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First on CNBC: CNBC Transcript: Moderna CEO Stephane Bancel Speaks with CNBC’s “Squawk Box” Today

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WHEN: Today, Wednesday, April 14th  

WHERE: CNBC's "Squawk Box"

Following is the unofficial transcript of a CNBC interview with Moderna CEO Stephane Bancel on CNBC's "Squawk Box" (M-F, 6AM-9AM ET) today, Wednesday, April 14th. Following are links to video on CNBC.com:

https://www.cnbc.com/video/2021/04/14/moderna-ceo-jj-covid-vaccine-pause-will-not-increase-hesitancy.html

https://www.cnbc.com/video/2021/04/14/moderna-ceo-we-hope-to-have-covid-booster-shot-ready-by-the-fall.html.

All references must be sourced to CNBC.

MEG TIRRELL: This is a brand new virus so every six months gives us new information about how long these brand new vaccines will last. Stephane Bancel, the CEO of Moderna, joins us now he's got that information. Stephane, let's start with of course the big news of this week which Joe was just talking about the, the J&J vaccine and the safety concerns around those six reports of these serious but rare blood clots. You've looked into your data, your vaccine has been given to millions of people, do you see any similar risk of blood clots or any kind of safety event with your vaccine as of now?

STEPHANE BANCEL: Good morning Meg. Indeed, we are following very closely the safety as we should and are in constant dialogue with the CDC and the FDA. And indeed, we put a statement out yesterday that we look at the data of 64.5 million doses that are being administered to people around the world, and we have not seen any data suggesting any association with blood clotting or thrombotic events.

TIRRELL: What is your interpretation of sort of the FDA's move here. There was a lot of criticism yesterday that this would lead to vaccine hesitancy. A lot of messaging also that because we had not seen this with the mRNA vaccines, you know, people will be encouraged to get those, as this gets worked out with the J&J vaccine, but are you concerned about hesitancy about vaccines as a result of this situation.

BANCEL: Actually, I believe quite the opposite. If you think about it, this is yet another proof to the American people that we have the best regulatory agency in the world and they care deeply about the scientific and medical safety of our products and they will take any signals, like we saw last fall if you remember some companies at pause on their clinical trials because the FDA wanted to proceed safely, I think you see the same thing. So I think it will just show again to the American people that the FDA will not hesitate to be very cautious, to analyze the data, to take the time required to do so, to protect the safety of the American people.

TIRRELL: This of course puts more pressure on Moderna and Pfizer here in the United States to deliver vaccine doses and perhaps around the world as well. You know this might just last a few days for Johnson & Johnson and then it might be back up contributing to supply but as of now, how does your manufacturing look? Are you confident you can hit all of your targets here in the US and are you looking at the same goals around the world? Is there any way of increasing output this year?

BANCEL: Yes. So, as you know, we had a goal of 100 million doses for the first quarter, we finished that a few days before the other quarter which was an amazing effort by our teams and our partners. Just to put that in perspective, in 2019, we made less than 100,000 doses for a full year. So you can imagine the type of ramp up that the team had to do and that confirmed that we are on track to deliver the second tranche of 100 million doses to the US government by the end of May and on track for the third one by the end of July. If you look at the data which you know, I happen to do every morning on the CDC website of vaccinations, it's really heartwarming to see that, you know, we have around 80% of adults above 65 years of age in the country that have already gotten one dose. And so, I think we're getting to a point, as we know, most states will allow vaccinations 16 and above as of next week. So, I think we're already getting into a phase that I believe in the next 30 days-ish I believe this country is going to go from a situation of not having enough vaccines to having potentially too many vaccines.

JOE KERNEN: Stephane, when we look at the efficacy, we can't help but think both as individuals and as populations so, 90% is such a great number, but as an individual you would think wow, I've got a one in ten chance still even though I've gotten the Moderna vaccine, I've got a one in ten chance of still getting COVID. That, that might be what to draw from that conclusion. But in reality, if you had 90% of the population, you know, vaccinated that had that type of efficiency that there is a number where the virus just sort of burns out. It's and I'm sure it's much lower than 90% I'm not asking you to be an epidemiologist, but what is that number for like six months from now we may not be 90%, we may be 80%. Six months from then we may be 70%, we may be 60%. But isn't, can't you keep this virus under control it even at 50%?

BANCEL: So I think it's a bit too early to know Joe exactly what is required as you know Dr. Fauci and others have said. What I think this really shows is what we have been saying for now for months is that we believe we are all going to need boosting. And as you know, Moderna has been very active in its boosting strategy, while testing three different in parallel, to make sure we pick the best one. We're testing in the clinic right now, boosting our currently authorized vaccine. And we believe that's going to be helpful because it's basically going to boost antibodies to people who have received our vaccinations already. And we're testing, as you know, a new program for mRNA 1273.351, which is 100% copy of the full spike protein of the virus variant that was identified in South Africa and we're also testing a combo of those two 50 50 mass ratio product called 1273.211 and so we actually put out yesterday, the preclinical papers showing that those boosting strategies with variant vaccines show very high neutralizing antibodies so we are pretty confident that the data in the coming weeks in humans, we should see the same thing.

KERNEN: Which is part of the promise of this very agile technology, the messenger RNA technology so you can boost just normal immunity to the original COVID and combine it with some sequences for some of the variants in the booster and do that fairly quickly and fairly easily.

