In a major blow to the U.S. Food and Drug Administration (FDA), a federal judge on Thursday ordered the agency to produce all data it utilized in approving Pfizer’s COVID vaccine at a rate of 55,000 pages per month — which means all information should be available within eight months.
In ordering the release of the documents, U.S. District Judge, Michael Pittman, recognized the release of Pfizer’s data is of “paramount public importance and should be one of the FDA’s highest priorities. “
“Open government is fundamentally an American issue—it is neither a Republican nor a Democrat issue,” Pittman said. “As James Madison wrote, [a] popular Government, without popular information, or the means of acquiring it, is but a prologue to a farce or a tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be
their own Governors must arm themselves with the power which knowledge gives.”
Quoting John F. Kennedy, Pittman said “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”
As The Vault Project reported on Nov. 18, the FDA asked a federal judge to give it fifty-five years to fully release all of the data and information it relied upon in licensing Pfizer and BioNTech’s COVID vaccine. Some sources reported seventy-five years based on how many documents the FDA said it needed to turn over versus how much the group said should be turned over.
The FDA said there were more than 329,000 pages responsive to Plaintiff’s FOIA request and proposed releasing 500 pages per month. The group found that number unacceptable and said there are more than 400,000 pages of data needed, which could mean it may be 2097 before all the documents are made public.
The FOIA request sought “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System” from the FDA.
The FDA’s request was made in a filing as part of a Freedom of Information Act (FOIA) lawsuit by a medical transparency group made up of doctors and scientists, including Harvey Risch, a professor of epidemiology at the Yale School of Public Health.
Aaron Siri, the lawyer representing the group, said yesterday’s ruling was 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 said no person should ever be coerced into receiving an unwanted medical procedure. “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,” Siri said. “That form of governance is destructive to liberty and antithetical to the openness required in a democratic society.”
Even though the FDA argued releasing 55,000 pages per month would be burdensome, Pittman said releasing the documents should be a high priority for the FDA. Citing the late Sen. John McCain, Pittman said the excessive 55-year dissemination plan “feeds conspiracy theories and reduces the public’s confidence in the government.”
The FDA has not indicated whether or not it intends to appeal the ruling.
A full copy of the order can be read here.