First on CNBC: CNBC Transcript: Moderna CEO Stephane Bancel Speaks with CNBC’s “Squawk Box” today, about protection against severe Covid-19 at 100% efficacy.
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Moderna CEO: Most Exciting Vaccine Data Is Protection From Severe Covid-19
MEG TIRRELL: Joining us to discuss all of this is Stephane Bancel, CEO of Moderna. Stephane thanks for being with us this morning for another Monday morning of vaccine news, you know your, your answers this morning gave us a lot of the big answers, you protect against severe Covid-19 at 100% efficacy, the vaccine appeared protective across age groups. Those are two big questions that experts have had. What can you tell us about two other ones, that we know it's, it's early to answer, whether your vaccine can protect against infection completely and how long that protection might last?
STEPHANE BANCEL: A good morning Meg and thank you for having us back. So indeed, those are two questions that we still need a bit more time to go over the scientific data to understand first the duration of a vaccine. I hope that soon we should be able to share some data from Phase One as you know the Phase One started in March. So, we have much more data on neutralizing antibody, which, as these Phase Four data shows is very predictive to efficacy. And so, I think we should be able to get a good sense for the shape of a curve to give us an idea of duration. In terms of preventing infection, we need a bit more data I hope in a couple of months we should have that data and of course, as soon as we have it, we share it and we publish it.
TIRRELL: Well, also help us put this update today into context when you know we just heard from you two weeks ago about your efficacy rate at. What did these results mean and really what did they mean for Moderna, as a company that is now heading toward its first product reaching the market, and one that will help with a pandemic?
BANCEL: Yes, I think the first piece, of course, is around the COVID vaccine, which is the first entering data two weeks ago was very promising. But as its name says it was interim analysis. As you know, we defined the protocol with the FDA back in July, to have at least 151 cases so we're happy this morning to have 196 cases because as you know infection is going very strong in the US, unfortunately, so we feel very confident about the 94.1% efficacy, that we'll be filing to the FDA today. But as you say the most exciting news to me yesterday when I learned the data was with severe Covid-19 cases, because if we can prevent severe Covid-19 cases, it means you know reduced on those utilization and know there, and that will be of course, I believe a game changer in this pandemic. What it means for Moderna as you say I mean we're going to be fighting today, around the world of first regulatory approval for product for regulators to review it and hopefully, given the FDA has told us that our advisory meeting is likely to be on December 17, it is highly possible that between the 17th and Christmas, you know, the product is approved. If you look at the FDA, it might be a few days after the Advisory Committee. So, it means that we'll be able to first ship products as soon as we get approval. We have worked very closely with Operation Warp Speed and as we said you know we should have up to 20 million doses, by the end of the year. So as soon as we get approval, General Perna and his teams are going to get hold of a vaccine that we have and start shipping it in the country. His goal is to vaccinate Americans within 24 hours from approval. But what it means from Moderna is much more. As you know, Meg because you and I have been talking for almost 10 years now, we have a platform mRNA is an information molecule. Now we have six more vaccines in development. We're going to start another Phase Three in 2021 against CMV Cytomegalovirus. It's the number one cause of birth defects in this country. 10,000 kids per year are born with birth defect because the mom got infected during pregnancy. There is no vaccine approved on the market, our Phase One and Phase Two data were very strong. And so, I believe that we have a very high chance now that we know this platform is providing strong efficacy, to have potentially a CMV vaccine launch as well and that vaccine we believe is 2 to 5 billion of annual peak sales. And then, as we said recently we're going to go into flu, looking at the strong data we got in the elderly, as you know efficacy of flu vaccine varies between 30 and 60%. We think the world needs a better flu vaccine and we'll work really hard to get that to the world.
ANDREW ROSS SORKIN: Question for you, wanted to, wanted to understand to the extent that you can tell us about whether you could have the vaccine and still be contagious if you were exposed to COVID. Do we know about that yet?
BANCEL: No, that's a point that Meg was making we don't know about prevention of infection yet. And so, the protocol has been designed so that we can understand that from a scientific standpoint. We need to gather a bit more data and I hope that hopefully in the new year, we should be able to have enough data to share that information.
JOE KERNEN: So, Stephane well tolerated in terms of side effects. Can you describe the worst side effect that you saw on whether there's any subgroups of the people that we're talking about whether it's someone with a compromised immune system or elderly or with some other comorbidity of, not a morbidity but you know people that have, you know, different pre-existing conditions. Were there any side effects that were concerning or more concerning given the person's medical history?
