sharon sanders
Editor-in-Chief & President
FDA Caught Creating and Using Unreliable and Inconsistent Data to Create An Illusion of COVID-19 Vaccine Efficacy as They Attempt to Justify Approval for Use in Infants and Toddlers
https://popularrationalism.substack.com/p/fda-caught-creating-and-using-unreliable
Urgent Action Item Below.
As promised, the 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). Here’s the report for your reference.
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: exaggerate the apparent risk of the virus and minimizing the perception of risk. In other words, lies.-more...
- 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. FDA’s own reports cites 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 US (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.
- Inconsistent use of the idea “vaccinated”. This has been the pattern from the very first study. FDA, CDC, 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 FDA is suspect. Moderna’s and Pfizer’s vaccines never achieved >90% true vaccine efficacy; the best estimate is more like 75%.
- 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 FDA’s report whenever convenient, all in an ad-hocmanner. It’s more than irritating. It’s moving the goal post and represents reckless (and ineffective) attempts to manipulate public perception. This practice continues in the reports and studies that are cited by FDA. I do not trust the efficacy data FDA cites in their report (why would we given Point 1?).
Further evidence of the futility of the evidence used to claim efficacy comes from Moderna’s Sponsor Briefing report to the FDA:
Please see comments in the post above.
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To James Lyons-Weiler:
Children DO GET COVID-19. If you want people to fairly evaluate your points - do not present information, as fact, that defies common sense. It calls into question your entire argument.
From the UK government - (My bolding in red).
Most school pupils in England had COVID-19 antibodies by March 2022
27 June 2022
Almost all primary and secondary school pupils in England had detectable levels of coronavirus (COVID-19) SARS-CoV-2 antibodies in March 2022.
Adjusted antibody data from the Schools Infection Survey, for March to April 2022, showed that more than 99% of secondary school pupils had SARS-CoV-2 antibodies, comprised of 64.9% who were vaccinated and 34.4% who were unvaccinated.
For primary school pupils, 82.0% had SARS-CoV-2 antibodies, based on adjusted figures. This is comprised of 0.4% who were vaccinated and 81.6% who were unvaccinated. (This means they had antibodies due to natural infection. s.s.)
High levels of antibody positivity among secondary school children were driven by both vaccination and natural infection
more...
https://www.ons.gov.uk/peoplepopula...cles/coronaviruscovid19/latestinsights#pupils

