A former testing site researcher in Texas has alleged that Pfizer’s pre-licensure BNT162b2 (also known as “Comirnaty”) COVID-19 biologic trials included falsification of data, unblinding patients, employing inadequately trained vaccinators, and delays in following up on experimental COVID vaccine adverse reaction reports.1
According to clinical trial researcher Brook Jackson, the incidences occurred during the phase III trial and were reported by Jackson to the U.S. Food and Drug Administration (FDA) after the private research group she worked for failed to investigate her concerns. Jackson, who was a regional director, was fired from Ventavia Research Group, a Pfizer subcontractor, the same day.1
The British Medical Journal (BMJ) reported that Jackson was a trained clinical researcher who, prior to her position with Ventavia, had over 15 years of experience in clinical research coordination and management.1 During the course of the investigation, Jackson provided the BMJ and other news sources with records including documents, photos, audio recordings, and emails to support her claims.1 2 3
Records of Sloppy Documentation and Falsifying Data in Pfizer Experimental COVID Vaccine Clinical Trial
Several of these records, which included emails from Ventavia staff discussing “sloppy” documentation and falsifying data in the Pfizer pre-licensure clinical trial of its experimental COVID biologic, can be seen in an article written in The Disinformation Chronicle.3Another record displayed in the article is an e-mail from Jackson to Ventavia officials outlining several issues she was seeing with the trials. Jackson ends the e-mail with “I might be in a little bit of shock.”3
In a recording of a meeting between Jackson and two Ventavia directors in September 2020, an executive can be heard discussing the company’s inability to quantify the amount of errors they were finding during the Pfizer COVID biologic clinical trial paperwork for quality control. The executive is heard saying:
In my mind, it’s something new every day. We know that it’s significant.1
According to the BMJ, additional former employees of Ventavia have also spoken out anonymously. One of these employees alleged that the company had been nervous about expecting a federal audit of its Pfizer biologic trial. This claim is supported by an e-mail Jackson provided.3
DHHS Report Concludes FDA Inspections Should Focus on Human Subject Protections
Jill Fisher, PhD, a professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials, states that the FDA audits are rarely anything more than paperwork inspection that typically don’t occur until months after a clinical trial has ended.1
A 2007 Department of Health and Human Services Office of the Inspector General report entitled The Food and Drug Administration’s Oversight of Clinical Trials estimated that the FDA inspected only one percent of clinical trial sites.4 The DHHS report outlines a summary of findings including the fact that the agency is unable to even identify ongoing clinical trials because there is no clinical trial registry. Findings of the Inspector General also state:
The (FDA) centers conduct more inspections that verify clinical trial data than inspections that focus on human subject protections.4
Pharmaceutical Companies Pay FDA for Drug and Vaccine Licensure
Former HHS official Michael Carome, MD has cited concerns over the FDA’s funding which largely comes from “user fees” from the very pharmaceutical companies the FDA is legally responsible for regulating.
