- According to a whistleblower who worked on Pfizer’s Phase 3 COVID jab trial, data were falsified, patients were unblinded, the company hired poorly trained people to administer the injections, and follow-up on reported side effects lagged way behind
- Brook Jackson was the regional director of Ventavia Research Group, a research organization charged with testing Pfizer’s COVID jab at several sites in Texas. Jackson repeatedly “informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues,” and when her concerns were ignored, she finally filed a complaint with the U.S. Food and Drug Administration
- The FDA did not follow up on her complaint. Ventavia was not one of the nine trial locations audited, and Pfizer did not bring any of those issues up when applying for emergency use authorization for its COVID shot
- Documentation shared by Jackson shows a Ventavia executive had identified three site staff members who had falsified data
- After being notified of Jackson’s complaints, Pfizer contracted Ventavia to conduct four additional trials — one for COVID shots in children and young adults, one for the COVID jab in pregnant women, a booster shot trial, and an RSV vaccine trial
Yet again, mainstream media have completely ignored what should have been front-page news. According to a whistleblower who worked on Pfizer’s Phase 3 COVID jab trial in the fall of 2020, data were falsified, patients were unblinded, the company hired poorly trained people to administer the injections, and follow-up on reported side effects lagged way behind.
What makes the media’s silence all the more remarkable is that this revelation was published in The British Medical Journal. Paul Thacker, investigative journalist for The BMJ, writes in his November 2, 2021, report:
“Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight …
[F]or researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety … Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding.”
As noted by Bill Bruckner for transparimed.org:
“Editors’ widespread failure to pick up on the story is deeply problematic. First and foremost, it lets the U.S. Food and Drug Administration off the hook for what appear to be severe lapses in regulatory oversight over this trial … Where are the media outlets questioning the FDA about its oversight processes? Where are the politicians calling for an enquiry? …
Second, it lets Pfizer off the hook for apparently failing to adequately oversee the operations of its subcontractor … Where are the media outlets questioning Pfizer about its oversight and quality assurance processes? …
Third, it undermines confidence in democratic institutions and public health bodies because it gives citizens … the impression that mainstream media are deliberately ignoring a big story in order to avoid fueling vaccine hesitancy.”
The whistleblower in question is Brook Jackson, a former regional director of Ventavia Research Group, a research organization charged with testing Pfizer’s COVID jab at several sites in Texas.
Jackson repeatedly “informed her superiors of poor laboratory management, patient safety concerns and data integrity issues,” Thacker writes, and when her concerns were ignored, she finally called the U.S. Food and Drug Administration and filed a complaint via email.
Jackson was fired later that day after just two weeks on the job. According to her separation letter, management decided she was “not a good fit” for the company after all. She has provided The BMJ with “dozens of internal company documents, photos, audio recordings and emails” proving her concerns were valid. According to Jackson, this was the first time she’d ever been fired in her 20-year career as a clinical research coordinator. Thacker explains:
“Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management.
Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box.
Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants … Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel …
In a recording of a meeting in late September 2020 between Jackson and two directors, a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. ‘In my mind, it’s something new every day,’ a Ventavia executive says. ‘We know that it’s significant.’
FDA Ignored Whistleblower Concerns
In her complaint to the FDA, Jackson listed a dozen incidents of concern, including the following:
- Participants were not monitored by clinical staff after receiving the shot
- Patients who experienced adverse effects were not promptly evaluated
- Protocol deviations were not being reported
- The Pfizer injection vials were stored at improper temperatures
- Laboratory specimens were mislabeled
Not a single one of the problems Jackson raised in her complaint to the FDA were noted or addressed in Pfizer’s briefing document submitted to the FDA’s advisory committee meeting December 20, 2020, when its emergency use authorization application was reviewed.
The FDA went ahead, granting the Pfizer jab emergency use authorization the very next day, despite being in receipt of Jackson’s complaint, which ought to have put the brakes on the FDA’s authorization. At bare minimum, they should have investigated the matter before proceeding.
What’s more, the FDA’s summary of its inspections of the Pfizer trial, published in August 2021, revealed the agency only inspected nine of the 153 trial sites, and Ventavia was not one of them. The complaint also appears to have been ignored when the FDA granted full approval to Comirnaty, Pfizer/BioNTech’s COVID shot that is not yet available.
Pfizer is also in on the cover-up. Shortly after Jackson’s firing, Pfizer was notified of the problems she’d raised. Despite that, Pfizer has since then contracted Ventavia to conduct no less than four additional trials — one for COVID shots in children and young adults, one for the COVID jab in pregnant women, a booster shot trial, and an RSV vaccine trial.
So, clearly, Pfizer is not opposed to contractors falsifying data or otherwise undermining the integrity of the trials. That alone is a fiery indictment against Pfizer.
They can feign ignorance and proclaim to adhere to “the highest scientific, ethical and clinical standards” all they want. Those are just words which, unless backed by consistent action, are completely meaningless. Behind the scenes, they’re clearly well-aware that their trials are resting on fraudulent foundations.
Source article available through 11-16-2021: https://bit.ly/3nkCRKJ