A whistleblower involved in Pfizer's pivotal phase III Covid-19 vaccine trial has leaked evidence to a notable peer-reviewed medical publication that poor practices at the contract research company she worked for raise questions about data integrity and regulatory oversight.
Brook Jackson, a now-fired regional director at Ventavia Research Group, revealed to The BMJ that vaccine trials at several sites in Texas last year had major problems - including falsified data, broke fundamental rules, and were 'slow' to report adverse reactions.
A regional director who was employed at the research organisation Ventavia Research Group has 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.
Jackson, a trained clinical trial auditor with more than 15 years' experience, says she repeatedly warned her superiors of poor laboratory management, patient safety concerns, and data integrity issues.
On former Ventavia employee told The BMJ that the company was petrified over the potential for an FDA audit, and were in fact expecting one over the Pfizer vaccine trial.
"I don't think it was good clean data," the employee said of the data Ventavia generated for the Pfizer trial.
Since Jackson reported issues with Ventavia to the FDA in September 2020, Pfizer has contracted with the company for four other vaccine clinical trials.
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