Court orders FDA to produce 180,000 documents per month related to mRNA vaccines

A federal judge last week ordered the Food and Drug Administration (FDA) to produce an estimated 4.8 million documents by July 2025 — an average of 180,000 documents per month — related to its approval of the mRNA vaccines from Pfizer and Moderna.

The court order came in response to a lawsuit filed in October by the Public Health and Medical Professionals for Transparency (PHMPT) which had filed a FOIA request with the FDA to see all the data it relied on to approve Pfizer’s COVID-19 vaccines for children ages 12–15, and the Moderna vaccine for adults.

Around the same time, Stephanie and Patrick de Garay also filed a similar FOIA request with the FDA. Their then-13-year-old daughter Maddie had participated in Pfizer’s clinical trial for 12 to 15-year-olds. Within 24 hours after the second shot, she developed severe abdominal and chest pain. Doctors at the emergency room initially diagnosed Maddie with a vaccine-induced adverse reaction. When her condition worsened to the point that she wound up in a wheelchair with a feeding tube, medical staff backtracked and diagnosed her with “anxiety”. 

PHMPT and the de Garays asked the FDA to expedite the FOIA requests because parents of adolescents, who were at present being injected with Pfizer’s vaccine, as well as those taking the Moderna shots, deserved to see the data. The FDA denied their request. When they brought the issue to court, the FDA told the judge they would be happy to produce the documents — over the next 23.5 years.

Expediting the request would be “impossible without severely impacting the agency’s ability to respond to other important obligations,” the FDA claimed.

Nevertheless, Texas District Court Judge Mark Pittman last week ruled against the FDA.

“Democracy dies behind closed doors,” the judge quoted in his order, and notified the FDA that the millions of documents must be procured by June 31, 2025, which averages out to about 180,000 documents per month.

Aaron Siri, an attorney with PHMPT, called the decision “another blow for transparency and accountability”. 

Siri and PHMPT won a similar legal battle against the FDA last year when the same judge ordered the agency to produce 55,000 documents per month related to its approval process for the Pfizer vaccine for adults.

The batch of documents released on March 1st contain some disturbing revelations, such as the FDA and Pfizer having prior knowledge of thousands of adverse side effects resulting from the vaccine.