by Josh Mitteldorf, PhD, The Pulse:
In September, the U.S. Food and Drug Administration (FDA) — over the objections of the agency’s own advisors — authorized Pfizer’s COVID-19 bivalent booster on an emergency basis, without any testing or demonstration that the products had any benefit in human beings.
The only “emergency” was that collapsing demand for Pfizer’s original shots had caused a lapse in the drugmaker’s windfall profits.
Responding to this embarrassment, the Centers for Disease Control and Prevention (CDC) last week published the first data on efficacy of the bivalent boosters.
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Using the agency’s own data and methodology, we calculate an effectiveness of 9% compared to no vaccine at all. However, inexplicably, the CDC reported an effectiveness in the range of 19% to 50%, depending on previous vaccination history.
Even accepting the CDC’s computation, the FDA’s authorization was illegal because their rules demand a minimal efficacy of 50% for emergency use authorization.
It gets more interesting when we look at subjects in the study who were fully vaccinated but did not get the new booster. They did much worse than the unvaccinated. This is more evidence of something we reported in the past: Modest efficacy of the COVID-19 “vaccines” lasts a short while, then falls to zero and continues falling well below zero. A few months after vaccination, the vaccinated are more likely to get COVID-19 than the unvaccinated.
Breaking down the study
The study in question is a Morbidity and Mortality Weekly Report (MMWR) released Nov. 22 by the CDC that purportedly demonstrated a protective benefit of the bivalent COVID-19 booster that was authorized for emergency use on Sept. 1 of this year.
The CDC authors offered some rare transparency up front:
“Postauthorization immunogenicity studies have shown similar neutralizing antibody titers to BA.4/BA.5 after receipt of either a monovalent or BA.4/BA.5–containing bivalent vaccine as a fourth dose; however, immunogenicity studies are not generally designed to measure clinical impact.”
Let’s break that down …
First, “immunogenicity” refers to an immune response in the form of antibody production that can be detected in a blood test. It’s a further leap to draw conclusions about how your body will respond when it is exposed to an actual virus.
Nevertheless, there is no requirement for Pfizer and Moderna to demonstrate that their new booster formulation will prevent COVID-19 or any other clinical outcome.
Second, the studies have not shown that the bivalent booster produces an antibody response to the new Omicron subvariants that is any better than an additional booster with the original COVID-19 shot.
Given these first two points, evidence of any form of booster effectiveness would be a remarkable finding from the start.
Third, the studies were conducted after authorization was granted, i.e. “post-authorization.” This is the Alice in Wonderland script, where the trial takes place after the execution.
And this new after-the-fact “trial” is not a double-blind placebo-controlled study of the type that was done two years ago for the original mRNA products. The MMWR study was based on data from people who came in for COVID-19 testing at their local drug stores.
All “participants” were sick. Every person had a respiratory disease with symptoms similar to COVID-19. So the study was capable only of distinguishing people who were sick with COVID-19 from people who were just as sick but tested negative for the virus.
