Judge scraps 75-year FDA timeline to release Pfizer vaccine safety data, giving agency eight months

The Food and Drug Administration won't have 75 years to release thousands of pages of documents it relied on to license its COVID-19 vaccine. Instead, the federal agency will have just over eight months to do so, per a federal judge's ruling.

The timeline ordered Thursday by U.S. District Judge Mark Pittman radically shortens the timeline under which the FDA has to produce troves of documents. The order stems from a Freedom of Information Act document lawsuit by a coalition of doctors and scientists with the nonprofit Public Health and Medical Professionals for Transparency. The group seeks an estimated 450,000 pages of material about the vaccine-creation process during the COVID-19 pandemic, which came into full force in the United States in March 2020.

Rather than producing 500 pages a month, the FDA's proposed timeline, Pittman ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of September rather than the year 2097, the deadline that the FDA wanted.

“Here, the court recognizes the ‘unduly burdensome’ challenges that this [Freedom of Information Act] request may present to the FDA," the court ruling noted. "But, as expressed at the scheduling conference, there may not be a ‘more important issue at the Food and Drug Administration … than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not rush[ed] on behalf of the United States."