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The Highwire with Del Bigtree

PFIZER MISSED DEADLINE TO TURN IN MYOCARDITIS DATA

The Highwire with Del Bigtree

The Highwire with Del Bigtree

Health & Fitness, News, Society & Culture

4.93.3K Ratings

🗓️ 17 February 2023

⏱️ 4 minutes

🧾️ Download transcript

Summary

Pfizer missed a deadline to turn over internal studies on myocarditis, per an FDA order. The deadline came and went. Now, they quietly have a new date in June. Why the delay on such important data? And, why does the FDA set arbitrary deadlines which aren’t enforced?
#VRBPAC #Myocarditis #Deadline #FDA #Pfizer

Transcript

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0:00.0

The FTA, the Berbatt committee, if anybody's watched this before, Pfizer representatives,

0:07.5

scientists march in there and they present their data.

0:10.4

And that's usually kind of held up as like, this is gold standard data from the company,

0:15.6

making the product, and then the FDA moves forward with that.

0:19.3

So when FDA gave the licensing, the EUA to Pfizer's mRNA coba shot, they gave them some stipulations.

0:26.6

They said, we're going to give these EUA, but you have to do some stuff for us.

0:29.6

You have to make sure that you continue studying any of these issues that come up in populations.

0:36.0

Obviously, not a perfect system.

0:37.9

It's already out in the world giving to hundreds of millions of people, and they're not even

0:41.4

getting their shoes on and start studying this.

0:43.8

But putting that aside, they had homework to do, and that was given to them by the FDA.

0:48.0

One of them was this, and this was directly from their 2021 approval letter from the FDA.

0:54.0

And it says they need to study, they may have a substudy to perspectively assess the

0:59.4

incidences of subclinical myocarditis, following the third dose of a common already as their

1:04.4

Pfizer vaccine.

1:05.4

And a subset of participants, 16 to 30 years of age, very important, because we know that's

1:10.1

where a lot of the myocarditis is happening, especially in males.

1:12.9

Now, if you look at the bottom there in the highlighted spot, final report submission,

1:16.3

December 31, 2022, they should have this report in their hands.

1:19.7

And by the way, the vaccine is just completed on June 30, 2022.

1:23.4

So they're giving them all that time to finish it up.

1:26.6

Yeah, yeah, exactly.

...

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