> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Loses Again in FOIA Suit on Vaccine Records
- URL: https://www.fdaweb.com/fda-loses-again-in-foia-suit-on-vaccine-records/
- Published: 2024-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:48:45.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158321

A Texas federal court [12/6 ruled](https://fingfx.thomsonreuters.com/gfx/legaldocs/lgpdjabmbpo/Public%20Health%20and%20Medical%20Professionals%20for%20Transparency%20v%20FDA%20-%20order%20-%2020241206.pdf?ref=fdaweb.com) against FDA in an ongoing Freedom of Information Act (FOIA) lawsuit by Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The group sued FDA in 2021 and the agency was ordered in 2022 to produce 55,000 pages each month from the supporting documents behind the BLA approval.

After 1.2 million pages received, plaintiffs recently asked the court to compel the agency to produce documents that Pfizer relied on to obtain an emergency use authorization (EUA) prior to its BLA approval. However, FDA argued that the EUA file does not fall within the FOIA request because the BLA and EUA are separate applications that are subject to different standards. The agency further contended that an FOIA request for one does not necessitate production of the other.

“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,” the court ruling said. It further relied on earlier FDA statements that the EUA was not “mere\[ly\] reference\[d\]” in the BLA but that the BLA incorporated and relied heavily on the EUA. Additionally, it found that the EUA was “submitted with or incorporated by reference in” Pfizer’s BLA, adding that “Either way, the EUA must be produced.”