Former Pfizer-BioNTech coronavirus vaccine clinical trial participant Brooke Jackson has alleged scandalous irregularities and tampering that took place during Ventavia Research Group's trials of the medicine.
Brooke Jackson is the former Regional Director of Ventavia. She has more than 15 years' experience in managing clinical trials for medicines.
According to Jackson, she repeatedly asked the company's head office to end with the numerous irregularities and adulterations that took place during the vaccine trial. She was suspended from research because of her unwillingness to turn a blind eye to what was going on at the company. In September 2020, she was fired for filing a complaint with the Food and Drug Administration (FDA).
Brooke Jackson has told BMJ journalists that the staff who carried out the research and vaccination were not sufficiently qualified for such activities, and the team improperly monitored the side effects. She published dozens of internal company documents, including photographs, videos and audio recordings. Jackson also provided emails. All of these documents have been verified and proved gross violations by the research team. The management of Ventavia Research Group also concealed these irregularities.
For example, the photos show that used needles are disposed of in a plastic bag for biological waste, rather than in a separate container for the sharp objects. Vaccine packs had participant numbers written on them. So, participants were able to know whether they were being given the vaccine or a placebo. In addition, Jackson provided documentation showing that the prescription of the drug or placebo was written on the participants' cards.
Brooke Jackson also provided journalists with an email from the research company ICON (a Pfizer partner) to Ventavia. In this letter, ICON reminds Ventavia staff to respond promptly to any feedback from trial participants within the first 24 hours of administering the drug. However, about 100 unchecked requests older than three days were then highlighted in the email.
According to Jackson, participants did not receive proper medical supervision after they were injected, and that patients with adverse reactions were not watched in time. Moreover, the vaccine was kept at the wrong temperature.
The BMJ also questioned two other Ventavia employees, but they also reported all the irregularities. One the participants said she had never seen such gross mistakes in Ventavia during a Pfizer vaccine trial, even though she had previously been involved in more than 40 clinical trials.
During an independent investigation by BMJ staff, it was found that the test results had been falsified constantly. Much valuable information was concealed, and the identities of the volunteers were made public. The fact that Ventavia representatives turned a blind eye to numerous patient complaints about serious side-effects during the trials and did not act promptly on the nature of the health complications also seems strange.
Accordingly, the Pfizer-BioNTech vaccine, which is approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use in the US and EU countries, has not been properly tested for quality, safety and efficacy. Trials of the vaccine failed to meet the standards and regulations that Pfizer executives have consistently reported to the media. At the same time, under-explored drug is actively used in most countries of the world. In May, the US approved the vaccine for adolescents over the age of 12, and on November 3 it was approved for children aged 5 to 11.
