Was Pfizer forced to disclose 9 pages proving that their COVID-19 vaccine has 1,291 side effects?!
Take a look at the viral claim, and find out what the facts really are!
Updated @ 2022-04-20 : Added a new variant of the story, and corrected several minor mistakes.
Originally posted @ 2022-03-11
Claim : Pfizer Was Forced To Release 9 Pages Of Vaccine Side Effects!
This warning from China has gone viral, claiming that after the FDA lost their court case, Pfizer was forced to release vaccine documents that would have been kept secret for 55 years!
And amongst those documents are 9 pages of proof that the Pfizer COVID-19 vaccine has 1,291 side effect!
It’s a long read, so feel free to skip to the next section for the facts…
Truth : Pfizer Was NOT Forced To Release 9 Pages Of Vaccine Side Effects!
This is yet another example of vaccine fake news created and propagated by Chinese netizens, and here are the reasons why…
Fact #1 : FDA Did Not Lose Their Case
The FDA did not lose the case brought by PHMPT (Public Health and Medical Professionals for Transparency) – the group requesting the data that the FDA used to licence the Pfizer COVID-19 vaccine.
The PHMPT demanded that the FDA redact and release 329,000 pages of documents within 108 days, which would require them to process over 91,000 pages per month.
The FDA had been processing the documents at a rate of almost 5,000 pages per month, and had already released 7 of the 8 priority items by 31 January 2022.
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 their 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.
Fact #2 : FDA Did Not Try To Suppress Pfizer Trial Data
This is a completely bogus claim, which I fact checked last year. The FDA did not ask to suppress data from the Pfizer mRNA vaccine trial.
That was the “interpretation” of Aaron Siri, the lawyer working for PHMPT. The truth is – the FDA was already releasing documents to PHMPT.
They not only released more than 12,000 pages of the requested 329,000 pages by end of January 2022, they were on track to deliver the remaining documents in about 5 years.
Fact #3 : There Is No Pfizer Report To Be Released In 2085
The fake story falsely claimed that Pfizer was forced to release a document that was “originally scheduled to be released in 2085”.
There is no such Pfizer report. Neither is Pfizer expected to produce a report for release in the year 2085.
Those documents belong to the FDA, and that is why it is the FDA that has to process, redact and release the documents, not Pfizer.
Fact #4 : Pfizer Document Was Released In November 2021
The Pfizer document that the fake story was referring to is “5.3.6 postmarketing experience.pdf“.
As the PHMPT themselves noted, it was part of the first batch of five Pfizer documents released to them on 17 November 2021.
It apparently took them more than 3 months to read through those 5 documents, and “discover” the 9 pages listing some 1,291 adverse events of special interest.
It 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.
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 pages they demanded…
Fact #5 : Pfizer Document Did Not Reveal 1,291 Side Effects
The fake story falsely claimed that the first batch of Pfizer documents included 9 pages of side effects.
There are nine pages of potential “adverse events” listed in the “List of Adverse Events of Special Interest” (AESI).
However, that was 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 in the reports of adverse events.
Think of it as a shopping list of adverse events that everyone agreed that Pfizer should be looking out for.
Even if these adverse events did occur, scientists still need to find out if they actually occurred because of the vaccine, or some other causes.
Fact #6 : 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.
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 #7 : 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.
These AESIs are usually specified before clinical trials even begin, although new ones may be added later. Hence, a generic list is used.
Fact #8 : 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 #9 : Pfizer Document Showed No New Safety Concerns
The fake story falsely claimed that the document showed that the Pfizer vaccine caused 1,200 deaths.
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 – the Pfizer document pointed out that despite looking for 1,291 potential dangers, they found no new risks from the vaccine.
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