FDA Used Critically Flawed Risk-Benefit Analysis to Justify COVID Vaccines For Children

The US FDA used a ‘critically flawed’ risk-benefit analysis to ‘justify’ COVID vaccines for children. The hazards of COVID-19 vaccination exceed the advantages for millions of children.

FDA Used Critically Flawed Risk-Benefit Analysis to Justify COVID Vaccines For Children

On October 29, 2021, the US Food and Drug Administration (FDA) issued Pfizer’s COVID-19 vaccine Emergency Use Authorization (EUA) for children aged 5 to 11.

On Nov. 2, 2021, the Centers for Disease Control and Prevention (CDC) recommended Pfizer’s COVID-19 vaccination for 28 million American kids under the age of 5 to 11.

Pfizer petitioned the FDA this week to approve the administration of a two-dose vaccination in children aged 6 months to 4 years. When statistics on a third shot becomes accessible in the spring, it will be presented to authorities, paving the path for the government to approve a three-shot program for the youngest infants who could be immunized. This age group’s vaccination might be ready as early as February.

Upon vaccination with Pfizer’s COVID-19 vaccine, the FDA and CDC safety monitoring programs discovered an elevated risk of cardiac inflammation (myocarditis/pericarditis). This danger was shown to be greatest in 12- to 17-year-old males, especially after the second dose.

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Vaccine risks versus benefits

The FDA must assess that the vaccine’s advantages exceed the dangers before issuing an EUA.

As per 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.”

Regrettably, the FDA’s risk-benefit analysis was severely faulty, failing to take into consideration the following essential variables:

Natural immunity

As of June 2021, the CDC predicted that 42 percent of children aged 5 to 11 have seroprevalence of past COVID-19 infection. Considering that many months had elapsed since this piece of evidence, more contemporary projections should imply even greater seroprevalence levels among youngsters.

The FDA’s risk-benefit analysis overlooked the vast number of youngsters in the United States who’ve already been exposed to COVID-19, healed, and now have natural resistance.

The hazards of COVID-19 vaccination exceed the advantages for all these millions of children, as research shows that natural immunity is preferable to vaccine-induced resistance.

An FDA senior consultant for risk-benefit evaluation revealed that if natural immunity equaled vaccine-induced protection, all advantages in the FDA’s risk-benefit calculations would be reduced by 45 percent.

fda flawed analysis children vaccines 1
FDA’s “base” modeling scenario #1 risk-benefit analysis (males only)

The threat of hospitalisation from vaccine-related cardiac inflammation in 5 to 11 year-old boys is higher than the amount of COVID-19 hospitalizations avoided by vaccination, according to the FDA’s risk-benefit analysis (seen above), when cautiously trying to adjust for 42 percent of children having already obtained natural resistance via earlier COVID-19 infection.

By controlling for natural immunity (and a 42 percent decrease in vaccine advantages), vaccination can save 39 ICU stays while also increasing the chance of 57 vaccine-related myopericarditis ICU stays, as shown below.

Furthermore, whilst vaccination prevents 118 hospitalizations, it also puts 5-11-year-old boys at danger of 156 vaccine-related myopericarditis hospitalizations.

fda flawed analysis children vaccines 2
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]

Underestimated myocarditis rates

The FDA’s risk-benefit analysis used a myopericarditis incidence rate of 106 cases per million vaccinated youngsters. According to a Kaiser Permanente research, the true incidence rate of myopericarditis is 208 instances per million children who have been vaccinated.

The following is from the study’s authors:

“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.”

fda flawed analysis children vaccines 3
FDA’s “base” modeling scenario #1 risk-benefit analysis (males and females combined)

We get 67 ICU admissions and 180 hospitalizations from myopericarditis per million children vaccinated applying the FDA’s risk-benefit analysis (given above) and accounting for the undervalued myopericarditis frequency after immunization (by applying a multiplier of 1.96).

We estimate that immunization prevents 36 ICU admissions and 111 hospitalizations after controlling for natural immunity (with a 42 percent loss in vaccination advantages). We discover that the probability of hospitalization from vaccine-related myopericarditis is larger than the percentage of COVID-19 hospitalizations averted by vaccination, for both boys and girls, after accounting for the FDA’s underestimated myopericarditis rate and controlling for natural immunity (as illustrated below).

