‘We’re not trying to have the first vaccine. We want the best vaccine’: Moderna CEO

As the vaccine race heats up, conflicting reports over when a vaccine will be ready and distributed has many wondering of the efficacy of the vaccine process and its safety. Moderna CEO Stéphane Bancel joins The Final Round to discuss all things related to coronavirus and the pharmaceutical industry.

Video Transcript

MYLES UDLAND: All right. Welcome back to "The Final Round" here on Yahoo Finance. Myles Udland with you on this Thursday afternoon. Well, earlier today Moderna held an Investor Day. Stock here is off just about 2%.

But to join us now, talking everything about what the company announced today, what the future holds for this company that's really been at the center of the pandemic trade, we're joined now by Stepháne Bancel, the company's CEO. We're also joined by Yahoo Finance's Anjalee Khemlani. So Stepháne, thanks so much for joining the program.

Let's start away from the COVID news, which I know we're going to get into. And if you could kind of give us an overview of what this Investor Day, I guess, means to the company, given what the last 12 months has been like. Where these-- where that 12 months has taken you, and some of the news, again, that you announced, very exciting for you and the company, that is, again, outside of the COVID news that I think so many investors have come to know you guys by.

STEPHÁNE BANCEL: Yeah. So good afternoon, and thank you for having me back. Yeah, so we held this morning our annual R&D Day that we have been doing since 2017. And I think the big news-- if you think-- first of all, the vaccines. We've announced a positive phase 2 for CMV vaccine.

So CMV stands for Cytomegalovirus. It's a virus that basically caused birth defects. It's the number 1 cause of birth defects in this country, around 10,000 kids per year. There is no vaccine on the market.

The world industry has strived for more than 20 years to make a vaccine against CMV, and everybody failed, because it's a very complex herpes family virus. And so what we have been able to do, thanks to mRNA technology, is mix-- make a very complex vaccine that has actually six different mRNA molecules in each vial.

We were very happy to report a positive phase 2 this morning. We shared that data with investors and analysts. Then we also announced that we picked the dose for phase 3, and the phase 3 is on track to start next year.

So that's a $2.25 billion annual peak sales product, in our opinion. And it will be a first-in-class. [INAUDIBLE] product on the market, and a big medical need. Every woman in the age of having a child, we believe, could have this vaccine. So that's news number 1.

On COVID, and I'm sure we're going to talk about it, there was no new data today, because the phase 3 is ongoing. We just gave an update, which we do usually every Friday. The update that is as of last night, we had 25,000 participants enrolled in the study, out of a goal of 30,000, which is the goal that the FDA has set as what is required for phase 3 filing for approval.

And we announced for the first time how many people got their boost. You remember, it's a vaccine with a prime and a boost, like the other key vaccines in that race against the virus. And we've announced that we passed-- over 10,000 participants have got their boost. And that's very important, because that will determine the timing to [INAUDIBLE], which I'm sure we'll talk about.

But what we announced this morning on this study is that we filed online the full and redacted protocol. As you know, there's been a lot of questions about how the vaccine study is carried. Are they going to be safe once they are approved?

And so we wanted to make sure that we get access to the public, to clinicians around the world, to nurses, to the media, the full, unredacted protocol of our phase 3. It's 100-plus pages. It's all online since this morning. And to our knowledge, no of our company has done that before, including no other company going after a COVID vaccine.

And the third news on the vaccine is that we are entering the flu business. As you know, flu still kills 10,000 to 60,000 Americans every year. There are hundreds of thousands of hospitalizations. A big loss of economic output when people are sick.

We believe that the current vaccines available are really not very good, in terms of efficacy. And we believe, with what we have shown so far in the elderly and the quality of elderly data, that we should be able to go after the flu and get a vaccine much more efficacious than want you can get at the CVS Pharmacy today. And then we also made some announcements on the therapeutic side, in terms of repeat dosage. So that's kind of the big news of the day. Plus last night, some new partnership with Vertex on gene editing.

- Definitely a lot of energy, Stepháne, around the company. And really, a great timing, right? It was sort of riding the momentum that you've gained from being a front-runner in this COVID vaccine race. But talk to me about the emergency use authorization.

