A small group of Pfizer’s Covid vaccine trial researchers may have biased their conclusions, according to an investigation.
A US subcontractor paid to run an arm of the study has been accused of cutting corners, obscuring data and putting patients in harm’s way.
Brook Jackson, a former boss at Ventavia, said the firm did not always test patients with symptoms, which potentially skewed how well the jab performed.
She told a British Medical Journal probe that as well as obscuring data, Ventavia hired underqualified staff as vaccinators and failed to follow-up on side effects.
To support her claims, the whistleblower provided “dozens” of documents and photos from within company.
The BMJ stated that Jackson was confirmed by two other Ventavia workers who wish to keep their identities private.
A contractor based in Texas was responsible to 1,000 participants at 3 sites within the state. This is just 2.3% of all Pfizer phase three trial participants.
However, there is concern that the same problems could have reached other arm of the trial because of the pressure the researchers felt to provide results.
Ventavia has been rehired by Pfizer to continue working on its four additional jab trials, which include for young children, pregnant women and booster doses.
Worldwide, billions of Pfizer dosages were administered and severe adverse reactions have not been reported.
Pfizer may have falsified the study findings of researchers who ran a limited number of its original Covid vaccine trials (file).
Australia’s Medicines Regulator was the first to publicly announce that it had sought further information from Pfizer in response to the investigation.
However, it stated that vaccines are ‘highly secure and efficacious’. This highlighted the fact that this incident is likely to be isolated.
MailOnline has contacted Britain’s drug watchdog — the Medicines and Healthcare products Regulatory Agency — to ask if it is also probing the claims.
Ventavia employed Ms Jackson to manage its clinical trials in September. She is a certified auditor for clinical trials with over 15 years of experience.
The BMJ stated that she became irritated by the problems on these sites, and she documented them on her phone and computer.
One photo, provided to the journal, showed needles discarded in a plastic biohazard bag instead of a sharps container box, breaching infection control rules.
One showed vaccine packaging materials that had participants’ identifications exposed, which revealed who was and wasn’t given the actual vaccine.
In order to prevent bias in research, the researchers need to be “blinded” during the trial. They should also not know who has been given a placebo. According to the BMJ, unblinding might have taken place on a much larger scale.
Ms Jackson said that Ventavia was also not keeping track of the numbers of errors that occurred during the trial.
One secret recording of an executive from the company could be heard saying, “In my mind it’s something that’s new every day.” It is significant, and we are aware of it.
The BMJ stated that the issues existed even though Ms Jackson left the firm. One email contained three names that an executive wanted to “go over the e-diary/falsifying information etc” with.
According to a note, one was verbally counseled about changing data and not noting late entries.
Another document shows that more than 100 patients did not follow up three days or more after receiving their jab. This is despite the fact that guidelines state this must be done in 24 hours.
Two participants reported side effects or severe symptoms after receiving vaccinations.
The protocol stated that the call was made in order to obtain further information and decide if it is appropriate for a site inspection.
Jackson named a total of 12 issues she observed, which included the mislabeling and improper storage of vaccines.
Ventavia was unable to provide sufficient staff to perform a skin test on trial participants with Covid-like symptoms.
While it’s not known how many patients didn’t get tested, FDA reviewed the full trial that Pfizer conducted of 44,000 participants found that samples were not taken from 477 individuals with Covid.
Ms Jackson claims she notified Ventavia repeatedly about the issues during her two-week spell at the firm and eventually lodged a complaint with the FDA on September 25.
Ventavia claimed that allegations against Ventavia were investigated last year and “determined not to be supported”.
Ms. Jackson was fired the next day by her employer, who claimed in her letter of dismissal that she wasn’t a “good fit”.
A former employee of Ventavia told the BMJ Ventavia was nervous about a federal audit. However, one did not come.
They said that they didn’t believe the Ventavia trial results were good data. It is a mad mess.
Following its August approval, the FDA released a summary document containing the results of inspections conducted during the three phase trials.
Ventavia’s site was not among nine of the 153 sites.
MailOnline was informed by a Ventavia spokesperson that Ventavia knew of the recent allegations in an article written and published by Paul Thacker [of the BMJ]
Ventavia was not contacted by Mr Thacker prior to publication. She was only employed for two weeks in September 2020. No part of her job duties related to the clinical trials.
Ventavia informed the relevant parties that these same allegations were made one year earlier.
“The allegations have been investigated and found to not be supported. Ventavia values research compliance and data integrity as well safety of participants. Our support for the development and use of lifesaving vaccines is backed by Ventavia.