Moderna President details new clinical data on COVID-19 vaccine

Moderna Presdient Stephen Hoge joins Yahoo Finance to discuss the latest infomration about Moderna's COVID-19 vaccine.

Video Transcript

[MUSIC PLAYING]

ADAM SHAPIRO: So with the focus today between President Biden and CEOs from the nation's largest companies on COVID-19 vaccines and mandates and all that comes with it, we thought it'd be a good idea to bring Anjalee Khemlani in, because she covers COVID-19 for us here at "Yahoo Finance Live" and has the best understanding of what's going on with different vaccines and different vaccine developments and where we stand with all of it. Anjalee.

ANJALEE KHEMLANI: That's right, Adam. A lot of debate really right now focusing on that booster shot. As we know, September 17 is the day that the FDA advisory panel is set to look at the Pfizer data and make a decision on that. And we also got the release of documents today, and a lot of it really depends on Israel data, which is interesting.

And that is something that the FDA has acknowledged is data that it has not independently verified and vetted. We do, however, do have some new data that is US focused, and that is coming out of Moderna, which announced the release of data today, which is yet to be peer reviewed. I had a chance to discuss all of this with President Stephen Hoge. So listen to all of what he had to say about the timeline and what's expected.

STEPHEN HOGE: We're actively engaged with them now. I would expect in the coming weeks to months that we would have full approval.

ANJALEE KHEMLANI: OK. And then what about for adolescents?

STEPHEN HOGE: Adolescents, I would hope, is any day now. We filed for that about three months ago, as you know, and we've continued to work productively with the FDA. And so it's really up to them. But to be fair to them, they have a lot on their plate right now, and that might not be at the top of the-- the top of the pile.

ANJALEE KHEMLANI: Very understanding of you. And then we also have heard from Pfizer about the 5-to 11-year-olds, so I just wonder where you stand on that and when you anticipate getting that data in?

STEPHEN HOGE: Well, we're starting to see data even this month, and we're trying to pull together our filings on really similar timelines of what's been described by Pfizer over October and November. At the end of the day, though, it's really up to regulators to decide when we're done with those filings, when they have enough information so that they can make the decision of whether the vaccine should be authorized or not.

ANJALEE KHEMLANI: Awesome. Well, let's start talking about boosters because, of course, that's a hot topic this week. Looking at the data that you've released today, it's clear that a booster shot is beneficial, especially with providing better protection. And especially looking at the comparison of eight months post the first dose versus 13 months is definitely showing some more efficacy there. So walk me through what that means in terms of what you're thinking about, what Moderna is thinking about when it comes to who specifically would benefit from a booster shot, either with age groups or just regionally. Walk me through that.

STEPHEN HOGE: Right. Well, this is the key scientific question we're all wrestling with right now, which isn't how the vaccines are doing today, it's how are they going to do this winter, three months from now when we would expect there to be an increase in cases as people go traveling for the holidays and come together? And there's only one way we can look into the future a year out from when most of us have been vaccinated. And that's in our phase III trials, where many people were vaccinated over a year ago.

And that's the data that you just described that shows a significant increase in the number of COVID-19 cases for those who were vaccinated over a year ago when you compare them against somebody vaccinated just six, eight months ago. And that's where we think most Americans will be towards the end of this year as we get into the winter season. If you extrapolate the number of breakthrough cases that are resulting from waning immunity in the broader US population of folks who've received our vaccine, it actually is almost 600,000 incremental cases of COVID-19 that we'd expect to emerge over just the next three, four months, so quite a large number of people.

Now, the data in our phase III trial that we were just referencing really covers all age groups, and so those from 18 to, I think, 87 or 89 in that study. But it's important to note that there's a higher risk for those who are older and those who have co-morbidities. And so while we do see breakthrough cases across the entire adult population, and we ultimately do think there's a benefit to boosters for the whole adult population, it's clear the need is most acute in those over the age of 65 or those who have diabetes, obesity, or chronic pulmonary diseases, other things that put them at high risk of severe disease if they ever did get COVID-19.

ANJALEE KHEMLANI: Walk me through that, too, because I know that there's been a discussion, as you said, you know, there's a lot of debate right now around this about whether or not this would be a true booster or if it's an additional dose and we're looking at sort of like a three-course-- sorry-- a three-dose initial course, and possibly even more time between what would be a booster. Where does Moderna fall on that right now?

STEPHEN HOGE: Well, it's a great question. And we don't really know. I think there is a lot of precedent in vaccinology that shows that a third dose six months after you've received your primary series really is what's needed to lock in long-term protection. Many of the vaccines we receive as children have that feature, as well as some of the ones we receive now as adolescents.