“Instead of a regulator and a regulated industry, we now have a partnership,” Carome stated. “That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.”5
The FDA was entirely a taxpayer-funded agency until 1992 when Congress passed the Prescription Drug User Fee Act (PDUFA). The Act directed pharmaceutical companies to pay the FDA a fee to review drug and vaccine license applications. It also allowed for manufacturers to pay annual user fees to fast track experimental drug or vaccine licensure.5 6 7
FDA Approval Process Faster Than Any Other Country’s Regulatory Agency
According to an article in ProPublica, “Today the FDA approves drugs faster than any other regulatory agency in the world. ” The article goes on to point out that there are significant conflicts of interest between the FDA and pharmaceutical companies:
The FDA is increasingly green lighting expensive drugs despite little-known side effects and inconclusive evidence.8
Former FDA commissioner Scott Gottlieb, MD who encouraged fast tracking of many of these drugs and vaccines, left the FDA in 2019 and now sits on the Board of Directors for Pfizer.9
Vaccine Testing Site Not Investigated by FDA After Employees Report Violations During Pfizer COVID-19 Clinical Trials
According to the BMJ, Jackson’s e-mail to the FDA, which was sent on Sep. 25, 2020, outlines several concerns surrounding the mishandling of the Pfizer clinical trials of its experimental COVID biologic, including:
- Participants placed in a hallway and not being monitored by clinical staff following vaccination
- Lack of timely follow up with patients who experienced adverse events after being vaccinated
- Protocol deviations not being reported
- Vaccines not stored at proper temperatures
- Mislabeled laboratory specimens
- Targeting of Ventavia staff for sanctions for reporting any problems1
After Jackson reported protocol violations, she received a follow up e-mail and call from the FDA but was told that no further information could be provided. Following FDA’s approval of Pfizer’s COVID biologic, the FDA published a summary of its inspections of the trial. Of the 153 clinical trial sites, only nine were inspected. Ventavia’s sites were not listed among those inspected by FDA despite Jackson’s report directly to the FDA.1
In the summary, the FDA’s inspection officer noted:
The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].1
Ventavia Denies Jackson’s Duties Included Clinical Trial Involvement
MedPage Today reports that Ventavia spokeswoman Lauren Foreman objected to the BMJ article and stated the company was working with an attorney. Foreman also alleged that Jackson was employed “for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials.”2
Following the published MedPage Today article, Jackson provided MedPage Today a copy of an email showing that she had indeed been hired by Ventavia as a regional director to be involved with two sites for the Pfizer COVID biologic clinical trial.2 Jackson’s name is also listed on Pfizer’s clinical trial delegation log in which you can see her printed name, signature, and delegated duties.5 According to the document, Jackson had several delegated duties including investigational product accountability, maintenance of regulatory binder, and “compliance assessment of investigational product.”3
A Cease and Desist letter from Jackson’s attorney was issued to Ventavia demanding that a public retraction of the statement that Jackson was not involved in clinical trials. The legal letter states:
Point in fact, as you know, Jackson was in fact hired to be the regional director specifically for the ‘clinical trials at issue.’10
Asked by MedPage Today whether the FDA is investigating the accusations against the trials, the FDA stated in an e-mail: “Although the agency cannot comment further at this time in the ongoing matter, FDA has full confidence in the data that were used to support the Pfizer/BioNTech COVID biologic authorization and the Comirnaty approval.”2
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.Click here to view References:
1 Thacker P. COVID-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ Nov. 2, 2021.
2 Clark C. Experts Blow Whistle on Alleged COVID Vaccine Whistleblower Claims. MedPage Today Nov. 5, 2021.
3 Thacker P. Pfizer COVID-19 Vaccine Clinical Trial Whistleblower’s Documents Released. Disinformation Chronicles Nov. 30, 2021.
4 Department of Health and Human Services Office of Inspector General The Food and Drug Administration’s Oversight of Clinical Trials Daniel R Levinson, Inspector General, September 2007.
5 Hobley N. The FDA has a history of rushed drug approvals. The Vaccine Reaction Sept. 6, 2021.
6 The Vaccine Reaction Staff. Drug Companies Pay FDA and NIH to Fast Track and Market Vaccines. The Vaccine Reaction Sept. 28, 2018.
7 Raines K. Experimental Drugs and Vaccines on FDA’s Fast Track. The Vaccine Reaction Jan. 17, 2019.
8 Chen, C. FDA repays industry by rushing risky drugs to market. ProPublica June 26, 2021.
9 Pfizer Confidential. Signature sheet and delegations of duties log. June 15, 2018.
10 Barnes Law. Re: Libel of Brook Jackson. Nov. 11, 2021.
The same falsified data bing used as verification by the CDC, etc., that was essentially, made up but. Companies and Their labs…are still being sued as truthful analysis and I’ll causing massive numbers of injuries and death..a th eve beginning 1988 and after when the CDC and AMA decided to overload the childrens vaccine schedules…and the same results are showing up as when the brain damage and mitochondrial damage function and gut bowel damage, was causing what was described by clinicians as ..Autism…which has ever been denied by those..agencies and manufacturers. And yet…even today …is still occuing and the VAERS keeps..almost secretly I still awarding damages and money to its vaccine(s) victims…in the Billions of dollars. This time it’s so Much worse in that there has been extensive campaigns to convince people of the terror of this plague and people have believed it. So much being done to just get rid of populations of people…it appears to be true.
