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FDA used ‘critically flawed’ risk-benefit analysis to ‘justify’ COVID vaccines for children

(by Luke Yamaguchi | Children’s Health Defense) – The U.S. Food and Drug Administration (FDA) on Oct. 29, 2021, granted Emergency Use Authorization (EUA) of Pfizer’s COVID-19 vaccine for children 5 to 11 years of age.

The Centers for Disease Control and Prevention (CDC) went on to recommend Pfizer’s COVID-19 vaccine for 28 million American children 5 to 11 years of age on Nov. 2, 2021.

This week, Pfizer asked the FDA to authorize the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators once they became available in the spring — clearing the way for the agency to authorize a three-shot regimen for the youngest children who can get vaccinated. The vaccine for this age group could be available as early as February.

The FDA and CDC safety surveillance systems have found an increased risk of heart inflammation (myocarditis/pericarditis) following vaccination with Pfizer’s COVID-19 vaccine. This observed risk was found to be highest in 12- to 17-year-old males, particularly following the second dose.

Vaccine risks versus benefits

For EUA to be issued for a vaccine, the FDA must determine the benefits of the vaccine outweigh the risks.

According to an FDA news release:

“FDA conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children 5 through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause. The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age.”

Unfortunately, the FDA’s risk-benefit assessment was deeply flawed and failed to account for the following critically important factors:

1. Natural immunity

According to CDC data, an estimated 42% of children ages 5-11 had seroprevalence of previous COVID-19 infection as of June 2021. More recent estimates should suggest even higher seroprevalence rates among children, given that several months had passed since the time of this data point.

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.

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 for risk-benefit assessment admitted that should natural immunity be equal to vaccine-induced immunity, then that would result in a 45% reduction of all the benefits in the FDA’s risk-benefit analyses.

Males 5-11 years old (cases per million)

Males 5-11 years old (cases per million)
FDA’s “base” modeling scenario #1 risk-benefit analysis (males only)

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.

As illustrated below, by adjusting for natural immunity (with a 42% reduction of vaccine benefits), 39 ICU stays are prevented by vaccination, but at the risk of 57 vaccine-related myopericarditis ICU stays.

Additionally, while 118 hospitalizations are prevented by vaccination, this is at the risk of 156 vaccine-related myopericarditis hospitalizations, for 5-11-year-old boys.

Males 5-11 years old (cases per million)

Males 5-11 years old (cases per million)
Hospitalization and ICU risk-benefit analysis adjusted to account for natural immunity (males only) [Calculations: 67 prevented ICU stays x (1 – 0.42) natural immunity adjustment = 39 prevented ICU stays after adjustment. 203 prevented hospitalizations x (1 – 0.42) natural immunity adjustment = 118 prevented hospitalizations after adjustment]

2. Underestimated myocarditis rates

The FDA’s risk-benefit analysis assumed an incidence rate of 106 myopericarditis cases per million children vaccinated. However, a Kaiser Permanente study found the actual myopericarditis incidence rate to be 208 cases per million children vaccinated.

The study authors write the following:

“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.” Read Full Article >

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