Episode 6: Dubious Claims Regarding the Johnson & Johnson Pseudovaccine

The Second Society Project of the Third Millennium

Joe Atwill and David Schmitt Review the Memorandum for an Emergency Use Authorization (EUA) for an UNAPPROVED [emphasis ours] Product Review Submitted by Janssen Biotech, Inc.(a J&J subsidiary), Application No. 27205. This application for an EUA is for the Janssen COVID-19 "vaccine" [such as it is called by its proponents] (Ad26.COV2.s).
Many important points are brought out. A point that is of huge importance was Joe Atwill's observation and analysis regarding the occurrence of all seven deaths within a placebo (control) group of 3290 individuals (compared to zero deaths in 3286 for the Ad26.COV.s-treatment group). All 3286 + 3290 individuals in this cohort within the whole study were from South Africa. Six of the seven deaths involved obesity as a co-morbidity. Actually, there was one death in the vaccine group, but the death occurred at day ten after vaccination, thus placing it just outside of the technologist's window to be considered as having been due to the treatment.
Based on these data, the sponsor of this study, Janssen Biotech, Inc., makes the statement (see p. 34, "COVID-related deaths"): "These results suggest that the vaccine is efficacious against mortality associated with COVID-19.
A finer examination reveals this to be--even in its use of the tentative word, 'suggest', an unfounded claim.
In South Africa, according to World-o-meter on March 14, 2021, there was an all-cause death rate of 858 deaths per million of population in South Africa. The study period appears to last from one month to roughly two months. Thus, considering a 30- to 60-day range, the per-person expectation (odds) of dying in the placebo group--without knowing any other predictive information---falls within a likely range of from one part in 7,000 to one part in 14,000.
Now, for a reminder of odds making probability. If you rolled one gambling die with six sides and asked what the chances were of it turning up one snake eye, the answer would be 1 chance in six, or 1/6. If you rolled the die 3600 times, you could expect to come up with snake eyes 600 times. Those are not bad odds.
Now, imagine a large die with 14,000 sides instead of six. This die has built into it the duration of the study of one month and the death rate of the South African population at large. Imagine, further, that one and only one side is marked with a snake eye indicating the occurrence of the event of one "death." If you asked what would be the expectation of rolling this one die with 14,000 sides, and having it come up on one specific side indicating a death, it would be one part in 14,000. To ask the likelihood of rolling such a die 3290 times and having it come up indicating at least one death, it would be 3290/14,000 or one trial of 3290 individuals in 4.25 trials of 3290 individuals. This represents a likelihood of 0.235. To put it more explicitly, one would have to run trials of 3290 individuals 4.25 times just to--on average--encounter one death!
Now, let's ask how likely it would be to produce seven deaths in a placebo group of 3290 individual "rolls of the die" using this 14,000-sided die. Multiplying our odds of 0.235 times itself seven times produces a likelihood of this event of 0.0000395, which is equivalent to one chance in 25,265 attempts at sets of rolls of 3290 dice!. Those are not good betting odds---and it is a lot of rolling of a very large die.
If we assume a two-month study period, which should "catch" more deaths in the placebo group, that would improve the expectation of getting seven deaths in each set of 3290 rolls to one chance in 12,632 rolls. I do not see anyone at the gambling table ponying up to bet on that with a large amount of cash. I think if you do, and you win, mean men take you out back and convince you to never return to the casino.
Table 19 on p. 35 breaks down the state of comorbidities of al seven deaths. Specifically, this includes obesity in six of seven cases, with asthma, hypertension, diabetes, and heart failure variously overlapping in these seven cases. There is evidence, then, that a more extensive analysis involving weighted risks and a Bayesian analysis could sharpen the expectation and thereby increase the expectation of encountering seven deaths in the placebo group. This was not described in this document and the argument remains that these numbers of deaths are very unlikely.
Remember, these individuals in the placebo group should have not 'a priori' factor that predisposes their group to die, compared to the "vaccine"-treated group, other than what the sponsors of the study would likely argue to be the vulnerability presented by not having the vaccine. However, this level of vaccine efficacy is not suggested by data in the rest of the study with regards to the occurrence of what were considered to be symptoms considered by "test" or adjudication to be COVID.
But are the sponsors claiming that a link exists between a vaccine's capacity to counter disease are also efficacious in preventing death, presumably due to the same disease? Yes, but with some backtracking, on page 60, "Vaccine effectiveness against mortality," the sponsor states: "A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality. However, non-COVID vaccines (e.g., influenza) that are efficacious against disease have also been shown to prevent disease-associated death. Benefits in preventing death should be evaluated in large observational studies following authorization."
The fact that obesity appears to be a strong signal associated with death in victims aged 49, 52, 54, 60, 63 and 68 suggests that if there is any story about a presumptive disease called COVID, that it is a story of age and obesity. Thus, the argument for other politically-exploited aspects of this non-pandemic collapse. There are means of improving the outcomes for such an at-risk population regarding contracting and surviving such an essentially respiratory illness.
Furthermore, the benefits of the J&J product in reducing symptoms and conditions presumed to be related to COVID (note the term, "adjudicated" as a substitute for 'diagnosis') involves reductions of "cumulative incidence" from roughly 2% to 1%. Using Bayesian calculation--which is entirely appropriate--one can magnify measures of efficacy. That is, when a disease occurs only in small numbers, as is true for COVID, what is the measured likelihood that some treatment affects the chances of truly being ill when some process which is largely bureaucratic rather than clinically diagnostic suggests that one is ill. The component that remains in these studies that makes a claim to laboratory diagnosis relies upon the PCR method which has been repeatedly undermined as a reliable means of determining if a patient is COVID positive. The PCR method has a generalizable dial that allows it to be adjusted to varying levels of sensitivity versus specificity. The data has not been reported regarding these aspects of the study.
We would humbly argue that if anything, "[b]enefits in preventing disease-associated death," should be evaluated in animal studies BEFORE authorization is granted.
More seriously, long-term risks to the individual have not been evaluated by medical experts. These are not trivial and are far beyond our expertise. What is not beyond the expertise of general biologists and well-educated, general technologists are the potential species-wide, evolutionary harm that could--indeed most likely will--come from these and expanded applications of these technologies. It is folly and malfeasance to even suggest widespread, let alone, universal vaccination using even traditionally-defined vaccines. This dire condition is manifold true to indeterminable degrees for technologies that only incidentally involve properties of vaccines, but will as promised by industry officials will also be applied to other physiological processes, especially protein-receptor structure and especially receptor function in the nervous system. The affects on behavior, mood, cognition and spiritual characteristics and safety of human beings are gravely at risk.