The U.S. Food and Drug Administration published a report to justify authorizing COVID-19 vaccines for infants and toddlers, but the report is just more of the same: exaggerating the risk of the virus and minimizing the perception of the risk posed by the vaccines.
Editor’s Note: The U.S. Food and Drug Administration’s vaccine advisory council will meet June 15 to consider granting Emergency Use Authorization (EUA) of the Pfizer and Moderna COVID-19 vaccines for children under 5 years old, even though the White House last week announced it is already filling orders for the vaccines placed by states and healthcare providers. Click here to tell your members of Congress to oppose EUA of these vaccines for young children.
As promised, the U.S. Food and Drug Administration (FDA) has ginned up a report that ostensibly will be used to try to justify “approval” (whatever they mean by that now) of COVID-19 vaccines for infants and toddlers (children < 5 years old).
This report comes after a torrent of massive reports from Moderna and Pfizer that claim to review studies of the safety and efficacy of COVID-19 vaccines in children.
It is not hard to see what shenanigans the FDA has been up to — to try to bolster a vaccine that fewer and fewer adults want. It’s more of the same: exaggerating the apparent risk of the virus and minimizing the perception of risk posed by the vaccines.
In other words, lies.
1. There is no evidence of clinical urgency.
Infants and toddlers (and children in general) do not get COVID-19; they do not (yet) die from COVID-19.
All that can change when antibody-dependent enhancement kicks in for the vaccinated.
The FDA’s own reports cite 1,086 deaths “from COVID-19” and 10,700,000 “cases” of COVID-19 in children aged 0-17. There have been 832 days since April 1, 2020, when diagnoses started for COVID-19.
For the entire population of children in the U.S. (73,000,000), the risk of COVID-19 infection since the onset of COVID is 10,700,000/73,000,000 = 0.14657.
The risk of a child dying if they have a diagnosis is 1,086/10,700,00 or 1086/10700000 = 0.00010149532. The risk of any child dying of COVID-19 over this time period is 1,086/73000000 = 0.00001487671.
The per-day risk is on the order of 1.78806611e-8 (0.000000001788). There is no real unmet clinical need and the FDA needs to go back to college to understand how to use RT-PCR correctly. Children do not get COVID-19, and they do not die.
2. Inconsistent use of the idea ‘vaccinated.’
This has been the pattern from the very first study. The FDA, the Centers for Disease Control and Prevention, Moderna, Pfizer and others pull out whatever definition of “vaccinated” they want.
Examples: “Vaccinated” is defined in the original trials as people who received both doses and who did not develop COVID-19 before two weeks passed after the second exposure to the vaccine.
In fact, that means that people who developed COVID-19 due to disease enhancement were dropped from the study calculations.
First, this is the first time people were dropped from a vaccine trial for getting infected with the pathogen targeted by the vaccine up to 13 or 14 days after being vaccinated.
Second, it’s actually five entire weeks — one month and one week — 44 days — after the first exposure. ALL of the vaccine efficacy being cited by the FDA is suspect.
Moderna’s and Pfizer’s vaccines never achieved >90% true vaccine efficacy; the best estimate is more like 75%.
3. Inconsistent use of the idea ‘vaccine efficacy.’
Over the time period since the first COVID-19 vaccine trials, various definitions of “vaccine efficacy” have been used.
Decreased transmission. Reduction in infection rates. Reduced hospitalization. Presence of neutralizing antibodies. Presence of antibodies.
All are used and cited in the FDA’s report whenever convenient, all in an ad-hoc manner. It’s more than irritating. It’s moving the goal post and represents reckless (and ineffective) attempts to…
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