Tag Archives: PHMPT

Did Pfizer Call mRNA Vaccines Deadliest Drug In History?!

Did Pfizer just admit that the mRNA COVID-19 vaccines are the deadliest drug in history?! Take a look at the viral claim, and find out what the facts really are!

Claim : Pfizer Calls mRNA Vaccines Deadliest Drug In History!

People are sharing an article (archive) by The People’s Voice (formerly NewsPunch), which claims that Pfizer just admitted that the mRNA COVID-19 vaccines are the deadliest drug in history!

Here is an excerpt from the article, which is long and (intentionally?) rambling. Feel free to skip to the next section for the facts!

Covid Vaccines Are Officially Deadliest Drug In History and Nobody Is Allowed to Talk About It

The Pfizer Covid-19 mRNA vaccine is now officially the most deadly drug in the history of Western medicine, killing and injuring hundreds of millions of people, with new cases emerging every single day as the fallout from the rollout continues to blow out exponentially.

But don’t take my word from it. The data that proves Covid vaccines are the deadliest drug in the long history of Western medicine is taken from Pfizer’s own documents. That’s right – Pfizer have released documents admitting the unprecedented carnage caused by their product.

This is the deadliest drug ever rolled out in human history by Pfizer’s own legally mandated 90-day post-rollout document known as Pfizer 5.3.6.

Dropped on April Fools Day 2022 after being ordered by a federal judge, this Pfizer document is available to everybody – but of course the mainstream media has done everything they can to suppress knowledge about what it contains.

This is the same document in the video above. The page shown in the video proves Pfizer’s experimental mRNA vaccine is not only the deadliest drug ever rolled out in human history, it is also by far and away the most injurious drug.

You can see an injure-to-kill ratio in the video above. 33.4 to 1. For every death, more than 33 people have been injured by the vaccine. Remember this is Pfizer’s own data.

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Truth : Pfizer Did Not Call mRNA Vaccines Deadliest Drug In History!

This is yet another example of FAKE NEWS created / promoted by The People’s Voice, and here are the reasons why…

Fact #1 : Pfizer Did Not Call mRNA Vaccines Deadliest Drug In History

This is really silly, but let me start by pointing out that Pfizer never said / admitted / called the mRNA COVID-19 vaccines the deadliest drug in history.

The People’s Voice article certainly offered no evidence to back up its “fact checked” claim. Did it include a link to a Pfizer statement? A quote by Pfizer CEO Albert Bourla whose visage featured prominently in their video cover?

Nope. Zilch. Nada. Not a single shred of evidence that Pfizer ever called the mRNA vaccines the “deadliest drug in history”.

Fact #2 : FDA Released Pfizer Documents

The People’s Voice article claimed that Pfizer released documents “admitting the unprecedented carnage caused by their product”. That’s not true – Pfizer did not release any documents.

It was the US FDA that was releasing those Pfizer documents under a Freedom of Information Act (FOIA) request by the PHMPT (Public Health and Medical Professionals for Transparency) group.

Fact #3 : FDA Released Pfizer 5.3.6 Document In 2021

The People’s Voice article claimed that the Pfizer 5.3.6 document was “dropped on April Fools Day 2022”, but that’s not exactly true either.

The Pfizer 5.3.6 Postmarketing Experience document was first released by the FDA to the PHMPT (Public Health and Medical Professionals for Transparency) group, with three small pieces of information redacted on 17 November 2021.

The FDA later decided that the redacted information were not confidential after all, and reissued the same document in full on 1 April 2022. You can read more about this here.

Fact #4 : Pfizer 5.3.6 Deaths + Injuries Were Not Vaccine-Linked

The People’s Voice video pointed out that the Pfizer 5.3.6 document appears to list 42,086 injuries, and 1,223 deaths. That’s not accurate.

The deaths and injuries listed in the Pfizer 5.3.6 document were not linked to the mRNA vaccine, because it was based on the “List of Adverse Events of Special Interest” (AESI).

