Moderna CEO Interview Transcript on Promising Coronavirus Vaccine Results

Becky Quick: (00:00) How many people were involved or are involved in that phase one study? Stéphane Bancel: (00:04) Good morning, Becky. And thank you for having me. The first three cohorts of a healthy adult, 18 to 55 years old, we're at 45 subjects. We decided, NIAD, the department of Dr. Tony Fauci to add their daily calls, 55 to 70 additional free cohorts and then three additional cohorts, 71 years and above. As Mick said, this is a very exciting data. It's still interim data, so phase one is still ongoing. But if you think about where we sit today with the data that may be described, we could not be happier. Becky Quick: (00:45) Were there any side effects or any ill effects among any of the people who took this vaccine? Stéphane Bancel: (00:51) So the vaccine was safe and well tolerated, very typical to a vaccine. You have two type of side effect basically. The first one is local pain. As you can understand, when you inject a needle in somebody's arm, it never feels good. So you have pain. And then when you press on the needle, the volume of liquid basically goes and creates harm into your muscle cells. So it's a bit painful, but not worse or better than another vaccine. Stéphane Bancel: (01:16) You have some time for a few people, a bit of redness around the site of injection for they also. Again, my immunologist telling me this actually a good sign, to see some immune response. And then on the system, you clearly, you have a few subjects that have some chills at the end of the day, a couple of people, a tiny bit of fever. Like when you get a flu shot, it goes away by itself. Don't even need a Tylenol, just go to bed at night. And then the next day you're on your feet again. Again, even though at least we tell you, these type of observation are very consistent with an immune response. Becky Quick: (01:51) Stefan, let's talk a little bit about how long ago these people were injected with the doses as well. Because I think there are questions about whether there are after effects that come further down the line. I know people have questions about that. Especially seeing some of the situations we've seen with children, where it seems like they're fine and then a few weeks later they're getting this related sort of symptoms that are bad news from Corona virus itself. How long ago did these injections take place? Stéphane Bancel: (02:20) Yeah, so the first subject we injected on March 16. And if you think about the sentinel dose, those that we reported neutralizing antibodies, antibodies, that's combined and neutralize the virus. They were injected basically in March, mid March. And one, we are monitoring of course, safety very carefully. We care deeply about safety because vaccine obviously augments very few people. If you look at the totality of the data across the nine vaccines before the COVID that we put into a clinic, some into the elderly, some in viruses like RSV, which is another respiratory virus for which we have been in the past, you know, 40 years ago reported some enhanced disease. We have not seen that across our platform. We have not seen that, as to date, on this vaccine. Again, with [inaudible 00:03:13], we don't have a reason to believe it should be any issues with this technology, but again, we want to be safe and will of course, we need to offer patient safety. Joe Kernen: (03:20) So Stefan, over the years, whenever we're watching a drug progress through these clinical trials, it's always hard for lay people to understand the difference between phase one, phase two, phase three. So we're in phase one or phase one to phase two, and we're thinking it's just safety. All right, we're trying to measure safety and dosage and things like that. But you are reporting at the same time, evidence of efficacy because you're saying eight out of eight developed neutralizing antibodies. So the phase three that is a test for efficacy. How will that be different from what you're already seeing here? It'll be a much larger study, I guess. And you'll be looking for basically the same thing you just told us though, right? You want to see neutralizing antibodies in all the patients that get the vaccine, without side effects. So is this that different than what you're expecting to see in the phase three? Or will that just be a confirmation? Stéphane Bancel: (04:13) So a bit of both, Joe. So the first thing is safety. So phase one are typically in vaccine in the tens of subject, it was 45 here. Phase two in the hundreds, as we said on phase two will be 600 subjects. And we look at safety and same immunogenicity. And the phase three would be thousands of subjects. You can expect many thousands. We are still discussing with the agency. Once we have finalized the protocol, we will communicate it, but we care deeply about assessing the safety of these vaccines. So that's for the size of a study. In the phase three, we will monitor neutralizing antibody, of course, which what