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COVID-19 rates in children ages 5 to 11 are so low that there were ZERO cases of severe COVID-19 and ZERO cases of death from COVID in either the treatment (n= 1,518) or control group (n= 750). So any claims you see in the press about the Pfizer vaccine being “90% effective” in children are meaningless because they are referring to mild cases from which children usually recover quickly (and then have robust broad spectrum immunity). So there is literally no emergency in this population for which one could apply for Emergency Use Authorization.
The risk-benefit model created by the FDA only looks at one known harm from the Pfizer mRNA shot — myocarditis. But we know that the real world harms from the Pfizer mRNA shot go well beyond myocarditis and include anaphylaxis, Bell’s Palsy, heart attack, thrombocytopenia/ low platelet, permanent disability, shingles, and Guillain-Barré Syndrome (GBS) to name a few. Cancer, diabetes, endocrine disruption, and autoimmune disorders may show up later. But the FDA does not care about any of that because they have a vaccine to sell so they just ignore all of those factors in their model.
How on earth did the FDA claim any benefits at all from this shot? You should probably sit down for this part because it’s a doozy!
Here’s the key sentence:
Vaccine effectiveness was inferred by immunobridging SARS-CoV-2 50% neutralizing antibody titers (NT50, SARS-CoV-2 mNG microneutralization assay).
Wait, what!? I’ll explain.
There were ZERO cases of severe COVID-19 in the clinical trial of children ages 5 to 11. So Pfizer and the FDA just ignored all of the actual health outcomes (they had to, there is no emergency, so the application is moot). INSTEAD Pfizer switched to looking at antibodies in the blood. In general, antibodies are a poor predictor of immunity. And the antibodies in the blood of these 5 to 11 year old children tell us nothing because again, there were zero cases of severe COVID-19 in this study (none in the treatment group, none in the control group). So Pfizer had to get creative! What they came up with is “immuno-bridging”.
Pfizer looked at the level of antibodies in the bloodwork of another study, this one involving people 16 to 25 years old, figured out the level of antibodies that seems to be protective in that population, then figured out how many kids ages 5 to 11 had similar levels of antibodies in their blood, and then came up with a number for how many cases, hospitalizations, ICU admissions, and deaths would be prevented by this shot in the 5 to 11 population in the future, based on the antibody levels and health outcomes from the 16 to 25 year old population.
The whole ballgame comes down to Table 14 on page 34 of the FDA’s risk-benefit document. And there the red flags come fast and furious.
The FDA model only assesses the benefits of vaccine protection in a 6-month period after completion of two doses. Furthermore it assumes constant vaccine efficacy during that time period.
This is problematic on several counts.
First, reducing mild cases in children is not a desired clinical outcome. Mass vaccination turns kids into shedders of more infectious variants.
Second, we know that vaccine efficacy in the month after the first dose is negative because it suppresses the immune system and it begins to wane after 4 months so all of the FDA’s estimates of vaccine efficacy are inflated.
Third, the harms of myocarditis from these shots will likely unfold over the course of years. Robert Malone, the inventor of mRNA technology notes that the FDA is admitting that children will be injected twice a year forever (hence the six month time frame in the FDA risk-benefit model). But the risks of “adverse events such as cardiomyopathy will be cumulative.” So any model that only looks at a six month time frame is hiding the true adverse event rate.
Pfizer’s application should be dead on arrival if the FDA actually followed the science and their own rules.
Perfect. Trying to subject our children to this is shameful.
JCB, are you vaccinated?
Brent – I work in healthcare and in surgery. Personal healthcare is a private matter. If our country would get back to proper HIPAA compliance, peer reviewed prospective studies, and transparent and honest data, we’d be in a better place.
Should we ask your private health history?
Great summary JCB