Federal Judge Tells FDA it Must Make Public 55,000 Pages a Month of Pfizer Vaccine Data
A federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for Pfizer/BioNTech’s COVID-19 vaccine — and then release 55,000 pages every 30 days after that until all 450,000 requested pages are public.
The request for FDA’s Pfizer/BioNTech data flows from an August 2021 Freedom of Information Act (FOIA) request from the nonprofit group Public Health and Medical Professionals for Transparency (PHMPT), filed just after the FDA granted full approval to the vaccine for people 16 and older.
In response to the FOIA request, the FDA had previously said that it takes approximately eight minutes per page to process records for a FOIA request, and that it could only review and release 500 pages a month, which is 6,000 pages a year.
At that rate, it would take 75 years to release all the data.
In his Jan. 6 ruling, U.S. District Judge Mark Pittman said the court “concludes that this FOIA request is of paramount public importance.”
Pittman, from the U.S. District Court for the Northern District of Texas Fort Worth Division, is a 2019 appointee of President Trump.
PHMPT is made up of about 200 doctors, scientists, professors, public health professionals and journalists, including some who have publicly questioned the usefulness of lockdowns, mask mandates and the COVID-19 vaccine. The group focuses entirely on data relied upon by the FDA to license COVID-19 vaccines, the organization said on its website.
The group has said it will publish all the information the FDA makes public about the Pfizer/BioNTech vaccine.
If the agency can keep up with the 55,000-pages-a-month requirement, all the data should be in the public domain by summer’s end.
Neither the FDA nor PHMPT responded to requests for comment.
Reach the judge’s order here: www.fdanews.com/01-07-22-PittmanFOIAOrder.pdf. — Suz Redfearn