FDA misled the judiciary about Pfizer’s vaccine documents

On December 6, 2024, a federal judge ordered the US Food and Drug Administration (FDA) to release documents related to the emergency use authorisation of Pfizer’s COVID-19 vaccine. These documents had been hidden from public view.

The legal battle traces back to September 2021, when attorney Aaron Siri filed a lawsuit under the Freedom of Information Act (FOIA) on behalf of the Public Health and Medical Professionals for Transparency. The plaintiffs sought access to the vast trove of documents the FDA relied on to approve Pfizer’s vaccine.

Initially, the FDA proposed a slow release schedule. In November 2021, the agency stated it would release just 500 pages per month—a pace that would have stretched the full disclosure process to 75 years.

However, in January 2022, District Judge Mark Pittman of Texas rejected the FDA’s proposal, ordering the agency to expedite its release to 55,000 pages per month, aiming to complete the disclosure of all 450,000 pages by August 2022.

As the documents trickled out, researchers began uncovering glaring gaps that prevented a systematic review of the data. These gaps fueled suspicions about what else the FDA might be withholding.