Moderna CEO Stephane Bancel: 94.5% Effective Covid Vaccine

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First on CNBC: CNBC Transcript: Moderna CEO Stephane Bancel speaks with CNBC’s “Squawk Box” today on their 94.5% effective Covid vaccine

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Moderna CEO Stephane Bancel on its 94.5% effective Covid vaccine: We hope to get it to market soon

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BECKY QUICK: All right, listen up everybody some breaking news from Moderna. Meg Tirell joins us right now with the headlines and special guest, Meg, take it away.

MEG TIRRELL: Hi Becky well we're getting Moderna is phase three interim results 94.5% advocacy for their COVID-19 vaccine in this phase three trial, based on 95 cases of COVID-19 among these 30,000 participants 90 of those cases were in people who are not vaccinated who were in the placebo group five cases were in those on vaccine so that's how they get almost 95% efficacy of course the bar was set very high by Pfizer last week at 90%, this met it and exceeded it. They also are disclosing more information so they saw 11 severe cases of COVID-19 in the trial and all of those were among people who did not receive the vaccine suggesting this is not only highly protective but can protect against severe disease as well, no major safety concerns seen side effects were things that they'd expect including fatigue and muscle pain after the second shot.

They say they plan to submit for emergency use authorization, with the FDA in the coming weeks and to talk with global regulators about applying around the world. Also updating on supply 20 million doses expected in the US. This year between 500 and 1 billion doses globally in 2021, and also guys some news this morning about the shelf life of this vaccine being able to store it at a regular refrigerated temperature for up to 30 days to talk about all of this we're going to bring in Stephane Bancel the CEO of Moderna right now. Stephane, thanks for being with us this morning, another historic day 94.5% advocacy for your vaccine help us understand what this means. The second vaccine to show such high efficacy for getting us through this pandemic

STEPHANE BANCEL: I think it is great news we're all excited last week when we heard the good news about the Pfizer vaccine. And I think with the data that we're presenting this morning. It just hope that we should be able to get those vaccines soon into the marketplace to well vaccinate people at higher risk to stop the pandemic.

TIRRELL: Well, you also disclose some more data at the severe disease you saw 11 cases of severe COVID-19 in your trial, and there was zero among people who got the vaccine. So, tell us what that means I mean this could really keep people out of the hospital potentially prevent you know this this severe disease and even potentially death although it's probably too early to say that right.

BANCEL: Yes, and I think this is actually the data that excites me the most Meg, of course, we are delighted that the vaccine is close to 95% efficacy. But as you said, what we all want is, if somebody gets infected, that they don't get severe disease. And that's the great news we had yesterday when the independent health and safety monitoring board shared with us, all those data. Yesterday, early in the afternoon. That was the news that we are most excited about this, if this can afford with a bigger number I want to remind everybody is a first interim 95 case the full study will be completed 151 so we have to wait a few more days, it's going to come pretty soon given the quick base of cases that we are all observing in our studies. So, we are, we are very excited about what this could mean for patients and we're working very closely and at speed to get this in the hands of Americans. As soon as of course the FDA has the ability. In the coming weeks to review the final.

TIRRELL: One of the other really important things that experts are looking at here is the impact on different age groups people of different backgrounds who have underlying conditions, and you did have some more data there. Tell us what the data that you have seen suggests about how well this vaccine works for older people, for example.

BANCEL: Yes, and I looked up that data Meg and as you know the interim data. What we have is basically what we put in in press release, as we have done in the past months. We want it to be extremely transparent so everything that I learned yesterday you are seeing this morning. But I think because of a number of cases at 11 for severe. This was a number that starts to be kind of meaningful, as you might remember in the FDA guidelines for EUA. They said they wanted to see at least 5 severe cases so we're very happy to already be at 11. So as we get more data. I think around the time we file with the EUA in the coming weeks, we share those description by demographic.

TIRRELL:  And of course, everybody is going to want these vaccines at more than 90% efficacy, there's not going to be enough at the beginning, tell us about your supply 20 million doses in the US. This year, more next year, what is the pace that we in the US countries around the world will start to be able to get this vaccine.

