In a recent article in the BMJ, a whistle-blower exposed serious problems she had observed first-hand in the Pfizer vaccine trial in Texas.
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. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided the BMJ with dozens of internal company documents, photos, audio recordings, and emails.
Another Ventavia employee said of the data the company generated for the Pfizer trial: “I don’t think it was good clean data. It’s a crazy mess.”
The six-month trial results for the Pfizer vaccine have now been published in the New England Journal of Medicine. These findings, the researchers note, “contributed to the full approval of BNT162b2 [the Pfizer vaccine] in the United States”. A close inspection of the study, however, reveals a number of problems that raise serious questions about the reliability of its findings, as well as about the safety of the vaccine.
Here is the graph of cumulative incidence for the two trial arms, vaccine and placebo, over the six months of the study period, showing how the symptomatic Covid PCR-positives added up following receipt of the first dose.