This AESI list is not a list of side effects caused by the Pfizer mRNA COVID-19 vaccine. Rather, it is a list of adverse events that Pfizer must look for post-vaccination case reports. As the Pfizer document noted on Page 16 (with my emphasis in bold) :

The AESI terms are incorporated into a TME list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.

Pfizer also pointed out that this adverse event evaluation is different (distinct) from the safety evaluation of its COVID-19 vaccine.

This is distinct from safety signal evaluations which are conducted and included, as appropriate, in the Summary Monthly Safety Reports submitted regularly to the FDA and other Health Authorities.

Claiming that these are vaccine side effects is like pointing to a list of prosecutable crimes in a legislation, and calling it a list of crimes the government actually committed. That’s how stupid it really is.

Fact #5 : Adverse Events Are Not Side Effects

I should now point out that adverse events are not necessarily side effects. Adverse events are “unfavourable” or “unintended” events that happen after vaccination or taking a drug, like having an anaphylactic reaction or getting into a car accident.

All reported adverse events have to be investigated to find out if they are related (anaphylactic reaction) or not (getting into a car accident) to the vaccine or drug that was taken.

Even if an adverse event was “possibly caused” by the vaccine, it must still be confirmed that the vaccine directly caused it, because an anaphylactic reaction (for example) can also occur from a bee sting, or an existing peanut allergy.

Only once an adverse event is confirmed to be caused by the vaccine, is it then a vaccine side effect. Otherwise, it is merely an adverse event, not a side effect.

Fact #6 : The People’s Voice Is Known For Publishing Fake News

The People’s Voice is the current name for NewsPunch, which possibly changed its name because its brand has been so thoroughly discredited after posting numerous shocking but fake stories.

Founded as Your News Wire in 2014, it was rebranded as NewsPunch in November 2018, before becoming The People’s Voice. A 2017 BuzzFeed report identified NewsPunch as the second-largest source of popular fake news on Facebook that year.

Its articles have been regularly debunked as fake news, so you should never share anything from NewsPunch / The People’s Voice. Here are some of its fake stories that I fact checked earlier:

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

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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

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.

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.

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…

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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FDA Refused To Release Vaccine Myocarditis Results?!

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Did the FDA refuse to release results from studies investigating subclinical myocarditis caused by the Moderna COVID-19 vaccine?!

Take a look at the viral claim, and find out what the facts really are!

Claim : FDA Refused To Release Vaccine Myocarditis Results!

People are sharing an article by The Epoch Times which claims or suggests that the US FDA is refusing to release results from studies investigating subclinical myocarditis caused by the Moderna COVID-19 vaccine!

Here is an excerpt of The Epoch Times article. Feel free to skip to the next section for the facts:

FDA Has Results of Subclinical Myocarditis Studies, but Won’t Release Them Yet

The U.S. Food and Drug Administration (FDA) has received results from two studies of subclinical heart inflammation following Moderna COVID-19 vaccination, but is refusing to release them to the public—at least for now.

FDA officials in January 2022 directed Moderna to run three prospective studies on subclinical myocarditis, or heart inflammation without symptoms, after COVID-19 booster vaccination. One study, mRNA-1273-P204, would examine the incidence of subclinical myocarditis in children aged 6 months through 11 years. Another, mRNA-1273-P203, would examine the incidence in adolescents aged 12 years through 17 years. The third, mRNA-1273-P301, would examine the incidence in adults.

Moderna has shared the results of the P203 study with the FDA, an FDA spokeswoman told The Epoch Times in an email. But she declined to provide them. To obtain the results, she said, The Epoch Times would need to request them under the Freedom of Information Act (FOIA).

“The FDA doesn’t post PMR/PMC study reports,” she said, using acronyms for postmarketing requirements and postmarketing commitments, or requirements and commitments pharmaceutical companies make when receiving FDA clearance for their products. “They may be requested under FOIA.”

The spokeswoman did not disclose why the FDA doesn’t release the results absent a FOIA request. Moderna has not responded to requests for comment. The Epoch Times has submitted a FOIA request for the results but has not yet received them.