fda flawed analysis children vaccines 4
Adjusted hospitalization and ICU risk-benefit analysis (males and females combined)
[Calculations: 62 prevented ICU stays x (1 – 0.42) natural immunity adjustment = 36 prevented ICU stays after adjustment. 192 prevented hospitalizations x (1 – 0.42) natural immunity adjustment = 111 prevented hospitalizations after adjustment. Multiplication factor of 1.96 = 208 (true incidence of myopericarditis per million children vaccinated) / 106 (FDA’s underestimated incidence of myopericarditis per million children vaccinated). 34 excess myopericarditis ICU stays x 1.96 (multiplication factor) = 67 vaccine-related myopericarditis ICU stays after adjustment. 92 excess myopericarditis hospitalizations x 1.96 (multiplication factor) = 180 vaccine-related myopericarditis hospitalizations after adjustment]

Over-classification of COVID-19 hospitalizations

The discovery of moderate or asymptomatic infection through universal screening can inflate pediatric hospitalization rates, which are utilized as a metric of COVID-19 disease severity in children.

According to a Stanford University study, SARS-CoV-2 was improbable to be the cause of 45 percent of juvenile COVID-19 hospitalizations.

As per a CDC medical officer, roughly 19 percent of younger children who’d been labelled as COVID-19 hospital admissions in COVID-NET data were not hospitalized primarily owing to COVID-19.

The FDA, for some reason, did not account for this in their risk-benefit analysis.

Inflated COVID-19 hospitalization rates

According to COVID-NET statistics, the weekly rate of COVID-19-related hospitalization varied from zero to 1.1 per 100,000 children aged 5-11 as of December 25, 2021.

The total weekly average COVID-19 linked hospitalisation rate in this age range was around 0.4 per 100,000 kids at the time of the FDA’s risk-benefit assessment.

Instead of using the weekly aggregate COVID-19 hospitalisation rate since the outbreak began, the FDA’s risk-benefit analysis utilized a subjective average of the four weeks leading up to September 11, 2021, culminating in a COVID-19 hospitalisation rate of 0.74 per 100,000 children (which is nearly double the average COVID-19 hospitalisation rate of 0.4 per 100,000 children).

The FDA’s risk-benefit analysis was slanted even more in favour of vaccination as a result of this.

Waning immunity

The FDA’s risk-benefit analysis expected that vaccine effectiveness would remain consistent throughout a six-month period. This would be an incorrect presumption because it is well known that the efficiency of Pfizer’s COVID-19 vaccine falls significantly over time, with one trial indicating a reduction below 50% efficiency after five months.

Furthermore, the FDA’s risk-benefit analysis failed to factor for a possible five-month booster dose. Each supplemental dose would increase the chance of myocarditis, as well as other vaccine-related side effects.

Vaccine adverse reactions

In its risk-benefit analysis, the FDA only took into consideration the risks of myocarditis and pericarditis as a result of vaccination, but neglected to take into account adverse responses and other adverse events.

According to the FDA’s risk-benefit study, completely vaccination one million children aged 5 to 11 could avert 45,773 instances of COVID-19 over a six-month period.

This advantage of vaccination, nevertheless, would come at the cost of an overwhelming amount of vaccine hazardous responses (see section 7.6.2 Solicited adverse reactions): roughly 258,000 cases of mild to severe injection site pain; 174,000 cases of fatigue; 94,000 cases of headaches; 65,000 cases of fever; 55,000 cases of chills; 24,000 cases of diarrhoea; 18,000 cases of vomiting; and 82,000 cases of muscle or joint pain.

These side effects would’ve been in conjunction to allergy, lymphadenopathy, syncope, and Bell’s palsy, among other things.

Additionally, evidence from the United Kingdom indicates that those who have previously been infected with COVID-19 are much more prone to have systemic side effects after receiving COVID-19 vaccine.

The opportunity cost

According to the FDA’s risk-benefit study, fully vaccinating 1 million kids aged 5 to 11 years old would save one COVID-19 fatality.

At a pandemic pricing of $19.50 per dosage of Pfizer’s vaccination, preventing a solitary COVID-19 death for a youngster in this age bracket would require $39 million.

This raises the concern about how many additional lives could’ve been spared if the same amount of funds was invested in something else.

Conclusion

To validate the EUA of Pfizer’s COVID-19 vaccination for children aged 5 to 11, the FDA depended on a profoundly inadequate risk-benefit analysis.

The benefit-risk proportion of COVID-19 immunization for children 5-11 years of age gets even more difficult to defend in the backdrop of the Omicron variation, which is connected with less severe disease and reduced hospitalization rates.

Given the foregoing, it’s simple to see why Sweden opted not to promote COVID-19 immunizations for children aged 5 to 11. A Swedish Health Agency official argued that the gains did not exceed the hazards, saying:

“With the knowledge we have today, with a low risk for serious disease for kids, we don’t see any clear benefit with vaccinating them.”

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