The decision rejects the FDA’s request to release the data over what would be 75 years
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“A federal judge on Thursday ordered the U.S. Food and Drug Administration to produce, at a rate of 55,000 pages per month, the documents it relied on to license the Pfizer-BioNTech COVID-19 vaccine,” The Epoch Times reported.
“The rate of 55,000 pages a month would mean the FDA has just over eight months to fully produce all of Pfizer’s pre-licensure safety data. That is much faster than the 500 pages-per-month rate the FDA proposed in December 2021. That rate would have effectively given the agency roughly 75 years to fully produce the data,” Aaron Siri, a lawyer working on the case, previously observed.
U.S. District Judge Mark Pittman ordered the FDA to produce more than 12,000 pages on or before Jan. 31, which was what the FDA had proposed in part. Pittman then ordered the agency to “produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.”
“Here, the court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA … 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 rushed on behalf of the United States.”
The existing supply of COVID-19 vaccines under Pfizer continues to be administered under an updated emergency use authorization (EUA).
“All the documents sought in the FOIA request are urgently needed to allow independent scientists to review the FDA’s work and to provide assurance to the public that the liability-free vaccine [Americans] are being mandated to receive has truly passed the most rigorous review possible,” the group said in its filing in December, adding, “[T]he need for this information will be lost if all the documents are not promptly produced because people and governments are making decisions regarding the Pfizer vaccine now, not in 75 years.”
“Accordingly, the court concludes that this FOIA request is of paramount public importance,” Pittman wrote in the order (pdf).
In a statement to The Epoch Times, the FDA said it “does not comment on possible, pending or ongoing litigation.”
The case was brought by the Public Health and Medical Professionals for Transparency (PHMPT), which said the data should be made public quickly because the FDA took just 108 days to review the data before granting Pfizer-BioNTech’s COVID-19 vaccine full approval.
“Pfizer began its rolling submission on May 7, 2021, and the vaccine was licensed on August 23, 2021, a total of 108 days from initial submission to licensure,” the non-profit group noted in a December filing.
“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,” Attorney Aaron Siri concluded.