The FDA Has Approved Pfizer's COVID-19 Vaccine
MARY LOUISE KELLY, HOST:
To COVID news now and a, quote, "milestone in the nation's battle against the pandemic. That is what the Biden administration is calling the Food and Drug Administration's decision today to give full approval to the Pfizer COVID-19 vaccine. The long-awaited decision could give the nation's vaccination campaign a desperately needed boost. We're going to bring in NPR health correspondent Rob Stein.
ROB STEIN, BYLINE: Hey there.
KELLY: So tell me more. What exactly did the FDA do today?
STEIN: This is the first time the FDA has given full formal approval to any COVID-19 vaccine. This goes beyond the emergency-use authorization that the agency had granted the vaccine last December. Full approval is what vaccines usually need before they can be used widely in the U.S. The FDA has been allowing the use of all the COVID-19 vaccines with this temporary authorization because of the public health emergency created by the deadly coronavirus pandemic. Full final approval puts the vaccine in the same category as any other vaccine used in this country. Here's Dr. Janet Woodcock, the acting FDA commissioner, at a briefing announcing the approval today.
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JANET WOODCOCK: This is a pivotal moment for our country in the fight against the pandemic. And we know that vaccine approval holds the promise of altering the course of the pandemic in the United States.
STEIN: The FDA says it spent months poring over hundreds of thousands of pages of data involving 44,000 people and that the intensive review proves the agency didn't cut any corners. It affirmed that the vaccine is very safe and highly effective, especially at keeping people from getting sick.
KELLY: OK, so a shift from authorization to approval. But to be clear, this doesn't change anything about the vaccine itself or who gets it or how it's used, right?
STEIN: Absolutely, no. The same vaccine is available, and it's not going to change anything immediately. You know, the full approval is for anyone aged 16 and older, but the vaccine is still available for kids ages as young as 12 under that emergency-use authorization. Still waiting for the FDA to oak vaccines for younger kids. And, in fact, the FDA's Dr. Woodcock specifically warned doctors against using the approval as a kind of excuse to start vaccinating younger kids so soon.
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WOODCOCK: That would be a great concern - that people would vaccinate children because we don't have the proper dose, and we don't have the safety data, nor do we have all the efficacy data. They are not just small adults. We've learned that time and time again.
STEIN: You know, she also warned against giving everyone boosters before the FDA has thoroughly reviewed the evidence for giving that the go ahead. But, you know, that's expected soon.
KELLY: But again, why is this so significant? Why is this such a big deal to have formal approval?
STEIN: Yeah, yeah. You know, this move is being hailed by public health experts. They've been pushing for this for quite some time. Some have even questioned why it's taken this long. And the reason is that full approval could make it easier to mandate vaccinations. Some private companies, you know, hospitals, universities, federal agencies and others have started mandating vaccines. But others have been waiting for full approval, including the military, some colleges, some states and some big cities. In fact, immediately after the FDA's announcement, the Pentagon announced it was moving forward with plans to mandate vaccines for active-duty service members.
And the other thing is, you know, approval may reassure some people who are still - you know, they're on the fence trying to decide whether to get vaccinated. Polling has found that many people say they would be more likely to get a COVID-19 vaccine that has been fully approved. And that's obviously crucial. Only about half of the total U.S. population is fully vaccinated. And that's the main reason why the virus has come roaring back this summer. If more people were vaccinated, the highly contagious delta variant wouldn't be ripping through the country like it is right now, spoiling everyone's hopes of finally getting life back to normal.
KELLY: All right. Thank you for the update.
STEIN: You bet.
KELLY: That is NPR health correspondent Rob Stein.
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