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The FDA's deception about myocarditis
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Hi Friend,
The FDA's risk-benefit analysis used to authorize Pfizer's COVID-19 vaccine for children as young as six months is scientifically fraudulent.

This is part five of my ongoing newsletter series exposing the brazen fraud, each installment of which is a summary version from a section of the major paper I'm working on (and will probably publish as a downloadable e-book).

In case you missed any, you can read the prior newsletters here:


Today, I'll go over how the FDA, in its decision memorandum outlining its risk-benefit analysis, similarly misleads about the risk to children of myocarditis from COVID-19 versus the risk of myocarditis from COVID-19 vaccines.

To support its case for emergency use authorization (EUA) of the vaccine for infants and toddlers, the FDA suggested that vaccination would reduce the risk of children getting infection-related myocarditis. To that end, the FDA stated:

"While the overall incidence of myocarditis following COVID 19 is low, persons with COVID 19 have a nearly 16-fold increase in risk for myocarditis, compared to individuals without COVID 19."

That statement is false, and it is otherwise deceptive.

First, the source the FDA cited to support that statement did not show a "16-fold" increased relative risk for children who were diagnosed with COVID-19. It rather showed an 8-fold increased risk.

Second, the source cited did not only provide that relative risk estimate. It also provided an absolute risk estimate, pointing out that while they found an eightfold increased odds of myocarditis among COVID-19 patients, the absolute risk of a child with COVID-19 developing myocarditis was just 0.1%.

The authors remarked that this illustrated "how a very strong association of a condition with COVID 19 does not necessarily translate into a high overall risk". They also specifically emphasized the necessity of presenting both absolute and relative risk estimates for people to be able to have a meaningful understanding of the risk.

Yet, the FDA omitted the absolute risk estimate from its decision memorandum.

The FDA certainly knows better. In fact, in 2011, the FDA published a guidance document saying that "absolute risk is always more informative", and that when policymakers and providers communicate risk to the public, absolute and not only relative risk estimates should be provided.

Additionally, the FDA guidance document pointed out that both risk estimates should be quantified, since "Verbal expressions (e.g., rare, possible, large) are known to mean different things to different people and to the same people in different contexts."

Now consider again how the FDA plucked the relative risk estimate from its source and reported that quantified finding while ignoring the study authors' urging for the absolute risk to also be presented and instead brushing it aside as cryptically "low".

See, the FDA knows exactly what it is doing. The FDA knows that it is not being honest with the public.

Finally, even if the information presented by the FDA were correct, the FDA failed to produce any data to support its assumption that vaccination would reduce the risk of myocarditis among children six months to four years of age.

The clinical trial was not large enough to detect any cases of myocarditis, much less to be able to meaningfully compare the rate of myocarditis between the vaccine and placebo control groups.

As the FDA admits in its limitations section, "The risk of vaccine-associated myocarditis/pericarditis among children 6 months through 4 years of age is unknown at this time."

In my next newsletter, I'll go over how the FDA similarly deceives the public about the risk of multisystem inflammatory syndrome in children (MIS-C).

This ongoing project is being supported by generous donations from my community of readers. So far this month, 124 readers have contributed, bringing me 57% of the way toward my minimum funding goal for July.

If you appreciate the quality of the information content I provide, and if it's within your budget, please consider making a financial contribution:
In Solidarity,
Jeremy R. Hammond
Independent Journalist and Author

JeremyRHammond.com
 
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Jeremy R. Hammond
P.O. Box 76
Petoskey, Michigan 49770
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