Moderna, Inc. (NASDAQ:MRNA) Q1 2023 Earnings Call Transcript

Stephen Hoge: Yes. Thank you for both. So first on the flu question. So, we obviously have the immunogenicity data that already came out of the P302 study that shows that we’ve met non-inferiority or would have been considered with nonfert for the B strains. Even in the Northern Hemisphere, study that’s ongoing. And so I think our confidence of being able to clear that bar is high and supported by that data even before we made the improvements in the in the B strain update for the current Phase 3 study. We obviously have a preclinical data. We have a lot of experience with updating our antigens and vaccines now with COVID and others. And so we’ll look forward to that data in P303. — but I think we believe we will do even better than we just did in the P302 study with non-inferiority, and we hope to to see that we’ll be achieving something perhaps trending towards superiority.

But that’s not the goal specifically for the study. In terms of reactogenicity and dose, I’ll just say that we are not changing the dose for this 1010P303 study is still 50 micrograms, so it’s not a change in dose level. And in general, as we think about reactogenicity across our respiratory pipeline, we have a large number of candidates and vaccines where we’ve gone to doses substantially higher than 50 micrograms. Even in the flu study, we did that up to 100 micrograms on data we shared before. And we believe that there are populations for whom that works well. And in fact, there are vaccines like our RSV vaccine where 50 micrograms is extremely well tolerated. We’re very pleased by that profile to date. And so we actually think it’s going to be a vaccine by vaccine case.

You can’t look at the dose and decide. And as we start going into combinations, we will be optimizing the reactogenicity, the tolerability profile of that vaccine against the benefits in terms of high efficacy that we hope to deliver and often measured by immune responses in those combination studies. So, we currently don’t believe that there’s a limit on that. But in the specific P303 study, we’re continuing down a 50-microgram dose level for 1010. Now on RSV, yes, we are working closely with regulators on filing globally. And that includes all of the markets in which we hope to commercialize that product and launch it next year. And of course, we’ll keep you appraised as we move into those regulatory — that regulatory process in our normal quarterly updates.

Operator: One moment for our next question. Our next question comes from Luca Issi with RBC. Your line is open.