Tribune News Service
New Delhi, November 7
In a major expose this week, the British Medical Journal (BMJ) reproduced evidence from a former clinical trial auditor at a Pfizer Covid vaccine trial site to raise deep concerns of patient safety during the process.
In an article entitled “Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial”, the leading medical journal cited revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal Covid-19 vaccine trial and said the evidence “raises questions about data integrity and regulatory oversight”.
The article says for researchers testing Pfizer’s vaccine at several sites in Texas during the autumn of 2020, speed to develop the shot may have come at the cost of data integrity and patient safety.
The BMJ cites information procured from a regional director previously employed at Ventavia Research Group involved in testing Pfizer vaccine. She told the journal 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”.
The staff who conducted quality control checks were overwhelmed by the volume of problems they were finding, the regional director said.
After repeatedly notifying Ventavia of these problems, the whistleblower, Brook Jackson, also emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day.
Jackson provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.
Flagging concerns over FDA inspection, the BMJ article notes that in Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December last year to discuss Pfizer’s application for emergency use authorisation of its vaccine, the company made no mention of problems at the Ventavia site and the next day the FDA issued the authorisation.
Over 400 million doses of Pfizer have been delivered worldwide so far.
- The BMJ cited a regional director previously employed at Ventavia Research Group which conducted trials for Pfizer
- She claimed Pfizer falsified data, unblinded patients and employed inadequately trained vaccinators
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