FDA Says It Needs 75 Years to Release Vaccine Data

    icon Dec 09, 2021
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Back in September, 30 scientists and professors filed a lawsuit to force the FDA to release the documents it reviewed to approve the Pfizer COVID vaccine. The scientists want to “settle the ongoing public debate regarding the adequacy of the FDA’s review process,” which should “confirm the FDA’s conclusion that the Pfizer Vaccine is safe and effective and, thus, increase confidence in the Pfizer Vaccine.”
The lawsuit says that the FDA refused expedited processing of the scientists’ Freedom of Information Act request on the grounds that they did not demonstrate an urgent need.
The scientists replied:
“During a time when COVID-19 vaccine mandates are being implemented over the objection of those that have questions about the data and information supporting the safety and efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from employment, school, transportation, restaurants, entertainment facilities, and the military, the public has an urgent and immediate need to have access to this data.”
But the FDA said that would be too much work, because it has to review each document to redact confidential information. Instead, the FDA proposed releasing the documents on a rolling basis of 500 pages per month.
That means it would be just under 55 YEARS before the FDA released all 329,000 pages of documents it used to approve the Pfizer COVID vaccine. Moreover, the FDA later amended its request and asked for an additional 20 years to release the data.
The agency told the court it can work faster than its previously proposed 500-pages-per-month-rate. But it also said there are over 59,000 more pages than mentioned in an earlier filing.
That discovery, and a desire to make sure it can work on other Freedom of Information Act requests at the same time, prompted the fresh request to the judge to allow production of roughly 12,000 pages by Jan. 31, 2022, and 500 pages per month thereafter.
So here's a simple question: If they could properly review these documents to approve a new vaccine in a matter of months, why would it would take 75 years to review them to release to the public?

That timeline would take it until at least 2096, Aaron Siri, a lawyer working on the case, said in a blog post. “If you find what you are reading difficult to believe - that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure,” Siri said.

The case was brought on behalf of the Public Health and Medical Professionals for Transparency, which said the FDA was not complying with its request for data in a timely manner.

The group includes Dr. Carole Browner, a research professor at the University of California, Los Angeles’ David Geffen School of Medicine; Peter Doshi, an associate professor at the University of Maryland’s School of Pharmacy, and Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health.

The group says that the data should be made public quickly because the FDA spent just 108 days reviewing it before granting emergency use authorization to the Pfizer-BioNTech vaccine.

The FDA said its Center for Biologics Evaluation and Research maintains the records sought by the plaintiff but only has 10 staff members, and two of them are new, leaving them slower in processing pages than the other workers.




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