Above comment needs word correction…and I can’t get in to it….
Even if the FDA was involved in short-cutting the injection, what can be done at this point? If proof is found and admitted to, it won’t help those who are now open to all of the possible side effects and damages. It appears that no one is ever held to account in this type of issue. The customary response when caught is a smug, “we’ll be changing some of our protocols in response; We promise to do better going forward” or some such BS, then they continue as they did prior to being exposed, and no one even loses a day’s pay, let alone faces consequences deserving of this type of,…I’m not sure whether ‘incompetence’ or ‘corruption’ covers this better… let’s say ‘situation’. So long as TPTB continue to condone ‘business as usual’, trust in government agencies, Pharma, and the Federal Government itself will continue to erode. Current approval of the POTUS is at a record low already’; The Biden cabinet can’t afford to go any lower as things stand currently,.and anarchy is beginning to look more appealing than the current administration to many of the populace, at least as I read the sentiment in the various comment sections on the net.
I don’t see anything less than abolishing the FDA, (among other alphabet agencies that have gone rogue) and creating an incorruptable, non-partisan organization, perhaps with elected leadership to provide for accountability and potential repercussions for wrongdoing, as a workable solution to this matter. Nothing else will convince me to ever trust or rely on anything coming from FDA approval again, and I’m certain that I’m not alone in this sentiment.As a former nurse, and a naturalist/ herbal medicine user, I can survive without the FDA. Can it say the same about having no public support?
Robin it’s called free market principals. Adam Smith; The Invisible Hand.
None of this would be possible without the unlimited monetary infusion which is courtesy of the Federal Reserve. All the grant money, all the subsidies, all the bribes. That is the root cause of all this deception, the allure of a bigger piece of the pie taken rather than earned. If we just let the free market work with a sound monetary system the people would have put an end this a long time ago. Woodrow Wilson is still rolling in his grave to this day. Article 1 Section X.
It may seem off topic to incorporate the FDA argument alongside sound monetary arguments, but touches on the heart of the matter. In such a complex system it is impossible to correct all the wish list items you and the author and the whistle blowers call for… Unless the system was simplified with a true free market principal as the core structure. Because absent of the will of the people being imposed, corruption of the few occupies all the space.
One may ponder why a century and a half since the FDA was formed was not enough time to reign in functional checks and balances systems… It’s not a mystery but does require a bold move towards more constitutionally minded thinking in order to once again put the blinders on lady justice. But if enough people held to that, organizations like the FDA would never have been installed in the first place.
A century and a half ago people did argue against the formation of the FDA and their arguments are more valid today than ever before. The vexes we face today were in fact predictable and predicted. It is very difficult to track down links for you but basically many independent practitioners and product suppliers argued the system would become so large it would eventually lead to market monopolies and unfair trade restriction. And voila! That time has come. FDA grows in power and scope as time ticks on, and the revolving door of corporate monopolization inevitably follows. Every single thing they regulate has led to market monopolies. Hell, they even tried at one point to outlaw vitamins. It’s a miracle people even still turn to this FDA organization for any advisement what so ever. Face it; regulatory systems meant to foster consumer protection are irreparably broken and now function as mouthpieces for big corps. We have been on our own a very long time and the last thing they successfully regulated was lead and asbestos, some tobacco, it’s been a free for all ever since. Take a look at ‘product recalls’ from the FDA’s own site. It’s like a parody or something, how many times they get it wrong. Rubber stamp approval is the name of the game. RFK Jr called it many years ago, ‘you can’t trust an agency who’s majority funding comes from those they supposedly regulate.’ If you want to talk about disbanding the FDA, like the Federal Reserve, you have to start talking about revoking their charters. These are private organizations with governmental sounding names. But make no mistake about it, congress has no interest in holding them accountable and they are for profit organizations.
Who can take your money? Take it all away and give it to some other guy? The government. The government can. Who can tax the sun rise? Who can tax the trees? Let you run a business and collect up all the fees. The government can. Who can be a failure in so many ways, instead of getting fired they give themselves a raise. The government. Oh the government can.
Do “we the people” need to prepare a potential indictment for Scott Gottlieb for fast tracking and conflict of interest for those injured by the fast tracking of Pfizer vaccines and other drugs?