We've heard so much, really, about the filing. And you mentioned the 10,000 who have gotten their booster shot. That gets you one step closer to filing that EUA. With all the political discussion in the background, are you feeling that pressure to meet that November deadline? Or what does your own personal timeline look for that EUA?

STEPHÁNE BANCEL: So as I've said publicly over the last few, since we started racing this virus back in the first few days of January, we have had from no governments any pressure to go faster. I would actually say that what we got from the government, the FDA, the CDC, the NIH, Operation Warp Speed, is people wanting to help us, and spending a lot of time, including in the evenings, on the weekends, helping us. Not cut corners. Figure out how to go faster. A very quick response time.

That's what has happened. On timeline is what I've shared a few months ago. Nothing has changed. A base plan is we should get the first interim data in November.

There is a best-case scenario for October, but it is unlikely because it will assume that the vaccine is a very, very high efficacy, and a lot of infection. Because unfortunately, but it's true for all of our vaccine manufacturers, because we are all looking for efficacy data, we need in the placebo groups people to get disease. To get infected.

And so as you've seen over the last few weeks, the number of cases in the country has slowed down. That could potentially delay all of our vaccines by a few weeks, just because we have less people that will basically get-- in the study get disease. But we are sticking to a November timeframe. If the numbers were to slow down a lot in the country in terms of infection, like going from the 30,000, 40,000 we see right now to maybe 10,000 or less, it could potentially push it to December. But we're sticking with what we do today.

Our teams are doing daily re-forecasting of epidemiology by zip code. That's how precise our team is doing it. And we are sticking to our guns. We should have efficacy data for this vaccine in November.

And if we have a positive signal in efficacy given to us by the Safety Committee, which monitors, and does all the math and monitors safety, we should be able to find very quickly an emergency use authorization that I believe will be limited to high-risk populations. It is not for the whole public. But it should be able to help health workers, and most probably, older people that, as we know, are at very high risk from that disease.

- And you're looking at a lot of other things that have given investors a reason to pause. Because with the rush to start, and you being in the front, you've now sort of slowed down that timeline for various reasons, including your focus on diversity, which sort of matches the national discussion. And none of your competitors are necessarily as vocal on this. Do you think this harms your prospects for the future when you're looking further down the line for your pipeline?

STEPHÁNE BANCEL: No. I mean, the way we thought about it is we want to do the right thing, you know? We started the company 10 years ago to try to make medicine to help people. We started racing this virus. One of the first companies, early January, to help people.

Because at the time, we thought it was going to be an outbreak. And around the end of January, when I was at the World Economic Forum talking to a couple infectious disease experts, and seeing data in real-time coming out of China, it became clear to me this was going to become a pandemic. It was already everywhere.

And so what we wanted to do for diversity is to do the right thing. Because we are working hard with the teams and our partners to get the vaccine safely to the finish line. But if the Latino population, if the African-American population doesn't feel that there's enough safety data and/or efficacy data for their population, and they don't take the vaccine, that's just an awful outcome. We want people to be protected.

And as we have seen lately, those minorities populations actually have a higher risk to get severe diseases or deaths. And so what we decided to do a few weeks ago is to slow down the tail end of the study by focusing on the sites that had very good performance of finding people from minority groups. It was not going to slow down the efficacy readout, because as I said a few minutes ago, it's the first people in the studies that have a chance to readout in November.

People that are, let's say, being injected today, because there's a boost four weeks away-- and if you look at the protocol, we start looking and counting positive cases of disease two weeks after a boost, in six weeks from now. So if you look at it in a November timeframe, those people dosing today will have really no impact in the chance to improve the odds of getting efficacy in November.

So we felt it was the right thing to do from an ethical standpoint, and it was not impacting the time to efficacy without. So we decided to slow down, even though it might seem counter-intuitive. But it's because, again, it was not going to impact time to efficacy without.

DAN ROBERTS: Stepháne, Dan Roberts here. On the topic of slowing it down, obviously, there's very much kind of a race right now, a competition among many names, to have that first COVID vaccine. And we've talked on this show about the idea that there can be multiple winners, not just one.

Now, that said, is it important to you at all to be first? Obviously, it's going to be important to the stock market. And if it isn't you guys, you wonder if that's going to be damaging, as people wait to see the next few vaccines. Does that matter to you at all, being the first with one out?