Jessica Adams, a former FDA officer, asked for the P301 study results in July. She requested quick processing because, according to cardiologists, subclinical myocarditis can result in serious problems. She cited a recent study that discovered some sudden deaths in South Korea were caused by myocarditis, even though no inflammation was detected until autopsy.

The matter “represents an urgent and imminent threat to young people who may be mandated to take this vaccine,” Ms. Adams told the FDA.

A number of U.S. colleges have required COVID-19 vaccination for attendance. Some are requiring the newest version of the shots from Moderna, Pfizer, and Novavax, even though they were authorized with human data from just 50 people.

The FDA rejected the bid for quick processing.

“You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual,” Sarah Kotler, an FDA FOIA official, told Ms. Adams. “Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged federal government activity.”

An appeal was also turned down.

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No Evidence FDA Refused To Release Vaccine Myocarditis Results

In this article, I will go through some of their points, and show you what the facts really are!

Fact #1 : Moderna Studies Started In 2020-2021

First, let me start by pointing out that the three Moderna studies mentioned in The Epoch Times article did not begin in 2022. Rather, they started in 2020 / 2021:

mRNA-1273-P203 (NIH link) : 2020-12-09
mRNA-1273-P204 (NIH link) : 2021-03-15
mRNA-1273-P301 (NIH link) : 2021-05-28

Fact #2 : FDA Did Not Order Those Studies In 2022

The Epoch Times article claimed that “FDA officials in January 2022 directed Moderna to run three prospective studies on subclinical myocarditis“, and provided this FDA document (PDF download as evidence.

If you actually look at the FDA document, titled Summary Basis for Regulatory Action, you’ll realise that it tells a completely different story:

it stated that the Review Committee recommended the approval of the Moderna SPIKEVAX mRNA vaccine for COVID-19
it mentioned the P203, P204, and P301 studies which were already running by then.
it stated that Moderna requested the deferment of three paediatric studies, including P203 and P204.
it stated that the FDA approved Moderna’s request to defer the paediatric studies in December 2021.

To address requirements of the Pediatric Research Equity Act, the Applicant submitted a request for deferral of the following studies in pediatric individuals ˂18 years of age because the mRNA-1273 vaccine would be ready for approval for use in adults before such studies could be completed. The deferred studies are:

Deferred pediatric study P203 to evaluate the safety and effectiveness of mRNA-1273 vaccine in children 12 years through 17 years of age
Deferred pediatric study P204 to evaluate the safety and effectiveness of mRNA-1273 vaccine in children 6 months to <12 years of age
Deferred pediatric study to evaluate the safety and effectiveness of mRNA-1273 vaccine in infants <6 months of age

The deferral request and pediatric plans were accepted without revisions by the FDA Pediatric Review Committee on December 14, 2021.

To be clear – the P203, P204, and P301 studies were already running in 2021 – long before the FDA released that PDF.

Fact #3 : FDA Has PMR/PMC Website

The FDA requires manufacturers of certain drug products (including vaccines) to conduct postmarket studies and clinical trials to assess for possible serious risks associated with those drugs / vaccines.

Referred to as postmarket requirements (PMRs) and postmarket commitments (PMCs), these studies are conducted after the approval of the drugs / vaccines.

You can actually look up PMR / PMC studies on the FDA website (link). Here are the results of the three Moderna trials mentioned in the article:

mRNA-1273-P203 : Final report submitted to FDA on 13 January 2023
mRNA-1273-P204 : Study is ongoing
mRNA-1273-P301 : Study is ongoing

Fact #4 : PMR / PMC Report May Be Requested

Even though the FDA regularly releases information about PMR / PMC studies, it does not release the actual data or results. This is not just for COVID-19 vaccines. This policy extends to all PMR / PMC studies.

As an FDA spokesperson explained to The Epoch Times, those reports may be requested through a FOIA (Freedom of Information Act) request.

The FDA doesn’t post PMR/PMC study reports. They may be requested under FOIA.

