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FDA faces legal challenge over COVID-19 approval data, report says

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FDA faces legal challenge over COVID-19 approval data, report says

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A nonprofit group will have its day in court on Tuesday when it argues that the Food and Drug Administration should release all documents related to the approval of Pfizer / BioNtech’s COVID-19 vaccine, which the plaintiff’s request could take decades to produce, according to a report.

Public health and transparency medicine professionals have sued the FDA under a freedom of information law and are asking for more than 400,000 more pages on the approval process, Reuters reported. The FDA has proposed to publish 12,000 pages by the end of January and “a minimum” of 500 pages per month in the future, which the group says could mean it could take 2097 before all the documents would only be made public, according to the report.

The plaintiffs in this case want it all within 108 days, which is symbolic because that’s the time they say it took the agency to approve the vaccine, according to the report.

The FDA has come under pressure to release all data on its Pfizer COVID-19 jab approval process. (Photo by Jakub Porzycki / NurPhoto via Getty Images)

Aaron Siri, the attorney representing the plaintiffs, posted on his Substack that it is “dystopian for the government to give billions to Pfizer, to mandate Americans to take its product, to ban Americans from suing for damages, but to refuse to let the Americans see the underlying data. his driving licence.”

Public health officials have always said the vaccines available are safe and effective. The vaccines were first marketed under an emergency use authorization. The Pfizer vaccine received full FDA approval on August 23, 2021. Johns Hopkins University said full approval is granted when the agency gathers “even more scientific evidence to support” their use.

Politicians on both sides have worked to allay public doubts about vaccine safety. So far, the United States has administered 484 million doses of approved vaccines. About 60.8% of the population has been fully immunized.

FDA faces legal challenge over COVID-19 approval data, report says

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A syringe is prepared with the Pfizer COVID-19 vaccine at a clinic at the Norristown Public Health Center in Norristown, Pa. On Tuesday, December 7, 2021. (AP Photo / Matt Rourke)

The complainants’ website identifies the group as a non-profit organization made up of professionals from the medical and health fields. The group says it takes “no position on data other than that which should be made public to allow independent experts to conduct their own reviews and analyzes.”


Jenna Greene, the Reuters reporter, wrote earlier that the plaintiffs include 30 professors and scientists from various schools, including Harvard, Yale, UCLA and Brown.

Tuesday’s hearing will be held in Fort Worth, Texas, before Trump-appointed U.S. District Judge Mark Pittman.

The report says the FDA’s proposed timeline for releasing the documents may not be fully seen by the public until 2097. The FDA and the Department of Justice did not immediately respond to an email from Fox News after the reports. Normal hours.

The report made it clear that the agency is not challenging the disclosure of the information; the only source of contention is timing. An FDA official said in court documents that the agency must do a “line-by-line, word-by-word review” before producing the documents and said it takes about eight minutes to properly review each page, Reuters reported. She also said the office that processes FOIA requests is understaffed.

Earlier this month, Representative Ralph Norman, RS.C. introduced legislation that could require the FDA to release all vaccine-related documents within the next 100 days.

The legislation is a direct response to a request made last month by the federal agency to extend the release of COVID vaccine data to age 55.


“How does a vaccine that gets 108-day approval now need 55 years just to publish information?” Norman told Fox News. “It sounds like the start of a really bad joke.”

Fox News’ Caitlyn McFaul contributed to this report

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