Fate of the Pfizer Whistleblower Case to Be Decided by Federal Judge in Texas

BEAUMONT, Texas—Attorneys for a whistleblower alleging violations occurred during the Pfizer–BioNTech COVID-19 vaccine clinical trial argued in federal court on March 1 that their case should advance to the discovery phase.

Attorneys for the defendants—Pfizer and two subcontractors, Ventavia Research Group and ICON—tried to convince the judge to dismiss the case. If successful, their clients would avoid depositions under oath.

Defense attorneys told the judge Wednesday that whether protocol violations occurred was ultimately irrelevant because the federal government was made aware of them but still granted emergency authorization to Pfizer’s vaccine.

They pointed out that the federal government backed the defendant’s motions, asserting that even if rules were violated, the problems only affected a small number of trial sites.

Lawyers for Brook Jackson, the whistleblower, countered by saying the U.S. Food and Drug Administration (FDA) authorized the vaccine before reviewing the information Jackson provided.

U.S. District Judge Michael Truncale, the Trump appointee overseeing the case, said he would not issue a ruling from the bench, and a decision has not been handed down as of March 2.

Truncale said he did not usually allow oral arguments on motions to dismiss but felt it was necessary for due process in a case that had captured the public’s attention.

Violations
Ventavia ran some of the sites for Pfizer’s COVID-19 vaccine Phase 3 clinical trial. The company didn’t properly report adverse events and failed to keep all participants blinded, according to internal communications revealed by Jackson.

Ventavia and other companies were hired by the clinical research company ICON, which Pfizer hired to oversee trial sites.

Jackson was hired by Ventavia in September 2020. She worked on clinical trials for 18 years and has been described as an expert. She was fired the same day she alerted the U.S. Food and Drug Administration (FDA) of trial irregularities, 18 days after starting the new job.