Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial.
Revelations of poor practices at a contract research company raise questions about data integrity and regulatory oversight. 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
- 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
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