Here’s a really great example of the irrationality and pure cognitive dissonance within the medical establishment when it comes to public vaccine policies.
Last month, it was reported that Dr. Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), sent an internal memo titled “Deaths in children due to COVID-19 vaccines and CBER’s path forward”.
The Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota ran an article by Liz Szabo, MD, objecting to Prasad’s suggestions for how to reform the FDA’s vaccine approval process.
Szabo’s article is titled “FDA official proposes ‘impossible’ standards for vaccine testing that could curtail access to immunizations”.
Prasad’s memo describes an investigation by senior advisor Dr. Tracy Beth Hoeg into reports of child deaths after COVID‑19 vaccination in the Vaccine Adverse Event Reporting System (VAERS). She identified a number of cases where the vaccine evidently caused the child’s death.
Prasad followed up by tasking the FDA’s Office of Biostatistics and Pharmacovigilance (OBPV) to perform a detailed analysis of reported deaths, which concluded that no fewer than ten out of ninety-six deaths examined were vaccine-related.
“This is a profound revelation”, Prasad wrote in the memo. “For the first time, the US FDA will acknowledge that COVID‑19 vaccines have killed American children.”
He questioned the policy of recommending children to get the vaccine because “the truth is we do not know if we saved lives on balance.”
Prasad also noted that the popular claim that the rate of myocarditis from SARS‑CoV‑2 infection is greater than from COVID‑19 vaccines is unsupported by available evidence.
Studies used to support that claim never use estimated infections as the denominator but instead typically use number of hospitalized COVID‑19 cases in a sample population. These studies simply do not measure the rate of myocarditis from SARS‑CoV‑2 infection.
Further into the memo, Prasad outlines a path forward for the FDA, as follows (emphasis added):
Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine. This means: we will take swift action regarding this new safety concern, we will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints (any prior promises will be null and void), and we will demand pre-market randomized trials assessing clinical endpoints for most new products. Pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers. Immunogenicity will no longer be used to expand indicated populations– these populations should be included in premarket RCTs.
In the CIDRAP article, Szabo objects to this, citing public vaccine policy apologist Dr. Jake Scott:
Demanding an RCT would prevent pregnant women from receiving most vaccines, said Jake Scott, MD, a clinical associate professor of infectious disease and geographic medicine at Stanford University School of Medicine.
That’s because pregnant women are almost never included in RCTs of vaccines or other drugs due to potential risks to the fetus, Scott said. Instead, the FDA does careful safety monitoring and measures antibody levels in women’s blood, which can show whether the vaccine is generating an immune response.
First, this completely overlooks the fact that Prasad is correct to note that merely looking at antibody levels in the blood is not a scientifically valid method for determining vaccine effectiveness.
For more on the scientific invalidity of using antibody titers as a surrogate measure of immunity, see my 2019 article “Paul Offit Unwittingly Exposes Scientific Fraud of FDA’s Vaccine Licensure”.
Note the circular reasoning. Prasad notes that the premise is false that antibody titers are a perfect correlate of immunity, and Szabo and Scott respond by saying he’s wrong that pregnant women should be included in clinical trials since the FDA already uses antibody titers to determine vaccine effectiveness.
As if that weren’t bad enough, we’re told that Prasad is wrong to suggest that pregnant women be included in randomized controlled trials because that would be unethical due to the potential risks to the fetus from the vaccine under study.
But it’s okay to just go ahead and start using the vaccine in pregnant women?!
How is that not far more unethical?
If it’s unethical to include pregnant women voluntarily in a controlled experiment, how is it not unethical to include pregnant women in a mass uncontrolled experiment without properly informed consent?
The cognitive dissonance is staggering.
The idea that postmarketing surveillance is an adequate substitute for randomized controlled trials is ludicrous. Talk about being anti-science!
For more about just how unethical this practice is, see my article “The CDC’s Criminal Recommendation for a Flu Shot During Pregnancy”.
Next, the CIDRAP article rejects Prasad’s suggestion that pneumococcal vaccines should no longer be licensed based just on immunogenicity data, meaning measurements of antibody levels in the blood against the target strains of pneumococcus bacteria.
Szabo again cites Scott and a former CBER director (emphasis added):
Pneumococcal vaccines on the market today are approved based on antibody levels that correlate with protection and have been validated over decades, Scott said.
Proving that childhood vaccines prevent cases of pneumonia would be difficult, Scott said, because so many pathogens can cause pneumonia, including the flu, COVID-19 and respiratory syncytial virus (RSV).
. . . Conducting RCTs of proven vaccines could also be unethical, said Jesse Goodman, MD, who previously filled Prasad’s role at the FDA and now directs Georgetown University’s Center on Medical Product Access, Safety and Stewardship.
“It would be unethical to use placebos and let people get pneumococcal pneumonia,” Goodman said.
So, the argument against doing new clinical trials is that we can already presume effectiveness based just on antibodies, and, besides, it would be very hard to prove vaccine effectiveness in a randomized controlled trial because so many other pathogens also cause pneumonia.
Also, it would be “unethical” to conduct randomized, placebo-controlled trials to determine safety and effectiveness because . . . we can just presume to know that the outcome of such trials would be evidence for safety and effectiveness.
This is the opposite of science. It’s the fallacy of begging the question and an expression of faith.
It’s the vaccine religion.
