FDA Says It Needs Until Year 2076 To Reveal Data Pertaining To Pfizer Vaccine Approval
(Photo by Sarah Silbiger/Getty Images)
The FDA denied Sept. 9 a request for an expedited release of the vaccine’s approval records from a group of doctors and scientists, the Public Health Medical Professionals for Transparency (PHMPT). The PHMPT has since filed a lawsuit against the FDA for failure to complete their Freedom of Information Act (FOIA) request.
The agency had determined that there were a total of 329,000 pages that needed to be reviewed in order to fulfill the plaintiff’s FOIA request, and proposed that they would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” The FDA said they would provide the plaintiff with prioritized documents and release the non-exempt portions of the records on a “rolling basis.” This rate of review places the FDA’s release of the documents at nearly 55 years.
“This rate is consistent with processing schedules entered by courts across the country in FOIA cases,” said the FDA, explaining that the plaintiff’s request for documentation within a 4-month timeframe would force the FDA to have to work through 80,000 pages per month.
Due to an inability to reach an agreement on a set disclosure schedule, the plaintiffs have called for a hearing to argue their case before a judge, according to The Epoch Times.
A vial of Pfizer-BioNTech Covid-19 vaccine is seen at a pop up vaccine clinic in the Arleta neighborhood of Los Angeles, California, August 23, 2021. (Photo by Robyn Beck / AFP) (Photo by ROBYN BECK/AFP via Getty Images)
The PHMPT had filed the lawsuit on Sept. 16, 2021, stating that although the Pfizer vaccine was approved and described by the FDA as meeting “the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” others with large social or media platforms have publicly raised questions regarding the sufficiency of data used in the review of Pfizer’s vaccine.
The PHMPT states in the lawsuit the importance of releasing this information to the public, as federal law provides that “After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.” The PHMPT stated that the purpose of their organization is to adequately disseminate information to the public regarding all COVID-19 vaccines and to ensure that the FDA is maintaining its commitment to transparency.
“The FDA’s promise of transparency is, to put it mildly, a pile of illusions,” wrote attorney Aaron Siri in a blog post, whose firm is representing PHMPT in the lawsuit, according to The Epoch Times.
“It took the FDA precisely 108 days from when Pfizer started producing the records for licensure to when the FDA licensed the Pfizer vaccine,” said Siri. “Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. While it can conduct that intense review of Pfizer’s documents in 108 days, it now asks for over 20,000 days to make these documents available to the public,” Siri continued, reported The Epoch Times.
Pfizer’s BioNTech vaccine was approved for use Aug. 23, 2021 for individuals 16 or older, and approved for kids ages 5-11 Oct. 29, 2021. (RELATED: Pfizer To Request Approval For Nearly 90% Effective COVID-19 Pill)
“Releasing this data should also confirm the FDA’s conclusion that the Pfizer Vaccine is safe and effective and, thus, increase confidence in the Pfizer Vaccine,” the PHMPT said.
The Daily Caller reached out to the FDA with a request for comment, but the agency did not respond in time for publication.
https://dailycaller.com/2021/11/18/fda-requests-year-2076-publish-data-pfizer-vaccine-approval/
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