Report of Problems With Pfizer COVID-19 Vaccine Trial Being Investigated: Contract Company

The alleged problems with a large objective proceedings examining Pfizer’s COVID-19 vaccine proceedings are being probed, a declaration institution progressive successful the probe has confirmed.

Ventavia Research Group operated respective of the proceedings sites successful the autumn of 2020. Brook Jackson worked for the institution during this time. She told the British Medical Journal (BMJ) that the proceedings 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 wrong hours of doing so.

Ventavia confirmed to The Epoch Times that it employed Jackson for 2 weeks past year.

Lauren Foreman, manager of concern improvement and communications, said successful an email that Ventavia is investigating the allegations from Jackson.

“Ventavia takes probe compliance, information integrity, and subordinate information precise earnestly and stands down its important enactment supporting the improvement of lifesaving vaccines and is conducting its probe accordingly,” she said.

The FDA appeared to corroborate it was alert of the matter.

“Although the bureau cannot remark further astatine this clip successful this ongoing matter, FDA has afloat assurance successful the information that were utilized to enactment the Pfizer-BioNTech COVID-19 vaccine authorization and the Comirnaty approval,” a spokeswoman told The Epoch Times successful an email.

Ventavia worked connected the proceedings that led to exigency usage authorization (EUA) for Pfizer’s jab. The FDA aboriginal approved the shot, though galore oregon each of the doses being administered successful the United States continue to be the EUA-version.

Pfizer did not instantly respond to a petition for comment.

Jackson, who worked with objective trials for implicit 15 years, told the BMJ she repeatedly raised concerns with her superiors astir what she was witnessing, including diligent information concerns. She began to consciousness her reports were being ignored and began taking photographs utilizing her phone. One photograph seemingly showed that needles were discarded successful a integrative container alternatively of a box, portion different was said to person showed packaging materials that revealed proceedings participants’ recognition numbers, signaling they whitethorn person been unblinded.

Jackson listed 12 concerns she had successful a Sept. 25 connection to the FDA, including participants not being monitored aft receiving an injection and vaccines not being stored astatine due temperatures. She besides alleged that Ventavia unit members were targeted by higher-ups for reporting problems.

Jackson said the FDA sent her an email acknowledging receipt of the database and she received a telephone from an FDA inspector, but has heard thing from the bureau since then.

The Epoch Times has submitted a Freedom of Information Act petition concerning Jackson’s email to the FDA and interior communications from the bureau regarding the message.

The FDA said successful August it inspected 9 of the trial’s 153 sites. None of Ventavia’s sites were inspected.

The inspections were constricted “because the survey was ongoing, and the information required for verification and examination were not yet disposable to the IND [investigational caller drug],” an FDA serviceman wrote successful a summary of the inspections.

Some pharmaceutical companies person seen inspections waived oregon FDA officials deciding to behaviour an inspection remotely, Philip Crooker, method vice president of Paraexel, told a forum successful December 2020. Inspections of home sites plunged from 13,001 successful 2019 to 6,574 successful 2020, according to FDA data.