Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial, Revelations of poor practices at a contract research company https://www.bmj.com/content/375/bmj.n2635 Pfizer’s pivotal covid-19 vaccine trial, raise questions about data integrity and regulatory oversight This was the original paper https://www.nejm.org/doi/full/10.1056/nejmoa2034577 Autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla As I’ve said before, we are operating at the speed of science Ventavia Research Group https://www.ventaviaresearch.com Researchers were testing Pfizer’s vaccine at several sites in Texas A regional director, Brook Jackson has told The BMJ that the company falsified data unblinded patients employed inadequately trained vaccinators was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. US Food and Drug Administration (FDA) were informed Ventavia fired her later the same day. The BMJ has been provided with dozens of internal company documents, photos, audio recordings, and emails. She repeatedly informed her superiors poor laboratory management patient safety concerns data integrity issues that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel (later corrected) company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control ICON, the contract research organisation https://www.iconplc.com/services/clinical-research-services/data-management/?creative=528047015643&keyword=small%20clinical%20research%20organizations&matchtype=b&network=g&device=c&campaignid=6471798703&adgroupid=124362508020&feeditemid=54055202224&adposition=&gclid=CjwKCAjwz5iMBhAEEiwAMEAwGB-tlgJ18Rir0V_YfW6YdQNvt33JmuRwwwZiAkL22Zh99BWJbYLb2xoCWKUQAvD_BwE ICON then highlighted over 100 outstanding queries older than three days Worries over FDA inspection Concerns raised 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 Targeting of Ventavia staff for reporting these types of problems. FDA advisory committee meeting held on 10 December 2020 Problems at Ventavia not mentioned The next day the FDA issued the authorisation of the vaccine In August this year, after full FDA approval of Pfizer’s vaccine FDA published that 9 of the trials 153 sites were inspected FDA, full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19 Other employees’ accounts everything that you complained about was spot on Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community I don’t think it was good clean data It’s a crazy mess Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials covid-19 vaccine in children and young adults pregnant women a booster dose an RSV vaccine trial NCT04816643, NCT04754594, NCT04955626, NCT05035212).

• published: 06 Nov 2021
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