BANCEL: So you might remember the first agreement that we reached with the U.S. government was for an order of 100 million dose. So we anticipate to be able to ship, up to 20 million of those hundred million before the end of the year. So we are making product as you know, every day, and stockpiling it. And assuming we get the green light from the FDA. I will say sometime in December. I'm sure General Perna from operation warp speed will be ready with the trucks to load the product, and to distribute it in the US, we have a CDC guidelines. And then every week we'll be making more and more product and once the product is approved, basically every time we have a lot, that is approved by the quality cultivator Moderna as meeting specification will be shipped right away. We needed a way. Every day is going to matter, and we anticipate those hundred million those needs to be shipped to the U.S. government, in the first quarter. And, and that's what is really exciting. So I think our vaccine and the other vaccine, that's a good book that we should be able in Q1 to get people at high risk vaccinated in the US, if they desire so.

JOE KERNEN: Stephane it's great news for just the, the platform for the proof of concept for using the nucleic acids, a small amount and to generate that type of immunity, I just couldn't help but thinking about. So you get the vaccine, you get the, the antibodies come but you could still be infected. The way you tell them that you are infected you couldn't test for the spike protein because you've already made antibodies for that so you what do you do check for the PC, you use PCR to check the nucleic acids are present from the coronavirus, but at a very low level because the antibodies are already attacking it right but you can detect trace levels of it in people and see that the antibodies are taking care of it.

BANCEL: Yes, so you raise a very good question Joe. We are going to monitor, it's part of our protocol, infection and try to see does the vaccine reduce or prevent infection, which would be, you know, of course a big win. And so what we're going to do, because as you say once we vaccinate people, they will have antibodies spike as this we've shown and we’ve published in the New England this summer. So what we're going to look at is antibodies of over proteins that are in the virus, but not in the vaccine that is how we're going to be able to see if people got infected by the real virus or not.

KERNEN: Yeah, I had to try to figure that out how that would work since you're okay let me ask you another question so there, there are some that thought maybe if you use the other vector that some of the other companies are using that the adenovirus itself is helpful in generating immunity maybe with it, mediated a different way maybe with T cells or with an adjuvant at 94%, it doesn't look like you need any, of the looks like this is fine for the further type of an immunity that you're looking for it seems just as good is that, can you make that statement?

BANCEL: I think so, Joe, and one other thing that we've worked really hard because this is not an overnight success as you know we have been at this for 10 years now, a lot of investments and focusing on the science. And what we've realized, over the years, is if we're able to make a very pure mRNA and make a lot of copies of the antigen of a protein of a virus in the human body, then we can get a very strong immune response like we are seeing today. And this is not the first time we know you know we are at the same results with our Zika vaccine. We will see for CMV cytomegalovirus. So, this is actually the 10th vaccine that Moderna has put in the clinic. And so we starting to see the power of our platform and now with this validation, in 2021, we’re gonna invest even more heavily in our vaccine business. There's a lot of viruses that do not have vaccines that hurt humans today and we want to really scale up the business and to really leverage the beauty of mRNA because mRNA is an information moniker.

QUICK: Hey Stephane, on that point, what are your next targets? What, what are you attacking after this?

BANCEL: So, the one that we're very excited about Becky is CMV, cytomegalovirus is the number one cause of birth defects in this country around 10,000 kids every year are born with their blindness or deafness and there's no vaccine on the market. The industry I strive for 20 years to make vaccines against CMV or vaccine at the successful phase two study, presented in September. We're going to start the phase three next year in 2021. And we believe we have a very high chance, especially after today’s data on the COVID to make this vaccine work. It looks very strong in preclinical model, the antibody levels in humans in phase one and phase two were also very high. So we are cautiously optimistic that this vaccine could be approved it's a 2 to 5 billion annual peak sales opportunity and again, no vaccines on the market. The other one is flu. As we communicated in September, once we saw the very strong data in the elderly of a COVID vaccine, is we want to go after flu as we all know, the efficacy of the flu vaccines is 30 to 60%, not very good. Still thousands of people die in this country every year of flu. We think we have a shot at doing a great flu vaccine that we're going to go it.

