Song Hong
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- Ventavia, a subcontractor for Pfizer’s COVID-19 vaccine phase 3 clinical trial, allegedly falsified data, unblinded patients and was slow to follow up on adverse events.
- Brook Jackson reportedly brought these problems up with her superiors – but was fired shortly after she emailed a complaint to the US Food and Drug Administration.
- The FDA didn’t follow up on Jackson’s complaint – and Pfizer, which has known of the problems at Ventavia, has hired the company for four more trials.
The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to the BMJ. She alleges that Ventavia falsified data, “unblinded” patients (that is, researchers could see who was receiving the vaccine and who the placebo), employed inadequately trained vaccinators, and was slow to follow up on adverse events during one of the final trials.
www.bmj.com
theconversation.com
- Brook Jackson reportedly brought these problems up with her superiors – but was fired shortly after she emailed a complaint to the US Food and Drug Administration.
- The FDA didn’t follow up on Jackson’s complaint – and Pfizer, which has known of the problems at Ventavia, has hired the company for four more trials.
The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to the BMJ. She alleges that Ventavia falsified data, “unblinded” patients (that is, researchers could see who was receiving the vaccine and who the placebo), employed inadequately trained vaccinators, and was slow to follow up on adverse events during one of the final trials.
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
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 In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open...
Vaccine trial misconduct allegation – could it damage trust in science?
Pfizer contractor Ventavia denies accusations of scientific misconduct on COVID vaccine trial.
theconversation.com
