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Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

2 Novembre 2021 by

… the company falsified data, unblinded patients

… emailed a complaint to the US Food and Drug Administration (FDA)

… fired her later the same day

… has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails

… patient safety concerns, and data integrity issues

… recording … wasn’t able to quantify the types and number of errors … for quality control

… “Subject has reported with Severe symptoms/reactions”

… a list of “action items” … “Go over e-diary issue/falsifying data, etc.”

… “verbally counseled for changing data and not noting late entry,” a note indicates

… Participants placed in a hallway after injection and not being monitored by clinical staff

… Lack of timely follow-up of patients who experienced adverse events

… Protocol deviations not being reported

… Vaccines not being stored at proper temperatures

… Mislabelled laboratory specimens

… FDA review memorandum released … not taken from 477 people with suspected cases of symptomatic covid-19