According to Jackson's reports, Texas Contractor, Ventavia Research Group held unblinding phase III vaccine trial, leading to the vaccine's approval and deployment of insufficiently or not at all trained vaccinators. Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trials.
Who is Brook Jackson?
Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration.
"After repeatedly notifying Ventavia of poor laboratory management, patient safety concerns, and data integrity issues, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA," the BMJ article said. "Ventavia fired her later the same day." The report further stated that Jackson "provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails," some of which depict "poor laboratory management" by the firm.
'Unblinding clinical trial
"One photo showed needles discarded in a plastic biohazard bag instead of a container box. Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants," the BMJ article stated.
The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. The BMJ investigative report has now alleged that the documentation of the clinical trials that Pfizer submitted to the FDA is brimming with data reporting errors and clinical trial misconduct. According to Jackson, Ventavia "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."
Ventavia and Pfizer denied Accusations
Ventavia spokesperson Lauren Foreman discredited Jackson's claims. Foreman noted that Jackson was employed "for approximately 2 weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue."
Pfizer also released a statement and said it was "disappointed by the recent article published by the British Medical Journal that failed to contact us prior to publication and selectively reported certain claims with the goal of undermining confidence in a vaccine that has been given to hundreds of millions of people worldwide."
BioNTech Shares Fall by 20%
After the explosive whistleblower report came out, shares of BioNTech, the German company that co-developed the vaccine with Pfizer, took a drastic 20% plunge on Friday, November 5. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60.