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Dr. Fauci Weighs In On The FDA's Approval Of The Pfizer Vaccine

MARY LOUISE KELLY, HOST:

Today the Food and Drug Administration gave full approval to the Pfizer vaccine for people 16 and older. Right after that, the Pentagon announced it will require active duty troops to be vaccinated. And New York City instituted a similar requirement for public school teachers and other staffers. To talk about the approval of vaccine mandates and other ways this milestone could change the face of the pandemic, I am joined by Dr. Anthony Fauci. He is the White House chief medical adviser.

Dr. Fauci, welcome back to ALL THINGS CONSIDERED.

ANTHONY FAUCI: Thank you very much, Mary Louise - good to be with you.

KELLY: I just called this a milestone that could change the face of the pandemic. Could it? How big a deal is this?

FAUCI: Yes. You know, Mary Louise, I think it's going to have a major impact for the following reason. First of all, I divide it into two major components. There are those individuals who understandably, in some respects, don't want to get vaccinated until they get the full stamp of approval. I believe that that will mean - and this is purely an estimate. But I think there are probably about 20 or more percent of people who are not getting vaccinated among the 90 million or so people who are eligible to be vaccinated who have not gotten vaccinated - I believe that those people will now step forward and get vaccinated. So you're going to have a group of people who otherwise would not have got vaccinated.

KELLY: Well, there is data out there, if I may inject it - polling from the Kaiser Family Foundation that's even suggesting 3 out of every 10 people, 30%, who have been hesitant to get it would be - they say they would be more likely - not definitely but more likely to get the vaccine when it has full approval. Do you think that's real? Is that real? You know how deep vaccine hesitancy runs.

FAUCI: You know, I do because I've been out there trying to counter vaccine hesitancy by providing as much of factual information about the effectiveness and the safety at multiple different fora - I mean, with younger individuals, older individuals, minority groups, et cetera - and the idea of waiting and feeling that this was done too quickly with the emergency use. And they really want to wait for the full approval. So I do believe that there is a basis - you know, a sociological basis to the fact that people do want to wait for that. But that's not the only thing, Mary Louise. What I think is going to be equally as impactful would be that there are going to be organizations and enterprises and companies - whoever - are going to feel much more empowered now to mandate vaccines.

KELLY: Right.

FAUCI: That could be colleges.

KELLY: The Pentagon, which we just mentioned.

FAUCI: Exactly. The Pentagon, colleges, universities and even major organizations of places of employment, large corporations may say, this is it. If you want to work for us, you've got to be vaccinated. So I think you're going to see a lot more mandates and hopefully a combination of people who, on their own, decide because of this stamp of approval that they want to get vaccinated, combined with the mandates that we may be able to make a big dent in that 90 million people or so who are eligible but not vaccinated.

KELLY: You sound, if I may say, hopeful. I've interviewed you quite a few times during this pandemic. That has not always been the case.

FAUCI: Well, you know, you're detecting something that's real in me because obviously, you know, as a public health person who sees the extraordinary advantage of vaccination and realizing that the only way we are really going to get control of this outbreak and get back to the kinds of normality that we all crave and long for is through a highly, highly successful vaccination program. And I see this as another step in that very important direction.

The other thing I do like about it is that it really proves the independence and the capability of the FDA. You know, the FDA is the gold standard of regulatory agencies throughout the world. All of the other countries' regulatory agencies look to the FDA for their stamp of approval for the principles that guide the care that the FDA puts into this. And I believe that they actually now have shown that they have done it expeditiously, but they did not rush it. They dotted all the I's, and they crossed all the T's. And now we have something that's essentially really a firm imprimatur.

KELLY: Am I right in remembering, Dr. Fauci, you got the Moderna vaccine?

FAUCI: I did.

KELLY: As did I. Why is it just Pfizer that's getting full approval? Where are we on Moderna and Johnson & Johnson?

FAUCI: They're on their way. You know, Moderna started a little bit later in the sense of getting the clinical trials' data organized and analyzed and to the FDA. Even as we're speaking now, Mary Louise, they are actively very doing that. So I believe that the process is just a bit behind but not much behind.

KELLY: So this FDA full approval is for the vaccine for people aged 16 and up.

FAUCI: Right.

KELLY: And it comes at a moment when millions of school-age children who are too young to get vaccinated are heading back into buildings. A lot of parents out there, as you know, want to know; when's it coming? What can you tell them if I have an 11-year-old, a 10-year-old, a 9-year-old and so on?

