FDA Rubberstamps the Moderna COVID-19 Vaccine for Kids Aged 6-17 Based on Insufficient Evidence
Yesterday, the vote was in 100% in favor of "approval" of the vaccine for kids 6 to 17. None of the votes were based on Science.
This article is dedicated to the parents of the children not yet harmed or killed by COVID-19 vaccines. We are trying to warn you that the FDA and CDC are whole-hearted engaged in fraud.
Dr. Toby Rogers deserves credit for sitting through a grueling, “heart-breaking” nine hours of FDA rubber-stamping COVID-19 vaccines based on clinically trivial endpoints. This rubber-stamp is based on data showing no serious cases of COVID19 in children (no hospitalizations). Here I review most of his interview with Steve Kirsch. (Link to video).
Under EUA rules, an emergency must be in place. Yesterday, I pointed out the vanishingly small number of cases since March 2020.
-Insufficient sample sizes
-Claims of 80% “efficacy” - on what?
Efficacy is based on the “Great sliding scale of evidence” - 300 blood samples in the vaccinated only - based on antibody responses. This is called a proxy endpoint - for what? Clearly not prevention of severe COVID-19. They didn’t measure transmission and the proxy endpoint provides a hypothetical guess at immunity - determined by FDA in April to NOT be a “correlate of protection”) - ignoring the real-world evidence that the vaccinated are not protected.
FDA’s Actions Are Extreme
Toby pointed out that no one asked questions about adverse events. He then shares the perspective that those who bother to follow, look and critique seem extreme because FDA’s actions are extreme. “The reason why we look so extreme is because their actions are so extreme that for us to describe it plainly risks looking radical somehow. We’re not the ones being radical. We’re just the messenger; we’re just pointing out what they’re up to, and what they’re up to is no good; they’re not doing science, and it’s outrageous”.
He also correctly described yesterday’s action as “political theater”.
“FDA and CDC Laundered Data For Moderna”
The standard MO of vaccinologists is to manipulate the data to make evidence of harm go away. Toby was shocked by what he saw and concluded: “I was not nearly cynical enough”.
Toby names what calls FDA and CDC’s “fixers”: Thomas Shimabukuro, and John Su, who routinely and regularly fail to find evidence of vaccine harm and injury - even when others are quite capable of finding deeply concerning signals. These guys managed to make the myocarditis disappear after 26 studies found association with myocarditis. Toby: “In the intervening year, the FDA and the CDC laundered the data for them”. One of the tricks is merely redefinition of medically diagnosed cases of myocarditis - a trick called “diagnostic substitution”, including changing “myocarditis” to “mild myocarditis” - and invention which of course has no basis in the clinical long-term. In the present case, FDA and CDC didn’t count anyone who died from heart problems before they got to the ER. Toby noted the amplification of risk in the background rate as another trick to fix the data.
Of course, since the start of COVID-19 trials, the placebo group was unblinded and then vaccinated - preventing any long-term safety data.
Toby also points out that Paul Offit pointed out that 3 shots would be needed, not two - before the vote, so 100% of rubberstamp committee voted knowing that long-term immunity is not provided by the vaccine and that a third booster would be needed for another round of temporary antibodies.
Of course these antibodies do not target the right variant - a detail completely ignored by the FDA committee.
Many people have pointed out that FDA’s Peter Marks got his numerical facts wrong, even though the data were on the screen right in front of him.
I believe FDA has abdicated their sacred responsibility - and their charter - granted to them by legislation by the US Senate.
The details of the manipulations are being reported and noted by Dr. Meryl Nass, James Roguski, Toby Rogers, and others. Many of us literally cannot tolerate listening to the lies and manipulations. We are grateful for your ability to stay calm enough to not throw your laptops across the room in disgust.
Roguski has provided a detailed punchlist that might be useful for the summons and arraignment of these criminals. He’s listening now to the VRBPAC meeting considering “approval” of the vaccine for infants and babies and he will have a punchlist tomorrow.