By law, federal agencies are required to respond to a Freedom of Information Act request within 20 business days, but the FDA is asking for a delay of 55 years to a request for documents related to COVID-19 vaccines.
In court papers this week, the agency proposes that the plaintiffs in a FOIA lawsuit, Public Health and Medical Professionals for Transparency, see the full record in 2076, Reuters reported.
Earlier this month, hours before a CDC panel’s approval of the Pfizer vaccine for children 5-11, the British Medical Journal published an article featuring a whistleblower’s charge that poor practices at a contract research company helping to carry out the crucial third phase of Pfizer’s COVID-19 vaccine trial last fall may have compromised data integrity and patient safety.
The government’s central FOIA website allows for extension of the deadline, explaining the actual time for delivery of the documents “will vary depending on the complexity of the request and any backlog of requests already pending at the agency.”
Justice Department lawyers representing the FDA argue the plaintiffs – a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown – are seeking a massive volume of documents, about 329,000 pages.
The plaintiffs want the records so they can be assured, amid significant public skepticism, that the Pfizer vaccine is indeed “safe and effective.”
DOJ lawyers, in a joint status report filed Monday, argued the FDA must review the records to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”
The FDA says it has only 10 employees, who currently are processing about 400 other FOIA requests. The agency believes it can handle only about 500 pages of the vaccine request per month.
The plaintiff’s lawyers want the FDA to release all the material no later than March 3, 2022.
“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court papers, Reuters reported.
They argue that the purpose of the Freedom of Information Act is to assure government transparency.
“It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse,” the plaintiffs’ lawyers said.
Further, they argue FDA regulations require the agency “to make ‘immediately available’ all documents underlying licensure of a vaccine.” And they point out that the FDA has 18,000 employees and a budget of $6 billion.
Meanwhile, the agency “has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine.”
U.S. District Judge Mark Pittman will consider the timeline for processing the documents Dec. 14 in Fort Worth, Texas.
Pfizer CEO: Vaccine ‘misinformation’
Earlier this month – amid concern expressed by members of FDA and CDC advisory panels that safety data for children regarding Pfizer’s COVID vaccine is lacking – the pharmaceutical company’s CEO charged people are spreading “misinformation” about the vaccines, calling them “criminals” who have cost “millions of lives.”
The FDA approved the Pfizer shot for young children one week after an FDA advisory panel voted 17-0, with one abstention, to recommended it, despite acknowledging the lack of safety data and the nearly 100% survival rate for children from infection.
During the FDA advisory committee meeting, Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, expressed the concern of many members about possible severe side effects that cannot yet be measured. He concluded, nevertheless, there was no other way forward.
“We’re never going to learn about how safe the vaccine is unless we start giving it,” he said. “That’s just the way it goes.”
More than 18,000 deaths attributed to COVID-19 vaccines have been reported to the CDC’s Vaccine Adverse Events Reporting System website.
Health and Human Services points out that a VAERS report is not documentation that a link has been established between a vaccine and an adverse event. However, HHS also notes that VAERS is a “passive” system of reporting, and it “receives reports for only a small fraction of actual adverse events.” Many health care workers have disclosed they are instructed by their superiors not to report to VAERS any harm caused by COVID vaccines.
And the website OpenVAERS, which compiles summaries of the data on VAERS, points to an analysis known as the “Lazarus Report,” which concluded VAERS represents only 1% of vaccine injuries.
In early October, three Pfizer scientists were captured on hidden camera in a Project Veritas investigation admitting, contrary to the claims of Dr. Anthony Fauci and other public health officials, that natural immunity is superior to the immunity afforded from COVID vaccines.
Project Veritas interviewed an employee of the U.S. Department of Health and Human Services who secretly recorded colleagues voicing alarm about the safety of the vaccines. She alleged a cover-up of “evil at the highest level.” In another investigation by Project Veritas, two Johnson & Johnson officials said children don’t need the vaccine and it poses the risk of “unknown repercussions down the road.”
Pfizer scientist Rahul Khanke said employees are “bred and taught” to insist that the “vaccine is safer than actually getting COVID.” He said “we cannot talk about this” in public.
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