A Texas federal judge has ordered the U.S. Food and Drug Administration (FDA) to significantly accelerate its release of Covid vaccine trial data.
The FDA previously had the records sealed by the courts and wanted to keep the data hidden from the public for 23.5 years.
However, President Donald Trump-appointed U.S. District Judge Mark Pittman just dropped the hammer on the FDA and ordered the federal agency to release the data within two years.
The sealed records contain the data that the FDA relied on to quickly license COVID-19 vaccines for public use.
The data is from Moderna’s vaccine trials for adults and Pfizer’s for children.
Judge Pittman’s ruling now requires all documents to be made public by mid-2025 rather than before the end of 2046, as the FDA wanted.
The decision has been hailed as a huge victory for transparency by the lawyer representing the plaintiffs in a lawsuit against the FDA.
The lawsuit was brought by the parents of a child injured by a Covid shot.
“Democracy dies behind closed doors,” is how Pittman opened his order, issued on May 9.
The requires that the FDA must now produce the data on Moderna’s and Pfizer’s Covid vaccines at an average rate of at least 180,000 pages per month to meet the mid-2025 deadline.
The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.
Aaron Siri of Siri & Glimstad, who represents the plaintiffs in the legal action against the FDA, called the decision “another blow for transparency and accountability” that builds on an earlier court order targeting Pfizer’s COVID-19 vaccine data for those aged 16 and older.
The January 2022 order, also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.
“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.
The latest order requires the FDA to produce all of its data on Pfizer’s Covid shot for 12- to 15-year-olds and Moderna’s vaccine for adults by June 31, 2025.
While the judge noted in his order that the court recognizes the FDA’s limited resources dedicated to freedom of information requests (FOIA), he argued that “the number of resources an agency dedicates to such requests does not dictate the bounds of an individual’s FOIA rights.”
“Instead, the Court must ensure that the fullest possible disclosure of the information sought is timely provided—as ‘stale information is of little value,’” Pittman wrote.
In order to ensure the FDA can meet the accelerated deadline, the judge ordered the parties to the lawsuit to confer and submit a joint production schedule for the data by May 23, 2023.
In the earlier case adjudicated by Pittman, the FDA had argued it only had the bandwidth to review and release around 500 pages per month of an estimated total of 450,000 pages of material about the Pfizer COVID-19 vaccine for those aged 16 and older.
The FDA has not disputed in either case that it has an obligation to make the information public but it has argued that its short-staffed FOIA office could not meet the pace of production sought by the plaintiffs.
The judge disagreed, however, arguing in both cases that the imperatives of transparency and accountability are of paramount importance.
In the January order, Pittman said that too much foot-dragging and secrecy on the part of federal agencies is fueling a public backlash that reduces the American people’s trust in government.
Confidence in the FDA over Covid jabs approvals was shaken by the disclosure that regulators sped up the approval of Pfizer’s vaccine.
In March, Republicans on the House Select Subcommittee on the Coronavirus Pandemic announced they were seeking answers after recently released emails indicated that the FDA rushed the approval of Covid shots and boosters to accommodate vaccine mandates.
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