Federal Judge: FDA Must Release Covid Vaccine “Emergency Use Authorization” Files by June 2025
Legal Insurrection readers may recall my 2022 report on a federal judge ordering the Food and Drug Administration (FDA) to expedite the release of Pfizer’s COVID-19 vaccine trial data.
Judge Mark T. Pittman of the Northern District of Texas ruled that the FDA must release the documents much faster than initially proposed. The FDA had wanted to take 75 years to release the data fully.
The FDA tried to put a stop to the public records lawsuit
The judge rejected the FDA’s plea, recognizing the “paramount public importance” of the information.
Now Pittman has ordered the release of records related to “emergency use authorization” (EUA) files.
In a ruling, on Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, ordered the agency to produce its “emergency use authorization” file to a group of scientists who wanted to see licensing information that the FDA relied on to approve the Pfizer-BioNTech coronavirus vaccine.“The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” wrote Pittman, appointed in 2019 by then-President Donald Trump.The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case.
Under the judge’s order, the FDA must produce the responsive EUA files on or before June 30, 2025.
Attorney Aaron Siri, representing the Public Health and Medical Professionals for Transparency that brought the case, indicated one million pages of data would be released with this order.
“The FDA clearly lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review,” Siri said.He said the agency was “hiding from the court and the plaintiff one million pages of clinical trial documents from the COVID-19 vaccine clinical trials.”The FDA has power to grant “emergency use authorization” for vaccines and some other medical products.The lawsuit said, “the medical and scientific community and the public have a substantial interest in reviewing the data and information underlying the FDA’s approval of the Pfizer vaccine.”
Public Health and Medical Professionals for Transparency (PHMPT) is a nonprofit organization composed of public health professionals, medical professionals, scientists, and journalists. The organization’s purpose is to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines. PHMPT maintains a neutral stance on the data, focusing only on making it publicly available for independent experts to review and analyze.
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