And so there's every reason to expect that this could be similar and that by giving a third dose sometime 6 or 12 months after you've received your primary vaccine that we'll get really long-term protection for the majority of adults, maybe not all. Maybe high-risk people will still need a regular booster. But that's certainly the hope.

The challenge is that we won't know until we provide that third-dose booster and really follow people out for 6 or 12 months and see whether or not immunity is actually holding up, when it's not waning anymore after that third dose. And so it's one of the situations that we've been in multiple times over the past year where we need to follow the data and the science, but we do need to take action ahead of the virus and ahead of really knowing what that long-term benefit will be.

I think the reason we should be doing boosters, even not knowing whether it's a third-and-done or that this will be something we have to get used to annually, is that we know, based on the phase III data that we released today, that there is a benefit for this fall and winter. We can reduce the number of COVID-19 cases. We believe we should do it for that reason alone, as the added benefit that as we look in the spring, we might find that actually we've created really long-term protection.

ANJALEE KHEMLANI: Yeah, I want to focus on that idea of the fall and spring being a major concern and the reason why the administration is so eager to get ahead of this. We've also looked at, you know, with "The Lancet" article that came out and the idea that there isn't sufficient data, even if you're looking at whether it's global data, including in Israel, which the FDA acknowledged that it has not verified and independently vetted, your data does cater to the US population and follows them, including through when Delta has been prominent in July and August.

And you saw that in the results, specifically in California, Florida, and I believe Texas, where you saw that surge in breakthroughs as well. What does that indicate to you about whether or not this idea of titers being the key focus versus sort of memory playing a role in what we need for protection?

STEPHEN HOGE: Well, we think-- I think many people think that the debate between whether it's memory cells or antibody titers is a bit false. Both are important. In fact, in most immunity and protection against viruses, you need both antibodies to be there and protect you right away, as well as cells that have memory of the virus that can rapidly expand.

Now, there's a little bit of time that it takes for those cells to expand. And so not having antibodies puts you at high risk. And then the opposite is equal true. If you only have antibodies and you don't have good memory, you won't be able to rapidly fight back that infection. We think it's both.

Now we all measure antibodies because they're easier to measure, but we do think that one correlates with the other. And so we do have a sense of both. And in fact, when we do go study T-cells, for instance, there have been a number of publications showing those are quite high on our vaccine as well over time, which is good news.

So both of them. But antibodies do wane. And as they wane, what we're seeing in the real-world data and in the phase III study results that we released today is that as they wane, you start to see increasing breakthroughs. And that really correlates with how recently somebody had been vaccinated.

So we do think it's a reasonable measure, a reasonable measure of the risk that we face of breakthrough, to look at those antibody titers and say, let's try and maintain them at a high level. Now maybe that's not something we have to do forever, for 10 years. But in the middle of the pandemic, which is not over yet, which may go for another year as we fight it globally, it seems prudent to us to try and maintain immunity and protection at the highest levels possible.

ANJALEE KHEMLANI: I'm glad you mentioned globally, because I'm curious about your thoughts on that, weighing the idea of a booster market and what that potentially, you know, presents for you as a company and for growth and for the revenue that you can gain from that versus the global distribution and concerns about global equity. How do you think about that in terms of the production, because I know that's still somewhat a concern?

STEPHEN HOGE: Right. Well, important to say for us as a company, we are flat-out in manufacturing. We're making as much as we can and have been for the better part of a year and will be for the better part of the next year. We're trying to scale up and invest in manufacturing to create more doses. But the most important thing that we could do is continue to be efficient about how those doses are used.

So as we look forward to next year, a booster for us is really a question of whether there's a benefit or not. And in this country, we do think that there's a benefit to a third-dose booster, a 50-microgram booster, that we think will prevent COVID-19 in this country. We also know that using our vaccine as a primary series in other countries that maybe haven't been as well vaccinated will help prevent COVID-19 there.

And we want to find a way to do as much of both as we can. We're not the only company working on the problem. There are many others. And we hope that all of those solutions are brought to bear. But for our part, one of the things we did look at is whether or not we needed to use a 100-microgram dose, which is the dose you get in a primary series with our vaccine, or whether we could use a slightly lower dose and still get to the highest levels of protection.

And what we were able to show, actually, is that a 50-microgram dose in our clinical studies got to the same levels, actually better levels of protection as a dose-- as a third dose than you were after your primary series. That gave us confidence to say that was the right dose for a third-dose booster in this country and has the added benefit of meaning that we might be able to manufacture up to 1 billion more doses next year for the rest of the world.

ANJALEE KHEMLANI: Lots to unpack there. I also verified that if, in fact, it ends up being a three-and-done situation, that it would be two doses of 100 micrograms and that third dose would still be 50 micrograms, so really interesting strategy that they've unfolded there. Back to you, guys.