FDA Asked To Fully Release Pfizer Vaccine Data By 2076?!

Did the US FDA ask to fully release the Pfizer vaccine data only by the year 2076?!

Find out what’s going on, and what the facts really are!

 

Claim : FDA Asked To Fully Release Pfizer Vaccine Data By 2076!

The infamous DiedSuddenly account on X (formerly Twitter) just posted a screenshot of an article which claims that the US FDA just asked to fully release the Pfizer vaccine data only by the year 2076!

DiedSuddenly : What were they hiding?

Here is what the screenshot said:

FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data

The fed gov’t shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its products. But won’t let you see the data supporting its safety/efficacy. Who does the gov’t work for?

Aaron Siri
18 hr ago

Recommended : Did FDA Ask For 75 Years To Release Pfizer Vaccine Data?!

 

Truth : FDA Did NOT Ask To Fully Release Pfizer Vaccine Data Only By 2076!

This is yet another example of misinformation posted by the infamous DiedSuddenly account on X (formerly Twitter), and here are the reasons why…

Fact #1 : Screenshots Was From November 2021

First, let me just point out that the screenshot is not new or even recent, but was apparently taken in November 2021.

Aaron Siri posted that article on his Substack on 17 November 2021, and based on the time, the screenshot was likely taken on 17 or 18 November 2021.

Why would DiedSuddenly repost this screenshot almost 2 years later?

Fact #2 : FDA Did Not Ask To Fully Release Pfizer Vaccine Data By 2076

First, let me be clear – the US FDA did not ask to fully release the Pfizer COVID-19 vaccine data only by the year 2076. In fact, as best as I could tell – the FDA never mentioned the date 2076.

That appears to be 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 appears to be based on ignoring facts and basic math…

Fact #3 : 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 estimated that it would take 8 minutes per page to read and review records for FOIA production.

Fact #4 : FDA Had 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).

That is a small department with just ten employees, including the director and two trainees. So they really only had just seven people who were trained well enough to process FOIA requests.

At that time, that small team was 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 #5 : PHMPT Demanded 329,000 Pages!

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!

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.

Recommended : Did Pfizer Vaccine Documents Reveal 1,291 Side Effects?!

Fact #6 : 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.

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 #7 : 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 suggest that the two processes were similar in effort and time.

Fact #8 : 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.

Read more : Full FDA Approval vs EUA for Vaccines : What’s Different?

Fact #9 : 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.

Even back in December 2021, the FDA was doing above and beyond what it pledged to do, delivering almost 5000 pages per month – about 10X its promised rate.

At that rate, the FDA would finish processing 329,000 pages in 69 months – just under 6 years. Obviously, 6 years is far less than the 55 years claimed… and would put the end date at sometime in 2027, not 2076.

Fact #10 : It Would Take PHMPT Months To Read Everything

PHMPT stated that they are a group of over 30 people. Let’s say they 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 #11 : PHMPT Took Almost 108 Days To Read 5 Documents!

PHMPT took almost 108 days to read through the first batch of five documents that the FDA released to them on 17 November 2021.

It was only in early March 2022 when they found the 9 pages listing some 1,291 adverse events of special interest.

This not only proves that the FDA was right about how much time it takes to read these documents, it also shows that the PHMPT does not really need all 329,000 documents within 108 days.

After all, it took the PHMPT almost that long just to read 5 documents! At this rate, it will take them some 16,450 years to read all 329,000 Pfizer documents…

Read more : Pfizer Forced To Release 9 Pages Of Vaccine Side Effects?!

Fact #12 : FDA Released 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 was able to provide 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 #13 : Judge Asked FDA To Release 55,000 Pages A Month

On 6 January 2022, US District Judge Mark Pittman ordered a compromise, noting that “the Court recognises the “unduly burdensome” challenges that this FOIA request may present to the FDA“.

  • The FDA will produce “more than 12,000 pages” as it proposed, by 31 January 2022.
  • The FDA will produce the remaining documents at a rate of 55,000 pages per month, starting 1 March 2022.

Granted, the FDA did not win the right to continue processing at its own pace, but neither did the judge agree to let PHMPT force the FDA to deliver all documents within 108 days. It was ultimately a compromise.

For certain, Judge Pittman’s order would mean that the FDA would have to fully release the Pfizer vaccine documents by August 2022!

His January 2022 judgement effectively wiped out the claim that FDA will only fully release the data by 2076. So it is curious why the DiedSuddenly account on X (formerly Twitter) would repost this old claim…

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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.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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