FDA used “critically flawed” risk-benefit analysis to approve covid “vaccines” for children
02/07/2022 // Ethan Huff // Views

The risk-benefit analysis used by the U.S. Food and Drug Administration (FDA) to grant emergency use authorization (EUA) to Pfizer's Wuhan coronavirus (Covid-19) "vaccine" for children aged 5 to 11 is "critically flawed," warns Children's Health Defense (CHD).

The FDA failed to take into account natural immunity, for instance, which U.S. Centers for Disease Control and Prevention (CDC) data, as of June 2021, estimates is held by upwards of 42 percent of all children aged 5 to 11. More recent estimates would likely show an even higher level of seroprevalence.

"The FDA's risk-benefit assessment failed to account for the large proportion of children in the United States who already had COVID-19, recovered from it and now have natural immunity," writes Luke Yamaguchi.

"For these millions of children, the risks of COVID-19 vaccination outweigh the benefits, as studies show natural immunity is superior to vaccine-induced immunity."

An FDA senior advisor admitted that if natural immunity is at least equivalent to vaccine immunity – it turns out that natural immunity is far better than so-called vaccine immunity – then this would result in a 45 percent reduction in all of the alleged benefits outlined in the FDA's risk-benefit analyses.

"Using the FDA's risk-benefit analysis (shown above) and conservatively adjusting for 42% of children having already acquired natural immunity through prior COVID-19 infection, the risk of hospitalization from vaccine-related heart inflammation in 5 to 11 year-old boys is greater than the number of COVID-19 hospitalizations prevented by vaccination," Yamaguchi further points out.


FDA has been lying about the number of "covid" hospitalizations in children

Another thing the FDA conveniently overlooked is rates of myocarditis, which the agency vastly underestimated as a potential consequence of children getting "vaccinated."

The FDA's risk-benefit analysis assumed an incidence rate of 106 myopericarditis cases per one million children vaccinated. However, a Kaiser Permanente study found that the actual rate is nearly double that amount at 208 cases per one million children.

"The true incidence of myopericarditis is markedly higher than the incidence reported to US advisory committees ... we identified that the encounter text description methodology identified approximately twice as many cases of myopericarditis following COVID-19 mRNA vaccination," the authors of the Kaiser study wrote.

After correcting for the FDA's underestimate, a more accurate assessment is that for every one million children who get vaccinated, 180 will have to be hospitalized for myopericarditis and 67 will have to be admitted to an ICU for critical care.

The FDA also vastly over-classified the number of hospitalizations for "covid."

"Pediatric hospitalization rates, while used as a marker of COVID-19 disease severity in children, can be inflated by the detection of mild or asymptomatic infection via universal screening," Yamaguchi explains, pointing to a Stanford University study which found that 45 percent of all pediatric covid hospital admissions were unlikely to have been caused by SARS-CoV-2.

Then we have waning immunity from the injections and adverse reactions, both of which were skewed in the FDA's risk-benefit analysis to make the jabs seem safer and more effective than they actually are.

"The FDA's risk-benefit assessment assumed a constant vaccine efficacy over a time span of six months," Yamaguchi says, noting that the FDA also failed to account for a potentially necessary booster dose after five months, with each booster further increasing the risk of myocarditis.

"This was an inappropriate assumption, as it is well established that the effectiveness of Pfizer's COVID-19 vaccine rapidly declines over time, with one study showing a drop below 50% effectiveness after five months."

The FDA also only accounted for the risks of myocarditis and pericarditis caused by the jabs, and nothing else. As we know, there is an entire laundry list of serious adverse events caused by the jabs that the FDA is ignoring.

More related news about the corrupt FDA can be found at FDA.news.

Sources for this article include:



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