番茄社区

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 in The BMJ claimed that Texas contractor 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 番茄社区.

"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 15 years of experience, "has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails," some of which document poor laboratory management.

"One photo showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants," the article said.

Another prominent vaccine expert, who asked not to be quoted by name, said that many of the issues alleged by the article's main source "are things you wouldn't want to see happen, like needles and syringes and things discarded in bags. But that doesn't have to do with data integrity.

"There's a lot of stuff in there that really doesn't speak to whether the [Pfizer vaccine trial] data were recorded correctly."

The expert acknowledged that in the earliest days, there was a rush to get trials up and running with different companies in various locations around the country.

Asked for a response, Ventavia spokeswoman Lauren Foreman objected to The BMJ article, written by investigative journalist Paul Thacker. She said Thacker's article did not include any of the evidence the accuser claims she had, and that he did not contact Ventavia for a response before publishing. (Attempts to reach Thacker were unsuccessful.)

"There's more to this," she said. "We have an attorney we're working with. And this is due to the sensitivity of this issue."

Foreman said the "accuser" Jackson was employed "for approximately 2 weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue."

After this article was published, Jackson reached out to 番茄社区, providing a copy of an email showing that she had been hired by Ventavia to be a regional director for the company and would be involved with two sites for the trial.

Foreman also said Jackson's accusations "were made a year ago, at which time Ventavia notified the appropriate parties. The allegations were investigated and determined to be unsubstantiated.

"Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines," Foreman continued.

Foreman said that Ventavia has just under 100 employees and has been conducting clinical trial research since 2013.

In a statement, Pfizer said it was "disappointed by the recent article published by the British Medical Journal that failed to contact us prior to publication and selectively reported certain claims with the goal of undermining confidence in a vaccine that has been given to hundreds of millions of people worldwide."

Asked whether the FDA is investigating the matter, a spokeswoman for the FDA said in an e-mail, "Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval."

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