Judge Orders FDA To Expedite Release Of Pfizer Data On COVID-19 Vaccine: ‘Paramount Public Importance’

A federal judge in Texas ordered the Food and Drug Administration (FDA) to expedite the release of hundreds of thousands of pages of documents on the Pfizer vaccine, rejecting a request by the federal government to tranche out the data over the next 75 years.

U.S. District Judge Mark Pittman of the U.S. District Court for the Northern District of Texas ruled on Thursday that the FDA must release all data submitted by Pfizer for its application for its COVID-19 vaccine’s emergency use at a pace of 55,000 pages a month. The FDA had requested that it be allowed to put out the data at a far lower pace of 500 pages per month.

Pittman’s ruling comes as a result of a Freedom of Information Act (FOIA) Request filed by Public Health and Medical Professionals for Transparency, a group formed to make public the data used by the FDA to grant emergency approvals for COVID-19 vaccines. Attorney Aaron Siri, who represented the group in court over the FOIA request, celebrated the ruling in a piece on Substack.

“This is a great win for transparency and 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 – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission,” Siri wrote.

“No person should ever be coerced to engage in an unwanted medical procedure,” he continued. “And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also 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. That form of governance is destructive to liberty and antithetical to the openness required in a democratic society.”

Pittman’s ruling states that the FDA must turn over 12,000 pages of documents by the end of January, then 55,000 pages every 30 days until the entirety, omitting redacted portions, of the data submitted by Pfizer has been released. The judge rejected the FDA’s request for a slower release schedule citing the “paramount public importance” of the vaccine data. Pittman wrote in part:

Here, the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA. See generally ECF Nos. 23, 30, 34. But, as expressed at the scheduling conference, there may not be a “more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . .” ECF No. 34 at 46. Accordingly, the Court concludes that this FOIA request is of paramount public importance.

“[S]tale information is of little value.” Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism, therefore concludes that the expeditious completion of Plaintiff’s request is not only practicable, but necessary. See Bloomberg, L.P. v. FDA, 500 F. Supp. 2d 371, 378 (S.D.N.Y. Aug. 15, 2007) (“[I]t is the compelling need for such public understanding that drives the urgency of the request.”). To that end, the Court further concludes that the production rate, as detailed below, appropriately balances the need for unprecedented urgency in processing this request with the FDA’s concerns regarding the burdens of production. See Halpern v. FBI, 181 F.3d 279, 284–85 (2nd Cir. 1991) (“[FOIA] emphasizes a preference for the fullest possible agency disclosure of such information consistent with a responsible balancing of competing concerns . . . .”).

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