QUICK: Stephane, on the COVID vaccine, some of the exciting news I think you're announcing today is just what it takes with refrigeration because that's been a concern we talked about that with the Pfizer vaccine that it has to be kept at 80 below zero. Explain what this means, how you can actually get out and distribute this and what the shelf life is for this vaccine if it's not kept at those very low levels.

BANCEL: Yes, and we've worked really hard for around four years to invest in science and process development in how we make the product to be able to get to those temperatures. So what we have now is six months at -20 Celsius, which is a temperature that the distributors are used to because we are approved products at those temperatures, not deep freezing is just like a regular freezer, like we have at -20 Celsius. But then the big news of this morning is that we actually got on Friday, new stability data that show in a regular fridge at 2-8 Celsius like the fridge you have at home, like the fridge that are present in pharmacies and doctor's office for things like insulin, we can store a product up to 30 days, which was a big change before we had 7 days now 30 days and then when you want to administer a vaccine, you can keep it to 12 hours at room temperature and the other piece that I think is a big differentiator of our product, is we do not need dilution on site. So when you take the vial out of a regular fridge, you don't need to dilute the product, which is going to be simplifying everything for the nurse and the doctors speeding up a process because we have to vaccinate literally hundreds of millions of people.

TIRRELL: Hey Stephane, you know, thinking about this vaccine coming to the US you said, 100 million doses in the first quarter and the next year 500 million to a billion you hope to manufacturer for the whole year. How are you thinking about distributing this around the world, how will you make decisions about which governments come first? And are we facing a situation that public health experts have been warning about since this pandemic began that rich countries are going to get vaccinated and protected first and poor countries will have to wait longer?

BANCEL: Yeah, so that's a complicated one Megan. So what we've done, first is we sent it to the US supply chain, and outside the US supply chain, and this is based off of Geneva. We have a partner, Lonza, and the product is formulated in Spain, at our partner, Rovi. What we have seen in these governments from around the world already placing orders, you’re right it’s mostly so far high income and middle income country. We have been for now several months in discussion with COVAX, as you know, the facilities, set up by Gavvy, MP and WHO to provide pricing, we make proposal to them. Discussions ongoing and that we're going to find a way to provide a vaccine so it's accessible in low income, middle income and high income countries.

KERNEN: Stephane, one of the benefits is it's easier to manufacture this but it's still, we would still wish you could make a billion copies tomorrow, obviously. With other techniques, with DNA or whatever we're talking about, it's almost like Moore's Law – we've seen how quickly the time has shrunk to sequence and to produce and everything else. What are you working on that would allow much quicker production? Or have you already hit the limit of how quickly you can manufacture these little stretches of messenger RNA?

BANCEL: Yes, a great question, Joe. I think we still have room for improvement. As you recall, it took us 42 days earlier this year to go from a sequence, published online to shipping clinical grade, human grade products to—we are able to shorten that cycle time by investing in science, investing in robotics. And so I think we should be able to keep taking that time down. The reason that we are not able to make a billion dollars right away is this our first commercial product. And so we have like the older technologies, manufacturing capacity already built. We have to build everything this year. The good news for next outbreak because there's going to be more is that we will be ready with manufacturing capacity. And also once we engaged with governments to see how we can do more work to get prepared, because I think you've tested more collectively as a public private partnership before this virus appeared. I think we could have saved three to six months to getting this type of data.

KERNEN: So vaccines are great, but what about therapeutics? and it may not be perfect the way that this is delivered. But what's on the horizon for what you might try to do – whether it's a genetic deficiency that you can correct with this technology – this would seem like the tip of the iceberg and you could really tackle some of the scourges of disease that we humans still are subject to. What's next?

