Pfizer COVID vaccine WHISTLEBLOWER: 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.
Brook Jackson, a regional director employed at the research organization Ventavia Research Group (the largest privately-owned clinical research company in Texas), was testing Pfizer’s vaccine when she was faced with an overwhelming amount of quality control issues. She repeatedly notified Ventavia of the problems with no resolution of issues, so she progressed to calling and emailing a complaint to the FDA. She submitted her complaints to the FDA on September 25, 2020, Ventavia fired her later the same day, claiming she was “not a good fit”. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails such as the ones she sent to the FDA. In her FDA email, she explains how she enrolled more than 1,000 participants at three sites, with the full trial (registered under NCT04368728) enrolling around 44, 000 participants across 153 sites. Following, she listed out a dozen concerns she witnessed firsthand, including:
• Participants placed in a hallway after injection and not being monitored by clinical staff • Lack of timely follow-up of patients who experienced ADVERSE events • Protocol deviations not being reported • Vaccines not being stored at proper temperatures • Mislabelled laboratory specimens, and • Targeting of Ventavia staff for reporting these types of problems.
The FDA did email and call Ms. Jackson back, but to no surprise, nothing came of this exchange.
On December 10, 2020, an FDA advisory committee meeting was held to discuss Pfizer’s application for emergency use authorization. Pfizer’s submitted briefing documents did not mention the problems that had occurred at the Ventavia site. The following day, the FDA issued the authorization of the Pfizer vaccine.
Just this August, the FDA release that only nine of the 153 testing sites were inspected and Ventavia’s sites were not included in those nine. Now, you may be thinking, this is just one person making a complaint so these sites shouldn’t necessarily be targeted. WRONG. Two other whistleblowers that worked with Ms. Jackson came forward anonymously. One of these whistleblowers told The BMJ “In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint.” She also added “I don’t think it was good clean data” and “It’s a crazy mess.”
Despite all this, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212)...
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