FDA has been ordered by a federal judge to produce one million additional pages that Pfizer submitted to FDA to license its COVID-19 vaccine.
Despite its best efforts to keep the records hidden, FDA has been ordered by a federal judge to produce one million additional pages that Pfizer submitted to FDA to license its COVID-19 vaccine.
As long-time ICAN supporters will remember, back in January 2022, the attorneys who regularly represent ICAN won a historic case in which a federal judge ordered FDA to produce ALL documents it relied upon to approve Pfizer’s COVID-19 vaccine for ages 16+ at a rate of 55,000 pages per month. Based on FDA’s representation to the Court at that time that there were 450,000 pages, the expectation was that all the documents would be produced by the end of 2022.
However, long after the Court’s order, the FDA revised its estimate to 1.2 million pages and its document production dragged on until November 2023, when it finally announced production was complete. But scientists and other stakeholders kept pointing out that datasets were missing. When FDA was confronted about the missing datasets, it continued to assure that it had produced all records, but it soon became crystal clear they were hiding documents.
FDA finally admitted that it had failed to disclose a million pages in something it called an EUA (Emergency Use Authorization) file. FDA claimed the EUA file was not responsive to the FOIA request at hand because it was not part of the licensure file, but FDA’s own press release explicitly acknowledged that Pfizer’s license application “builds on the extensive data and information previously submitted that supported the EUA.”
U.S. District Judge Mark Pittman agreed and, after an extensive legal battle, on December 6, 2024, he struck another blow in favor of transparency. FDA has been ordered to produce all documents related to Pfizer’s EUA, estimated to be about one million more pages, by June 30, 2025.
Judge Pittman ended his order quoting Patrick Henry during the Constitutional Convention of 1787: “The liberties of a people never were, nor ever will be, secure, when the transactions of their rulers may be concealed from them.”
ICAN is thankful for judges like Judge Pittman who are committed to protecting the rights of the American people. We will continue to update you as the new batches of documents are released and will make them public for all—as FDA should have done from the start.
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