BANCEL: Yes, so Joe we don't know yet all the details by subgroup. The analysis is ongoing by our team, and by the time there will be a PAC meeting happen, we'll have much more data BFD as usually we put out a briefing book where all that data wil be released as we speak our teams are focused on the top line data so that we could release it this morning and we could file to the FDA to spend the whole of Thanksgiving weekend reviewing all the data and quality controlling the data. So we don't know yet for the safety side effect is very typical to what we described two weeks ago what you see in the pro vaccine you have local you know sight injection pain, a bit of redness, for some people that goes away itself resolving within 24 to 48 hours, those are for local side effects. And then for systemic side effects, you see some people have it a bit of headache, some people have a bit of fever, some people have chills usually again within 24 to 48 hours self-resolving without even taking an aspirin. So, we feel this as a typical vaccine safety profile that you see from existing approved vaccines.
MELISSA LEE: Stephane, your stock is hitting new highs in the pre-market session up 13% so I wanted to ask you about revenues and how investors should think about those in terms of vaccine pricing a lot of analysts are saying you know $20 to $40 but the pricing can't remain that high, you know, for, for very long it's eventually going to be price pressure given other competitors coming to market with vaccines at lower prices and also just vaccines in general, over time come down in price. And so, how should investors think about peak distribution time, and how, how long the price of the vaccine can remain that high?
BANCEL: Yes, so nobody really knows in detail because we have never been through a pandemic. But if you look at the clinical data of a vaccine and the supply chain in storage condition versus other vaccines, we think we have a premium product we think we have a product that you want to give to healthcare worker you want to give to be elderly again 94% protection of having no disease, and the few cases of mild disease, they don't have severe Covid-19 with our vaccine, unlike over vaccines. And so, I think we can keep a premium positioning of a product and so, you know, is price gonna go down a little bit for sure with time. But I think we should be able to keep a premium pricing. That's a company positioning and we're going to work out so that the healthcare system understand the positioning of a product and its differentiation best use of our products.
TIRRELL: Stephane it's Meg again. I mean you mentioned your vaccine is a premium product. Does that mean it will really be available, especially at the beginning, only to rich countries? What is your plan also for making sure that a vaccine that works so well could be accessible to less developed countries?
BANCEL: Yes, indeed Meg. We want to make sure that vaccine is available around the world. We have already made a proposal to COVAX with a tiered pricing where the pricing will be lower for its low income country. What we want is that this premium vaccine is used, especially for healthcare worker, for the elderly, for people with higher risk and, and this is why we are having those discussions with COVAX, I hope they can be finalized soon so that we can provide the vaccine, not only in the high income country but also for mid income and low income countries.
TIRRELL: And just before we let you go, two quick questions, testing in kids, Dr. Fauci suggested that might start in January, is that right? And we know this is your first product and you know, getting vaccine out on a pandemic scale is a tremendous challenge for even a company as big as Pfizer but is there anything you guys think you could do to increase supply more and faster?
BANCEL: Yes, so I think in terms of children, we have a strategy to go into two different age group, 11 to 17, which I think can start this year, so in December, and the younger children we are think we can start early in the new year, because for younger children, you have to go down in age very slowly and you have to start at the lower dose to make sure it is safe, so it's going to take a bit more time. Our goal for children is to have data in the spring for the 11 to 17 year old age group with a goal potentially to get this age group added to the label by regulatory agency at the end of a spring, which will allow us I hope in July and August to vaccinate the 11 to 17 year olds so that they can go back in middle school and high school to school normally in September ‘21. I think it would take a bit more time maybe the end of the year of ‘21 to get the data in, in younger children, and potentially if the data supports it, a label extension. In terms of manufacturing, you know we’re working literally on a daily basis with Operation Warp Speed. They have been really extremely helpful to help us with suppliers to get priority for all the raw materials we need. So we feeling because when we make the mRNA and we formulate it ourselves, we do not do feeling this is not an outside party. And so, we want to make sure that every you know gram or milligram of mRNA we make is filled that it's not wasted. And so, this is a place where Operation Warp Speed has been extremely helpful to us.
TIRRELL: Alright, Stephane Bancel, thanks for being with us this morning and we'll, we'll talk with you soon.