Pfizer research center whistleblower calls data reliability into question

How serious are the allegations that some are already referring to as “Pfizergate”?

Writing for The British Medical Journal, Paul D. Thacker has brought to light what are at the very least unprofessional practices at one research center testing Pfizer’s COVID “vaccine.” For its part, the Ventavia Research Group took the allegations seriously enough to fire the employee who tried to draw attention to them; Brook Jackson ultimately took her trove of internal company documents, photos, audio recordings, and emails to The BMJ.

The allegations date back to September, 2020, when Jackson was hired as Ventavia’s regional director. Jackson came with over 15 years of experience in research coordination and management, and she was looking forward to being part of Ventavia’s trials of the new Pfizer-BioNTech mRNA vaccine. Ventavia was then operating three different sites where Pfizer’s vaccine was being studied, with around a thousand trial participants enrolled out of a total of 44,000 world-wide.

At this point, the vaccine had reached Phase III of its trial, the last stage before applying to the FDA for authorization (emergency use authorization, in this case). But even the speed at which the vaccine had moved through the various study phases and the alleged urgency of getting a vaccine, even any vaccine out there to combat the pandemic, didn’t justify, to Jackson’s mind, the corner-cutting and plain bad science that she saw going on at Ventavia.

Jackson described a long list of what she called “unsound practices,” including trial participants being placed in a hallway after injection rather than being monitored by clinical staff; vaccine phials not being stored at proper temperatures; mislabeled lab specimens; protocol deviations not being reported.

More seriously, the double-blinding of the study was jeopardized on numerous occasions, with printouts including participants’ drug regimens left lying around. Jackson also discovered that follow-up on trial volunteers experiencing adverse events, even “severe” ones, was far slower than it should have been.

An email from ICON, a research organization Pfizer partnered with in the trial, sent to Ventavia, stipulated that, “The expectation for this study is that all queries are addressed within 24 hours,” and highlighted in yellow over one hundred queries over three days old, including at least two cases of severe adverse reactions: “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted…”

Other documents shown to The BMJ reveal that at least three site staff members were known to have falsified data; one of them was “verbally counseled for changing data and not noting late entry.”

Later on, after Jackson went public with what she’d seen, another former Ventavia employee revealed that due to understaffing, not all trial participants who reported COVID-like symptoms had been tested for coronavirus. Thacker notes that the FDA knew that this was an issue (though not specifically at Ventavia) when it reviewed Pfizer’s vaccine; a memorandum from August 2021 mentions that 477 people with suspected Covid-19 weren’t swabbed during Phase III trials.

Given that Pfizer’s results stated that: “162 COVID cases were observed in the placebo group versus 8 in the vaccine group,” this is a stunning admission.

Jackson didn’t immediately run to the FDA to complain about what she found. She tried to correct things at source, repeatedly, to no avail. Only then did she email a complaint to the FDA, detailing the issues she found disturbing. That very afternoon, Ventavia fired her.

It emerged later that Jackson wasn’t the only staffer to complain about unsound practices, nor the only one to suffer the consequences. Other whistleblowers who have preferred to remain anonymous described how Ventavia staff who reported issues were “targeted.” Thacker notes that in the “tightly knit research community,” it’s not a simple matter to stick one’s neck out. And given that the response from the FDA, when it came, was so patently inadequate, researchers might be forgiven for not even trying in the first place.

The FDA did respond to Jackson’s email, actually within hours. Jackson got an email thanking her for her letter and informing her that the FDA “could not comment” on any investigation that might result. No investigation did result.

Ventavia officials were anxious about a possible FDA audit, Jackson noted, but one never came. In August, 2021, after fully approving Pfizer BioNTech’s vaccine, the FDA published a summary of its inspections of the trial sites. There had been 153 sites and 9 were inspected. Ventavia’s three sites were somehow overlooked.

Since then, Pfizer has been continuing to test vaccines and other drugs at sites all over the world – including those managed by Ventavia. In fact, Ventavia is currently engaged in four different vaccine trials: COVID vaccine for children, for young adults, for pregnant women, and for booster doses.

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