Pfizer’s vaccine trial questioned over data integrity, regulatory oversight

U.S. multinational pharmaceutical corporation Pfizer has come under pressure over alleged data fraud suspicion in its COVID-19 clinical trials, according to British medical journal The BMJ.

A former employee of Texas-based research organization Ventavia Research Group, which managed Pfizer vaccine trial sites, recently raised concerns over Pfizer's data integrity and regulatory oversight, according to the article published in the BMJ, reports BSS.

In the article, the former regional director of Ventavia Research Group revealed that the company "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in its pivotal phase III trial."

Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding, the article added.

Before she blew the whistle to the journal, the former regional director, with more than 15 years of experience in clinical research coordination and management, was fired for repeatedly reporting massive clinical trial violations of the company, including having emailed a complaint to the U.S. Food and Drug Administration.

While verifying her statements and the information provided, The BMJ received more evidence confirming that the vaccine trials did not meet the standards declared by Pfizer, including improper storage of jabs, violations of the norms of blind testing, frequent data errors and slow response to side effects complaints, the article said.