As long as the general public remains ignorant about or unable to implement for whatever reason, good lifestyle choices, (sleep, nutrition, stress management, exercise, financial health) there will always be a public outcry for a better health care system. We also live in a very broken world that is spinning into a more disorganized state of random disorder. Put simply into Physics terminology, entropy is a measure of disorder, and the Second Law of Thermodynamics states that all closed systems tend to maximize entropy. Reversing this ever increasing tendency toward disorder requires the input of energy. That’s why housekeeping is so tiresome. Left on its own, your house would get dusty, spiders would move in, and eventually, it would fall apart. However, the energy put into preventing disorder in one place simultaneously increases it somewhere else. In other words you have to break down your own body by sweating and aging your self further while losing energy to the universe around you, just to keep your house in order. Therefore while trying to keep order in one place you have to create disorder in another place. Overall, the entropy (disordered state) of the universe always increases. For those other scientists out there, remember this, the Second Law of Thermodynamics relates the heat associated with a process to the entropy change for that process. Therefore as a redox reaction proceeds there is a heat change related to the extent of the reaction, dq/dξ = T(dS/dξ). There is no perfect way to transfer energy without some loss of energy forever to the universe. Here is another example of random disorder: has anyone ever seen an actual photo of a snow crystal? They look so intricately beautifully organized and well structured, while still frozen. However, the water molecules in that snow crystal soon become randomly separated and disorganized into a liquid state as the temperature rises and as the temperature rises further to produce water vapor, the molecules of that same snow flake become more randomized into a higher state of random disorder. There is only one state of random disorder that eventually can lead back to a state of final order for those who look deeper into their hearts and that is the chaos and disorder that took place since the dawn of mankind up to the specific time of 2000 years ago. I say to those who do not want to believe this: why do you even write a date with the year on your check?
Yeah, but what’s your point? In the context of this article I think we’re talking about a fly stuck in vasoline as we go nowhere in a never ending cycle of debate regarding accountability and proof points. Extending energy but getting nowhere.
Isn’t it interesting how little energy these big corps extend in comparison to how much energy people whom question them have to extend? Or how much energy is required for those injured by these decisions to seek fair redress and recourse? FDA allows them this power imbalance by way of situational positioning or at the top of the ladder so to speak. They can falsify data, manipulate studies, rubber stamp what they want through to approval. Send everything down with ease. But then proving them wrong requires endless debates, multiple redundant proof points, committees, further consideration, more studies. And we never get there, the argument never goes forward. Yes, a closed system.
Yet the laws of differential proportions also exist and balance must be eventually achieved. People are starting to get wise that it is their own acceptance of the unfair imbalance imposed by quasi private quasi governmental structures as the root cause of imbalance. It’s a miracle people even still listen to these corrupt organizations. They tried to tell me in my lifetime that vitamins should be illegal, gmo foods were safe, chemicals were good for me, and even several years back proposed that mercury should be listed as an essential nutrient or something similar to that regard. The absurdity of what comes out of the FDA is no longer shocking but it remains highly disconcerting. They have become the hammer in the hands of a 3 year olds and to them, everything looks like a nail. At this point over regulation of competition is where the profit comes from and the FDA is afraid of biting the hands that feed them. The FDA has become a bloated top heavy system which is collapsing under it’s own weight.
Joe Rogan episode #1757 with Dr Robert Malone MD. This is quite possibly the most important video anyone can watch to best explain the mechanisms of using third party research companies to pass off liability for medical product experimentation and lack of product safety abuse. Dr Malone breaks down the very core of this whistle blowers argument in his recent interview with Rogan. It’s not surprising how much effort they put towards censoring this, he is the equivalent of Faucci, less the insurmountable conflicts of interests. Just search with this paragraphs first sentence on bitchute dot com, you’ll find the video. It is an essential 3 hour watch which will illuminate the masses, if they are capable of understanding the content.
I recommend “The Real Anthony Fauci”, from RFK Jr. – and i don’t think we need any more evidence before we start to call the CDC a criminal organisation. Our main problem is, that our police / law system exists to protect the criminals, not to arrest them.