Eliana Merle: Hey guys, thanks for taking the question. On CMV, how are you thinking about the need or benefits of potentially boosting both from a clinical as well as a commercial perspective and if you would study this? And then second, just on CMV, if you don’t meet the interim analysis there, would you disclose that? Thanks.
Stephen Hoge: Great. Thank you. So first on the question of boosting. So, so far what we have, we obviously don’t have the efficacy readout. That’s the Phase 3 studies ongoing. But we do expect to have quite substantial durability data on immunogenicity. And it’s quite possible the efficacy data will give us a signal what the core production could be. And so we don’t right now have any evidence that they’re not good, durable, multi-year, possibly as long as five years, or continue to track the immunogenicity protection. It’s possible that it will extend out to 10 years and then some boosting is necessary. It’s also possible that we decide that a booster might be necessary shorter term, let’s say five years or 10 years. We just don’t know at this time.
And so at present, the data we do have on the durability of the immunogenicity, it looks quite strong. And so we do think a three dose series will likely be productive for a very long period of time, all subject to the efficacy data that you just referenced. So on the interim analysis for efficacy, as we’ve said before, we’re making great progress in that study in recurring cases and we do expect to be able to provide an update on or conduct at least an initial interim efficacy analysis this year. Because of the rate of case accrual and also because the protocol calls for us to cross a median of one year follow up, the timing may be such that by the time we get to that first interim analysis, we also have enough cases for a final analysis or that a final analysis is imminent.
Let’s say it’s a very short period of time away. And so because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don’t think we can commit one way or the other, whether we’re going to be updating. It will really depend upon the data we see and then how quickly we expect to get that final analysis. At the end of the day, if we have news to share both on the interim and the final, we, of course, will. But I don’t think we can commit at this stage because we haven’t seen the data yet.
Eliana Merle: Great, thanks.
Operator: Our next question comes from Hartaj Singh with Oppenheimer. Your line is open.
Hartaj Singh: Great. Thank you for the question. I just have a question on, you’re developing a refrigerator stable vaccine and flu vaccine, I believe. And I’d just like to kind of understand how you think about that, when could that get approved, and then will the combo vaccines also be refrigerator stable? Thank you.
Stephen Hoge: Great. Thank you, Hartaj.
Operator: Ladies and gentlemen, please stand by. Your conference will resume momentarily. Once again, ladies and gentlemen, please stay on the line. And, pardon me, can you hear me now? Could you try speaking again, your line was muted.
Stephen Hoge: Yeah, I’m here. Can you hear me?
Operator: Yeah, we can hear you now. Your line got muted, but you can go ahead and continue.
Stephen Hoge: Great. Sorry for that brief interruption. So, Hartaj thank you for the question. Just to quickly restate what I was saying. All of our respiratory protocol portfolio, RSV, flu, COVID, and the flu COVID combo are being developed towards refrigerator stable PFS. And so our mRNA-1083 program, the flu COVID program, as well as the flu program are intended to be refrigerator stable, prefilled syringes. As Stéphane mentioned a moment ago, we really view that as the ideal presentation now, whole presentation for healthcare providers really around the world to facilitate their delivery of the vaccine to patients.
Hartaj Singh: Great, thanks for the questions Steve.
Stephen Hoge: Thank you.
Operator: One moment for our next question. Our next question comes from Gena Wang with Barclays. Your line is open.
Gena Wang: Thank you for taking my questions. I have two. One is regarding COVID. So for the EU, you say up to 36 million doses every year in EU. What could be the scenario, you can get 36 million doses in EU and also the price in Brazil and the EU, should we use pandemic price of $25 to $30 per doses as the benchmark? Quickly on key accelerator approval pass based on today’s comments and the prior discussion, our impression as you could achieve all the three key components by the end of this year, is Merck is also fully on board to submit for the accelerator approval in melanoma?
Stéphane Bancel: Thank you, Gena, it’s Stéphane, I will take the COVID question and then Stephen will talk about INT. So the tender is up to $36 million. It will depend on the number of countries that apply to the tender for the EU. So this we will know at the end of the process. And as you know it is a tender process so there’s no dialogue which is enshrined all the files and all the data and that’s really ongoing, but we are obviously very active on it. And on price for obvious competitive reasons, we’re not going to share price in the markets because probably it doesn’t know the price right away. Stephen, INT?
Stephen Hoge: Yeah, so we haven’t specifically got into when we expect to complete, obviously, the second and third parts of our three part criteria, that being manufacturing readiness. As you can imagine work is going on around the clock, as well as the enrollment where we’ve made great progress, but you have to sustain that progress. On your question of where’s Merck on this, I think you’ll have to direct it to them. Our view is that if we’re able to get to the point where until your approval is appropriate, and regulators are supportive of that, we can’t imagine why ourselves and Merck wouldn’t want to make the product available to help people suffering from cancer right now. But the contingencies there are obviously we have to do our work and our diligence this year.
And then ultimately, we have to speak to regulators, and they get to decide whether that pathway is available to us. And so I think for both ourselves and our partner, Merck will want to defer to regulators ultimately on that choice.
Gena Wang: Thank you.
Operator: Our next question comes from Luca Issi with RBC Capital. Your line is open.
