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Chasing Life

The Secretive and Essential Work to Find a Vaccine

Chasing Life

CNN

Nutrition, Health & Fitness, Mental Health

4.5 • 8K Ratings

🗓️ 14 October 2020

⏱️ 12 minutes

🧾️ Download transcript

Summary

The race is on for a Covid-19 vaccine, but behind the scenes there’s a secretive group that has the power to stop a vaccine trial in its tracks. That’s the Data and Safety Monitoring Board, or DSMB, and they’re the only ones who get a look at the data during the trials. CNN’s Chief Medical Correspondent Dr. Sanjay Gupta speaks with Susan Ellenberg about her work with Covid-19 DSMBs. To learn more about how CNN protects listener privacy, visit cnn.com/privacy Learn more about your ad choices. Visit podcastchoices.com/adchoices

Transcript

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0:00.0

Anyone's hopes for getting a vaccine are going to be delayed at least some.

0:05.2

The FDA finally put out some new guidelines.

0:07.2

The White House had resisted them, but then allowed them to go forward.

0:10.3

The President for weeks has said we'll have a vaccine soon.

0:12.9

He keeps saying soon, and he keeps saying possibly before the election.

0:15.7

I think that's off the table now if you look at the new guidance.

0:18.8

After weeks of this tug of war between the FDA and the White House, the FDA released

0:24.6

new guidelines for coronavirus vaccine developers last week.

0:28.8

When a move the President claimed was a quote, political hit job, the FDA wants at least

0:34.0

two months' worth of data before granting an emergency use authorization in order to

0:39.6

ensure a vaccine is safe.

0:42.4

Here's Dr. Peter Marks.

0:43.9

He's the director of the FDA Center for Biologics Evaluation and Research.

0:48.9

If you look at when most adverse events, the majority of them have occurred by the kind

0:54.1

of a median time, it's somewhere around two to three months.

0:58.7

And so we picked two months as something that was, it was reasonably aggressive, yet also

1:04.4

somewhat kind of in the middle, not too aggressive, not too conservative in the middle.

1:10.3

And while these newly published recommendations all but ensure that a vaccine won't be authorized

1:15.1

before Election Day, it is important to note that the vaccine timeline is not up to the

1:20.8

President alone, or even the FDA for that matter.

1:24.8

Because there is a small secretive group that sees the data before anyone else.

1:30.4

And right now they have one of the most monumental tasks in the world.

...

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