FDA Begins Court-ordered Release of Comirnaty Data

03.03.2022 - Under order from a US federal judge in Texas, the US Food and Drug Administration (FDA) on Mar. 1 began publishing information relating to Pfizer’s application for approval of the Covid-19 vaccine it developed together with Germany’s BioNTech.

Judge Mark Pittman late last year ordered the papers to be published on the FDA website in reaction to a Freedom of Information Act (FOIA) filing in September 2021 by a group of more than 30 doctors and scientists opposed to Covid vaccine mandates.

The request by the group calling itself Public Health and Medical Professionals for Transparency covers 329,000 pages that the FDA said had to be processed and redacted before release. Initially, the agency had agreed to release 500 pages per month, but this timetable was rejected by the court on grounds the job would not be completed before 2076.

Current release rate mandated for release of the documents is 55,000 pages per month, which the FDA said would require hiring a team of 15 specialists and cost around $3 million of taxpayers’ money. Quoting the agency, the US trade journal Endpoints said the office charged with processing the request only has 10 employees and already is fielding some 400 outstanding bids for information.

Rather than 55 years, the process of releasing the documents is now expected to take about eight months, if the health watchdog can keep up the pace. In ordering the faster rate of release, Pittman said the case was “of paramount public importance.”

One of the attorneys for the transparency group, Aaron Siri of New York-based law firm Siri & Glimstad, has maintained that it is necessary to release all information relating to Pfizer/ BioNTech’s Comirnaty vaccine as the US government “wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead.”

Siri is seen as an especially vocal critic of vaccine mandates such as the one US president Joe Biden has been seeking for businesses with more than 500 employees that is still being held up in court.

Much of the information published is “typical for any drug or vaccine application,” experts told Endpoints. One that is being labeled as a priority review request is said to contain more than 100 pages of anonymous safety-related tables of data, while another contains a table of unidentified participants’ gender, age and body mass index.

Some of the information regarded as typical includes the nearly $2.9 million user fee payment to the FDA from Pfizer. Other documents, however, are said to include information not normally released. This pertains to the fast-track designation letter, the agency’s confidential nonclinical overview for the vaccine, Pfizer’s request for a waiver from adding a suffix to the vaccine’s name and a long list of anonymized trial subjects who didn’t receive the vaccine as randomized.

Some who evaluated the first FDA releases said it was unclear what message the filing group could put together as the documents are being published in unorganized form without any explanation as to what they show. Speaking to Endpoints, Siri said, “our job was to get the documents. We leave it to the scientists and others to analyze.”

Author: Dede Williams, Freelance Journalist