DALLAS, TX – A federal judge on Thursday shot down a previous request made by the Food and Drug Administration (FDA) to allow them 75 years to release the full data on the Pfizer/ BioNTech COVID-19 vaccine to the public, instead giving the FDA just over 8 months to accomplish the task instead.
U.S. District Judge Mark Pittman responded to a Freedom of Information Act lawsuit brought by the nonprofit group Public Health and Medical Professionals for Transparency, which had requested approximately 450,000 pages of documents chronicling the creation of the Pfizer/ BioNTech COVID-19 vaccine from the FDA.
The FDA had previously requested that they be allowed to submit the first 12,000 pages by January 21, 2022, and an additional 500 of the remaining 59,000 pages per month going forward from that point – which would wrap up the process by 2097 – citing the length of the discovery phase as well as maintaining availability to respond to additional Freedom of Information Act requests.
Pittman, who was appointed to the federal bench by former President Donald Trump in 2019, refused the FDA’s request in Thursday’s ruling, ordering the agency to instead provide 55,000 pages per month – with over 12,000 pages now before January 31 – which would provide a deadline for full delivery of the documents of September 2022.
“Here, the court recognizes the ‘unduly burdensome’ challenges that this [Freedom of Information Act] request may present to the FDA,” Pittman wrote in this ruling. “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.”
Representatives for Public Health and Medical Professionals for Transparency noted that the FDA should be required to release the vaccine data at an expedited rate because the agency only reviewed the materials for four months before bestowing their approval upon it for widespread use.
“Pfizer began its rolling submission on May 7, 2021, and the vaccine was licensed on August 23, 2021, a total of 108 days from initial submission to licensure,” the group wrote when they originally filed their lawsuit in December 2021.
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