It is a true bombshell of a report.
A leading medical journal, The BMJ (The British Medical Journal), published an eye-popping report on November 2 titled, “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial.” In the article, a former regional director told The BMJ “that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”
Yes, this is the jab that employees, students and people of all kinds have been coerced into receiving, at risk of their jobs, schooling, income, lifestyle and more.
Whistleblower Brook Jackson for two weeks in September 2020 served as regional director at Ventavia Research Group, the company contracted to assist in the “pivotal phase III trial.” Jackson was central to the public disclosure by providing “The BMJ with dozens of internal company documents, photos, audio recordings, and emails” supporting her concerns.
Jackson asserted that Ventavia staff “who conducted quality control checks were overwhelmed by the volume of problems they were finding.” She “repeatedly informed her superiors [at Ventavia] of poor laboratory management, patient safety concerns, and data integrity issues.”
In an internal document from August 2020, not long after the trial began and before Jackson’s employment, “a Ventavia executive identified three site staff members with whom to ‘Go over e-diary issue/falsifying data, etc.’ One of them was ‘verbally counseled for changing data and not noting late entry,’ a note indicates.”
In late September 2020, a recording of a meeting between Jackson and two Ventavia directors reveals one director “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.” The executive was heard saying, “In my mind, it’s something new every day. We know that it’s significant.”
In that same recording, they spoke several times about the “possibility” of an unwelcome FDA (US Food and Drug Administration) inspection. One was heard saying, “We’re going to get some letter of information at least, when the FDA gets here … know it.”
An email in September 2020 to Ventavia by ICON, Pfizer’s contract research organization partner on the trial, revealed that ICON was very dissatisfied with Ventavia’s inability to keep up with “data entry queries.” The email reminded Ventavia that “the expectation for this study is that all queries are addressed with 24hrs” and noted that more than 100 queries had remained outstanding for more than three days.
Among those more than 100 queries were two cases where test subjects had “reported with Severe symptoms/reactions.” Protocol dictated those “subjects experiencing Grade 3 local reactions [“severe” redness, swelling, or pain at the injection site] should be contacted.” ICON asked for confirmation as to whether contact had been made so as “to ascertain further details and determine whether a site visit is clinically indicated” and that the subjects’ forms be updated accordingly.
Frustrated by the lack of response from Ventavia, on September 25, 2020, the day after her meeting with the executives, Jackson called first and then emailed her concerns and complaints about “unsound practices” to the US Food and Drug Administration and was summarily fired by Ventavia later that same day as being “not a good fit.”
In that report to the FDA, Jackson “listed a dozen concerns she had witnessed including:
- Participants placed in a hallway after injection and not being monitored by clinical staff
- Lack of timely follow-up of patients who experienced adverse events
- Protocol deviations not being reported
- Vaccines not being stored at proper temperatures
- Mislabelled [sic] laboratory specimens, and
- Targeting of Ventavia staff for reporting these types of problems.”
Jackson’s account was corroborated and reinforced by several Ventavia employees who were either fired or since departed from the company. A former official who was present at that late September meeting has since apologized to her, telling her that “everything that you complained about was spot on.”
Two of those employees spoke anonymously to The BMJ and “confirmed broad aspects of Jackson’s complaint.” One of those employees who has worked on more than four dozen clinical trials in her career said she “had never experienced such a ‘helter skelter’work environment as with Ventavia on Pfizer’s trial.” The employee continued, “I’ve never had to do what they were asking me to do, ever. It just seemed like something a little different from normal – the things that were allowed and expected.”
A second former employee repeated the first’s comments and “described an environment at Ventavia unlike any she had experienced in her 20 years doing research.” She also said that shortly after Jackson was fired, “Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.”
Yet, in the document Pfizer submitted to an FDA advisory committee meeting in December 2020 to support its application for emergency use vaccine authorization, there was no mention made of any problems at Ventavia. Emergency use authorization was granted under fraudulent and falsified documentation and information.
This is not the first time the FDA has failed to function. “In 2007 the Department of Health and Human Services … released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites,” and in 2020, just 50 on-site inspections were conducted, as cited in The BMJ article.
Still, in August 2021, full FDA approval was granted for Pfizer’s “Comirnaty” vaccine (which is yet to be made available), and “the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation [sic].” Perhaps given as a reason, “the FDA’s inspection officer” stated in part that “the study was ongoing, and the data required for verification and comparison were not yet available…”
Here is the most stunning part. Since September 2020, when Jackson filed her complaints with the FDA, “Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials”: the use of COVID-19 vaccine in children and young adults; a COVID-19 trial involving pregnant women; a trial of COVID-19 booster doses; and a trial vaccine for RSV (respiratory syncytial virus).
Aside from The BMJ, it seems no other legacy media outlet or medical journal is disseminating this critical information. God help us all if this is the state of medical trials and oversight in the United States of America.