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What Next | Daily News and Analysis

TBD | What's Taking the FDA So Long?

What Next | Daily News and Analysis

Slate Podcasts

News, Daily News, News Commentary

4.32.4K Ratings

🗓️ 13 August 2021

⏱️ 25 minutes

🧾️ Download transcript

Summary

Experts say that a “fully approved” designation for the vaccines could have sweeping effects. Broader vaccination mandates, inclusion for new age groups, and reassurance for those hesitant to take a vaccine without the designation. As calls for approval grow louder and more urgent, the Food and Drug Administration is yet to give its blessing. What’s happening inside the FDA as they work toward this milestone? Guest: Sarah Owermohle, health care reporter at Politico  Host: Lizzie O’Leary Learn more about your ad choices. Visit megaphone.fm/adchoices

Transcript

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0:00.0

Lately, I've been thinking about how certain terms from the pandemic are just part of

0:09.5

our vocabulary now.

0:11.5

Words and phrases that were utterly unfamiliar to us in 2019.

0:16.1

Super spreader, social distancing, PPE, and one of those for me is emergency use authorization

0:23.1

or EUA.

0:25.2

You know, I realized that I, as a reporter, have been using the term emergency use authorization

0:32.9

and EUA a lot since December, and yet at the same time, I'm not sure I could actually

0:39.3

define what it means.

0:41.8

Can you define it?

0:43.2

So, emergency use authorization is something that came about in 2005, so it's relatively

0:49.4

recent to the history of drugs and regulation.

0:53.6

Sarah Overmal is not new to the term.

0:55.8

She covers healthcare for Politico.

0:57.6

Right now, she's mostly focused on COVID and vaccines.

1:00.6

It came about for an anthrax vaccine that the armed services needed because of biological

1:05.9

threats and has been used since then for desperately needed vaccines or treatments for things like

1:11.1

Ebola, for other viruses, and most recently, the coronavirus.

1:15.7

The three coronavirus vaccines that are on the market in the US now, Pfizer, Moderna, and

1:20.4

Johnson, also known as J&J, all got emergency use authorization from the Food and Drug Administration.

1:27.4

The whole point of an emergency use authorization is that you can get something to market fast,

1:32.4

even if there are some lingering questions about who it is best for.

1:35.6

As long as the benefits outweigh the risks.

...

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