will monitor, efficacy. It would be a placebo control study, lack of phase two is going to be placebo controlled to see people that get the vaccination versus people will get the placebo. How many people can you protect from disease to get us an efficacy rate, to be able to file, to regulate towards, assuming a good outcome for an approval. Meg Terrell: (05:15) Stefan, it's Meg Terrell, you mentioned, in terms of the side effects that you did see fever in a few of the patients. Can you tell us how many of the patients experienced fever in the study that you've observed so far? You know, I'm just getting some feedback from some folks who were very closely focused on this space and they sort of seized on the idea that some people might have developed fever as a reaction to the shot. Stéphane Bancel: (05:36) Yeah. So you still very few cases at the second dose of the highest dose, the 250 microgram, which we do not intend to take forward. If you recall, when we started this program very quickly, in 60 days from sequence of a virus to starting the phase one, we did not have time to do enough preclinical work. We did preclinical work obviously, but not enough. Like usually you would take months and quarters to really understand your vaccine. Stéphane Bancel: (06:03) And so we put a very big range, 25 microgram minimum, 100, and 250, just not to miss efficacy because we were running against this virus. And the time was very precious. From what we've seen today of the neutralizing antibody, at 25 and a hundred micrograms to all of the participants at or above people that have recovered from a virus, we don't need the 250 dose. And so again, that the fever, whereas at the second dose at the boost, at the highest dose, which again is typical when you have too much of an immune response, which now once we know of how strong the 25 microgram is, it's not surprising that 250 microgram, when you come again a second time, the immune system is kind of telling you, hey, that's a lot of antibodies I'm making now. Becky Quick: (06:53) Stefan, just the question that, I mean, again, this is amazing to see the efficacy that is taking place in this. And I think that's why you're now looking at the Dow up by more than 420 points. But just the idea that you need two doses, there are more than 320 million people in America. How quickly can you start knocking out doses? What does your timeline look like? And has it changed at all from when we talked to you a few weeks ago, when you were getting that phase two approvals from the FDA. Stéphane Bancel: (07:19) So we were already, as you know, working on process [inaudible 00:07:23] and we've all learned that out of shape, we've said we could go up to a billion dose per year. What is clear is with this new data, which we just got at the end of last week, we're going to increase our investment in capital equipment, in raw materials, so that we can make as many of those as we can. We know every dose has been the motto. Stéphane Bancel: (07:44) There's a very nice study and work that the CDC has done preparing for pandemic flu a few years ago, that is available online. And they described there, the priority that people would get the vaccine. Healthy young adults are not first in line. Healthcare workers are. Elderly with comorbidities are. So we're going at it by waves of people for vaccination. And as I said before on your show, I do expect that over vaccine making tool, because no manufacturer else can make enough doses for the entire planet. But if several vaccines have a chance to get to approval, we have a chance to significantly impact the reduction of infection and disease and go back to a normal life. Becky Quick: (08:28) Your stock is up 30% on this news this morning. Year to date, it's up 341%, where are you getting the money to make these additional investments? Stéphane Bancel: (08:38) So, as you know, Becky, we have a strong balance sheet, a 1.7 billion reported at the Q1 earning call, a grant from [inaudible 00:08:45], a grant from the Gates foundation and Novelis. So the company is very capitalized with our some partners. So the company is in the great place. We'll invest aggressively. Speaker 5: (09:02) Just to that point, though, given where the stock is, you think about making a billion of these things, a billion of these doses, what do you ultimately think the price could even be and what the profit margin should or shouldn't be, given these issues? Stéphane Bancel: (09:18) Yeah, so we have not spent too much time working on price yet. We need to get to it now. As you can appreciate, going from sequence to phase two in four months and six months to a phase three, but we had no time to do anything, but that and the team has been working literally seven days a week. And so we need to start thinking about pricing, as you can appreciate, we're going to be very fruitful. We know it's a pandemic. We know people are waiting for the product. And so we just have to figure out what's the right price for this product.