The U.S. Department of Justice (DOJ) on March 12 filed a motion to intervene in a lawsuit alleging that Pfizer committed fraud during its COVID-19 vaccine clinical trials to get the court to dismiss the case.
“The United States should not be required to expend resources on a case that is inconsistent with its public health policy,” the DOJ said in its motion to dismiss.
In January 2021, whistleblower Brook Jackson sued Pfizer and two contractors who worked on its COVID-19 vaccine clinical trials: Ventavia Research Group and ICON PLC. Jackson worked as a clinical researcher for Ventavia for a brief period in 2020 before being fired after she filed a complaint with the U.S. Food and Drug Administration (FDA) over alleged improprieties she observed during Pfizer’s vaccine trials.
Investigative journalist Matt Taibbi said a recording of a Ventavia executive showed the executive referring to problems with Pfizer’s vaccine clinical trial as a “cleanup on aisle five,” and the same individual asked Jackson whether she revealed information to outsiders.
This prompted Jackson to contact the BMJ, which published an article in November 2021 based on her evidence showing the research site’s repeated and unresolved issues.
Jackson gave The BMJ a cache of internal company documents, photos, and recordings highlighting Ventavia’s alleged wrongdoing and filed a complaint in the U.S. District Court, Eastern District of Texas, under the False Claims Act. The lawsuit included several charges of fraud and retaliation on the part of both Ventavia and Pfizer.
Jackson, in her complaint, alleged that the defendants violated clinical trial protocols for the Pfizer BioNTech COVID-19 vaccine at three study sites in Texas and that the vaccine maker misrepresented the safety and efficacy of its vaccine to the FDA to obtain Emergency Use Authorization (EUA).
Jackson also accused Ventavia of falsifying data, unblinding patients, employing inadequately trained vaccinators, and failing to follow up on adverse events reported in Pfizer’s crucial phase III clinical trial.
The original and amended complaints were dismissed in April 2023, prompting Jackson to file a second amended complaint in October 2023.
In the second amended complaint, Jackson said Pfizer “knowingly submitted false or fraudulent data to FDA, thereby fraudulently inducing the agency’s issuance of EUA of the Pfizer-BioNTech COVID-19 vaccine and improperly rendering it eligible for subsequent payment by the Government.”
Jackson said Pfizer fraudulently induced the FDA’s issuance of an EUA by failing to disclose violations of its clinical trial protocol and the existence of alternative treatments for COVID-19. Additionally, Jackson alleged flaws in the design, conduct, and analysis used by Pfizer in its vaccine clinical trial.
Oral arguments on whether the DOJ has good cause to intervene and whether Jackson’s second amended complaint should be dismissed are scheduled for April 17 before the U.S. District Court for the Eastern District of Texas Beaumont Division.
“When the DOJ seeks to intervene for the purpose of dismissal, it must be done in good faith, and they must show good cause to do so,” Jackson said in a March 12 post on X.
“Given their actions in this case for the last 3 yrs, 5 mths & 18 days now, it’s impossible to claim to act in good faith or justify allowing Pfizer to commit fraud on the FDA for ANY reason! But here, the DOJ argues their good cause is that they don’t want to expend resources and because Robert Califf, Peter Marks, and a publication in JAMA says the shots are safe!”
In 2020, Ventavia admitted it knew of problems with its clinical trial site and said it would investigate. Yet Pfizer continued to use Ventavia as a subcontractor for at least four other clinical trials. The FDA knew about the allegations against Pfizer and Ventavia but still granted EUA to the Pfizer-BioNTech vaccine for 5—to 11-year-olds. In August 2021, the FDA stated that it inspected only nine of the trial’s 153 sites. None of Ventavia’s sites were included.