You may wondering why the FDA cannot publicly release PMR / PMC study results. That’s because those documents may contain classified information, personal information, confidential business details, or even trade secrets.

Anyone can make a FOIA request for these reports, but the FDA must first go through the reports, and redact information that are exempt from disclosure under FOIA, before they can be released.

Fact #5 : FOIA Delays Due To Excessive Requests

Ironically, a key reason why the FDA cannot expedite FOIA requests for those three Moderna studies is because it was compelled by US District Judge Mark Pittman to expedite the processing of some 329,000 pages of documents requested by PHMPT looking into the Pfizer COVID-19 vaccine!

That decision came after the PHMPT demanded that the FDA release all those documents within 108 days. Now that the FDA is compelled to focus on processing those documents, it has far less resources to process other FOIA requests.

Fact #6 : No Evidence Of Vaccine Subclinical Myocarditis

While the article appears to suggest that the Moderna P203 study results may prove that the Moderna mRNA vaccine causes subclinical myocarditis, it offers no proof of that. The article only points out that:

Moderna submitted its final report on the P203 study to the FDA
The Epoch Times requested for the Moderna report
The FDA told The Epoch Times to file an FOIA request
The Epoch Times filed its FOIA request in July 2023
The Epoch Times has not received the report as of 11 October 2023

Jessica Adams, who requested the P301 study results in July 2023, was told by the FDA that it would take “at least two years” for her to receive the results.

The Epoch Times article actually mentioned this, so there is no reason to believe that its P203 request made in the same month would be released anytime soon.

To be clear – there is not even a hint of smoke, because none of them actually have access to any of the three Moderna study results – two of which are still ongoing!

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Don’t forget to protect yourself, and your family, by vaccinating against COVID-19!

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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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Did Pfizer Ignore Vaccine Autoimmune Adverse Events?!

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Did Pfizer ignore evidence that their COVID-19 vaccine caused many autoimmune adverse events?!

Take a look at the viral claim, and find out what the facts really are!

Claim : Pfizer Ignored COVID-19 Vaccine Autoimmune Adverse Events!

People are sharing an article by DailyClout, which claims to have found evidence that immune-mediated or autoimmune adverse events in a Pfizer COVID-19 vaccine document were ignored!

Here is their long article for reference. Feel free to skip to the next section for the facts!

1,077 Immune-Mediated/Autoimmune Adverse Events in First 90 Days of Pfizer mRNA “Vaccine” Rollout, Including 12 Fatalities. Pfizer Undercounted This Category of Adverse Events by 270 Occurrences.

The War Room/DailyClout Pfizer Documents Analysis Project Post-Marketing Group (Team 1) – Joseph Gehrett, MD; Barbara Gehrett, MD; Chris Flowers, MD; and Loree Britt – wrote an important review of immune-mediated/autoimmune adverse events found in Pfizer document 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021 (a.k.a., “5.3.6“). This category is comprised of the numerous diseases resulting from disordered immune attacks against tissues of any of the body’s organs. However, it excludes anaphylaxis which has its own separate report, as well as autoimmune diseases attaching nerve tissue (e.g., Guillain-Barré), which have been explored in other 5.3.6 neurological and musculoskeletal reports.

It is important to note that the adverse events (AEs) in the 5.3.6 document were reported to Pfizer for only a 90-day period starting on December 1, 2020, the date of the United Kingdom’s public rollout of Pfizer’s COVID-19 experimental mRNA “vaccine” product.

