As soon as you think that you’ve already heard all of the irregularities concerning the COVID-19 vaccine manufactured by Pfizer, another one surfaces out of the blue. But then, things get even more bizarre.
Besides being reported to contain questionable ingredients and being forcibly administered to a village of more than 140,000 residents in Brazil’s municipality of Toledo, a whistleblower recently revealed to the BMJ Medical Journal that the data gathered during Pfizer’s COVID-19 vaccine trial in the fall of 2020 mainly was “a crazy mess.”
Brook Jackson, who used to work as a regional director for a private clinical research firm, disclosed that Pfizer contracted her former company, the Ventavia Research Group of Texas, to conduct clinical trials for its COVID-19 vaccine in September last year. However, in the short time that she was connected to Ventavia, Jackson noticed several significant irregularities in the conduct of the said clinical trial.
Jackson, a seasoned clinical trial auditor with nearly two decades’ worth of experience in clinical research coordination and management, immediately notified her supervisors about the irregularities, particularly concerning the “blinding” quality control aspect of the study.
“Blinding” is the component of a clinical trial that ensures the placebo remains unknown and prevents bias in the collection of data from the study’s participants. Jackson’s most notable observation is that “vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.”
Apart from the breach in the blinding component of the trial, Jackson also spotted issues in protocol deviations not being reported, vaccines not being stored at proper temperatures, lack of timely follow-up of patients who experienced adverse events and mislabeled laboratory specimens, among others.
However, her emails regarding the irregularities remained unanswered by her superiors. Fearing that these issues will have disastrous effects in the future, she alerted the U.S. Food and Drug Administration (FDA) on September 25, 2020, to prevent them from happening. Jackson was subsequently sacked from her job later in the day after sending her email to the FDA.
BMJ’s Paul D. Thacker related that they have several emails, audio recordings, photos, and internal company documents forwarded by Jackson that reinforce her claims against Ventavia.
Moreover, Thacker also stressed that while Jackson’s exposé is already alarming, they believe that the “unblinding” committed by Ventavia and Pfizer may be on a much larger scale. This belief is not unfounded because they have proof that “drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel.”
Both Pfizer and Ventavia Research Group of Texas still hasn’t given their comment on Jackson’s revelations.