FAUCI: OK. So that people understand the different age range, what we've been talking about over the past few minutes have been for individuals 16 years of age and older. The individuals who are 12 through 15 years of age already have the capability of getting the vaccine through an EUA. OK. So if you go now to 11 - 5 to 11, there are a number of studies that are ongoing now, both from the company and from the NIH. And what those studies have been showing is that they're looking at safety, and they're looking at immunogenicity, or the ability to induce a response that you would predict would be protective.

And what we're seeing right now is that if you look at the timetable of that, both Moderna and Pfizer as well as the NIH are doing what's called an age de-escalation and a dose variation study. When I say age de-escalation, I mean, you go from 11 to 9, from 9 to 6, from 6 to 2 and then from 6 months to 2 years. Right now if you look at the calendar, if you take Pfizer and you look at the data that's been collected, you know, it depends. You could conceivably get an emergency use authorization in the mid- to late fall for individuals 5 to 11. Now, obviously...

KELLY: So you're still thinking the mid- to late fall.

FAUCI: Yeah. Yeah. And it could be, you know, wiggle room one month or another. But remember; I'm talking about the data that will be presented to the FDA. The decision about the relative risk benefit of safety and efficacy is going to be a regulatory decision. So even though I'm telling you that the data will be available at the time we get to mid- and late fall, it may be that when the FDA looks at the data, they may feel they want a little bit more time for safety. And that may end in a couple of months.

KELLY: And I - as a parent...

FAUCI: Yeah.

KELLY: I just have to chime in and say, you know, everybody wants this to be safe, of course, for everyone and especially for kids. But there is an urgency here. Can you say hand over heart that this is going as fast as it possibly could?

FAUCI: Yes. Yeah. Mary Louise, I can tell you that it is going as fast as it possibly could. I had a meeting with the staff literally this morning who are collecting the data and working with the company. And I asked them exactly the question you just asked me. Are we really pulling out all the stops, not cutting corners but doing it as quickly as we possibly can? And that's where we got to the mid- to late fall timetable on that.

KELLY: Yeah.

FAUCI: I hope that when the FDA looks at it, they say, good to go. And before we get to the end of the first term of the fall season, of the fall session of school, the semester, we'll be able to get kids vaccinated, but I can't guarantee it.

KELLY: Meanwhile, we are where we are. The American Academy of Pediatrics has new numbers out this week showing more than 180,000 kids were infected. And that was last week, just last week. There's also been a steep rise among hospitalized kids. So are you still confident that the push to reopen schools is the right move in the face of those numbers?

FAUCI: You know, you continually evaluate decisions that are made. But if you look at the balance of what you want - you want to get the children back to school in physical presence in the classroom because of what we know are the deleterious effects of keeping kids out of school - the mental issues, the social developmental issues. So you want to do that, but obviously you want to do it safely. You want to make sure the children's safeguarding their health. And you do that by a number of ways. You surround the children with vaccinated people, be they teachers or people who are on the school payroll, employees of the school system. Also, you try to get as many of the 12- to 15-year-old kids in school vaccinated. And for the rest, that's where you get the masking. And that's the reason why we feel it's important to make sure that in the school system, masks are worn.

KELLY: Last question, and it's one that I've learned is a dangerous question to ask. But it's the - where are we in the arc of this? Do you think we're near the peak, or are we looking at another possible wave with the arrival of cooler weather and kids back to school and people out and about?

FAUCI: Mary Louise, honestly, it's going to depend totally on how effective we are in getting people vaccinated. You can't have 90 million people who are eligible to be vaccinated who are not vaccinated and expect that you can make a good prediction about where we're going to be because when you have people unvaccinated to the extent that they are unvaccinated, you have the possibility of the virus continuing to circulate, mutating, forming more variants and getting us back into another situation similar to or worse than delta.

If all things go the way we want them to go and we're really successful with this BLA that we just discussed over the last couple of minutes and we get really the overwhelming majority of the people vaccinated, I think as we get into the fall and the winter, we could start to really get some good control over this as we get into 2022.

KELLY: Dr. Fauci, thank you.

FAUCI: Thank you for having me, Mary Louise. It's always a pleasure.

KELLY: Dr. Anthony Fauci, chief medical adviser to the White House and the nation's top infectious disease doctor.

(SOUNDBITE OF MONTAG'S "LABRADOR (ENCORE)") Transcript provided by NPR, Copyright NPR.