The U.S. Food and Drug Administration (FDA) has been ordered to disclose data it relied on when authorizing COVID-19 shots. U.S. District Court Judge Mark Pittman in Fort Worth, Texas ordered the FDA to release their file on “emergency use authorization” (EUA) related to the Pfizer/BioNTech Comirnaty COVID biologic to a group of scientists. Accordingly, an additional one million pages of COVID trial data will be released to the public by June 30, 2025.1 2 3
The landmark decision arises out of a 2021 case brought by Public Health and Medical Professionals for Transparency to compel the federal agency to release important vaccine trial data. The FDA had previously said it would not release the COVID shot trial data for 75 years.4 Judge Pitman ordered the FDA to expediate the release of 450,000 pages related to the COVID vaccine trials available to the public. The FDA was required to make 55,000 pages available each month until all documents were released by September 2022. Since that time, 1,200,874 pages have been released to the public by the FDA.5
The remaining issue from the 2021 order was whether the EUA file related to the COVID shots was covered by FOIA request by the plaintiffs and, therefore, must be released by the FDA.6 The FDA contended that their emergency use authorization file should not be part of the trial data previously ordered to be released and that they had already spent 3.5 million dollars complying with the court order to release the trial data. Many public health officials supported the FDA and claimed that releasing the information could lead to misinterpretation and fuel vaccine skeptics.7
Both parties moved for summary judgment on the matter.8 A summary judgment motion is brought when one party alleges that a trial is not necessary as the other side has no valid claims or defenses for the judge or jury to consider. The moving party argues that they are required to a judgment as a matter of law due to there being “no genuine issues as to any material fact.”9
There is a Lower Standard to Approve EUA Vaccines
The FDA granted vaccine manufacturers and EUA to release the COVID biologic to the public after fast tracking it to market. An EUA has a different standard for proof of safety and efficacy than vaccines licensed by FDA under standard licensing guidelines. FDA licensed vaccines approved for regular use by the public generally require randomized clinical trials that prove safety and efficacy, while those approved under EUA have a lower standard and a faster review as they merely require data supporting, rather than proving safety and efficacy.
Judge Pitman explained:
While it is normal for EUA standards to vary from those required for FDA approval the “EUA standards for COVID- 19 products varied considerably” and, in some cases, did “not require[] any FDA review of safety or efficacy.10
Plaintiff’s attorney, Aaron Siri said:
The FDA clearly lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review.11
The court concluded by quoting Patrick Henry…
The liberties of a people were, nor ever will be, secure, when the transactions of their rulers may be concealed from them.12
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Click here to view References:1 Reuters. FDA must disclose more COVID-19 vaccine records, US judge rules. The New York Post Dec. 6, 2024.
2 Econo Times. Judge Forces FDA to Release ‘One Million Pages’ of Pfizer COVID Vaccine Data—Sealed Secrets Spark National Uproar. Dec. 8, 2024.
3 Public Health and Medical Professionals for Transparency v. Food and Drug Administration, 4:21-cv-01058, (N.D. Tex. Dec 06, 2024) ECF No. 101.
4 Ibid.
5 U.S. Public Health and Medical Professionals for Transparency v. Food and Drug Administration, 4:21-cv-01058, (N.D. Tex. Dec 06, 2024) ECF No. 101.
6 Ibid.
7 Reuters. FDA must disclose more COVID-19 vaccine records, US judge rules. The New York Post Dec. 6, 2024.
8 Public Health and Medical Professionals for Transparency v. Food and Drug Administration, 4:21-cv-01058, (N.D. Tex. Dec 06, 2024) ECF No. 101.
9 Prevail Lawyers. A layman’s Guide to Summary Judgment. July 2, 2015.
10 Public Health and Medical Professionals for Transparency v. Food and Drug Administration, 4:21-cv-01058, (N.D. Tex. Dec 06, 2024) ECF No. 101.
11 Ibid.
12 Public Health and Medical Professionals for Transparency v. Food and Drug Administration, 4:21-cv-01058, (N.D. Tex. Dec 06, 2024) ECF No. 101.
