Pfizer Gate is the name given to the controversy around the Pfizer/BioNTech vaccine caused by the publication of an article in the British Medical Journal that questions the "bad practices" of Ventavia, one of the companies responsible for conducting phase III clinical trials of the Pfizer-BioNTech vaccine against Covid-19.
Testimony that questions the integrity of data from clinical trials of the Pfizer vaccine
The Pfizergate case follows an article published on November 2 in the British Medical Journal (BMJ) that questions the integrity of data relating to clinical trials evaluating Pfizer's Covid vaccine. These revelations are based on the testimony of Brook Jackson, former regional director at Ventavia Research Group, one of the subcontractors of the Pfizer laboratory responsible for evaluating the effectiveness of the Comirnaty vaccine against Covid-19. According to her, Ventavia Research Group had committed shortcomings during its tests, "falsified data" and "delayed in monitoring side effects".
What are Brook Jackson's accusations?
The origin of the accusations dates back to September 2020 when Brook Jackson told the BMJ that Ventavia Research Group allegedly falsified data, removed patient anonymity, employed "inadequately trained vaccinators" and "took time" to track adverse events reported in Pfizer's pivotal Phase III trial. After having repeatedly informed the Ventavia group of these problems, the regional director would have sent on September 25, 2020, a complaint to the Food and Drug Administration (FDA) of the United States. On the same day, she was fired by Ventavia.
In his email to the FDA, Brook Jackson accuses Ventavia of a dozen questionable practices she allegedly witnessed. Among her accusations, she recounts, among others:
- Participants were placed in a corridor after injection and not monitored by clinical staff
- Lack of timely follow-up of patients with adverse events
- Unreported protocol deviations
- Vaccines that were not stored at appropriate temperatures
- Mislabeled laboratory samples
- Targeting Ventavia staff to report these types of issues.
According to the BMJ, the former regional director of Ventavia Research Group "provided dozens of internal company documents, photos, audio recordings, and emails." However, the companies Ventavia and Pfizer have not reacted to these revelations.
What are health agencies saying in the face of these accusations?
Faced with the Controversial Pfizergate affair, the FDA refrained from any comment, but assured the newspaper of the Parisian "not being able, for the moment, to comment more on this case" but to have "full confidence in the data that have been used to approve the Pfizer-BioNTech vaccine". As for the European Medicines Agency, it said it "takes very seriously all claims involving the safety and integrity of data" and "works closely with the FDA and international partners" to shed light on these facts.
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