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I. Introduction, a shell game to hide the bad data
The risk benefit document for Moderna is 190 pages single-spaced. It was released two business days before the June 14-15 VRBPAC meeting. A similar risk benefit assessment for Pfizer’s EUA application for kids under 5 will be released tomorrow (just 24 hours before the meeting). This guarantees that NONE of the members of the VRBPAC will have read either of these documents prior to the meeting — which is exactly what the cartel wants.
One of the ways that Moderna and the FDA rig the game is by adding endless layers of complexity to hide how bad the data really is. This should have been four separate documents — Moderna in adolescents 12 to 17, Moderna in kids 6 to 11, Moderna in kids 2 to 5, and Moderna in kids 6 months to 23 months. Looked at individually, the shot fails in each of these four age groups. But by lumping them together it creates noise that makes it difficult to understand what’s going on.
Another really pernicious thing that Moderna does is to further subdivide these populations into eight different subpopulations (Randomization Set, Full Analysis Set, Immunogenicity Subset, Per-protocol Immunogenicity Subset, Per-protocol Set for Efficacy, Modified Intent-to-treat Set, MITT1 Set, Safety Set, Solicited Safety Set).
See what they did there? The public just wants to know — does the product work and what are the side effects? By dividing the data into eight subcategories involving four different age groups now you have to wade through 32 different tables to try to make sense of what happened in the clinical trial.
They do something similar with the adverse events by dividing it across five tables x four age groups = 20 adverse event tables in all.
Subdividing the data in this way also allows Moderna to eliminate or hide data that it does not like. This is what people call “massaging the data” and it is unethical and a violation of scientific norms. We’ll return to this topic below.
II. No actual health benefits so Moderna/FDA use the immunobridging trick
The risks of Covid-19 are so low in the childhood population that there were ZERO severe cases of Covid-19 in either the treatment or the control group.
Therefore, the number needed to vaccinate, to prevent a single severe case of Covid-19 in the childhood population is infinity. (Technically it’s undefined because you cannot divide by zero, but you take my point). The FDA and CDC guidance documents for how to write a risk benefit assessment state that one must provide a number needed to treat, the absolute risk reduction, and the relative risk reduction. Moderna just skipped all that because the cartel makes its own rules.
Moderna is in a race against natural immunity. But natural immunity has already won because 74.2% of kids had natural immunity by February — so by now the number is probably closer to 100%. The God-given immune system in kids has already done its part to stop the pandemic and now the FDA wants to mess that up to enrich the cartel and keep the pandemic going forever.
So how does Moderna/FDA claim that this shot was “effective”? They use an unethical statistical trick called “immunobridging.”
It makes me mad that I even have to explain it because it’s such junk science. But we all need to know exactly how the FDA rigged the process so that we can explain to the jury at Nuremberg 2 why these monsters should be convicted so here goes:
Remember, the Moderna shots produced NO reductions in severe outcomes because the risk of Covid-19 in this age group is infinitesimally small (see studies: here, here, here, and here). So Moderna ignored the actual health outcomes and switched to looking at antibodies in the blood. In the process, they engaged in two egregious sleights of hand:
First, Moderna claims that the sample size for each of the four subgroups of children is about 3,000. But when it came to looking at antibodies in the blood, Moderna threw out about 90% of the sample and only looked at the bloodwork of about 300 kids in each age group. No explanation was given for the criteria they used to exclude 90% of the sample from their analysis. We know that up to 30% of kids have no antibody response at all to Covid-19 shots so perhaps they actually started with a much larger sample and then threw out the data that showed no effect from the shot?
The second sleight of hand is that “no placebo recipients were included in the Immunogenicity Subset” (p. 26). Do you realize how huge this is? This is no longer an RCT at all — they did not include the bloodwork from anyone in the placebo group. So the study cannot rule out the possibility that the increase in antibody levels was not from the vaccine at all but could have been from natural immunity. Just astonishing.
After these sleights of hand, Moderna then compares the antibody levels in the blood of about 10% of the children against the antibody levels in a sample of about 300 adults ages 18 to 25 enrolled in a previous clinical trial. If the antibody levels are similar (which they are), Moderna claims, ‘And therefore it will prevent disease in the future in kids!’
A few problems with that claim:
The Moderna study only measured antibody levels two months after the second dose — the time period when the antibody levels are at their peak (what Berenson calls “the happy valley”). But real world experience with these vaccines shows that any efficacy quickly wanes to zero by six months and then goes NEGATIVE after that.
The second problem, and this is unresolvable and instantly disqualifying for Moderna, is that at the April 6, 2022, meeting of the FDA’s “expert advisory committee” one member after another acknowledged that there are no “correlates of protection” for these vaccines. What that means in plain English is that you cannot use antibodies (or B-cells, T-cells, or any other proxy) to predict whether someone is immune or not.
Eric Rubin, who serves on that committee and is also the editor of the NEJM stated it bluntly, “We know what kind of antibody response can be generated, we just don’t know if it works.”
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