The Brook Jackson alert launcher, employed by the company Ventavia to oversee a fraction of the test, denounces serious failures, judged on the contrary minor by the pharmaceutical laboratory.
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The Food and Drug Administration (FDA), the American drug agency, has it ignored the warning launched by Brook Jackson, ex-employee of Ventavia, a subcontractor of Pfizer for a small portion of Phase 3 clinical trial of the Pfizer-Biontech vaccine? This is one of the major questions asked by the testimony of this alert launcher, who declares it to supervise the course of this research, carried out in two of the three sites whose company was in charge.
It denounces failures to the ethical and regulatory frameworks guaranteeing the protection of the participants and the quality of the medical data – of the assertions initially reported in the British Medical Journal (BMJ), November 3 . “It’s been over a year that I’m waiting to tell my story. I was disgusted and disappointed by the FDA because I believed in the process of 100% clinical trials. Now I have the Documentation, e-mails and evidence about the problem in Ventavia and the FDA has done nothing, “says Brook Jackson in the world.
It was employed for fifteen days, in September 2020, by Ventavia, which is a contract research company (Contract Research Organization, Cro), specializing in the conduct of clinical trials, missioned by Pfizer to conduct the test Phase 3 out of 1,000 participants. In total, this test has included 46,331 people, spread over 153 sites around the world. According to his testimony, Brook Jackson has been dismissed after emailing the Food and Drug Administration (FDA) a series of serious dysfunctions, detailed in the article of the BMJ. They concern the quality and registration of the data collected, the safety of Ventavia staff, the follow-up of the participants, the respect of the principle of double blind and that of informed consent. The double blind method is intended in particular to eliminate the biases that would lead the participant or the doctor to adopt a behavior likely to distort the results of the study.
In the case of the VVID-19 vaccine, this could lead participants who received the vaccine to feel protected and neglecting barrier gestures. Neither the investigator nor the participant must therefore know the nature of the product received. However, according to the article of the BMJ, information concerning the attribution of placebo or the vaccine would have been negligently left in the record of the participants, making them accessible to the doctor. Brook Jackson also involves the quality of the data collected. Thus, because of the lack of staff, nasal levies for the virus infection tests would not have been made, while they are necessary for the evaluation of the vaccine.
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