Did the US FDA ask for 75 years to fully release the Pfizer COVID-19 vaccine data to the public?
Find out what’s going on, and what the facts really are!
Claim : FDA Asked For 75 Years To Release Pfizer COVID-19 Vaccine Data!
According to Aaron Siri, a lawyer working on the case, the US FDA just asked a federal judge for 75 years to produce the Pfizer vaccine data and documents.
A prior post explained that the FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. Literally, a 55-year delay.
My firm, on behalf of PHMPT, asked that this information be disclosed in 108 days – the same amount of time it took for the FDA to review and license Pfizer’s vaccine.
The Court ordered the parties to submit briefs in support of their respective positions by December 6, 2021. The FDA’s brief, incredibly, doubles down.
It now effectively asks to have until at least 2096 to produce the Pfizer documents. Not a typo. A total of at least 75 years.
Truth : FDA Did NOT Ask For 75 Years To Release Pfizer Vaccine Data!
This is really just some “creative hyperbole” by Aaron Siri, the lawyer working on this FOIA (Freedom of Information Act) request.
And here are the reasons why…
Fact #1 : FDA Did Not Ask For 75 Years To Release Pfizer COVID-19 Vaccine Data
First, let me be clear – the US FDA did not ask US District Judge Mark Pittman for 75 years to release the Pfizer COVID-19 vaccine data.
That is merely the “interpretation” of Aaron Siri, the lawyer working for PHMPT (Public Health and Medical Professionals for Transparency) – the group requesting the data that the FDA used to licence the Pfizer COVID-19 vaccine.
As you will see below, it’s based on ignoring facts and basic math…
Fact #2 : FDA Has To Redact Files Before They Are Released
It is not simply a matter of handing over the documents to PHMPT.
The FDA has to go through every document and redact information that are exempt from disclosure under FOIA, before it can release them.
That process is not only time-consuming, it is resource-intensive because it requires government information specialists to review each page line-by-line.
The FDA estimates that it takes 8 minutes per page to read and review records for FOIA production.
Fact #3 : FDA Has 400 Other Pending FOIA Requests
The FOIA request by PHMPT is being handled by the Access Litigation and Freedom of Information Branch at the FDA’s Center for Biologics Evaluation and Research (CBER).
This is a small department with just ten employees, including the director and two trainees. So they really have just seven people who are trained well enough to process FOIA requests.
This small team is currently processing “approximately 400 currently pending FOIA requests“, while being embroiled in “6 active FOIA litigation matters“.
Needless to say, the heavy workload greatly limits how many pages this office can go through and redact every month.
Fact #4 : PHMPT Demanded “Everything” In 108 Days
The FDA asked PHMPT to narrow their request by specifying records they don’t require, so they can focus on processing the important documents they need.
The PHMPT, however, insisted that the FDA process and deliver ALL documents related to the approval of the Pfizer COVID-19 vaccine – some 329,000 pages!
On top of that, the PHMPT demanded that the FDA accomplish that within 108 days. That would require a processing rate of over 80,000 pages per month – far in excess of what the FDA FOIA office is capable of handling.
Fact #5 : FDA Vaccine Approval Is Different From FOIA Process
It seems obvious, but it has to be said – the FDA vaccine approval process is different from the FOIA process.
So it is ridiculous for the PHMPT to insist that their 108-day demand is valid because it “is the same amount of time” it took the FDA to review the documents and licence the Pfizer COVID-19 vaccine.
The vaccine approval process involves FDA scientists evaluating the Pfizer COVID-19 vaccine for the EUA (Emergency Use Authorisation) or full FDA approval.
The FOIA process, on the other hand, involves FDA information specialists going through each page line-by-line to identify and redact proprietary information.
Fact #6 : FDA Vaccine Approval Process Adds A Ton Of New Documents
The FDA vaccine approval team went through fewer documents, because they only need to look at relevant information provided by Pfizer and BioNTech.
The FDA team in charge of this FOIA request would necessarily have to go through far more documents, because the approval process itself adds a ton of new documentation.
Even the PHMPT acknowledged that, specifically asking for “all correspondence and written summaries of oral discussions” related to the FDA approval of the Pfizer COVID-19 vaccine.
Hence, it is ludicrous for the PHMPT to claim that the two processes are similar in effort and time.
Read more : Full FDA Approval vs EUA for Vaccines : What’s Different?
Fact #7 : FDA Processes FOIA Requests In 500-Page Blocks
The FDA processes FOIA requests in 500-page blocks, which allow them to provide documents to more requesters, and avoid a few large requests monopolising their “finite processing resources”.
This is not a special processing limitation on the Pfizer COVID-19 vaccine data, but a standard FDA processing rate that the courts have upheld for a long time.
Fact #8 : FDA Processing FOIA Requests Faster Than Proposed
The FDA was able to process some records faster than the 500-page rate, as they noted in their 6 December 2021 brief. They also said that they can release more than 12,000 pages by end of January 2022.
As it stands, the FDA appears to be doing above and beyond what it pledged to do, delivering almost 5000 pages per month – about 10X its promised rate.
Even if they end up delivering half that performance, they would finish processing 329,000 pages in 137 months – just under 11.5 years.
Obviously, 11.5 years is far less than the 55 years claimed…
Fact #9 : It Would Take PHMPT Months To Read Everything
PHMPT stated that they are a group of over 30 people. Let’s say there are 35 strong, and they take the same 8 minutes to read through each page.
Even if they all sat down and read for 8 hours a day, it would take them over 7 months just to read through the 329,000 pages ONCE.
And it should be noted that this involves 5X more people than the FDA FOIA team, and they are all dedicated to this singular task of reading those Pfizer documents.
Fact #10 : FDA Will Release Almost All Of PHMPT Priority List By Jan 2022
PHMPT appears to be cognisant that it is stupid to request for “everything” when most of the pages may not be relevant at all.
That’s why they sent the FDA a priority list of eight (8) items. And guess what – the US FDA said that they will be able to furnish seven (7) of those items by January 31, 2022!
So Aaron Siri’s public griping about the FDA taking so long appears to be nothing more than theatre.
Fact #11 : Processing Time Depends On PHMPT, Not FDA
Aaron Siri claimed that the FDA disclosed in their 6 December 2021 brief that there are many more pages to process, thereby increasing the time to fully-release everything from 55 years to 75 years.
In addition to the original 329,000+ pages, the FDA discloses there is another “approximately 39,000 pages,” an additional “tens of thousands of additional pages,” and an additional 126 data files, many of which have over ten thousand rows for which the FDA intends to treat twenty rows as one page. Assuming an average of only ten thousand rows per data file, and that its amorphous “tens of thousands of additional pages” amounts to 20,000 pages, the grand total is at least 451,000 pages.
That’s nonsense, because the processing time ultimately depends on what the PHMPT is demanding.
As the FDA noted, their initial assessment of 329,000 pages was based on their interpretation of PHMPT’s request for all information from the original Pfizer vaccine BLA (biologics licence application).
But if the PHMPT insist that they want OTHER RECORDS like BLA supplements, amendments and product correspondence, then the FDA would have to process an additional 39,000 pages.
And if the PHMPT insist that they also want the “investigational new drug applications” (whatever for?), then that’s tens of thousands of additional pages.
So the ball is really in the PHMPT’s court. They can drag this out to 100 years and more. All they have to do is insist that they want the FDA to process even more (irrelevant) pages.
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.
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