A report from a purported "whistleblower" alleging that Pfizer falsified data and failed to promptly pursue reports of adverse events in its COVID-19 vaccine trial raised some eyebrows among vaccine experts.
An article published Wednesday in The BMJ claimed that Texas contractor Ventavia Research Group unblinded patients in the phase III vaccine trial that led to the vaccine's approval and employed inadequately trained vaccinators. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA.
The article said that Ventavia, who Jackson said was selected to quickly ramp up Pfizer's COVID vaccine trial, fired Jackson the same day she complained to the agency.
However, several vaccine experts familiar with COVID vaccine clinical trials questioned the article's accuracy, and advised people not to believe it outright.
"It's all this sort of vague kind of hand waving; I have no idea whether any of this is true, nor do you," Paul Offit, MD, of Children's Hospital of Philadelphia, and a member of the FDA's Vaccines and Related Biological Products Advisory Committee, told MedPage Today.
"That The BMJ published it doesn't make it any more true," Offit, who formerly sat on CDC's Advisory Committee on Immunization Practices, added. "If this whistleblower believes that they have a whistle to blow, then blow it. And then let's have the company respond."
The BMJ article said Jackson, "a trained clinical trial auditor" with...
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