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.n...

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...

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/clin...

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).