STEPHÁNE BANCEL: No. We're not striving to be the first vaccine. We want to have the best vaccine. We want to do it safely so it's trusted from the public and from clinicians around the country.

And so I would rather be two weeks behind the first vaccine and have the best vaccine, and the vaccine that is trusted. Plus, from a business standpoint, and potential turnover, it will have no impact. Because everybody is supply-constrained.

I am making as much product as I can now. And as soon as we get the green light from the FDA, if we get it, we will ship to the US government all the vaccines we have in our warehouse. So if you think about it, whether I ship the vaccine I made from mid-November or the week after, it's going to be the same, in terms of the Q4 sales. It will have zero impact on sales.

And we believe we have a very strong vaccine profile because of the data that we have in the elderly. Unlike other vaccines that have shared data in the elderly population, where they have seen a drop in neutralizing antibodies in older people versus young people, in the Moderna vaccine, we've shown that we have the same level of antibodies in a 22-year-old or in a 75-year-old. And that gives us good hope that this should translate in efficacy in phase 3. But again, we have to wait for the data in the next few months.

But we believe we might have one of the best vaccines. And I would rather be launching a few weeks after the first one, because it will have, again, no impact on sales. But we have to do it correctly. Safety is number 1 priority when you develop a vaccine.

- Stepháne, there have been some people who have said that the first round of vaccines, and that includes yours, will likely be less effective, because there's still so much unknown about what antibody production means to this virus. How do you rectify that with the optimism of this vaccine coming out this year?

STEPHÁNE BANCEL: I think it's an interesting scientific judgment that I don't understand the scientific basis. What is clear is you have companies that are six, nine months, 12 months behind the first companies in that race against the virus that are older, proven technologies. They are just a bit slower to get to a finish line.

So it is true that there are vaccines that-- behind us that have a higher chance of working. But based on the data we have seen where we make high level of neutralizing antibodies, we published that in "The New England Journal", the top medical journal. We published in non-human primates, when you give a challenge--

So you vaccinate the non-human primates and then you wait. And then you give them a very high dose of virus in their nose, like 10 to the 6 copy of a virus. And we were able to show we had no virus in the lungs of the animals.

And in their nose, we had virus for a couple days, but much less than what we gave them. And that therefore, they had no more virus. Meaning, the vaccine could potentially, again, to be proven in humans, could potentially reduce infection from people-to-people. So I think it's very interesting that people have judgments. The data we speak at, at the end of the day, as always in science.

SEANA SMITH: Hey Stepháne, Seana here. I have a question just about timing, just because I was reading a little bit about this, in terms of what you released today. And the protocol allows you for the possibility of stopping the trial early if you get enough data. If you get what you need.

The fear, though, that's out there is that if you do stop early, then it could lead to this exaggerated perception of the vaccine's efficacy. Where do you stand on that? And how do you address some of those fears out there, just in terms of the public's perception of this?

STEPHÁNE BANCEL: Yeah. And I think it will only depend on what the Safety Monitoring Board sees in terms of the data. If the efficacy is off the charts, it becomes an ethical question to say, do you keep everybody who was on placebo, who has a risk to get disease, and for some of them, at high risk to die? Do you keep them on placebo?

That's going to be a very important scientific, medical, and ethical discussion, which is tough for me to have an opinion today. Because first, I have seen no data. And I could describe a different world where, in some circumstance, we say, let's keep going. And in some data set, we say, look, it's just unethical to keep going.

Maybe you have to keep going for young adults, because you have lower risk. But older adults, you get everybody who was on placebo, you give them the active. The real vaccine.

This will all depend on the data. The Safety Committee will see the data before us. They will make a medical and ethical recommendation. And based on that, we will decide what we think is the best course for the people that are in the study first.

MYLES UDLAND: All right. Stepháne Bancel, the CEO of Moderna. Stepháne, thank you so much for joining the show today. I hope for the world we don't have another three- to four-year accelerating event for your company in the next year. It's certainly been an incredible year for you guys. I hope we can stay in touch, and we'll talk soon.

STEPHÁNE BANCEL: Thank you so much for having us.