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The Food and Drug Administration's full authorization to the Pfizer COVID-19 vaccine has a number of public health officials hopeful the move will encourage people who had been reluctant to get a shot now. For more on the approval and inoculation efforts, Judy Woodruff turns to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.
We have two major stories tonight. Our Jane Ferguson will be live from the Kabul Airport on the chaotic fall of Afghanistan.
But, first, the U.S. Food and Drug Administration gave full approval to Pfizer's COVID-19 vaccine today. Almost immediately, the Pentagon announced vaccinations will now be mandatory for U.S. service members.
And, in New York, the nation's largest public school system ordered all staff to get shots, without the opt-out provision that it previously allowed.
Following today's announcement, a number of public health officials say they hope that full approval will encourage people who had been reluctant to get a shot now.
We turn once again to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the chief medical adviser to the president.
Dr. Anthony Fauci, thank you very much for joining us.
Let me just start and ask you, in brief, what does this full approval mean? Because we know this is many months after the FDA had given emergency approval, and after, what, more than 90 million Americans have already had the vaccine.
Dr. Anthony Fauci:
What this is, Judy, is really the really final imprimatur and the stamp of approval. The FDA, as is their job to do, and they did it well, has meticulously gone every single bit of data, from the standpoint of the effectiveness of the vaccine, the safety of the vaccine, and also things that the public doesn't appreciate, namely, the inspection of the facilities that manufacture the vaccine to make sure that there's consistency in the production of it.
So, I believe people now, understandably, who have felt, well, this was under an emergency use authorization, does that mean it doesn't really have the full approval, well, even under the EUA, the experience that we have had with the efficacy and the safety should make people feel that that was a very, very good stamp of approval, based purely on the data that we were getting.
But now that it's official — and what that's going to mean, I believe, Judy, is that there are probably maybe 20, up to 30 percent of people who in good faith felt that they really wanted that ultimate approval before they felt comfortable in getting the vaccine.
And we have about a little bit less than 90 million people who are eligible to be vaccinated who have not yet gotten vaccinated. I hope that this is going to get those 20 to 30 percent or so of people to wind up deciding that now they feel comfortable with getting vaccinated.
In addition, it's going to allow people who feel they want to mandate — I mean, they could be schools, universities, colleges, places of business — who are reluctant to make vaccination a requirement for attendance or employment or what have you, who will feel much more comfortable now doing that you have an official stamp of approval from the FDA.
So, in two areas, I think it's going to really impact the number of people who get vaccinated.
And you're answering questions, in fact, I was going to ask you.
But just that question about why it took so long, because there's been a lot of discussion for months now about, why don't we have full approval?
It took so long — and I wouldn't say so long, because I don't think, Judy, it was so long.
It took a period of time which allowed the FDA to do their job, which they do so well. They are the gold standard of regulatory agencies throughout the world. In fact, there are some people who are saying, well, they did it too quickly. It usually takes years, sometimes, before you get a full approval.
They did it now because they had a voluminous amount of data. They worked double-time fast. They just did not cut any corners. They examined every bit of it. And they did it well. And I think that's the reason why, when the FDA approves a product and intervention, you can feel comfortable that it's safe and it's effective.
As we know, Dr. Fauci, this applies only to people who are 16 and up.
So I want to ask you about those 12-to-15-year-olds who would still be taking the vaccine under emergency authorization. We heard today from Dr. Peter Hotez. I'm sure you know him. He is a dean, professor of pediatrics and molecular virology, microbiology at the Baylor College of Medicine, works in vaccine development.
He said mandates — he said, by excluding this group of young people 12 to 15, mandates for middle schools may be out the window. And he spoke about how many pediatricians are still having a hard time convincing families that it's safe.
Well, I mean, mandates will be very difficult, I believe, in some situations when you don't have the full approval.
But they looked at the data that was presented by the company. And the data were for 16 and older. The 12 to 15 can still get the vaccine through EUA, which is the way that were getting it all along. But that is the point.
Sometimes, entities, organizations, schools are hesitant to mandate because it doesn't have the full approval. But I believe, Judy, that you may get an indirect effect. I understand what Peter's saying. He's a good friend and a really highly competent person. I understand what he's saying.
But my feeling is, the very fact that you have a full approval of a BLA for 16 and older, that would even indirectly give some backing for mandates for anybody who is approved either through an EUA or through the BLA.
What is your best understanding, Dr. Fauci, of when we are going to see full approval for the 12-to-15-year-olds and any approval for children who are younger than 12?
Well, let's start with the children who are younger than 12.
So, what you have is, we are already doing, together with the companies, what's called an age de-escalation and dose — a dose adjustment for younger children. And you do it from 11 to 9, from 9 to 6, from 6 to 2, and then from 6 months to 2 years.
The data have already been very actively collected. We will probably have enough data by the time we get to the early to mid-fall, and then they will be presented to the FDA. Then it becomes a regulatory decision, Judy, where you balance safety for children against the efficacy and the immunogenicity and all the other factors that go into it.
And the data will be there by the middle of the fall. The FDA will have to do what they do well, will have to make a risk/benefit analysis of whatever safety signals, which are good safety…
… depending upon what it means for the benefit of the children.
And full approval for the 12 to 15?
Well, that likely is going to happen. I mean, I again, I don't ever want to get ahead of the FDA.
They will look at an examine the risk/benefit ratio, because you know there is a very rare risk in some of the vaccines of an adverse event. So what they're going to figure out, if you look at the benefit in those children of that age, compared to the risk, which is very, very small, but you want to do a balance.
They haven't done that yet because they're still examining the safety data. When they get the safety data, they will then make the same determination that they made with 16 and older.
And last question, Dr. Fauci, when do you think we're going to see full FDA approval for the Moderna vaccine and for the J&J?
Well, I don't think people should interpret, by any means, that there's any difference in safety or efficacy with that because Pfizer came first.
Pfizer presented their data in a very timely way to the FDA. Moderna is a bit behind in the presentation of their data to the FDA. That doesn't mean the data is any less effective or less safe. It's just that's the timing of when they present it.
So, as soon as they get their data presented in a way that the FDA can look at it the same meticulous way, you're going to see very likely the same thing. They have already accepted some of the data from Moderna and from J&J. They don't have the full package yet. And when they do — they may have the full package, and they're still examining it.
But the timing was a little bit different. So, people need to understand it's a timing issue, not an efficacy or a safety issue.
Dr. Anthony Fauci, we appreciate, as always, your joining us. Thank you.
Thank you for having me, Judy. Always good to be with you.
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