Transcript: Dr. Paul Burton on "Face the Nation"

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Moderna's main aesculapian serviceman connected vaccines for kids

Moderna's main aesculapian serviceman says kids' vaccine information volition beryllium acceptable for FDA by June 07:40

The pursuing is simply a transcript of an interrogation with Dr. Paul Burton, main aesculapian serviceman astatine Moderna, that aired Sunday, May 1, 2022, connected "Face the Nation."

MARGARET BRENNAN: Last week, Moderna asked the FDA to authorize its vaccine for children nether the property of six. The company's main aesculapian officer, Dr. Paul Burton, joins america present from Princeton, New Jersey. Doctor, invited to FACE THE NATION.

DR. PAUL BURTON: Thank you, MARGARET. Good morning.

MARGARET BRENNAN: Well, the FDA said Friday it volition not hold 1 vaccine to hold for the other. In different words, they're not trying to enactment Pfizer and Moderna head-to-head present necessarily, each exertion volition beryllium considered erstwhile the information is ready. So are you assured that Moderna volition beryllium acceptable for the FDA to reappraisal your vaccine astatine their June meeting?

DR. BURTON: Yes, absolutely, MARGARET. So we submitted our information past week. I deliberation the FDA present have, you know, each of the halfway cardinal information they request to beryllium capable to statesman that exertion review. So, yes, we're- we're precise confident.

MARGARET BRENNAN: You've begun it, but you won't person each of it successful until May 9th, I had read. You're- you're- committed to that date?

DR. BURTON: Yes, absolutely. So the information successful the survey has been completed. We person the data. Now, typically, what we past bash is to bundle the information electronically, proviso it to the FDA. So, of course, they tin behaviour their ain views, their ain analyses of the data. That's what volition spell successful by May 9th. But they person the information that they request present to begin.

MARGARET BRENNAN: Okay. So, I mean, afloat disclosure, I person children successful this property group. So arsenic a parent, I'm precise funny in- successful the explanations you person for however this vaccine volition work. According to the Moderna release, the vaccines is 37% effectual successful kids 2 to 5, astir 50% successful those 6 months to 2 years. What is your assurance level successful that performance?

DR. BURTON: Yes. So archetypal of all, on- connected information and we tin speech astir that, the information illustration we spot with this vaccine successful these precise youngest kids was precise reassuring. Actual rates of information events adjacent little than we spot successful the six-year-old to 12-year-old. So that's great. But let's deliberation astir that number, Margaret, 37, 51% vaccine effectiveness. What does that truly mean? The vaccine effectiveness against symptomatic disease, symptomatic COVID disease, astir 10 weeks aft the 2nd dose of vaccine. So what it means for parents, for caregivers, is that if they springiness the Moderna vaccine to these small kids, they would fundamentally chopped successful fractional the hazard of that kid getting symptomatic COVID. Now the number, 50%, I cognize is- is often little than we are utilized to seeing without our- our vaccine, but it's due to the fact that this survey was conducted during a clip of Omicron.


DR. BURTON: When we look astatine the U.K. information that was released conscionable past week, erstwhile we look astatine symptomatic disease, precisely determination we spot vaccine effectiveness of astir 50%. But, erstwhile we look astatine vaccine effectiveness against hospitalization, that fig is 89 to 95%. So, that's wherefore I deliberation we tin beryllium precise reassured and precise assured successful this result.

MARGARET BRENNAN: Well, that 50% benchmark acceptable by the FDA is cardinal due to the fact that that's usually, you know, the level they person for- for approval. But erstwhile you look astatine the data, you're doing a vaccine, that's 25 micrograms, arsenic I recognize it, successful size. It's a- it's a higher dose than Pfizer's vaccine, which was 3 micrograms that's inactive being reviewed. What are the broadside effects for a toddler of a dose that size?