Highlights of this report include:

Twelve immune-mediated/autoimmune adverse events were fatal.
Of adverse events with gender specified, 77% (526) were female, and 23% (156) were male – a female to male ratio of 3.4 to 1.
Ages of affected patients were 19% elderly, 71% adult, <1% adolescent, and 10% not reported.
Time from vaccination to onset was given for 75% of events with a range of 24 hours to 30 days. Half started within 24 hours of injection.
Only immune-mediated/autoimmune diseases or conditions with over 10 cases are included in Pfizer’s reporting, leaving out 270 adverse events of this type. Thus, adverse events in this category were undercounted by Pfizer.
Adverse events in this group include:
- Hypersensitivity (which is not further defined, though it accounts for 55% of the AEs.
- Peripheral neuropathy, which often causes weakness, numbness and pain, usually in the hands and feet, and can also affect other areas and body functions including digestion, urination, and circulation.
- Pericarditis (inflammation of the lining of the heart).
- Myocarditis (immune attack against the heart muscle).
- Encephalitis (brain inflammation disorders).
- Diabetes.
- Psoriasis.
- Dermatitis.
- Blistering Skin disorder.
- Autoimmune disorder.
- Raynaud’s phenomenon.
Immune rejection of transplanted organs was not mentioned whether from there being zero instances of it or, perhaps, because there were 10 or fewer instances.

Pfizer concluded, “This cumulative case review does not raise new safety issues. Surveillance will continue.” However, as of the date of this report, 25.5 months after the completion of Pfizer’s post-marketing analysis, no additional safety data has been released to the public.

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Truth : Pfizer Did Not Ignore COVID-19 Vaccine Autoimmune Adverse Events!

This is yet another example of FAKE NEWS by anti-vaccination activists, and here are the reasons why…

Fact #1 : This Document Was First Released In Nov. 2021

First, let me just point out that the Pfizer 5.3.6 Postmarketing Experience document was first released by the FDA to the PHMPT (Public Health and Medical Professionals for Transparency) group, with three small pieces of information redacted on 17 November 2021.

The FDA later decided that the redacted information wasn’t confidential after all, and reissued the same document in full on 1 April 2022. You can read more about this here.

The redacted information have no bearing on this current issue, so it looks like the DailyClout team took about 17 months to scour through this 9-page document. Impressive.

Fact #2 : Adverse Event Data In That Document Was Global

I don’t know if DailyClout was trying to be misleading when it mentioned the United Kingdom rollout, or it was just referring to the start of the adverse event monitoring.

Just to be clear – the adverse event data in the Pfizer 5.3.6 document includes reported US and foreign adverse events, as stated in the last paragraph of its introduction.

This document provides an integrated analysis of the cumulative post-authorization safety data, including U.S. and foreign post-authorization adverse event reports received through 28 February 2021.

Fact #3 : First Pfizer Vaccine Was Administered On 8 December 2020

DailyClout stated that December 1, 2020 was the date of the United Kingdom’s public rollout. That’s incorrect.

The first person in the world to receive the Pfizer COVID-19 vaccine was Margaret Keenan, a 90 year-old UK grandmother, who received it at 6:31 AM GMT, on 8 December 2020.

The Pfizer 5.3.6 document clearly states, in 3 different locations, that the 1 December 2020 date referred to “the first temporary authorization for emergency supply” under Regulation 174 in the UK.

In other words, 1 December 2020 was the date when Pfizer was authorised to supply their COVID-19 vaccine to the United Kingdom. It was not the start of the UK vaccination programme, which only started a week later – on 8 December 2020.

Fact #4 : Adverse Events Are Not Side Effects

I should now point out that adverse events are not side effects. Adverse events are “unfavourable” or “unintended” events that happen after vaccination or taking a drug, like having an anaphylactic reaction or getting into a car accident.

As Pfizer noted in Page 6, the large number of adverse event reports (AERs) do not necessarily mean that they are actually caused by the vaccine. In fact, open reporting systems like VAERS and Yellow Card are notably open to abuse, and false reporting.

That’s why reported adverse events have to be investigated to find out if they are related (anaphylactic reaction) or not (getting into a car accident) to the vaccine or drug that was taken.

Only once an adverse event is confirmed to be caused by the vaccine, is it then a vaccine side effect. Otherwise, it is merely an adverse event, not a side effect.

In other words – the adverse events in the Pfizer vaccine document are not vaccine injury reports.

Fact #5 : 11X More People Died Of COVID-19

DailyClout highlighted that “twelve immune-mediated/autoimmune adverse events were fatal”, but interestingly, did not point out that the same document showed that 136 people died from COVID-19.

