FDA to release Pfizer data but the devil could be in the detail

Jan 7, 2021

Aaron Siri, US attorney acting on behalf of the plaintiff that filed the lawsuit in September 2021, said it was a great win for transparency.

“This removes one of the strangleholds federal health authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program.”

The serious issues cited by Mr Siri included waning immunity of the vaccine, variants that evade vaccine immunity, and the CDC’s assertion that the vaccines do not prevent transmission.

“The government also sought to delay full release of the data it relied upon to license this product until almost every American alive today is dead.  That form of governance is destructive to liberty and antithetical to the openness required in a democratic society,” said Mr Siri.

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Devil in the detail

As the Pfizer documents are released, the FDA will have redacted information that it decides is not for public consumption.

Prof Jefferson says the FDA might redact blocks of important information, to the point where it becomes meaningless, so the devil will be in the detail.

“If the FDA redacts important information like batch numbers, then it will be difficult to identify which participants were potentially harmed or benefited most, by a particular batch of vaccines,” said Prof Jefferson.

“Or they might redact participant’s ID numbers making it hard to track how many adverse events that person experienced because each adverse event would be recorded separately.” 

When asked if there was legal solution to inappropriate redactions made by the FDA, Mr Siri said, “If the FDA make any improper redactions, we intend to challenge those in court.”  

https://maryannedemasi.com/publications/f/fda-to-release-pfizer-data-but-the-devil-could-be-in-the-detail

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