Robert Barnes of https://vivabarneslaw.locals.com/ to break down the biggest vaccine whistleblower news in history as the FDA is exposed falsifying data in COVID jab trials.
Leading medical journal The BMJ has published an incendiary report exposing faked data, blind trial failures, poorly trained vaccinators, and a slow follow-up on adverse reactions in the phase-three trial of Pfizer’s Covid jab.
Central to the exposé is Brook Jackson, who, for two weeks, served as regional director at Ventavia Research Group, the company contracted to assist with the pivotal trial. She provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails supporting her concerns.
Jackson reveals that Ventavia staff who conducted quality-control checks were overwhelmed by the volume of problems they were identifying. She repeatedly informed her superiors of poor laboratory management, and patient safety and data integrity issues.
In a cited internal document from August 2020, shortly after the Pfizer trial began, a Ventavia executive identified three site staff members with whom to “go over e-diary issue/falsifying data, etc.” One employee was said to have been subsequently “verbally counseled for changing data” and “not noting late entry.”
Jackson reported her concerns to the US Food and Drug Administration (FDA), but was fired later the same day on the basis that she was “not a good fit.”
In a recording of a late September meeting provided by Jackson, in which she met with two Ventavia directors, the unwelcome prospect of an FDA inspection had been openly discussed. “We’re going to get some kind of letter of information at least, when the FDA gets here … I know it,” one said to Jackson.
Another former Ventavia employee has confirmed that the company had been expecting a federal audit of its Pfizer vaccine trial, though this did not materialize. A 2007 US Department of Health report found that, between 2000 and 2005, the FDA inspected just 1% of clinical trial sites, while, in 2020, just 50 on-site visits were conducted.
In the aforementioned recording, an executive can also be heard explaining that, when examining paperwork for trial quality control, the company wasn’t able to quantify the types and number of errors that were being identified. “In my mind, it’s something new every day,” the senior staffer says. “We know that it’s significant.”
An email sent in September to Ventavia by Icon, the research organization with which Pfizer partnered on the trial, shows Icon was dissatisfied with Ventavia’s inability to keep up with data entry queries. Icon reminded Ventavia that “the expectation for this study is that all queries are addressed within 24 hours,” noting that more than 100 queries had remained outstanding for more than three days.
Among those queries were two cases in which test subjects had “reported with severe symptoms/reactions.” According to protocol, subjects experiencing grade-three local reactions – “severe” redness, swelling, or pain at the injection site – should have been contacted. Icon asked for confirmation as to whether contact had indeed 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.
The BMJ – Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then 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 laboratory specimens, and
- Targeting of Ventavia staff for reporting these types of problems.
Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.
In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, 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. 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].”
Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”
Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.
“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”
She added that during her time at Ventavia the company expected a federal audit but that this never came.
After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)
“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”
A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.
Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.