Pfizer’s Secret Documents - XXXII:
Report 97: Posted 3/25/24
https://dailyclout.io/report-97-pfizer-obscured-myocarditis-safety-signal-specific-to-young-men-fda-did-not-notice-until-may-2021/
Joyce Allen, RN; Linnea Wahl, MS
Pfizer Obscured Myocarditis Safety Signal Specific to Young Men. FDA Did Not Notice Until May 2021.
“Career scientists are struggling with attention to detail in fulfilling their vaccine safety duties. Their conclusions, marked by errors and oversights, have led to lives lost and debilitating disorders, as proven by the government scientists’ own review documents.
In spring 2021, the US Food and Drug Administration (FDA) granted emergency use authorization for the Pfizer mRNA COVID-19 drug to be given to children older than 12 years and renewed its approval for adults. These approvals came despite the fact that FDA officials had reviewed and signed off on data proving that Pfizer’s mRNA drug was dangerous, especially to young men and boys. …
Consider … the job description of the professionals evaluating vaccines for emergency use: “The FDA staff are career scientists and physicians who have globally recognized expertise … they are fathers, mothers, daughters, sons, sisters, brothers and more. They … are also directly impacted by the work that they do, and are exactly who you want making these important … decisions … “
Now consider these … examples of how the “globally recognized expertise” of FDA staff ignored safety signals that brought misery and even death to young men …”
Missing the Signal in Monthly Safety Data
From December 2020 until September 2021, Pfizer collected data on the safety of its mRNA COVID-19 drug and submitted summaries of the data to FDA … FDA employees, in turn, reviewed the Pfizer data … and prepared checklists documenting their reviews. … These … checklists reveal much …
… who are the FDA employees who prepared and reviewed these checklists?
[The piece goes on to detail three reviewers and their backgrounds - one a preventive medicine specialist, another a biochemist and the third a ‘regulatory information specialist.’]
Each month … answered … question 4: “Have there been any new safety issues …” Each month, she marked the “YES” box and … concluded that “the contents of this … [periodic adverse experience report] do not indicate a need for further regulatory action …” …
Each month, that is, except one. In the May 2021 data, … finally noticed that Pfizer’s data signaled that heart disease - specifically, myocarditis - could be a safety issue for young men …
How would the FDA’s “globally recognized career scientists” identify a safety signal … Pfizer’s monthly data summaries provide one such metric, the observed-to-expected (O/E) ratio. … this ratio compares the number of people who are observed with an adverse event … to the number of people who are expected to have the disease without receiving the drug. An O/E greater than 1 is a safety signal: more people are getting the disease after receiving the drug than is normal …
For myocarditis, European researchers had published expected values, based on European healthcare databases, as of December 2020 … In this database, the lowest expected value for myocarditis was in the population of Spain. Yet the Pfizer monthly O/E values … used a much higher expected value … that of the population of Sweden published in 2007 …
Worse, the Pfizer monthly O/E value calculated for May 2021 used an even higher expected value … from the Italian population. The Italian expected value is more than double the Swedish expected value …
And even worse yet, for data from January to May 2021, Pfizer researchers made no attempt to identify myocarditis risks by age or sex. Using a single, all-ages, all-sexes expected value for myocarditis, Pfizer was able to obscure any safety signal specific to young men.
[Here the piece goes on to ask why Pfizer’s reviewers didn’t notice any of this until an Israeli researcher pointed out the high incidence of myocarditis in young men in that country.]
Clearly, the FDA employees with “globally recognized expertise” missed a critical safety signal. They are exactly NOT “who you want making these important public health decisions for the United States.”
My Takeaways: This report goes on at some length questioning the process used by Pfizer. Once the myocarditis risk was finally acknowledged, it did not prompt any action. Rather merely continuing post-marketing safety surveillance was advised.
How was the signal missed? Was it intentional? Was it mere happenstance that unusually high expected values were used for comparison and not average expected values in calculating safety signals? Was it normal to mix all ages and sexes when calculating, and not separating these out when myocarditis incidence is known to vary by age group and gender?
The report rightly questions how many deaths and disabilities occurred due to this process. And it notes the marked lack of accountability.
Finally I will quote from “The Rest of the Story” section of the report: “This is but a small piece of the mRNA COVID-19 drug tragedy - a handful of FDA employees, a small subset of Pfizer and FDA documents, but countless lives lost or destroyed. What will the full story reveal? Are FDA’s “globally recognized career scientists” at fault? Are these really the people we want in charge of health care for ourselves, our families, and our neighbors?”
In health,
DocofLastResort