BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635
(Published 02 November 2021)
Cite this as: BMJ 2021;375:n2635
"Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight.
Paul D Thacker reports"
Excerpt:
Poor laboratory management
"On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues."
"Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone."
"One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos."
From Karl Denninger’s thread mentioned by ransomnote:
https://market-ticker.org/akcs-www?post=244109&page=10
129 pages of FDA recalls over past 4 years. It is not a complete list and I didn’t see any (not just covid) vaccine related entries. Various reasons including potency,labeling, microbial contamination, and packaging. One hopes this doesn’t happen but it does ...
https://www.bcbsm.com/content/dam/microsites/medicare/documents/drug-recall-list.pdf