The Highwire with Del Bigtree - PFIZER MISSED DEADLINE TO TURN IN MYOCARDITIS DATA
Episode Date: February 17, 2023Pfizer 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? An...d, why does the FDA set arbitrary deadlines which aren’t enforced?#VRBPAC #Myocarditis #Deadline #FDA #PfizerBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.
Transcript
Discussion (0)
The FDA, the BIRPAC committee, if anybody's watched this before,
Pfizer representatives, scientists march in there and they present their data.
And that's usually kind of held up as like, this is gold standard data from the company,
making the product.
And then the FDA moves forward with that.
So when FDA gave the licensing, the EUA to Pfizer's MRNA COVID shot, they gave them some stipulations.
They said, we're going to give these EUA, but you have to do some stuff for us.
You have to make sure that you continue studying any of these issues that come up in populations.
Obviously not a perfect system.
It's already out in the world giving to hundreds of millions of people.
And they're not even getting their shoes on and start studying this.
But putting that aside, they had homework to do.
And that was given to them by the FDA.
And one of them was this.
And this was directly from their 2021 approval letter from the FDA.
And it says they need to study, they may have a sub-study to prospectively assess the
incidences of subclinical myocarditis following the third dose of commonarity, that's their
Pfizer vaccine, in a subset of participants 16 to 30 years of age. Very important because we know
that's where a lot of the myocarditis is happening, especially in males. Now, if you look at the bottom there
in the highlighted spot, final report submission, December 31st, 2022, they should have this report in their
hands. And by the way, it's supposed to be completed on June 30th, 2022. So they're giving them all
that time to finish it up. Yeah, yeah, exactly. And what we just have,
was a vert back committee talking about maybe annual boosters talking about now we're adding the another
we have the bilive valent vaccine we had another strain the virus in there so obviously this is a
really important topic to have this data from Pfizer to talk about in that committee they didn't have
it why didn't they have it they should have because it was due that day it was due on december 31st
if you go to fda's website now you go to post marketing requirements and comments and if you look at that
under the original projected completion date of that same study.
Now all of a sudden it says June 30th, 2023.
What?
That was, it's kind of just slipped in there.
They gave them a little bit of an extension,
little extra credit there on the homework.
And this was reported,
Epoch Times reported this,
the FDA quietly changing,
and at least some people had their eye on this.
FDA quietly changes end date for study of heart inflammation
after Pfizer-COVID vaccine.
That is just so shady.
I mean, they rushed this thing out within a,
couple of weeks and you can't get a decent myocarditis study done in a year. Now you need two years.
I mean, they're basically extending this a year while people are getting it, while athletes are
collapsing on fields all over the country, high school students, junior high students, all,
you know, in our news feed, we're watching these poor kids, you know, die grabbing their chest
or being rushed to the hospital and, oh, just take a little more, and you have to imagine. Jeffrey,
I'm sorry, maybe I'm jaded. I don't have any proof of this, but I'm going to assume that this study
is done and nobody likes what it says. And let's think about it. Let's be honest. The FDA has pushed this
debacle on our entire population. Hasn't given up. Keep saying give it to your kids. Oh, let's give
one every single year. Are they really, really going to see a study? And spies are going to hand them
and say, you know what, sorry, but as it turns out, this thing is causing heart attacks. Oh, great.
I'm glad you told us that. Let's take it to the American public and let them know. It's just,
Our system doesn't work like that anymore.
It's really unfortunate.
I don't see that happening as well.
And our system is somewhat broken in that response.
And this is why there's so many people talking about these things now
because they're leading the response.
And I want to say one thing, too, about the Pfizer executive,
I guess you want to call them, Conantate by Project Veritas.
This is how a lot of these adverse events are being reported.
So we're talking about menstrual cycle issues now.
This brings them to the forefront to make the FDA,
to make the policy makers pay attention to this and get these warning labels up and make moves on this.
So it's actually the people that are driving, the media that are driving these adverse events and
getting this to the public. So that's why it's so important for this. We unfortunately can't rely on the FDA.
