FDA Ordered to Produce COVID-19 Vaccine Adolescent Data at Rate of 180,000 Pages Per Month
A federal judge on May 9 ordered the U.S. Food and Drug Administration (FDA) to produce all data it relied on in the licensure of Moderna’s COVID-19 vaccine and Pfizer’s vaccine for 12-to-15-year-olds at an average rate of at least 180,000 pages per month.
The Public Health and Medical Professionals for Transparency (PHMPT) brought the lawsuit on behalf of the parents of Maddie de Garay, a young girl who suffered severe injuries during Pfizer’s clinical trial for 12 to 15-year-olds that left her paralyzed, unable to eat, with seizures and no bladder control. Her extensive injuries have been ignored by the pharmaceutical giant and U.S. regulatory agencies.
The FDA argued it would take 23.5 years at a rate of 1,000 to 16,000 pages per month to release approximately 4.8 million pages. In a document uploaded to his Substack, attorney Aaron Siri argued timely production was important and demanded all documents be produced by mid-2025.
Judge Mark Pittman ordered the FDA to produce all data by June 31, 2025, at a rate of at least 180,000 pages per month, stating, “Democracy dies behind closed doors.”
This is the second lawsuit brought against the FDA by PHMPT to produce data the agency relied upon in approving COVID-19 vaccines. The FDA, in January 2022, was ordered by the same judge to produce all data on Pfizer’s COVID vaccine for individuals 16 years and older at a rate of 55,000 pages per month—as opposed to the 75 years requested by the FDA.
Documents turned over so far have been made available on PHMPT’s website and show the American people were lied to about the safety and efficacy of COVID-19 vaccines.
Considering the FDA asked for 75 years and 23 years, respectively, to produce requested documents, one can only wonder how the agency’s safety advisors could get through millions of documents in mere days and what their decisions were genuinely based upon if not the data.