I should pointed out that those twelve immune-mediated / autoimmune adverse events were not verified to be caused by the vaccine.

But even if we assume that they all were caused by the Pfizer vaccine, the data in the 5.3.6 document showed that you are 11 ⅓ times more likely to die from COVID-19 than an autoimmune adverse event.

Fact #6 : It Was A List Of Most Frequently Reported AEs

DailyClout claimed that Pfizer undercounted autoimmune adverse events, but that’s not true.

The Pfizer report specifically mentioned that 1,050 immune-mediated / autoimmune adverse events were reported, of which 760 were medically confirmed, and 290 were not.

It then goes on to list the “most frequently reported” adverse events, which was defined as “>10 occurrences“. That doesn’t mean Pfizer “ignored” them. The remaining 221 cases were still accounted for.

The report was just listing the “most frequently reported” adverse events! It wouldn’t be a list of the “most frequently reported” adverse event if it listed every adverse event!

The cut-off point of 10 occurrences appear to have been chosen because such adverse events would account for less than 1% of all reports. Not very frequent then, is it?

Fact #7 : Scary Photos Are Of Raynaud’s Phenomenon

The DailyClout article used scary looking photos of discoloured hands. Those are actually photos of patients suffering from Raynaud syndrome, which is also known as Raynaud’s phenomenon.

Raynaud’s phenomenon is actually mentioned in the Pfizer 5.3.6 document. It’s listed as one of the more common reported adverse events, albeit just making the cut at 11 reports (1%).

Fact #8 : Raynaud’s Phenomenon Was First Described In 1862

Just to be clear – Raynaud’s phenomenon is not new. It was named after Auguste Gabriel Maurice Raynaud, who first described it in his doctoral thesis in 1862.

Raynaud syndrome is often idiopathic – it develops spontaneously, typically between 15 and 30 years in age and more commonly in female.

The secondary type is less common, and is associated with other autoimmune diseases like lupus or scleroderma, generally affecting older people.

Raynaud’s phenomenon is also pretty common – affecting some 4% of people globally. Hence, a 1% reporting rate is far lower than the background rate, and would rule out the Pfizer COVID-19 vaccine as a cause of Raynaud’s phenomenon.

There is certainly no evidence that any COVID-19 vaccine causes Raynaud’s phenomenon. So DailyClout likely used these photos for its “shock value”.

Fact #9 : These Are Old Photos From Wikipedia

You may think that these are the hands of people who developed Raynaud’s phenomenon after getting the Pfizer COVID-19 vaccine.

The truth is – these Raynaud’s phenomenon photos are not new. In fact, they date back to at least 2011, and Wikipedia was the source!

Fact #10 : No New Safety Concerns Despite 158K Adverse Event Reports

The Pfizer document noted after shipping 126 million doses, 42 thousand people reported over 158,000 adverse events in the first 3 months.

Even if we assume that they are all genuine, only 0.033% of people who received the Pfizer vaccine reported at least one adverse event. That’s 1 in 3,000 people.

And yet, despite so many reported adverse events, their investigation showed that the “data do not reveal any novel safety concerns or risks“.

Pfizer could only confirm that anaphylaxis is an important risk of the COMIRNATY vaccine.

In other words – the 158K adverse events were weighed, measured… and found wanting. There was NO NEW SAFETY CONCERN with the vaccine!

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Why Adverse Events of Special Interest Are NOT Side Effects!

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Pfizer looked out for 1,291 Adverse Events of Special Interest after their COVID-19 vaccine was approved and used to vaccinate billions of people around the world.

Find out why these Adverse Events of Special Interest (AESI) are not actual vaccine side effects!

Claim : Adverse Events of Special Interest Are Vaccine Side Effects!

People keep sharing a list of 1,291 adverse events in 9 pages of a Pfizer document that was recently released by the FDA.

They are claiming that these are actual side effects of the Pfizer vaccine. Some claimed that this is proof that Pfizer was fully-aware that their vaccine caused those 1,291 side effects.

