For researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety.
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).
Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.
Read the full investigation:
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
https://www.bmj.com/content/375/bmj.n2635