3 Responses
This is laughable. The judge ordered june 30th 2025 for additional paperwork disclosure. The health and human services department just issued their controlling pharmasuetical corporations blanket immunity starting jan 1 2025. See how this works yet?
There is a saying; if you can’t explain something in simple terms, you really don’t have a comprehensive grasp on the subject matter you’re trying to describe.
Nearly one billion two hundred and one million documents furnished. As the pharmasuetical companies whom profited billions and trillions have their government minions complain about the cost of legally complying. When in fact the pharmasuetical industry has long since been in charge of the structure of institutions like the NIH, CDC, and FDA. Their own mutually agreed upon business model they all set up together, as the FDA and pharmasuetical industry obviously work hand in hand. There is no effective regulation, only the illusion thereto. As the revolving door spins along.
Don’t worry, there is one individual figurehead judge somewhere in Texas who’s going to save the day for everyone. Maybe he can wave a magic wand and bring all those dead children and adults back to life too. Nobody will go to jail. However; Switching our regulatory and penalty systems to fines based on income may go a very long way to solving this problem. A fines based on income structure would incentivize the legal community and give them the tools to actually pursue class action lawsuits against these mega corporations whom are otherwise untouchable as they have infinite resources compared to everyone else.
Let’s perform some simple web research today. Search this term; ‘pharmasuetical industry profit 2022’. / The top hit via google states boldly on the screen; The revenue of the worldwide pharmaceutical market in 2022 reached a colossal $1.4 trillion!
Your average desktop calculator does not have that many numerical entry slots on the screen, so we’ll use an online calculator to come about a ratio. 1.4 trillion pharma revenue, vs the cost of 3.5 million cost of complying with the courts for paperwork disclosure on this one individual subject matter. Probably the figure is less as the 3.5m is not a single year number worth of cost, while the 1.4 trillion is a single year number. For simplicity sake we’ll just use these figures.
3.5 million divided by 1.4 trillion, that’s 11 zero’s fyi. = 0.0000025%
In front of the decibel is up to one hundred, or one percent, two percent, etc. ten percent would be a tenth. Fifty percent would be a half. All of that is before the decibel. Beyond the decibel is portions of a single percent. So five zeros would mean (in order counting down); tenth of a percent, hundredth of a percent, thousandth of a percent, one ten thousandth of a percent. Then the actual numbers which are not zeros for our calculation today start in the hundred thousandth of a percent slot. The numbers occupying this slot is 2 then five. So we’d express that as two hundredth thousand and a half of a percent.
The 3.5 million the FDA is complaining costs so much to deal with the paperwork request by the judge is a mere two hundred thousandth and a half of a percent of the actual revenue of the pharmasuetical industry in 2022. 0.0000025%. In other words; for every $3.5 individual dollars spent being transparent with paperwork regarding this vaccine, the pharmasuetical industry revenue was…..
This is where math can be rather difficult. For every dollar spent on FDA FOIA compliance, the pharmasuetical industry claimed a revenue of what amount? So we’ll reverse the number and move the zeros to the other side. A hundredth thousandth becomes a hundred thousand. We’re working within the percentage here which is not yet a whole number. Add two more zero’s. A hundred thousand is now ten million.
I’ll defer to others better at this sort of ratio extraction math than me but it would appear that for every $3.5 individual dollars the FDA spends complying with paperwork requests for this one specific disclosure issue, the pharma industry claimed a revenue of thirty five million dollars or $35,000,000. So what we have here is a financial relationship of $3.5 individual dollars vs $35,000,000 dollars.
What an amazingly low cost of doing business! And the real kicker is that your tax dollars pay for the FDA disclosure costs, the pharmasuetical industry actually pays nothing. What incompetent moron is complaining about costs associated with being transparent and honest with paperwork disclosure to the public with these staggering cost vs revenue income relationships? Why don’t they make the pharmasuetical companies pay this cost if the pharmasuetical companies are the ones whom flooded the organizations with this much paperwork?