DR. BURTON: Yes. So we springiness 2 25 microgram shots a period apart. And erstwhile we looked astatine the safety, arsenic I say, the information illustration was precise reassuring. Lower events of information successful this precise young property group, adjacent compared to the- the 6 to 12 twelvemonth olds, communal broadside effects of injection tract symptom and immoderate fever. Really a batch of what each of america person after- aft vaccination. But again, reassuringly, erstwhile we look astatine the rates of precise precocious fevers, a fever implicit 104 degrees Fahrenheit, lone 0.2% of these small kids acquisition that. And typically successful this property range, for different approved vaccines, we would spot rates of possibly 1%. So I deliberation wide precise reassuring.

MARGARET BRENNAN: You- you mentioned safety, and I'm gladsome you bring that up due to the fact that I cognize your exertion for the vaccine for that property group, 6 to 11, 12 to 17, that's been pending for the FDA since June of 2021. So wherefore bash you consciousness comfy putting your vaccine successful my three-year-old oregon someone's four-year-old, if the FDA hasn't approved it, to beryllium enactment successful the assemblage of a 12-year-old?

DR. BURTON: Yeah. Well, so, look, present we've submitted further information information to the FDA for the 12- to 18-year-olds. We've besides conscionable submitted our exertion for the 6- to 12-year-olds arsenic well. And present we person the information connected the precise youngest kids--

MARGARET BRENNAN: --So bash you expect the FDA to o.k. it for those older property groups? Is that what you're saying?

DR. BURTON: Yes. I mean, those applications are present nether progressive reappraisal by FDA. So they person the afloat spectrum of information with us. And we are, of course, approved for over- implicit six-year-olds successful galore different countries astir the satellite wherever it's being utilized safely and efficaciously to supply extortion for those young kids. So I'm precise hopeful that the FDA volition follow- travel suit present crossed that afloat property range.

MARGARET BRENNAN: So I conjecture the cardinal question present is erstwhile we speech astir that benchmark of 50%, is- is putting a vaccine successful the- successful the smallest of children who don't person immoderate protection, right? They're excessively young to adjacent deterioration a mask, galore of them. Is conscionable getting immoderate extortion worthy it? Or does it request to conscionable that modular 50% benchmark the FDA sets?

DR. BURTON: Yes. So the 50% benchmark, you know, truly was successful a pre-Omicron era. As I say, we cognize present that 50% means to chopped successful fractional your hazard of symptomatic disease. I deliberation from the antibody levels that we besides saw successful this study, we tin expect precocious extortion against the important thing, which is hospitalization, adjacent death. Omicron is not a mild disease. In kids, we spot information from Hong Kong, the rates of admittance of kids to pediatric intensive attraction units precise high. So what I deliberation we tin reassure parents, caregivers present is that if approved, this vaccine should beryllium capable to safely and efficaciously support your kids, your youngest kids, against terrible disease, hospitalization. That's what counts.

MARGARET BRENNAN: And for adults, erstwhile bash you expect a rebooted mentation of the vaccine to beryllium available? A booster changeable that would enactment against Omicron, for example.

DR. BURTON: Yes. So look, adjacent Spikevax which we person now, the Moderna vaccine, does supply protection, surely against terrible disease, hospitalization. People are eligible present to get boosted. I would perfectly urge it. We're inactive successful this BA.2 question of the variant sweeping present passim the United States. We announced a mates of weeks agone a caller variant circumstantial booster that we've been tested and we person an further candidate, our pb campaigner successful investigating present that I judge is going to beryllium adjacent much superior. So, MARGARET, we are assured that by the autumn of this year, we should person ample amounts of that caller booster vaccine that volition support against Omicron and different variants and truly support Americans and radical astir the satellite arsenic we spell into autumn of 2022.

MARGARET BRENNAN: Doctor, convey you precise overmuch and we volition beryllium watching intimately what happens next. We'll beryllium backmost successful a infinitesimal with Dr. Deborah Birx. Stay with us.

Thanks for speechmaking CBS NEWS.

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