Judge Orders FDA to Release Pfizer Vaccine Data, Rejects Long Delay
A federal judge has ruled that the FDA must release a significant collection of documents related to the emergency-use authorization of the Pfizer-BioNTech COVID-19 vaccine. The case, heard in the U.S. District Court for the Northern District of Texas, was initiated by the advocacy group Public Health and Medical Professionals for Transparency (PHMPT), which sought detailed data on the vaccine’s approval process.
The FDA initially argued it would need up to 75 years to process and release the documents, citing the sheer volume of materials and limited staff resources. Judge Mark Pittman rejected this timeline, mandating the FDA to release all requested documents by June 30, 2025. He emphasized that the pandemic has ended, leaving no valid reason to withhold this information from the public.
The dispute began in 2021 when the FDA proposed releasing 500 pages per month, delaying full disclosure until 2097. In 2022, Judge Pittman intervened, ordering the agency to release 55,000 pages per month, which ensured most documents were made public by fall of that year. Despite this progress, PHMPT’s legal team argues that key documents remain undisclosed.
Aaron Siri, an attorney for the plaintiffs, criticized the FDA, alleging it concealed critical information. “The FDA clearly lacks confidence in its review process for Pfizer’s COVID-19 vaccine, as it continues to block independent scrutiny,” he said. Siri also claimed the agency withheld a million pages of clinical trial documents related to the vaccine.