BANCEL: Yes, so that's a great question. So, we have a few exciting areas that we're working on. You know, we have a product in phase two now with AstraZeneca where we inject our mRNA coding into people's hearts after a heart attack. And the idea here is that if you still have a heart attack, your heart is going to be damaged – your heart muscle. So you're going to have heart failure. And so the question is can you inject the mRNA in one – to have basically your stem cells make new blood vessel in your heart muscle. The phase one data looks very encouraging. There was no safety issue. We show that we can increase blood flow in the arms of diabetes patients. The pigs, which is as you know – is a good translation from animal to human was also very nice for nature by the AstraZeneca team. So that's one that I'm quite excited about. The phase two is ongoing. We went over data. The other piece is as you said, Joe, is a rare genetic disease. We have now five programs in rare genetic disease, mostly targeting the liver right now. And the next property we're working on and I work with early next year is autoimmune disease. We are able to code mRNA against into immune cells to make inside those cells on a membrane of those cells on the outside, which you cannot do using recombinant or small molecules to make a protein of interest to basically help patients with autoimmune disease. As you know, we're also working with Vertex to get mRNA to – and we recently announced a second partnership with Vertex that is actually messenger mRNA to code for gene editing. And we're going to start this on cystic fibrosis with our colleagues at Vertex.

QUICK: Wow. Stefan we'll definitely have you back to talk more about that at another time too, because that sounds incredibly interesting but let me ask you more about the COVID vaccine right now. I see in the release that you put out today that the COVID cases – the 95 COVID cases included 15 older adults who are age 65 and plus, and 20 participants coming from diverse communities, including Hispanic or Latin x, Black or African Americans, Asian Americans, one multiracial. And that's good news because there's so many questions about what this would mean for different people with different genetic backgrounds. I guess my question is one that I'm a little bit of a broken record on. I have a child who is particularly exposed to this, it could have some serious problems with this and I just wonder – I know that kids in general are not a huge issue or a huge concern – when will you have testing that kind of moves to other groups that haven't been covered like this, including younger children?

BANCEL: It is a great question, Becky. So, as typically done in vaccines because we need those products to help keep reporting in clinical trials. It is a visual practice to wait for adult data, both safety and efficacy to assess the idea of Is it worth going into teenager first and then younger children. So we're going to start very soon in teenagers and so, of course, we'll let you know when this starts, but definitely this year. And then, so that's 12 to 17. And then we also want to go down to somewhere else. We of course will have to go to a lower dose and try a lower those than what we gave to adults. And we will have to start very slowly and, basically, age the escalate. So if we are going from let’s say, you know, people in 5 to 8 years old and then go down slowly. Because as you can imagine, given the difference in weight from our children and also immune system, we have to be very, very careful because safety is priority number one. But we are very committed to get us all vaccine working in teenagers first and then toddlers.

TIRRELL: Stephane, it is Meg again. You're thinking about what it's going to be like for folks to take this vaccine. It's two shots, four weeks apart. It is a very high dose of the vaccine. Any plans to look at a single shot for efficacy or perhaps that sort of next generation version to increase supply and increase compliance?

BANCEL: Yeah, so there's a few things we're going to be looking at Meg. And no decision has been made, so I won’t go into specific details. But when you look at this type of efficacy, as you know, in the study if you look back to protocol, we actually looked at cases after one dose. So, as we get all that data because, as you know, as a company, we were blinded to the data until yesterday, as we're going to look at the data and engage in the discussion with the SMB and the FDA, we're going to think about, is it relevant, to your point, to go single dose. Maybe at least in the younger population that has a stronger immune system. Or is it to go to a lower dose. As you recall, I told you in the spring that we spend a lot of time with the team is taking between 50 micrograms and 100 micrograms because the two dose. And the reason we picked 100 micrograms was it was well tolerated. And we wanted to give ourselves and future user of our vaccine, the highest efficacy. In this industry efficacy is always brought to number one, and getting to this type of level of 95%, especially as we said in the severe disease, is what is very exciting for us. We think these vaccines can have serious impact on this pandemic. And so we're going to look at the other possibilities to save by playing with a number of those dose developments –  but that’s for probably weeks to come.

TIRRELL: Alright, Stephane Bancel, thanks for being with us this morning. A huge day. We really appreciate you being here.

BANCEL: Thank you so much for having us.