What has Pfizer and the FDA Been Up To?
It’s true that Pfizer’s ‘COVID ‘vaccine trial’ was exposed by a whistleblower. The BMJ (The British Medical Journal) published an eye-opening report on data integrity issues in a Pfizer vaccine trial on November 2 under the title “Covid-19: Researcher blows the whistle on data integrity issues.”
“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,” a former regional director told The BMJ.
Yes, this is the shot that people of all kinds have been forced to take at the risk of their jobs, education, earnings, way of life, and much more to receive.
“Pivotal phase III trial” whistleblower Brook Jackson served as Ventavia Research Group‘s regional director for two weeks beginning in September 2020. “The BMJ received numerous internal company documents, photos, audio recordings, and emails” from Jackson to support her concerns, which made the public disclosure possible.
There were “too many problems” for Ventavia’s quality control staff to handle, according to Jackson. Ventavia’s laboratory management, patient safety, and data integrity were all issues that she “repeatedly informed her superiors [of].”
Quality Control? What is Quality Control?
“A Ventavia executive identified three site staff members with whom to ‘go over e-diary issue/falsifying data, etc.'” in an internal document from August 2020, a few months after the trial began and before Jackson’s employment. A note indicates that one of them was “verbally counseled for changing data and not noting late entry.”
The Ventavia’s director “explained that the company couldn’t quantify the types and number of errors they were finding when examining the trial paperwork for quality control” in a meeting with Jackson in late September 2020, according to a recording of the meeting. “In my mind, it’s something new every day,” the executive was heard saying. “It’s important to us.”
An unwelcome FDA (Food and Drug Administration) inspection was mentioned several times in the same recording. Another said, “We’ll get at least a letter of information from the FDA when they arrive… know it.” No surprise visits, hmmm… Pfizer’s COVID ‘Vaccine Trial’ FAILURES.
“Data entry queries” from ICON, Pfizer’s contract research organization partner during the trial, was revealed in an email to Ventavia in September 2020. ICON was very dissatisfied.” In the email, the researcher reminded Ventavia that “the expectation for this study is that all queries are addressed within 24 hours” and noted that more than 100 queries remained outstanding for more than three days.
Test subjects who “reported with severe symptoms/reactions” were included in two of the over 100 queries. If a patient has a Grade 3 local reaction (severe redness, swelling, or pain at the injection site), they have to be contacted, according to protocol. “To ascertain further details and determine whether a site visit is clinically indicated,” ICON requested confirmation as to whether contact had been made and that the subjects’ forms be updated accordingly.”
To vent her frustration at being ignored by Ventavia, Jackson called and then emailed the FDA on September 25, 2020, the day following her meeting with executives, and was fired by the company as “not a good fit” the following day.
Pfizer’s COVID ‘Vaccine Trial’
Among the issues she brought up with the FDA in her report were:
- After receiving an injection, participants were placed in a hallway and not monitored by clinical staff.
- Patients who have had adverse events are not being properly monitored in a timely manner.
- Lack of reporting of protocol deviations
- Lack of proper temperature control for vaccine storage
- Laboratory specimens that have been mislabeled
Ventavia employees are specifically targeted for reporting these kinds of issues.
Ventavia employees who were either fired or have since left the company have corroborated and supported Jackson’s story. “Everything that you complained about was spot on,” a former official who was present at the late September meeting has since apologized to her.
In an interview with The BMJ, two of Jackson’s former employees “confirmed broad aspects of his complaint.” According to one of those employees with extensive clinical trial experience, “I had never experienced such a ‘helter-skelter work environment’ as with Ventavia in Pfizer’s trial.” That’s something I have never had to do in my life,” said the employee. A little out of the ordinary, as far as what was permitted and expected was concerned.”
In an interview with another former employee, Ventavia “created an environment unlike any she had ever encountered in her 20 years of conducting research.” “Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place” shortly after Jackson was fired, she said.
Pfizer submitted a document to an FDA advisory committee meeting in December 2020 to support its application for emergency use vaccine authorization, but there was no mention of any problems at Ventavia. Fake documents and information were used to grant emergency use permission.
When it comes to FDA failures, this isn’t the first time.
An official report from the Department of Health and Human Services on FDA oversight of clinical trials from 2000 to 2005 was released in 2007. The FDA only inspected 1% of clinical trial sites, according to the report, only 50 on-site inspections were conducted in 2020, according to an article in The BMJ.
However, in August 2021, Pfizer’s “Comirnaty” vaccine received full FDA approval, and “the FDA published a summary of its inspections of the company’s pivotal trial. Inspections were conducted at nine of the trial’s 153 sites.
Eight months after the December 2020 “emergency authorization [sic]” was issued, there was no inspection of adult recruitment sites by Ventavia. 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……”
The best part is here. As of September 2020, when Jackson filed her FDA complaints against Pfizer, “Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials”: a trial of COVID-19 vaccine in children and young adults; a study of COVID-19 booster doses; and a study of RSV vaccine (respiratory syncytial virus).
The British Medical Journal appears to be the only legacy media outlet or medical journal to be distributing this critical information. If this is the state of medical trials and oversight in the United States of America, we are all in for a very long line of fuckery..
This certainly explains why the FDA, due to Pfizer’s COVID ‘Vaccine’ Trial’ FAILURES, wants 55 years to release research data from Pfizer.
We have the CDC manipulating data, Pfizer (at least the outed one) falsifying data, and the FDA wanting 55yrs to release the data that they reviewed in 10 weeks. We have 10’s of thousands of injuries and deaths reported and the message is: ‘Get Vaccinated’.
The New Normal Documentary by happen.network
A great documentary that investigates The Fourth Industrial Revolution, what the 1% has to gain and the rest of us are about to lose.