FDA must hit the gas on FOIA request tied to Pfizer's COVID-19 vaccine, judge orders

FDA Building
In November, the Justice Department, which represented the FDA in the litigation, argued the regulator didn’t have the staff or resources to meet the plaintiff’s original deadline of March 3, 2022. (FDA)

Rather than 75 years, it will now take about eight months for the FDA to make public the information it used to license Pfizer and BioNTech’s COVID-19 vaccine—provided the regulator can keep up with the new schedule.

U.S. district judge Mark Pittman on Thursday ordered the FDA to produce all remaining data on the vaccine at a rate of 55,000 pages per month, much faster than the 500-page-per month quota the FDA proposed in November.

Additionally, the FDA must hand over more than 12,000 pages articulated in its own proposal by January 31 at the latest, Pittman said in court documents filed this week.

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Alongside plaintiff Public Health and Medical Professionals for Transparency, the FDA will be required to submit joint status reports on the progress of the Freedom of Information Act (FOIA) request every 90 days, starting on April 1.

The court acknowledged the “unduly burdensome” challenge the speedy FOIA request poses for the FDA, Pittman said but argued that there “may not be” a more important issue at the agency right now than the pandemic, Pfizer’s shot, vaccinating every American and making sure that the public is convinced the process wasn’t rushed.

“[T]he expeditious completion of Plaintiff’s request is not only practicable but necessary,” Pittman continued in his order.

In November, the Justice Department, which represented the FDA in the litigation, argued the regulator didn’t have the staff or resources to meet the plaintiff’s original deadline of March 3, 2022. To hit that target, the FDA would have needed to process some 80,000 pages a month. The plaintiffs have requested some 450,000 pages of material on the vaccine, Reuters reports. 

The branch that would be in charge of processing the plaintiffs' FOIA request only has 10 employees and is already saddled with about 400 outstanding bids for information, lawyers for the defense said last year.

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So why do the plaintiffs, made up of doctors, scientists and professors, want the information on Pfizer's shot, Comirnaty? To hear representing lawyer Aaron Siri of Siri and Glimstad tell it, independent scientists need those data "to offer solutions and address serious issues with the current vaccine program." Those serious issues include waning immunity, evasive variants and the shots’ inability to prevent transmission, Siri said. Siri has come out strong against vaccine mandates in the past.

Last February, he penned an op-ed for STAT News arguing against employer vaccine mandates while the vaccine remained under an emergency use authorization.

Later in 2021, the FDA rejected Siri’s request to revoke the EUAs given to Moderna and J&J’s vaccines, Endpoints News reported. He asked that the emergency nods be taken away in light of the full approval of Pfizer-BioNTech’s vaccine.

No one should be coerced into an unwanted medical procedure, Siri argued in his emailed statement. 

“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,” Siri continued. “That form of governance is destructive to liberty and antithetical to the openness required in a democratic society."