The following is a transcript of an interview with Dr. Paul Burton, chief medical officer at Moderna, that aired Sunday, May 1, 2022, on "Face the Nation."
MARGARET BRENNAN: Last week, Moderna asked the FDA to authorize its vaccine for children under the age of six. The company's chief medical officer, Dr. Paul Burton, joins us now from Princeton, New Jersey. Doctor, welcome to FACE THE NATION.
DR. PAUL BURTON: Thank you, MARGARET. Good morning.
MARGARET BRENNAN: Well, the FDA said Friday it will not delay one vaccine to wait for the other. In other words, they're not trying to put Pfizer and Moderna head-to-head here necessarily, each application will be considered when the data is ready. So are you confident that Moderna will be ready for the FDA to review your vaccine at their June meeting?
DR. BURTON: Yes, absolutely, MARGARET. So we submitted our data last week. I think the FDA now have, you know, all of the core fundamental data they need to be able to begin that application review. So, yes, we're- we're very confident.
MARGARET BRENNAN: You've begun it, but you won't have all of it in until May 9th, I had read. You're- you're- committed to that date?
DR. BURTON: Yes, absolutely. So the data in the study has been completed. We have the data. Now, typically, what we then do is to package the data electronically, supply it to the FDA. So, of course, they can conduct their own views, their own analyses of the data. That's what will go in by May 9th. But they have the data that they need now to begin.
MARGARET BRENNAN: Okay. So, I mean, full disclosure, I have children in this age group. So as a parent, I'm very interested in- in the explanations you have for how this vaccine will work. According to the Moderna release, the vaccines is 37% effective in kids 2 to 5, roughly 50% in those 6 months to 2 years. What is your confidence level in that performance?
DR. BURTON: Yes. So first of all, on- on safety and we can talk about that, the safety profile we see with this vaccine in these very youngest kids was very reassuring. Actual rates of safety events even lower than we see in the six-year-old to 12-year-old. So that's great. But let's think about that number, Margaret, 37, 51% vaccine effectiveness. What does that really mean? The vaccine effectiveness against symptomatic disease, symptomatic COVID disease, about ten weeks after the second dose of vaccine. So what it means for parents, for caregivers, is that if they give the Moderna vaccine to these little kids, they would basically cut in half the risk of that child getting symptomatic COVID. Now the number, 50%, I know is- is often lower than we are used to seeing without our- our vaccine, but it's because this study was conducted during a time of Omicron.
MARGARET BRENNAN: Right.
DR. BURTON: When we look at the U.K. data that was released just last week, when we look at symptomatic disease, exactly there we see vaccine effectiveness of about 50%. But, when we look at vaccine effectiveness against hospitalization, that number is 89 to 95%. So, that's why I think we can be very reassured and very confident in this result.
MARGARET BRENNAN: Well, that 50% benchmark set by the FDA is key because that's usually, you know, the floor they have for- for approval. But when you look at the data, you're doing a vaccine, that's 25 micrograms, as I understand it, in size. It's a- it's a higher dose than Pfizer's vaccine, which was three micrograms that's still being reviewed. What are the side effects for a toddler of a dose that size?
DR. BURTON: Yes. So we give 2 25 microgram shots a month apart. And when we looked at the safety, as I say, the safety profile was very reassuring. Lower events of safety in this very young age group, even compared to the- the 6 to 12 year olds, common side effects of injection site pain and some fever. Really a lot of what all of us have after- after vaccination. But again, reassuringly, when we look at the rates of very high fevers, a fever over 104 degrees Fahrenheit, only 0.2% of these little kids experience that. And typically in this age range, for other approved vaccines, we would see rates of maybe 1%. So I think overall very reassuring.
MARGARET BRENNAN: You- you mentioned safety, and I'm glad you bring that up because I know your application for the vaccine for that age group, 6 to 11, 12 to 17, that's been pending for the FDA since June of 2021. So why do you feel comfortable putting your vaccine in my three-year-old or someone's four-year-old, if the FDA hasn't approved it, to be put in the body of a 12-year-old?
DR. BURTON: Yeah. Well, so, look, now we've submitted additional safety data to the FDA for the 12- to 18-year-olds. We've also just submitted our application for the 6- to 12-year-olds as well. And now we have the data on the very youngest kids--
MARGARET BRENNAN: --So do you expect the FDA to approve it for those older age groups? Is that what you're saying?
DR. BURTON: Yes. I mean, those applications are now under active review by FDA. So they have the full spectrum of data with us. And we are, of course, approved for over- over six-year-olds in many other countries around the world where it's being used safely and effectively to provide protection for those young kids. So I'm very hopeful that the FDA will follow- follow suit here across that full age range.
MARGARET BRENNAN: So I guess the fundamental question here is when we talk about that benchmark of 50%, is- is putting a vaccine in the- in the smallest of children who don't have any protection, right? They're too young to even wear a mask, many of them. Is just getting some protection worth it? Or does it need to meet that standard 50% benchmark the FDA sets?
DR. BURTON: Yes. So the 50% benchmark, you know, really was in a pre-Omicron era. As I say, we know now that 50% means to cut in half your risk of symptomatic disease. I think from the antibody levels that we also saw in this study, we can expect high protection against the important thing, which is hospitalization, even death. Omicron is not a mild disease. In kids, we see data from Hong Kong, the rates of admission of kids to pediatric intensive care units very high. So what I think we can reassure parents, caregivers here is that if approved, this vaccine should be able to safely and effectively protect your kids, your youngest kids, against severe disease, hospitalization. That's what counts.
MARGARET BRENNAN: And for adults, when do you expect a rebooted version of the vaccine to be available? A booster shot that would work against Omicron, for example.
DR. BURTON: Yes. So look, even Spikevax which we have now, the Moderna vaccine, does provide protection, certainly against severe disease, hospitalization. People are eligible now to get boosted. I would absolutely recommend it. We're still in this BA.2 wave of the variant sweeping now throughout the United States. We announced a couple of weeks ago a new variant specific booster that we've been tested and we have an additional candidate, our lead candidate in testing now that I believe is going to be even more superior. So, MARGARET, we are confident that by the fall of this year, we should have large amounts of that new booster vaccine that will protect against Omicron and other variants and really protect Americans and people around the world as we go into fall of 2022.
MARGARET BRENNAN: Doctor, thank you very much and we will be watching closely what happens next. We'll be back in a moment with Dr. Deborah Birx. Stay with us.
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