Moderna CEO: Could Take Weeks For More Clarity On Omicron Covid Variant

Following is the unofficial transcript of a CNBC interview with Moderna Inc (NASDAQ:MRNA) CEO Stephane Bancel on CNBC’s “Squawk Box” (M-F, 6AM-9AM ET) today, Monday, November 29. Following is a link to video on CNBC.com:

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Moderna CEO Stephane Bancel: Could Take Weeks For More Clarity On Omicron Covid Variant

MEG TIRRELL: Hey Joe, Stephane Bancel joins us now. Stephane, thanks for being with us this morning. I think the whole world wants to hear from you and what you're doing on Omicron. But let's start first with the level of alarm or concern that you feel about this variant given what we know about it right now.

STEPHANE BANCEL: Good morning, Meg. Thank you so much for having us. So, let me maybe start to tell you what I think we know about the virus. Clearly, it has been reported a lot of mutations, mutation in the spike protein, the one that is important for the vaccine. Just to remind people, there were very few mutations on the spike of the Beta or the Delta virus variants and I think it was a big surprise to the science community. I don't believe many people could have predicted such a big jump in evolution in one variant. What we also know is that it's taking over Delta in South Africa very quickly. It took around four months for Delta to take over Beta. It seems that in just a couple of weeks for this new variant to take over Delta so that's something to keep in mind. And we also know that it's in many countries already. What I think we should move on is what do we believe? We believe this virus is highly infectious. We need to get more data to confirm this, but it seems to be much more infectious than Delta which of course is problematic. And we also believe that it's only present in most countries. I think what happened with the planes coming from South Africa to Poland over the weekend is a good example. I believe that most countries that have direct flights from South Africa in the last seven to 10 days have already cases in that country that they might not be aware of. And then the last piece is what we not know yet, but we don't know. There are two key things that we don't know yet and we're gonna find out in the coming weeks. One is vaccine efficacy, what is the impact all these new variants on the vaccine efficacy, and we should know that in around two weeks. Given the large number of mutation, it is highly possible that the efficacy of the vaccine, all of them, is going down but we need to wait for the data to know if this is true and how much is it going down. The second piece that we don't know that we need to keep probably an open mind is the virulence of the virus, how much disease of the people. I believe this will take two to six weeks to really know and I think we need to be cautious that it could be more virulent, it could be as virulent, or it could be less virulent and I think today it's really impossible to know. I think the piece we should be cautious is I don't believe that what's going to happen in the coming week or two in South Africa will be predicting the true virulence of the variant and I think that's because if you think about it in South Africa, you have less than 5% of population over 60 years of age, and you don't have a lot of comorbidity and so it's not because it's going to look not very virulent in South Africa, that it will not be virulent in Europe or in America or in the north.

TIRRELL: Well, going back to that question of course about the vaccines. You know, what we saw from the Beta variant which also arose in South Africa is that there was in what Dr. Fauci likes to call a diminution of the protection from the vaccines, but it still seemed like the vaccines could provide protection against severe disease. What's your expectation for that dynamic with Omicron? What diminution we might see based on the mutations that are understood and the effect that there will still be on severe disease from the vaccines?

BANCEL: Yes, I think this really is the big question, Meg, is if you look at the new virus it does with Delta mutation, it does with Beta mutation, and many more on the spike up to 32 mutations. So we anticipate that there will be a loss of vaccine efficacy to prevent disease. What is important for people to remember is that unlike an antibody treatment, the vaccines provide you not one or two antibodies, but a soup of antibodies and so some antibodies will still be protective neutralizing antibodies even if you have a mutation and that's a piece that’s really hard to handicap what we did in the last few days to analyze the virus, you know, on computers and doing, you know, 3D modeling and so on. It’s tough to know how we going to lose no 5x, are we going to lose 8x of the antibody levels. These grids will be patient and see the data scientists have been working since middle of next week before Thanksgiving weekend and working through the whole weekend. Thursday, Friday, Saturday, Sunday, nonstop because we know it really matters. What is important I think to know is that Moderna we have a free line of defense strategy and I'm not aware of any company that has so many tools to help and respond if vaccine efficacy drops and the virulence is, is higher or same. One is as we know, we've lowered the dose of a booster of our current vaccine and so we have a lot of safety data showing that we could go back to 100 microgram dose and to double the dose of the current vaccine, which should provide better protection than the third dose booster of 50 micrograms. So that's first line of defense actionable right away. The second line of defense—

