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FDA Gives Full Approval To Pfizer's COVID-19 Vaccine


The Food and Drug Administration has given full approval to the Pfizer COVID-19 vaccine. The highly anticipated decision could give the nation's vaccination campaign a badly needed boost. NPR health correspondent Rob Stein joins us now with the latest. So Rob, let's start with the news. What exactly did the FDA do today?

ROB STEIN, BYLINE: Yeah. So, you know, as you said, the FDA gave Pfizer full approval of its vaccine. This goes beyond the emergency use authorization that the agency had granted the vaccine last December. Full approval is what vaccines and drugs usually need before they can be sold and widely used in the U.S. But the FDA has been allowing the use of the Pfizer vaccine as well as Moderna's and Johnson & Johnson's with this temporary authorization because of the public health emergency created by the deadly coronavirus pandemic. This is the first COVID-19 vaccine to be subject to a full review by the FDA and to get approval that puts the vaccine on par with any other vaccine sold in this country.

FADEL: OK. So what's the difference? Does this change anything about who gets the vaccine and how it's given out?

STEIN: You know, while the full approval is for anyone age 16 and older, the vaccine is still available for kids ages 12 to 15 under the emergency use authorization. We're still waiting for the FDA to OK vaccines for younger kids. But the approval comes after Pfizer gathered more - far more evidence that the vaccine is safe and effective and submitted that to the FDA. And in a statement today, the FDA's acting commissioner, Janet Woodcock, is calling the approval a milestone that puts the nation one step closer onto the course of - one step closer to altering the course of the pandemic in the U.S.

The agency says it spent months poring over hundreds of thousands of pages of data, involving more than 40,000 people and conducted an intensive analysis of the vaccine's safety and effectiveness. That's the kind of scrutiny a vaccine normally gets and why it sometimes takes years for a vaccine or a drug to get approved. The FDA says its intensive review affirmed that the vaccine is very safe and highly effective. You know, I should stress there's been plenty of evidence that's the case, but this is now even more assured.

FADEL: So what's the significance of this then?

STEIN: You know, this move is something that a lot of public health experts have been pushing for for quite some time. And some have even questioned why it's taken this long. And the reason is that full approval could make it easier to mandate vaccination. You know, some employers, hospitals, universities, federal agencies and others have started mandating vaccines. But others have been waiting for full approval, including the military, some colleges and some states and big cities. And, you know, it also may reassure some people who've been kind of on the fence. You know, polling has found that people say they would be more likely to get the vaccines if they'd gotten full approval from the FDA. Here's what Surgeon General Vivek Murthy said about this yesterday on CNN.


VIVEK MURTHY: For people who have been waiting for this - and that's a small number of people, but I think still significant - I think this may tip them over toward getting vaccinated.

FADEL: So pretty crucial at this moment.

STEIN: Yeah. Well, it totally is. I mean, you know, about two-thirds of Americans have gone at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccine, but only about half of the total population is fully vaccinated. And that's the main reason why the nation is still, you know, under siege by the virus.

FADEL: Right.

STEIN: If more people were vaccinated, the highly contagious delta variant wouldn't have been able to run rampant throughout the country and wouldn't be fueling yet another deadly surge at a time when the country is desperately trying to get back to normal.

FADEL: Yeah. That's NPR's health correspondent Rob Stein. Thank you so much.

STEIN: You bet, Leila. Transcript provided by NPR, Copyright NPR.

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

Rob Stein is a correspondent and senior editor on NPR's science desk.