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.
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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.
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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.
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.
In other words – the adverse events in the Pfizer vaccine document are not vaccine injury reports.
Read more : Why Adverse Events of Special Interest Are NOT Side Effects!
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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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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