BANCEL: Correct and the regulators have given very clear guidelines, they do not need efficacy study but neutralizing antibody in people that were vaccinated a year ago, we are doing this currently so I think it's going to be a few months to getting that data ready to file to the regulators. Our goal is to work really hard to get this ready before the fall. I want to make sure they are boost vaccines available in the fall so that we protect people, as we're going to see next fall in the US.

MELISSA LEE: Stephane, a lot has happened in the past 24 hours which has led investors to rethink how they value your stock. Yesterday's boost was a $4 billion add to market capital. It's like another couple billion this morning. Can you, can you walk investors through how you think about first of all, the move closer to full approval which would allow you to sell the vaccine directly to private companies, but then also the notion that Johnson & Johnson and AstraZeneca as vaccine makers, the competitive pressures largely abated and so therefore the pricing pressure on your vaccine and Pfizer's vaccine pretty much goes away or is ease, how should we think about these two items of news and how they impact your forecasts.

BANCEL: Yes, that's a great question. I mean, as you know we are now, you know, 15, 16 months chasing this virus. And if you look at how the different technologies are played out in a protein vaccines are not approved yet, the adenovirus vaccines have lower efficacy and potentially, this is again, this is for a regulator to define some, some rare safety issues, and also potentially more manufacturing sciences, as you know one of the great performance of mRNA is we do not need cells to make the product. It is made in water with enzymes, it's much more scalable. And if you look at the two mRNA companies that are on the market, they have been able to deliver whereas if you look at companies across the globe, there have been more challenges with other technologies so that because this race against this virus continues and accelerate because as Joe just said, the variants are going to be moving at a very fast pace, everywhere. I personally worry deeply about the next six months, as the southern hemisphere, move into its fall and winter we're gonna see a lot of cases in the south, we already see spikes around the world. And you will see many more variants coming because many of those people are not vaccinated. And many of those people are immunocompromised like there's a lot for example of HIV positive patients in those countries that I'm not surprised to see variants of concern in Brazil, in South Africa and in India, in other places and so I think now it's sort of race against this virus, you know, we've increased our manufacturing capacity we've announced it a few weeks ago. And assuming the variant strategy evolved at the 50-microgram dose, which is what we're testing in the clinic right now, we could have up to 2.8 billion doses for boosting in 2022. So I think that as the race against this virus continues and need to keep a very strong pace, I really think based on technology better position in terms of efficacy, safety, manufacturing, scalability, and speed with mRNA technology.

LEE: Stephane, I've got a follow up question to that in terms of how we think about sales.

TIRRELL: Hey Stephane, apologies, my IFB just dropped so I can't hear anything. Oh Melissa.   

LEE: These cross currents, I'll continue with my question. In terms of, Meg is apparently having some technical, technical difficulties Stephane so I'll follow up on the question. Should investors increase what they think about sales, given what you said about, about the next six months potentially, but also based on your timeline for now for full approval for the vaccine, as well as the idea that pricing pressure has, has largely gone away one of the worries of the bear case from Moderna.

BANCEL: Yeah, I think the most important piece, piece for me is the boost. I know so many investors have not believed we're going to be selling boosts next year, and in 23 and in 24. This virus, as I've said before, and many preliminary stuff said, it's not going to go away. It is not leaving the planet. We have to live with it and we live with it like we live with flu. I anticipate that in the next year or so we're going to see a lot of variants. But as more and more people get vaccinated or naturally infected, the pace of a variant is going to slow down and the virus is going to stabilize, like you see with flu. And so what we're trying to do at Moderna actually is to get a flu vaccine in the clinic this year, and then combine flu vaccines with COVID vaccines so that you only have to get one boost at your local CVS store at your GP every year that will protect you to the variant of concern against COVID and the seasonal flu strain and we believe we can get a high efficacy flu vaccine as you know, the flu vaccines today in good years have 60% efficacy, in bad years, it's down to 30-40%, which is, by the way why many people don't take their flu shots and we believe we should be able to get a high efficacy flu vaccines combined in the same shot with the COVID variants, high efficacy so you can take one dose and then have a nice winter.

TIRRELL: Stephane, it's Meg Tirrell again, I'm hoping that my audio issues are worked out and apologies for that. Just one last question for you, you of course today are laying out your research and development in other vaccines using mRNA across diseases from RSV, CMV, HIV and flu as you just mentioned, I wonder if you could just say do you expect mRNA to work so well in all of these other viruses you've set a pretty high bar in COVID in your first horse out of the barn here.

BANCEL: So, we fully, we believe so Meg and I think there are three reasons. One is the fidelity of a biology, we're making virus protein in the human cell, not like protein vaccine in a bacterial cell. We're making these in the human cell in your own body, so it's totally mimicking a natural infection without giving you a virus, part number one. Number two on efficacy is we can make very complex protein as you know Meg for CMV vaccine we have six mRNA in the doors and five of those have to come together and form a patent, form a very complex protein that is very, very hard if not impossible to do using recombinant and it is made in your cells exactly like if you had a natural CMV infection. And the last piece is combination, we can combine things. And so if the right biology for this virus is 345 antigen, we can do that we can follow the biology to ensure high efficacy so, do I believe most of those vaccines have a high chance to get high efficacy to a market, I do believe so.

TIRRELL: Alright Stephane Bancel, it'll be quite the story to watch, we appreciate you being with us this morning.

BANCEL: Thank you.