This post has been read 692 times!
October 23, 2021- by Steven E. Greer, MD
On Tuesday, the FDA will convene another COVID vaccine advisory committee. The topic this time will be whether or not the FDA should approve the Pfizer Comirnaty vaccine for ages 5 through 11. They already have approval for ages 12 and up. Recall, Moderna does not have approval for under age 18 because of the risks for myocarditis, which was established as a genuine risk during the most recent vaccine panels.
For an FDA hearing, the drugmaker submits their data package. Then, the FDA internal reviewers submit their report, which indicates whether or not the agency favors approval. Making news today is that the FDA documents indicate the FDA finds the risk-benefit analysis to favor approval of gene-therapy “vaccines” for toddlers and up.
Upon reviewing the FDA report, the agency’s rationale is based on unreliable models and surrogate endpoints. The Pfizer data are totally lacking any real efficacy data (i.e., do vaccinated kids actually contract COVID less than placebo cohorts?). Instead, they used measurements of antibody levels (i.e., titers).
This method of testing efficacy of a vaccine is a joke. It is childishly simplistic. All they did was use a crude model of what they think is the crucial step needed to be blocked by a neutralizing antibody. Biology is never that simple. Their “SARS-CoV-2 mNG microneutralization assay” does not even use whole cells. It takes the ACE2 receptor and the viral spike protein in a lab machine and estimates whether the antibody in question prevents the spike from hooking up with the receptor. However, we know for a fact that these antibodies produced by the vaccines do not “neutralize” the virus because the real-world efficacy is below 50%. That is why we need booster shots. The vaccines no longer work. Therefore, this surrogate marker antibodies measured by the “SARS-CoV-2 mNG microneutralization assay” have been proven to be useless.
The FDA report also glosses over the fact that kids have such low levels of ACE2 receptors that they cannot become sick from the real SARS-CoV-2 virus. The FDA states that it drew from the “COVID-NET” database to determine the incidence of COVID among kids. But this COVID-NET is a non-transparent “black-box” calculation. There is no easily found COVID-NET on the internet that details accurately cases amongst kids. It is not transparent how the COVID-NET collects case data. It is garbage.
Then, to complete the “garbage in, garbage out” theorem, the FDA used another black-box model (remember how reliable those early models on COVID were) to “assess the benefits of vaccine”. Based on these complete junk-science models, the FDA generated its risk-benefit analysis and concluded that the risks from myocarditis, and unforeseen consequences of genetic engineering created by the vaccine, are smaller than the benefits of vaccinating kids.
The FDA report did not discuss the biological plausibility and likely mechanism for the vaccine-generated spike proteins to trigger autoimmune attacks. There was no case study of actual kids who suffered adverse events. The FDA report was sanitized and dehumanized by a statistical model that no one can understand. There will also no be human accountable for the decision because the black-box mystery model did it. Blame the bad model, not Janet Woodcock.
It was bad enough that the world has allowed unelected health officials to dictate lockdowns and vaccine mandates for adults. The red line should be drawn against this proposed crime against humanity of injecting gene therapy “vaccines” into kids, who need no protection from a virus that does not harm them.
Secretly, vaccine advocates will admit that kids themselves are not at risk, but they are germ spreaders and upset the teachers unions. Well, the COVID virus is not spread from kids to adults. In fact, it is the vaccinated adult population that is the super-spreader group to fear (They have no IgA in the nasopharynx so the virus colonizes n the noses of the vaccinated).
Update October 26, 2021- The FDA advisory committee votes to approve a vaccine with almost no benefit and known risks to be injected into 5-yo kids. This will open the door for mandates and booster shots.