Health

Researchers testing the safety of Pfizer’s Covid-10 vaccine before its worldwide launch had falsified data and hidden some of the worst cases of adverse reactions.

A whistleblower at one of the test centres was fired the same day she alerted the US’s drug regulator, the Food and Drug Administration (FDA), to the bad practices that were hiding data on the vaccine’s dangers.

Brook Jackson, a regional director at Ventavia Research Group, a test centre used by Pfizer, has now voiced her concerns to the press to reveal the company falsified data, ‘unblinded’ patients who until then had not known whether they had received the vaccine or a placebo, and was slow to follow up on adverse reactions to the vaccine.

In short, poor safety trials underpinned one of the world’s largest ever vaccine roll-out programmes—and people were told the vaccine was safe when there was insufficient evidence to support the claim.

In her testament to the BMJ, Jackson said Ventavia’s staff overseeing quality control were overwhelmed by the number of problems they faced, and she secretly recorded their concerns in September 2020, just a few months before the vaccine’s launch.  In the conversation, a director said: “In my mind, it’s something new every day.  We know that it’s significant.”

Several of the thousand participants Ventavia had recruited reported “severe symptoms or reactions” to the vaccine, although the cases were not followed up.

Frustrated by the mismanagement of the trial, Jackson reported her concerns to the FDA in September, 2020, and was fired later that day.  Jackson had more than 15 years’ experience in clinical research.

An FDA official phoned her a few days later and told her the agency couldn’t supply any further information into any ongoing investigation into her claims.  The vaccine was approved in December and no mention about any concerns about its safety were mentioned.

Last August, the FDA revealed the nine research sites it had visited during the safety trial period, and none of Ventavia’s centres were among them.

Since making her claims, several other former Ventavia employees have come forward to support Jackson.  One told the BMJ: “I’ve never had to do what they were asking me to do, ever.  It just seemed like something a little different from normal—the things that were allowed and expected.”
(Source: BMJ, 2021; 375: n2635)

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