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Wednesday, January 19, 2022

FDA Says It Now Takes 75 Years To Fully Release Pfizer’s COVID-19 Vaccine Data

The FDA is asking the judge to give him 75 years to produce data on Pfizer and BioNTech vaccines, 20 years more than in the previous request.

An agency known as the FDA told the court that it could run faster than previously estimated 500 pages per month. But it is also said to be 59,000 more pages than the earlier documentation.

This discovery and the desire to make sure it can work concurrently with other Freedom of Information Act requests prompted a new request to the judge to authorize the production of approximately 12,000 pages by January 31, 2022 and 500 pages per month. after that.

This timeline will run until at least 2096, Aaron Siri, a lawyer working on the case, said in a blog post.

“If you find it hard to believe what you’re reading, it’s because it’s a dystopia for the government to give Pfizer billions, to require Americans to accept its products, to prohibit Americans from filing harm claims, but refuse to let Americans see the data behind it.” licensed, said Siri.

The case was filed on behalf of the Public Health Service and Medical Specialists for Transparency, which said the FDA did not comply with its data request in a timely manner.

The team includes Dr. Carol Browner, research professor at UCLA’s David Geffen School of Medicine; Peter Doshi, Associate Professor at the University of Maryland School of Pharmacy; and Dr. Harvey Risch, Professor of Epidemiology at the Yale School of Public Health.

The group says the data should be released as soon as possible because the FDA only spent 108 days examining it before granting an emergency authorization for the Pfizer-BioNTech vaccine.

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The issue is more urgent because millions of Americans must take a picture or face repercussions such as losing access to business and being fired.

Pfizer Shot is the only drug approved by regulators. Approvals mean products meet a higher safety and efficacy threshold than those with an emergency permit.

“The whole purpose of the FOIA is government transparency. In many recent cases, upholding the FOIA’s “promptly release records” requirement, courts have required agencies, including the FDA, to provide 10,000 or more pages per month, and these cases did not include an almost-as-important request, i.e. the data behind a no-liability product licensing basis that the federal government requires that almost all Americans get it, ”Siri said.

“As the current pandemic rages on, an independent review of these documents by third-party scientists is urgently needed to help address the gaps and challenges in today’s pandemic response.”

The FDA said its Center for Biologicals Evaluation and Research maintains the records requested by the plaintiff, but it only has 10 employees, and two of them are new, so they are slower to process pages than other employees.

Every line of every page should be checked to ensure that the correct corrections are made, the documentation says.

In addition, the faster speed than requested would divert “significant resources from processing other FOIA requests that are also pending litigation” and requests prior to the request in question, the agency said, adding: “Overall, the FDA’s proposed processing schedule is fair for the plaintiff. “

To follow

Zachary Stieber covers US news and articles related to the COVID-19 pandemic. He lives in Maryland.

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