JOE KERNEN: Yeah, sorry, we've been just kicking around a couple of the things that maybe you can clear up for us. When you're designing your messenger RNA vaccine it, are surface proteins the only target you could use the spike protein because they do seem to mutate a lot. Is there any way you could use messenger RNA to I don't know to code for some other part of the virus, something that's more conserved, or does it have to be something that that the antibody sees right on the surface of the virus right away? Is that the only target you can use for a messenger RNA vaccine?

BANCEL: It’s a great question, Joe. In the past, we looked at several targets on the, on the surface of the virus and really the spike is the one that has always given us the best response in terms of efficacy of a vaccine and protection against disease. It is true that it is mutating but we really believe it is still the best target to provide protection.

KERNEN: Is the, the other question that I had was in terms of safety. You get these small changes random it appears in the spike protein and maybe it makes it more infectious, maybe it doesn't, I don't know. But is there a risk in just assuming that since we've been through the safety trials for the original messenger RNA vaccine, if there's slight changes in the base pairs that that you're talking about in the spike protein, could it make it much more dangerous to the immune system in terms of long-term side effects, or can we assume from the safety studies that we already did that you change a few things to adapt to these new variants and it's going to be the same or do we have to go all the way back through all those safety regimen again?

BANCEL: So, I think there's two sides to your question, what we believe from a science standpoint and what the regulator needs to see. From a science standpoint, we believe that changing a few builds won't change the safety of a product, we use the same chemical to bond, the same liquid around it, in the same machine. So, it'd be very comfortable having my loved ones getting a vaccine modified by just changing a few base builds in the spike in clinical studies. That's what I believe. Now, what a regulator will require in terms of change or not, I think we depend on what's happening in the community and the risk. I could see a world where if a virulence is less, the regulator asked us to do a full study of a new construct. But if the virulence is very bad, it's a massive public health from a risk benefit trader, the regulator might be comfortable allowing us to go straight to when you construct.

BECKY QUICK: Stephane, very quickly, I just wanna go back to something you said. You said that you think countries that have had flights that came from South Africa and I'm guessing you mean any of those eight countries in South Africa, not the official South Africa country, that you think any country having flights coming from the last seven to 10 days from those countries very likely already has this new variant there, even if they haven't detected it yet. If that's the case, how effective are these lockdowns or these potential moves at this point to try and stop it?

BANCEL: Yeah, so exactly Becky, I believe that any country that had direct flights from South Africa in the last seven to 10 days, you're now quickly that new variant to cover locally from the data we have seen, as that case exported to that country or imported of the virus. I think the, the measures that are being taken in a lot of countries can slow down the progress of the virus when we figure out the efficacy of the vaccine impact, when we figure out virulence and I think those actions can save a lot of lives down the road.

ANDREW ROSS SORKIN: Hey Stephane, I’m—

QUICK: So just a follow up real quickly, Andrew I'm sorry, I'll get out of the way in just a second. But just a follow up if you have a lockdown, you've got Israel and Japan that are doing total lockdown, other countries that are saying you can't come unless you're a citizen of that country. Does it matter? Does COVID check your passport to see if you're a citizen of that country?

BANCEL: Of course it does not. So, I think the piece is testing, testing, testing. I think what Holland did by testing all the people who landed on that plane was the right thing to do. And as you can see, between people who took the plane with a negative COVID test and people who’ve arrived, you had around 10% of the plane that was COVID positive and that's happening everywhere on most flights. That’s why we need to be very cautious.

SORKIN: Stephane, as you know, one of the, the great critiques of the world of pharmaceuticals right now and those making vaccines is that, is that we're not getting enough of them to folks as quickly as we should. Part of the issue in South Africa was there wasn't enough uptake. But I wanted to understand from you if you were king for the day, and you had unlimited funds, if the US government were to say we will, we will send you a check for $100 billion right this second, how quickly if a new version of the vaccine needs to be produced, manufactured and distributed, how you would do it and how you would do it differently?

