By T.J. Coles
This is part eight in our series. For articles 1 to 7, click here.
Photo: AJY
In previous articles, I made the not-too-brilliant prediction that Pfizer was dumping boring datasets to numb the minds of researchers and make them disinterested in the papers.
As a result, when major revelations appear, no one would notice.
Unfortunately, this simple hypothesis may be correct.
THE NEW BATCH
The latest batch of documents (January 2023) contains some astonishing information confirming that the company marketed a dangerous experimental product, skipping Phase IV trials — which are usually long-term, large population safety studies — in favour of a speedy rollout under emergency use authorisation.
The new documents confirm that the company knew about the increased risk of myocarditis, but did not pull the product.
Not only that, but the documents show track-changes in which both Pfizer and the US Food and Drug Administration (FDA) re-wrote key words in the “prescribing information” sheet (for health professionals), the most serious of all adjustments appears to be the rounding down of adverse events to zero.
The documents also confirm that the company acknowledged that no trials had been undertaken to confirm the safety of mix-and-match injections and boosters–e.g., a Pfizer first schedule with an AstraZeneca booster. Yet, governments told us it was safe to combine different injectable products.
In development, the Pfizer-BioNTech injectable product was called BNT162b2.
When it was marketed, the company named it Comirnaty.
THE DOCUMENTS
The latest batch of documents includes paperwork for the inserts, as well as instructions for nurses. In theory, these were publicly-available documents, but the public never got to see them.
The “prescribing information” draft is dated August 2021, when medical professionals and propaganda were still denying a link between the injection and heart-related adverse events.
For instance, the New York Times ran with: “CDC is investigating heart problems in a few young COVID vaccine recipients” — CDC being the US Centers for Disease Control and Prevention.
Notice the minimisation: “a few” and “young.”
A more accurate headline would be: “COVID injection increases risk of heart problems, particularly in young people.”
But there was no need for public authorities to investigate. Rather, the product should have been pulled.
Scandalously, the Pfizer papers were quite open. The prescribing information says:
“Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management…”
Minus the “short-term” stipulation, the final sentence may sound somewhat reassuring, but consider the following line:
“Information is not yet available about potential long-term sequelae” (a new condition triggered by previous injuries).
Another example of pro-injection propaganda circulating at the time, despite corporate internal warnings, is the New York Times stating: “Heart problems following vaccination in the U.S. are uncommon and short-lived, researchers reported.”
ADVERSE EVENTS
Appallingly, Pfizer advised medical professionals to report to the company in the first instance of patients experiencing adverse events. It recommended professionals contact the US government’s Vaccine Adverse Event Reporting System (VAERS) second:
“To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.”
Report to the company? Why?
For damage control?
Surely adverse events should, in the first instance, be reported to health authorities?
Recall American nurse, Tiffany Dover, who received a Pfizer injection live on air in order to promote the product, and then collapsed moments later? Dover later claimed that she has a rare condition that causes her to faint when experiencing even mild pain.
But Pfizer’s own prescribing information says:
“Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting.”
Quite amazingly and in a single paragraph, Pfizer debunks the entirety of its own clinical trials in relation to adverse events. The document says:
“Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.”
What? The real world is too complicated to accurately reflect the conditions of clinical trials?
So, what was the point of the trials?
This is why Phase IV studies usually exist: to apply laboratory conditions to everyday life.
RE-WRITING THE DOCUMENT
Pfizer says that it did “not have a source table for non-serious AEs” (adverse events).
Referring to a one-month period after the second dose for participants aged 16 to 55, the original line read: “In an analysis of serious and all adverse events…”
But Pfizer changed this to read: “In an analysis of all adverse events …”
In other words, they minimised the wording to reduce reference to serious adverse events.
The percentages of Pfizer-to-placebo participants experiencing adverse events included 0.2 v. <0.01 who experienced decreased appetite, 0.1 v. <0.01 hyperhidrosis (excess sweating), 0.1 v. 0.01 lethargy, and night sweats 0.1 v. 0.01.
Pfizer rounded the placebo group to zero, so medical professionals therefore have no real way of comparing the rate of injection-related adverse events to the placebo group.
In addition, it looks better on paper for Pfizer to have an adverse event ratio of 0.1 to 0, than 0.1 to 0.01, because the latter puts the former into context.
Interestingly, the FDA suggested “that the numbers in this paragraph [should] only include the non-serious adverse events.”
Perhaps wanting to protect their public image, Pfizer lobbied to keep the serious adverse event data in the particular paragraph.
PREGNANCY
Having exploded its own clinical trial data by saying that lab tests do not apply to the complexities of reality, Pfizer then writes:
“The following adverse reactions have been identified during postmarketing use of COMIRNATY, including under Emergency Use Authorization.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.”
Isn’t that their job, along with the FDA and CDC?
They included:
- Cardiac disorders, particularly myocarditis and pericarditis;
- Gastrointestinal disorders (diarrhoea and vomiting);
- Immune system disorders (angioedema, anaphylaxis, pruritus, rash, and urticaria (hives));
- Musculoskeletal and connective tissue disorders.
One final revelation: Pfizer did not bother to conduct long-term studies into the impact of the injection on pregnant women:
“Available data on COMIRNARTY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
But this not what the lying, fake news media told us.
They consistently told naive, pregnant women that the injection was safe and necessary, even though the internal documents say that Pfizer and the FDA didn’t even know.
CONCLUSION
In summary, Pfizer and/or the FDA:
- Rounded down patient data;
- Deleted passages in instructions to minimise reference to severe injury;
- Acknowledged that its trials had no real-world application in terms of measuring adverse events;
- Found adverse events post-marketing yet did not withdraw the product;
- And encouraged media and authorities to force pregnant women to get injected via “vaccine mandates” despite acknowledging that no safety data exist.
Stay tuned for part nine.
Dr. T.J. Coles is the author of several books, including — The War on You.
Check out T.J’s Amazon page by clicking here.
View more TOTT content from Coles here.
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The trials are a complete joke. Don’t even waist your time. It has no real world safety data, because if you have been following Team Enigmas work, Sasha has revealed through painstaking research that the DOD is behind it all. The current legal framing which was set up by the 3 previous USA Presidents, all working in relay, allows EUA trials to be purely ‘Demos’ and not regarded as actual trials. Merely mock trials to install public trust.