STEVE INSKEEP, HOST:
The Food and Drug Administration has now fully approved a COVID vaccine. It's the one from Pfizer, which, like other vaccines, had only emergency use authorization up to now. President Biden would like unvaccinated Americans to draw a conclusion.
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PRESIDENT JOE BIDEN: So let me say this loudly and clearly. If you have - if you're one of the millions of Americans who've said that they will not get the shot when it's - until it has full and final approval of the FDA, it has now happened. The moment you've been waiting for is here. It's time for you to go get your vaccination. Get it today - today. It's an important moment in our fight against the pandemic.
INSKEEP: Dr. Francis Collins joins us once again. He is director of the National Institutes of Health. Dr. Collins, welcome back.
FRANCIS COLLINS: Nice to be back with you, Steve, on a day where we have some good news.
INSKEEP: Well, let's talk about that news. I assume that full FDA approval is a higher standard of proof than the emergency authorization from late last year. So what does the FDA know now that they didn't know late last year?
COLLINS: Well, they've been able to look now over many more months of follow-up in terms of assessing both the safety and also the efficacy of this vaccine in the real world. They've pored over hundreds of thousands of pages of material from Pfizer about every detail, about every participant in the trials. They have learned more details about the manufacturing process. They've actually sent inspection teams to the places where the vaccine is being manufactured to be sure everything is exactly the way it's supposed to. And they have pronounced this all in order, and hence, the full approval. And as the president said a minute ago, that means if you're one of those folks who was waiting for that to be sure that this vaccine was going to be OK, that day has come.
INSKEEP: I guess we can also just point out the obvious here. To put it in simple terms, many tens of millions of people went ahead of you across that bridge, and the bridge didn't fall, so to speak.
COLLINS: Exactly. And they're actually in a much better place because of it. So, yeah, there's about 85 million Americans, Steve, that are still on the fence, have not yet gotten that first dose. The hope of many of us is that this will be a motivation for those folks to decide to go forward, because polls had said that was an issue for at least 3 out of 10, and now that 3 out of 10 - I hope they're listening right now - will decide to go to vaccines.gov, find out where the closest place is to get their immunization and do it today.
INSKEEP: Well, you must have had time to think about or been forced to think about the psychology of all this. You're absolutely correct. According to polls, a lot of people said they were awaiting final FDA approval to act. But what people say and what they mean is not always identical. Do you believe that final approval was the reason that some people hesitated?
COLLINS: Well, I hesitate to second-guess human behavior 'cause I'm always wrong, but I think that was a factor in there, amongst others, of course. And unfortunately, a lot of the resistance is also based upon misinformation or disinformation that is so widely spread across the internet. But maybe this would be a good day for people who have held back to kind of hit the reset button and say, OK, let's really look at the facts here about why I might want to take advantage of this safe and effective vaccine, both for myself, for my family and to help protect the people around me, 'cause it's up to all of us to do that, too.
INSKEEP: Does this approval make it easier for federal, state and local leaders who want to mandate more vaccinations?
COLLINS: Well, it already has. Within hours of the announcement, several universities - Minnesota, Louisiana - have moved forward. They said they were waiting for this. They didn't wait long to act upon it. Some businesses as well - and, of course, the military, now with the announcement that the 1.2 million military individuals will be required to be vaccinated - timetable not yet stated, but presumably soon. So I think you're going to see a lot of that in the next few days, of those industries, universities, other organizations that were kind of waiting because they wanted to be sure they were on the firmest possible footing, to step forward and say we're going to require this now.
INSKEEP: Dr. Collins, let me raise a question that is constantly on the minds of every household, and I live in one, where there is somebody under 12, who currently cannot be vaccinated. How soon can we expect approval of vaccines for kids under 12?
COLLINS: Oh, Steve, I know a lot of people are really anxious to see this move forward. It's a difficult situation because kids under 12 are not just little miniature human beings. They have differences in their metabolism, their immune system. So, for instance, the question, what's the dose you ought to give? Do you give the same dose to a 6-year-old as you would to somebody who's 30? Probably need to look at that.
So the companies - Pfizer, Moderna - are working hard on collecting data from rigorous trials to be sure they've got that part right. But actually, the data hasn't been submitted to FDA yet. Pfizer thinks maybe by the end of September they'll be ready to send in their trial data, and then FDA will have to review it. I got to be honest, I don't see the approval for kids 5 to 11 coming much before the end of 2021.
INSKEEP: OK, well, it's helpful to know that because there had been stories suggesting maybe in September, but you're saying the data may get in in September. That means that millions of parents are going to be sending their kids under 12 to school, in-person school. There might be masks, there might not be masks, but there are not going to be vaccines. Should parents worry about that, or maybe I should say, how much should we worry about that?
COLLINS: Well, of course we should worry about everything when it comes to COVID, and especially with delta. But there are mitigation methods to try to reduce the risk. Gosh knows, we all want to get the kids back in school to have that in-person experience for learning, for socialization. We ought to be doing everything we can to make that possible safely. This is why I'm just so puzzled about the big fight about masks in the school room. If you want to avoid having that outbreak that's going to send all the kids home again, you should be doing everything to avoid that, and that means wearing masks. My understanding when you talk to students - they seem a little less worried about wearing masks than some of their parents. It just makes good sense.
And by the way, if somebody tries to tell you we don't really have scientific evidence to say that masks reduce infection in schools, that's just not true. There are dozens of publications, both from the U.S. and other countries, to show that's the case. So boy, I wish we could get over that fight. That one is really getting in the way of what is going to be a tough enough fall as it is.
INSKEEP: Dr. Collins, thanks for the update - really appreciate it.
COLLINS: Glad to be with you, Steve.
INSKEEP: Dr. Francis Collins, director of the National Institutes of Health. Transcript provided by NPR, Copyright NPR.
