Did recently released Pfizer documents reveal 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!
Claim : Pfizer Vaccine Documents Reveal 1,291 Side Effects!
People are sharing a Children’s Health Defense (CHD) press release, which went viral after it was posted by Yahoo.
It’s a long read, so feel free to skip to the next section for the facts…
In a 55,000-page set of documents released on Tuesday, the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is for the first time allowing the public to access data Pfizer submitted to FDA from its clinical trials in support of a Covid-19 vaccine license.
This follows U.S. District Judge Mark T. Pittman’s decision on January 6 to deny the request from the FDA to suppress the data for the next 75 years, which the agency claimed was necessary, in part, because of its “limited resources.”
Truth : Pfizer Vaccine Documents Did NOT Reveal 1,291 Side Effects!
This is yet another example of vaccine fake news being created and propagated by the Children’s Health Defense (CHD), and here are the reasons why…
Fact #1 : It Was A Children’s Health Defense Article
The “news” that was published on Yahoo News was really an article by Children’s Health Defense (CHD), an organisation well-known for creating and propagating COVID-19 and vaccine misinformation.
Yahoo News irresponsibly posted the statement, without fact checking it first, or clearly pointing out that it was a CHD statement, and not an actual news report.
They have since removed it, but the Yahoo News links and screenshots continue to circulate on social media, lending it credence.
Fact #2 : FDA Did Not Ask To Suppress Data For 75 Years
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 (Public Health and Medical Professionals for Transparency) – the group requesting the data that the FDA used to licence the Pfizer COVID-19 vaccine.
The truth is – the FDA had already released more than 12,000 pages of the requested 329,000 pages by end of January 2022, and would have completed the delivery of all documents in about 5.5 years at that rate.
Read more : Did FDA Ask For 75 Years To Release Pfizer Vaccine Data?
Fact #3 : Pfizer Document Was Released In December 2021
The Pfizer document that CHD was referring to is called “CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021“.
This document was released to the PHMPT, which promptly released it publicly on 17 November 2021.
It apparently took Children’s Health Defense 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 CHD 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…
Read more : Pfizer Forced To Release 9 Pages Of Vaccine Side Effects?!
Fact #4 : Pfizer Document Did Not Reveal 1,291 Side Effects
The “bombshell” Pfizer document lists the adverse event reports, mainly from the US VAERS and UK Yellow Card systems, as part of the post-authorisation safety monitoring requirement.
CHD’s claim that the Pfizer vaccine has 1,291 side effects is based on a “List of Adverse Events of Special Interest” (AESI) on pages 30-38 of the document.
The truth is – that was NOT a list of side effects caused by the Pfizer mRNA vaccine. Rather, that was just a list of adverse events that Pfizer was specifically looking for in the post-vaccination 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, on the same page, that this adverse event evaluation is different (distinct) from the safety evaluation of the 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 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 : AESI List Not Specific To Pfizer Vaccine
The Adverse Events of Special Interest list is not specific to the Pfizer mRNA vaccine. That was actually made clear 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.
This was a catch-all AESI list that was specified before the Pfizer clinical trial even began.
Fact #7 : AESI List Included Irrelevant Adverse Events
We know that this is a catch-all 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.
Read more : Why Adverse Events of Special Interest Are NOT Side Effects!
Fact #8 : Pfizer Document Showed No New Safety Concerns
Instead of reading the document, CHD appeared to have to spent their time counting the number of side effects Pfizer was looking out for.
If they read the Discussion and Summary + Conclusion sections, they would have noted 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 adverse events, they found no new risks from the vaccine.
Don’t risk your life or your family’s lives on the bad science and misinformation promoted by Children’s Health Defense.
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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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