fda-faces-legal-challenge-over-covid-19-approval-data,-report-says

A nonprofit group will get its day in court Tuesday when it argues that the Food and Drug Administration should release all documents tied to the approval of the Pfizer/BioNtech’s COVID-19 vaccine, which the plaintiffs claim could take decades to produce, a report said.

Public Health and Medical Professionals for Transparency sued the FDA under a Freedom of Information Act and seeks more than 400,000 additional pages about the approval process, Reuters reported. The FDA has offered to release 12,000 pages by the end of January, and “a minimum” of 500 pages a month going forward, which the group said could mean that it may be 2097 before all documents are made public, the report said. 

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

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

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

Aaron Siri, the lawyer representing the plaintiffs, posted on his Substack that it is “dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harm, but yet refuse to let Americans see the data underlying its licensure.”

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

Politicians from both parties have worked to assuage public doubt about vaccine safety. So far, the U.S. has given 484 million doses from the vaccines that have been approved. About 60.8% of the population has been fully vaccinated.

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

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

The website for the plaintiffs identifies the group as a nonprofit comprised of professionals from within the medical and health fields. The group claims to take “no position on the data other than it should be made publicly available to allow independent experts to conduct their own review and analyses.”

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

The court hearing on Tuesday will take place in Fort Worth, Texas, in front of U.S. District Judge Mark Pittman, a Trump appointee. The FDA asked the court for 55 years to complete the FOIA request, but Reuters reported that the plaintiffs say that timeframe is more likely to be 76 years.

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

The report made it clear that the agency does not contest the release of the information; the only source of contention is the timing. An official from the FDA said in court documents that the agency needs to conduct 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 handles the FOIA requests is understaffed.

Earlier this month, Rep. Ralph Norman, R-S.C., introduced legislation that could force the FDA to release all documents relating to the vaccine within the next 100 days.

The legislation is a direct response to a request made last month by the federal agency to prolong releasing data on COVID vaccines for up to 55 years.

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“How does a vaccine that receives approval in 108 days now require 55 years just to release information?” Norman said to Fox News. “It sounds like the beginning of a very bad joke.”

Fox News’ Caitlyn McFaul contributed to this report

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