-inferior immunogenicity with influenza B strains or other things in subsequent studies, but we do believe there is a possibility there. But at the end of the day, it will be dependent upon data and discussions with regulators, including the FDA. And so we will wait until we have that data and have those conversations, but I think it’s certainly a possibility. Now, as it relates to age for approval, we are currently studying mRNA-1010 only in older adults. And so as I have said, the P301 was in 18-plus, P302 is in 50-plus, and that’s really where we see the broadest recommendations for seasonal influenza vaccine and where we have been most focused initially on building out our respiratory portfolio.
We will evaluate our influenza vaccine, in fact, many of our respiratory vaccines in younger populations over time. But we will have to do age de-escalation, dose finding and then bridge down from an immunogenicity perspective, very much like what we did with COVID. And so our initial filings for approval, if they proceed based on data, would be in adults and older adults principally. And then eventually, we would follow-on with pediatric populations. And as I said a moment ago in response to Michael’s question, that may involve using updated B antigens to increase immunogenicity in that population. But again, that’s subsequent studies that we would do in children. Could you remind me of the second question?
Jessica Fye: For RSV, what are you thinking for dosing frequency and how do you think about value and potential pricing of that vaccine, maybe benchmarking off of other vaccines for that age group?
