Judge Orders FDA to Release Vaccine Data Rapidly

Beginning March 1, the U.S. Food and Drug Administration (FDA) will be required by a federal court to disclose 55,000 documents each month of the filings it relied on to license the Pfizer COVID-19 vaccine.

U.S. District Judge Mark Pittman of the Northern District of Texas ordered the FDA to produce 12,000 documents by the end of January and the rest of the 450,000 documents of documents within months instead of the 500 pages per month the FDA requested—which could have taken 75 years to complete—on January 6.

The nonprofit Public Health and Medical Professionals for Transparency filed the Freedom of Information Act (FOIA) lawsuit on September 16.

In his ruling, Pittman wrote, “… this FOIA request is of paramount public importance.” Pittman cited the decision in Payne Enterprises, Inc. v. United States, in which a three-judge panel of the D.C. Circuit Court of Appeals ruled “… [S]tale information is of little value…”

“The Court, agreeing with this truism, therefore concludes that the expeditious completion of Plaintiff’s request is not only practicable, but necessary,” wrote Pittman.

‘Access to the Data’

Pittman’s ruling comports with standards of transparency and accountability says Adam Siri, managing partner of Siri & Glimstad LLP, who represented Public Health and Medical Professionals for Transparency in the case.

“We are very pleased with the decision, which came down on the side of transparency and accountability,” said Siri.

“Americans are mandated to receive this product and cannot sue Pfizer for harm it may cause, so we are pleased that at least the public and independent scientists will have access to the data underlying its licensure,” said Siri. “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.”

‘Experiment on an Unsuspecting Public’

The FDA issued an emergency use authorization (EUA) for the Pfizer vaccine in 2020, but formally approved the shots on August 23, 2021, in a  process that was truncated, says Elizabeth Lee Vliet, M.D., president and CEO of the Truth for Health Foundation.

“Never in the history of the FDA has a brand-new technology for a novel medical intervention been approved with only three months of safety data when known long-term risks of this technology have been reported for more than a decade in the pharmaceutical research,” said Vliet.

Vaccine approval usually requires years of clinical trials, says Vliet.

“Traditional vaccines, which the COVID shots are not, have always had a minimum two years safety data and up to seven years safety testing before release,” said Vliet. “In addition, the mRNA- and DNA-based experimental shots for COVID are correctly classified under FDA regulations as ‘gene therapy agents,’ [for] which FDA regulations require 5 to 15 years [of] ongoing safety trials.”

“This unconscionable rapid approval has unleashed a vast human experiment on an unsuspecting public,” Vliet said. “Practicing physicians are seeing major complications and deaths in patients of all age groups as a result of these premature approvals.”

Mandates ‘Violated This Basic Liberty’

COVID-19 vaccine mandates violate the rights of individuals, says Siri. Further, the FDA’s attempt to withhold the data on which it based its approval denies the full disclosure necessary for informed consent, says Siri.

“No person should ever be coerced to engage in an unwanted medical procedure,” Siri said. “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.”

Troubling FDA Appointment

President Joe Biden nominated Robert Califf, who previously held the post in the Obama administration, as commissioner of the FDA, in November.

Califf’s appointment was approved by the Senate Committee on Health, Education, Labor, and Pensions on January 13, but he faces bipartisan opposition in the U.S. Senate.

The apparent ongoing collusion between the pharmaceutical industry and regulatory agencies to suppress alternative opinions on COVID raises concerns about Califf’s nomination, states Vliet in a press release.

“It is beyond alarming that private tech behemoths like Google, where Dr. Califf served as a senior executive at its Verily life sciences arm, are censoring the free flow of medical information from world-class academic physicians and scientists, as well as practicing physicians who have a legal and ethical duty to inform patients of risks of therapies they prescribe,” said Vliet. “It is entirely another matter for government to actively violate First Amendment free speech guarantees in censoring discourse and dissent, the cornerstone of scientific inquiry.”

Kevin Stone (kevin.s.stone@gmail.com) writes from Arlington, Texas.