The alleged problems with a major clinical trial examining Pfizer’s COVID-19 vaccine trial are being probed, a contract company involved in the research has confirmed.
Ventavia Research Group operated several of the trial sites in the fall of 2020. Brook Jackson worked for the company during this time. She told the British Medical Journal (BMJ) that the trial was riddled with issues, including the falsification of data.
Jackson said she alerted the Food and Drug Administration (FDA) to the problems she witnessed and was fired within hours of doing so.
Ventavia confirmed to The Epoch Times that it employed Jackson for two weeks last year.
Lauren Foreman, director of business development and communications, said in an email that Ventavia is investigating the allegations from Jackson.
“Ventavia takes research compliance, data integrity, and participant safety very seriously and stands behind its important work supporting the development of lifesaving vaccines and is conducting its investigation accordingly,” she said.
The FDA appeared to confirm it was aware of the matter.
“Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 vaccine authorization and the Comirnaty approval,” a spokeswoman told The Epoch Times in an email.
Ventavia worked on the trial that led to emergency use authorization (EUA) for Pfizer’s jab. The FDA later approved the shot, though many or all of the doses being administered in the United States continue to be the EUA-version.
Pfizer did not immediately respond to a request for comment.
Jackson, who worked with clinical trials for over 15 years, told the BMJ she repeatedly raised concerns with her superiors about what she was witnessing, including patient safety concerns. She began to feel her reports were being ignored and began taking photographs using her phone. One photograph apparently showed that needles were discarded in a plastic bag instead of a box, while another was said to have showed packaging materials that revealed trial participants’ identification numbers, signaling they may have been unblinded.
Jackson listed 12 concerns she had in a Sept. 25 message to the FDA, including participants not being monitored after receiving an injection and vaccines not being stored at proper temperatures. She also alleged that Ventavia staff members were targeted by higher-ups for reporting problems.
Jackson said the FDA sent her an email acknowledging receipt of the list and she received a call from an FDA inspector, but has heard nothing from the agency since then.
The Epoch Times has submitted a Freedom of Information Act request concerning Jackson’s email to the FDA and internal communications from the agency regarding the message.
The FDA said in August it inspected nine of the trial’s 153 sites. None of Ventavia’s sites were inspected.
The inspections were limited “because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug],” an FDA officer wrote in a summary of the inspections.
Some pharmaceutical companies have seen inspections waived or FDA officials deciding to conduct an inspection remotely, Philip Crooker, technical vice president of Paraexel, told a forum in December 2020. Inspections of domestic sites plunged from 13,001 in 2019 to 6,574 in 2020, according to FDA data.