Some also claimed that these Adverse Events of Special Interest (AESI) are the reason why Pfizer tried to block the release of those documents for 75 years!

Truth : Adverse Events of Special Interest Are Not Vaccine Side Effects!

The truth is those 1,291 adverse events of special interest (AESI) are not side effects of the Pfizer COVID-19 vaccine.

People making these false claims are accidentally misinterpreting OR intentionally misrepresenting what the document said.

And here are the facts you need to know…

Fact #1 : Pfizer Document Was Released Months Ago

These false claims are based on a Pfizer document called “5.3.6 postmarketing experience.pdf“, which the US FDA released to the PHMPT on 17 November 2021.

It apparently took them more than 3 months to read that document, and “discover” the 9 pages of 1,291 adverse events of special interest.

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

After all, it took anti-vaccination activists almost that long just to read 5 documents! At this rate, it will take them some 16,450 years to read all 329,000 pages related to the Pfizer vaccine approval…

Fact #2 : Pfizer Document Did Not Reveal 1,291 Side Effects

The “List of Adverse Events of Special Interest” (AESI) is NOT a list of side effects caused by the Pfizer mRNA vaccine.

Rather, that was a list of 1,291 potential adverse events that Pfizer was specifically looking for when vaccinated people send in their reports through VAERS or the Yellow Card systems.

Think of it as a shopping list of adverse events that Pfizer wanted their post-authorisation safety teams to look out for.

Even if these adverse events did occur, researchers still need to find out if they actually occurred because of the vaccine, or some other causes.

Fact #3 : Adverse Events Are Not Side Effects

I should now point out that adverse events are not side effects.

Adverse events are “unfavourable” or “unintended” events that happen after vaccination or taking a drug, like having an anaphylactic reaction or getting into a car accident.

All reported adverse events have to be investigated to find out if they are related (anaphylactic reaction) or not (getting into a car accident) to the vaccine or drug that was taken.

Only once an adverse event is confirmed to be caused by the vaccine, is it then a vaccine side effect. Otherwise, it is merely an adverse event, not a side effect.

Fact #4 : AESI List Not Specific To Pfizer Vaccine

The Adverse Events of Special Interest list is not specific to the Pfizer mRNA vaccine. It’s actually stated on Page 16 of the document.

The company’s AESI list takes into consideration the lists of AESIs from the following expert groups and regulatory authorities: Brighton Collaboration (SPEAC), ACCESS protocol, US CDC (preliminary list of AESI for VAERS surveillance), MHRA (unpublished guideline).

The AESI terms are incorporated into a TME list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.

These AESIs are usually specified before clinical trials even begin, although new ones may be added later. Hence, a generic list is used.

Fact #5 : AESI List Includes Irrelevant Adverse Events

We know that this is a generic AESI list, because it included diseases involving other viruses – Herpes, MERS, Varicella; as well as “exposure to SARS-CoV-2” and other “communicable disease”.

The list also included manufacturing and lab test issues, like “Manufacturing laboratory analytical testing issue, Manufacturing materials issue, Manufacturing production issue“.

Even product supply issues were included – “Product availability issue, Product distribution issue, Product supply issue“.

They are obviously not vaccine side effects, nor related in any way to the performance or safety of the vaccine.

Fact #6 : Pfizer Document Showed No New Safety Concerns

The document actually showed that despite monitoring for 1,291 adverse events of special interest, Pfizer found no new risks from the vaccine.

If you read the Discussion and Summary + Conclusion sections, you will see that the data :

did not reveal any “novel safety concerns or risks”
support “a favourable benefit risk profile” of the vaccine

In other words – Pfizer looked for “1,291 potential dangers” associated with vaccines in general, and found NO NEW SAFETY CONCERNS / RISKS.

Don’t risk your life or your family’s lives on the bad science and misinformation promoted by anti-vaccination activists.

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

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

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

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 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 #10 : 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…

Fact #11 : 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 #12 : 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.

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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