My greatest concerns about the report are inadequate follow-up of people with adverse reactions and not following long established protocols. The greatest violation was the huge number of deaths early in the Pfizer trials.
All previous vaccine trials were stopped when 100-200 people died. There were 1,223 deaths over a 90 day period in the Pfizer trial but the trial continued and the FDA approved the Pfizer jab!
This is a crime against humanity!
Pray justice be done for all vaccine victims and those responsible for these Pfizer deaths indicted
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial,
Revelations of poor practices at a contract research company
Full video https://youtu.be/THv33zWykJc
Pfizer’s pivotal covid-19 vaccine trial, raise questions about data integrity and regulatory oversight
This was the original paper
Pfizer’s chairman and chief executive, Albert Bourla
As I’ve said before, we are operating at the speed of science
Ventavia Research Group
Researchers were testing Pfizer’s vaccine at several sites in Texas
A regional director, Brook Jackson has told The BMJ that the company
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
ICON then highlighted over 100 outstanding queries older than three days
Worries over FDA inspection
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
a booster dose
an RSV vaccine trial