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The Journal.

The Flu Shot Drama at the FDA

The Journal.

The Wall Street Journal

Business News, Daily News, News

4.25.8K Ratings

🗓️ 18 February 2026

⏱️ 19 minutes

🧾️ Download transcript

Summary

The Food and Drug Administration agreed to begin a review of biotech company Moderna’s application to make a new seasonal flu shot available. The decision comes after the FDA initially refused to review the company's application. It's a back and forth that reveals increased turmoil within the agency. WSJ’s Liz Essley Whyte takes us inside the FDA’s unexpected reversals and explores what’s next for the mRNA flu vaccine. Jessica Mendoza hosts.  Further Listening: - The FDA Commissioner on Vaccines and Public Trust - Breakfast Battle: The Cereal Industry vs MAHA Sign up for WSJ’s free What’s News newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices

Transcript

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0:00.0

Liz, we're both here in D.C.

0:08.1

And I don't know about you, but I feel like flu season has been kind of nuts this year.

0:13.5

I just got over being sick for you or your kids or anybody in your household gotten the flu this year.

0:19.2

We have avoided it this year.

0:23.1

That's our colleague Liz Estley White.

0:25.4

She covers health policy for the Wall Street Journal.

0:28.1

And while she managed to avoid the flu this year,

0:30.5

a lot of people in the country haven't been as lucky.

0:33.6

U.S. officials estimate there have been at least 23 million cases

0:36.9

and 19,000 deaths since October,

0:39.9

making this one of the worst flu seasons in recent years.

0:44.0

I asked you about flu season because lately you've been following a story about the FDA and a new flu shot.

0:50.5

Can you tell us what's been going on?

0:52.4

Yeah, so the FDA has gone through a lot of change in the past year and it still really surprised

1:00.0

people when last week, Moderna, which is a company that makes vaccines, said that the FDA

1:09.0

had refused to even look at its application for a new flu shot.

1:14.3

And today, we heard from Moderna that the FDA had, in fact, agreed to finally review its application.

1:25.6

Okay, so Moderna submitted an application for a new flu shot.

1:30.1

The FDA refused to review it, but now it is going to review it.

1:34.4

What does this back and forth tell you about how the FDA is thinking about new drugs

1:41.1

and approving new drugs in this moment?

1:44.2

Well, the first kind of initial refusal to even look at the shot was pretty surprising because, as

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