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FDA Faces Legal Challenge Over COVID-19 Approval Data, Report Says

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 the Pfizer / BioNtech COVID-19 vaccine, which plaintiffs say could take decades. to occur, according to a report. .

Public health and medical professionals over transparency sued the FDA under a Freedom of Information Act and are seeking more than 400,000 additional pages on the approval process, it reported. The FDA has offered to publish 12,000 pages by the end of January. and “a minimum” of 500 pages a month going forward, which, according to the group, could mean it could be 2,097 before all documents are released, according to the report.

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

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

Aaron Siri, the attorney representing the plaintiffs, posted in his Substack that it is’ dystopian for the government to give Pfizer billions, force Americans to take their product, prohibit Americans from suing for damages, but refuse to allow Americans to see the underlying data »your license«.

Public health officials have consistently said that available vaccines are safe and effective. The vaccines were first released with 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 accumulates “even more scientific evidence to support” its use.

Politicians from both parties have worked to dispel public doubts about vaccine safety. So far, the United States has administered 484 million doses of the approved vaccines. Approximately 60.8% of the population has been fully vaccinated.

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

The plaintiffs’ website identifies the group as a non-profit organization comprised of professionals from the medical and healthcare fields. The group says it does not take “any position on the data other than what should be publicly available to allow independent experts to carry out their own reviews and analyzes.”

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

Tuesday’s court hearing will be held in Fort Worth, Texas, in front of Trump-appointed US District Judge Mark Pittman. The FDA asked the court for 55 years to complete the FOIA request, but. reported that the plaintiffs say the term is more likely to be 76 years.

The report said the FDA’s proposed schedule for releasing the documents may not be seen by the public until 2097. The FDA and the Justice Department did not immediately respond to an after-hours email from Fox News.

The report made clear that the agency does not contest the release of the information; the only source of controversy is the timing. An FDA official said in court documents that the agency must conduct a “line-by-line, word-for-word review” before producing the documents and said it takes about eight minutes to properly review each page, he said. He also said that the office that handles FOIA requests is understaffed.

Earlier this month, Representative Ralph Norman, RS.C., introduced legislation that could force 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 data on COVID vaccines for up to 55 years.

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“How come a vaccine that gets approved in 108 days now takes 55 years just to release information?” Norman told Fox News. Sounds like the beginning of a really bad joke.

Caitlyn McFaul of Fox News contributed to this report.

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