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FDA Ordered to Disclose Additional COVID-19 Vaccine Authorization Records

• A U.S. federal judge has mandated the FDA to release further information supporting the emergency use authorization of COVID-19 vaccines, specifically the Pfizer-BioNTech vaccine. • The ruling comes in response to a lawsuit by Public Health and Medical Professionals for Transparency, seeking access to the data the FDA relied upon for approval. • The court has instructed the FDA to disclose documents from the EUA file, including clinical trial data and safety information, by June 30, 2025. • The lawsuit gained traction after the FDA suggested it could take decades to process and release the requested records, raising concerns about transparency.

A U.S. District Judge in Texas has ordered the Food and Drug Administration (FDA) to disclose more records related to its authorization of COVID-19 vaccines. The ruling comes in response to a lawsuit filed by Public Health and Medical Professionals for Transparency (PHMPT), a group of scientists and professionals seeking access to the data underpinning the FDA's approval of the Pfizer-BioNTech COVID-19 vaccine. Judge Mark Pittman stated that the need to conceal the information relied upon for vaccine approval has passed.
The lawsuit, initiated in late 2021, gained attention when the FDA projected that processing and disclosing the requested records could take decades. PHMPT argued that the medical and scientific community, along with the public, has a significant interest in reviewing the data supporting the FDA's decision. The FDA countered that the requested "emergency use authorization" file did not fall within the scope of the group's records request.

Court Ruling Details

Judge Pittman ordered the FDA to produce its "emergency use authorization" file to PHMPT. This file includes critical data such as clinical trial results, safety information, and manufacturing details that the FDA used to approve the Pfizer-BioNTech vaccine. The FDA had argued that the EUA and the Biologics License Application (BLA) for the vaccine were separate, and the EUA data did not need to be released. However, the court found that the EUA data was incorporated into the vaccine's BLA and therefore must be disclosed.

FDA's Response and Compliance

The FDA has stated that it has already produced over one million pages of records in response to the lawsuit, incurring over $3.5 million in costs to expedite the search and delivery of responsive records. Despite these efforts, the court has mandated that the FDA release the remaining requested documents by June 30, 2025.

Perspectives

Aaron Siri, representing PHMPT, welcomed the court's order, suggesting that the FDA's reluctance to disclose the information indicates a lack of confidence in its review process. PHMPT, which includes professors and scientists from institutions like Yale, Harvard, UCLA, and Brown, has already posted thousands of records on its website.
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Reference News

[1]
Court orders FDA to release more COVID-19 vaccine records
beckershospitalreview.com · Dec 9, 2024

A federal judge ruled the FDA must release Pfizer-BioNtech COVID-19 vaccine EUA documents by June 30, 2025, after a laws...

[2]
FDA must disclose more COVID-19 vaccine records, US judge rules - ET HealthWorld
health.economictimes.indiatimes.com · Dec 7, 2024

A federal judge ordered the FDA to disclose COVID-19 vaccine authorization info, rejecting the agency's claim that it wo...

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