An employee at a US-based contract research company helping to carry out Pfizer’s pivotal Covid-19 vaccine trial was fired after reporting massive clinical trial violations, according to the British scientific journal The BMJ.

“A regional director who was employed at the research organization 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,” according to the publication.

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

In September 2020, Brook Jackson, the regional director of Ventavia, emailed a complaint to the US Food and Drug Administration (FDA) after repeatedly notifying the company of these problems, but was soon fired.

Jackson provided the BMJ with dozens of internal company documents, photos, video and audio recordings, which convinced the editors that her statements were true.

The British publication, which itself started verifying the information, received more evidence showing that the vaccine trials did not meet the required standards.

Jackson said the problems made the Pfizer executive board apprehensive about the audits by the FDA and other regulatory agencies, resulting in the falsification of data besides some of the information being covered up.

The situation has remained the same after Jackson was dismissed and Pfizer continues to use the company’s services while conducting new vaccine trials, according to the Ventavia Research Group’s employees.

Source: Agencies