BANCEL: So, the challenge is that the manufacturing capacity is what takes times to change drastically. I think today if you look at just the two amounted players, we are on track together to make around 7 billion doses of vaccine for 2022. We could of course increase that if required but if you look at just the number of people who don't want the vaccine around the planet, I think with 7 billion doses, we covering most people who want a vaccine with, with a single dose booster. In terms of timelines, I think as we've said there are 60 to 90 days to get a new virus vaccines already made and actually approved by the regulators. The question is how quickly can manufacturing and when do you decide to switch because today we're making the current vaccine because many countries still want it because that's the only protection available and when do you make that decision so we are getting ready to make the decision as soon as we have the data in the next week or two.

TIRRELL: And Stephane, just going back to all the different things that you're looking at as potential solutions for Omicron. I mean, you mentioned looking at the 100-microgram dose booster, that's the full dose rather than the half, seeing if that potentially provides enough protection on its own and then presumably, you've got that ready to go. You also have multi variant booster candidates that target parts of Beta and Delta that you say may potentially work and then you're also working that Omicron specific potential update to the vaccine. When do you think you'll know which one of those is the right solution? Are you working on all of them in parallel? When will we know what the right way to treat this is?

BANCEL: So first Meg, yes, we are working on the three solutions at the same time because those have different timelines of when they could be actionable. The higher dose could be done right away but it will be months before the Omicron specific variant is ready to ship in massive quantities. And I think the big pivot is going to be the vaccine efficacy impact when we learn that in a week or two, depending on how much it drop, we might decide on the one hand to start getting a higher dose of a current vaccine around the world to better protect people, maybe people at very high risk the elderly, immunocompromised should need a fourth dose, question mark. And then in the meantime, rolling them into balance. So, I think those are just different timelines and just depending how bad the vaccine efficacy is impacted, we'll have to use one or the other strategy or maybe the three of them because they might just come one after the other.

KERNEN: Hey Stephane, I wonder what your thinking is on, on people that have seen the entire virus. In other words, people that had COVID and so they got their antibodies were generated, the antigen was the entire virus itself, not just the spike protein. Would they have an advantage in terms of Omicron? Or because it's a different spike protein, would it be like that like their bodies seeing something entirely new as well and then they'd be defenseless, not defenseless, but maybe that the Omicron can get around the, the natural immunity a person had from, from getting COVID the first time around? Do you know?

BANCEL: We don't know. I think it's a really interesting question, Joe. I think the question depends on when were they infected naturally because what we've seen so far is people who get vaccinated get higher level of antibody than people who get naturally infected. But as you say, people who get naturally infected get a much broader repertoire of antibodies, and that tradeoff between diminishing antibodies and the breadth of the antibodies is really hard to not even if it's a new variant, but it's highly possible but we don't know.

TIRRELL: And Stephane, just thinking about the, the solutions to this, this issue. There have been calls from scientists in South Africa for, you know, if vaccines are needed to be updated or we need a higher booster dose or any of those solutions, there've been calls to prioritize that region of the world to try to stem the problem at its source. Is that possible to do? And of course, we've heard from Dr. Scott Gottlieb yesterday on “Face the Nation” saying that there is a resistance to accepting more vaccines in some of those countries because it's difficult to distribute them. The uptake in some places is, is low. What issues are you seeing there?

BANCEL: Well actually, it’s exactly the same issues that Dr. Scott Gottlieb described. We have right now between 50 and 70 million doses of a vaccine in our warehouse unfortunately, ready to ship that are either custom issues or people in some countries have too many vaccines right now, and not enough people who want to get vaccinated or not enough medical workers to inject those. So, I think the world has changed drastically from what it was at three months ago, where there was not enough vaccine. Now already believe there is there's too much vaccine, which is a good thing for a planet but the issue is really the last mile.

TIRRELL: Stephane Bancel, we really appreciate you being with us to help us understand how you're thinking through all of this and we hope to stay in touch with you as you learn more. Thanks again.

BANCEL: Thank you.

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