RE: The FDA's Criminal Cover-up of VACCINE DEATHS ... They Knew It Was Killing People In Early 2021 ...
What's interesting here is that the linked document neither supports the clickbait headline, nor the general sentiment of the article. Did you read it? Notably, the Alt Mind site presents it as some sort of smoking gun exposing criminal conspiracy. At face value, however, the document clearly and specifically lays out data and analysis related directly to the safety profile of the Pfizer vaccine.
Furthermore, the conclusion is that analysis "confirms a favorable benefit: risk balance for BNT162b2." There's also a note that "Pfizer will continue routine pharmacovigilance activities ... to assure patient safety." In fact, that continued activity is detailed rather comprehensively here: (Comirnaty EU Risk Management Plan (4.0) including Part I to Part VI (25Nov2021).pdf)[https://www.ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-management-plan_en.pdf]
This is either a relatively big misunderstanding of what was documented, or a gross misrepresentation of that information.
Note for instance that the Alternative Mind article linked here presents something called "Vaccine-associated enhanced diseases (VAED)" as a "surprise", alleging that the acknowledgement of such an effect indicates that the FDA was "up to its neck in a criminal conspiracy to conceal the truth about vaccine injuries and deaths". The truth is that scientists have learned how to mitigate the risks of this sort of vaccine-associated incident over the course of several decades.
Finally, the risk of such a thing is purely theoretical; a modified or more severe form of COVID hasn't been noted in an individual after (i.e. due to) prior vaccination. As I noted in a (recent post)[https://steemit.com/hive-160342/@primevaldad/prospects-for-a-safe-covid-19-vaccine], scientists have long known the need to evaluate this specifically, and we are now at a time when hopefully some definitive data will give us a clear understanding of that particular risk.
What do you think about the difference between the way things are presented in your linked article, and the actual document that was referenced?
On one hand, I am decidedly not a fan of the author of the source link. I am immediately skeptical of anything he writes because of perceived misrepresentations that I have found in previous articles by him over the course of somewhere around a decade. As a general rule, when I see his name as author, I stop reading. This adds to that general impression.
Further, from the document link, it looks to me like he is probably conflating "deaths after vaccination" with "deaths from vaccination".
On the other hand, this is analogous to the mistake that mainstream professionals (who should know better) have been making since the beginning of the pandemic -- the conflation of "death from COVID" and "death with COVID".
Since the mainstream reports refuse to fix the "death with COVID"/"death from COVID" confusion, I almost think it's better to compare their numbers against "death after vaccination" (provided that it's clearly understood as such). The worst thing to do is to compare "death with COVID" against "death from vaccination", and think it tells us anything at all about their relative risks. The best thing to do would be to fix reporting on both sides and compare "death from COVID" against "death from vaccination". But of course most of the "fact checking" is heavily biased in favor of the vaccines, so that's not going to happen.
Less consequential, but I think the author is also wrong on this point:
I don't remember where I read it, but my recollection is that the FDA proposed to produce 500 pages per month, and if you do the math, that means that the document production will end in 2076 - 55 years. Which leads me to immediately wonder how they could have effectively analyzed this safety data in the course of just a few months if they can only produce 500 pages per month for FOIA processing?
Excellent points!
On your last point though:
Who's "they" in "wonder how they could have effectively analyzed this safety data"?
And are you assuming adequate and accurate safety data is obscured save for release of the specific documents referenced in that court order?
I don't see how it's related, except if there is something in the n pages/documents per month that negates other data that contributed to safety analysis.
Merry Christmas!
"they" is the FDA, when they were approving the vaccines in the first place. I conclude one of two possibilities:
(i) They never actually looked at the safety data carefully because there is too much of it; or
(ii) They did look at it, and now they are slow-walking the release for some unknown reason.
I agree that it's not directly related, but it makes me wonder about the quality and integrity of the approval process.
That makes sense.
But I think you can expect that those responsible for validating would actually maybe not look too closely at every bit of information. That's obviously not a fool proof approach per se, but what I think about is that these are people who've been doing their professional work in the industry, and they probably know how to spot notable issues quickly without the same attention to detail a lay person would need to supply to the same evaluation.
Imagine if you had to evaluate some IT security data. Compared to a person new to tech reading through the same material, you would zoom right through the same breadth of documentation, and it might seem to others that you're not paying close enough attention. But you'd have a certain amount of confidence in the material without spending too much time with even large amounts of data.
Yeah, possibly. Still, though, if the data was understood well enough to justify an "all or nothing" blitz to inject the shot into 8 billion people, I would hope it was also understood well enough for public release.
Is this new, though? "Confidential" wasn't invented for what's going on now. It's been the business and government context.
I actually don't know what standard practices are, or how current practices for this series of vaccines compares to the historical gold standard? Do you?
I'd love to know if we're on par with standard practices re: releasing data, making testing records available for research, etc...