As reported by the British Medical Journal (Bmj), a scientific researcher allegedly denounced problems of strong data integrity in Pfizer’s Covid vaccine trial. Inadequate practices, errors, oversights and mismanagement of the Texas laboratory: this and much more is covered by the revelations by Paul D. Thacker, investigative journalist, using sources of a researcher of the Ventavia Research Group.
“As I said before, we are operating at the speed of science,” he promised in the fall of 2020 CEO of Pfizer, Albert Bourla, in the famous letter addressed to the whole world. Here, according to the mole researcher, “for researchers who were testing Pfizer’s vaccine at several sites in Texas during that fall, the speed may have come at the expense of data integrity and patient safety.” A regional director, Brook Jackson, employed at Ventavia, then always told the BMJ that Pfizer would even “falsified data, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III study. ‘ The documents sent to the FDA and to BMJ himself by the director concern dozens of top secret reports, photos, audio and e-mails: Jackson then explained that he had repeatedly reported to his superiors of the mismanagement of Pfizer vaccine tests, of safety problems. of patients and data integrity issues. Result? No move by the company, hence the researcher’s decision to denounce everything publicly.
EVERYTHING THAT DID NOT WORK IN THE PFIZER TESTS
One photo, provided to the British Medical Journal, showed needles being thrown into a biohazard plastic bag instead of a sharps container box: another showed vaccine packaging materials with trial participants’ identification numbers. written on them left “open”. The Ventavia executives then questioned Jackson for taking the photos: but that’s not all, explains the BMJ again as in a recording at the end of September 2020, between Jackson and two of his superiors, one can hear a Ventavia executive explain that “the company was unable to quantify the types and number of errors found during the examination of the test documents for quality control ‘. The company apparently was not up to date with the data entry requests, as shown by an e-mail sent by ICON, the contract research organization Pfizer collaborated with on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all questions will be addressed within 24 hours.” The company also highlighted in yellow over 100 pending queries older than three days. Among others, two examples included individuals with the following wording: “Subject has reported severe symptoms / reactions… According to the protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if any unscheduled contact has been made and update the corresponding form as appropriate. According to the trial protocol, a telephone contact should have been made to ascertain further details and determine if an on-site visit is clinically indicated ». there all concerns raised, black and white, from Jackson to the FDA in one mail of 25 September 2020: «participants placed in a corridor after injection and not monitored by clinical staff; lack of timely follow-up of patients who experienced adverse events; protocol deviations are not reported; vaccines are not stored at adequate temperatures; Lab specimens mislabeled; Ventavia personnel targeting for reporting these types of problems. The FDA then made it known that it would check later but, to date, there is no news regarding the “Jackson report”Presented, underlines the BMJ. “I don’t think they have been clean data”, the employee allegedly confessed to the data generated by Ventavia for the Pfizer study. crazy mess“. Obviously, a direct reply from the big pharma is expected to understand if these reports have a “clue” of truth or if they are only the result of a huge, gigantic slander.
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