Yet somehow an order of this magnitude is being handled by one judge, somewhere out there in the world. And we’re all supposed to be fine with this, continue to trust the system, because they’re finally being honest and one day, at some indeterminable point in the future, using funds net yet allocated to analyze all this disclosed data for the third and fourth time as it finally is made public, we’ll eventually know the truth.
Someone out there will read through the disclosed data and we’ll be able t trust them just as much as the FDA to tell us the truth of the matter. You don’t need to worry about the pharmasuetical industry co opting those people as easily as they co opted the government regulators. Finally, someone honest is on the job so we can all rest assured the products they’re pushing are safe, and the government oversight is trust worthy and effective. See how this system works yet? Who’s still buying into the illusionary legitimacy?
The exact figure and ratio becomes irrelevant at a certain point. It is beyond absurd that there is any excuses put forth there is inadequate resources to provide a safer product, and more transparent safety disclosure. Obviously the financial resources are available, these orgs and corps choose not to allot the funds in such a responsible manner.
If you want to really take a bite out of this runaway for profit faux health care model; (or any other runaway industry which has long since co opted governmental regulatory agencies)
FINES BASED ON INCOME.
In the movie ”The Outlaw Josie Wales”, Wales befriends an old Indian and they wind up in some town on their way south. In town, the Indian is approached by some sheister selling some kind of liquid “cure” for just about anything. The Indian asks, “Whats in it?” The sheister answers, “I don’t know, I’m just the salesman”. The Indian says, “You drink it”. That’s the perfect type of answer during these man made fake pandemics. You drink it, you take it, you stick it in your own arm, or just put it where the sun doesn’t shine. Everyone pushing these vaccines/poisons should back up their words, and take these shots themselves, under close observation by people representing both sides of the fake pandemic, all out in the open, so there would be no secret placebos given to any of them. These drug pushers would get quiet real fast, and this vaccine garbage would disappear in no time.
Exactly. And then tell them to get the hell off your lawn. If this website allowed photo uploads I would immediately post ten dozen visual examples of the fake needles and staged non vaccinations they performed in a grand theatrical effort to convince people to take the covid non-vaccine. What a total joke. Covid rnma non-vaccine push was an intelligence test that most people failed. You are watching political theater, always have been.
IW had their awesome truck winner person on as a guest not too long ago, whom was a retired military fighter pilot of all things. He brought up some really remarkable references and ideas. He mentioned how there was a story a while back from the pharmaceutical people whom work at DC locations. Apparently within the halls of the government buildings somewhere is an on site pharmacy and pharmacy technician. This pharmacy person had blown the whistle of sorts and stated he’s alarmed by the high quantity of high potency pharmaceuticals which are prescribed to elected persons and bureaucratic people alike. The news story was reportedly shut down shortly after. “These people are on a lot of drugs.”
The fighter pilot guest winner guy mentioned ‘a sound mind doctrine’ should be put in place through the whole of our government. This is an inspired take because look how frigging stupid the people in charge have become, how their minds addled. These are the people making decisions about our lives? If collectively we shall have peace or war? People whom have so many personal issues they need to be on a constant stream of prescription medicine? This is simply an unacceptable management situation. Central planning never works.
Tried to find that article, difficult research point, could not find. This is new though;
https://www.justice.gov/opa/pr/united-states-settles-false-claims-act-allegations-against-pharmaceutical-distributor-paying
Oh they’re ‘doing more investigations’! Oh wow, rest assured that effective legal oversight will be there to send nobody to jail and fine companies with disproportionately low pittance of fines as an effective deterrent to this behavior which has become so commonplace, everyone knows about it. Except apparently the DOJ, and they’ll need to investigate more. Kickbacks are the name of the game. Think they’ll do covid next? Doubtful. Ten quadrillion million zillion giga kabillion to the millionth power income dollars later, some corporation cops a million dollar fine. That’ll show em!
Want real solutions? Fines based on income.