The BMJ’s Damaging Report on Parts of Pfizer’s COVID Vaccine Trial

TrialSite StaffNovember 2, 20219 Comments

A bombshell report written by investigative journalist Paul Thacker in the peer-reviewed The BMJ, calls out Pfizer for poor practices and quality control during its COVID-19 vaccine trials. Brook Jackson, a regional director at Ventavia Research Group, an organization tasked with testing Pfizer’s vaccine at several sites in Texas, reported to The BMJ that the company falsified data, unblinded patients, was slow to follow up on adverse events, and was overwhelmed with quality control issues. Jackson filed a complaint to the FDA but was fired shortly after. Jackson has supplied The BMJ with documents that support her claim, including emails, photos, internal documents, and audio recordings.

Jackson’s Email to the FDA & the FDA Response:

Jackson is not a rookie to clinical research. She is a trained clinical trial auditor with more than 15 years of experience managing clinical trials. In her September letter to the FDA, Jackson listed multiple safety and quality concerns she had witnessed at 3 COVID-19 trial sites under Ventavia’s watch. These include participants not being monitored after receiving injections, lack of follow-up on patients who reported adverse events, devi…paidsubscription