Evidence for a Legal Case against Those Who Spread Misinformation and Enforce COVID-19 Vaccine Mandates
From TrialSiteNews.com Dr. Ron Brown – Opinion Editorial October 13, 2021
In a previous editorial, I posed the question: Should We Criminalize Public Health Authorities, Politicians, & Employers Who Spread Misinformation about Vaccine Mandates? The editorial touched a nerve, and positive feedback was immediate from people looking for a way to resist the COVID-19 vaccine mandates. In the present editorial, I provide evidence for a legal case against those who spread misinformation and enforce COVID-19 vaccine mandates that mislead and harm employees and the public. The evidence will show that the approximate 95% vaccine efficacy claimed for the COVID-19 mRNA vaccines is misleading and does not reveal the whole truth about vaccine efficacy. Furthermore, based on false statements of vaccine efficacy, the evidence shows that claims of vaccine effectiveness in preventing severe infections, hospitalizations, and deaths are also false, as are claims that unvaccinated people present a threat to others and that unvaccinated people are filling the hospitals because they lack vaccination protection.
COVID-19 mRNA vaccine efficacy is a measure of the vaccine’s ability to reduce infections with at least one mild or moderate symptom in randomized clinical trials conducted under controlled experimental conditions—the gold standard for demonstrating causality. Efficacy should not be confused with observational studies of vaccine effectiveness which lack controlled conditions and are less reliable.
After randomizing trial participants to vaccine and placebo groups, the trial vaccine infection rate is compared to the placebo infection rate. Two methods are used when comparing group infection rates to calculate vaccine efficacy, also known as the relative risk reduction (RRR). Both methods arrive at the same RRR, however, flaws in these methods fail to provide the complete vaccine clinical trial results.
Relative Risk Method
This method calculates the relative risk (RR) of infection by dividing the vaccine infection rate by the placebo infection rate, which is usually expressed as a decimal less than 1. The difference between the RR and 1 is the relative risk reduction or vaccine efficacy. To convert the decimals to percentages, multiply by 100.
The relative risk method only measures proportions between the group infection rates, and is not sensitive to the actual reduction in the number of infected people, known as the absolute risk reduction (ARR). The RR is used by epidemiologists to study the proportion of disease risk in populations, but the RR is not useful for clinical studies where the higher sensitivity of the absolute risk reduction is needed to measure infection rates in individuals, not populations.
The reciprocal of the absolute risk reduction (1/ARR) determines the precise number of people needed to vaccinate (NNV) to reduce one infection. NNV also allows clinicians to compare the vaccine efficacy of different trials.
The following examples illustrate how the relative risk and the relative risk reduction remain at 50% as the ARR with higher sensitivity decreases from 30% to 10%.
Examples of a constant 20% RR and 80% RRR as the more sensitive ARR decreases from 60% to 4%:
30% vaccine infection/60% placebo infection = RR 50% and RRR 50%. ARR 30%.
25% vaccine infection/50% placebo infection = RR 50% and RRR 50%. ARR 25%.
20% vaccine infection/40% placebo infection = RR 50% and RRR 50%. ARR 20%.
15% vaccine infection/30% placebo infection = RR 50% and RRR 50%. ARR 15%.
10% vaccine infection/20% placebo infection = RR 50% and RRR 50%. ARR 10%.
Examples of a constant 20% RR and 80% RRR as the more sensitive ARR decreases from 60% to 4%:
15% vaccine infection/75% placebo infection = RR 20% and RRR 80%. ARR 60%.
10% vaccine infection/50% placebo infection = RR 20% and RRR 80%. ARR 40%.
5% vaccine infection/25% placebo infection = RR 20% and RRR 80%. ARR 20%.
4% vaccine infection/20% placebo infection = RR 20% and RRR 80%. ARR 16%.
3% vaccine infection/15% placebo infection = RR 20% and RRR 80%. ARR 12%.
2% vaccine infection/10% placebo infection = RR 20% and RRR 80%. ARR 8%.
1% vaccine infection/5% placebo infection = RR 20% and RRR 80%. ARR 4%.
|Here is the approximate RR, RRR, and ARR for the Pfizer mRNA vaccine. Note that the RRR is more than 95% higher than the ARR:|
0.04% vaccine infection/0.75% placebo infection = ~RR 5%, ~RRR 95%, ~ARR 0.7%
The exact calculations for both the Pfizer and Moderna vaccines are available at Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials.
A free online calculator is also available that can be used to calculate the RR, RRR, and ARR from two groups in a clinical trial (Vaccine and Placebo groups) where an “event” is defined as an infection.
Risk Reduction Method
This second method to calculate vaccine efficacy measures vaccine protection relative to the group that didn’t receive the vaccine. Reduced infection from the vaccine, or the absolute risk reduction, is measured by subtracting the vaccine infection rate from the placebo infection rate. The ARR is then divided by the placebo infection rate to calculate the relative risk reduction or vaccine efficacy.
The problem with this method is that the placebo group is compared twice: first, in calculating the difference in infection rates between the groups, the ARR, and then again by dividing the ARR by the placebo group. You might recall that dividing a number by a fraction results in a higher number. Dividing the ARR by the placebo infection rate ensures that the vaccine efficacy, the RRR, is always higher than the absolute risk reduction. How much higher?
Sometimes, as seen in the above example of the Pfizer vaccine, the RRR can be as much as 95% higher than the absolute risk reduction. Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, insinuated that an analysis of AZT clinical trial data during the AIDS epidemic used a similar risk reduction method to increase the “significance” of trial results. Fauci documentary (25:14).
Now, if you work in a pharmaceutical company research and development department, and your job is to report the outcome of your clinical trial, which number would you prefer to report to increase your sales, a 1% ARR, or a 95% RRR? Take your time in answering; I know this is a hard question. Perhaps this will help: the U.S. Food and Drug Administration (FDA) stated in their publication, Communicating Risks and Benefits, that both the ARR and RRR should be reported to the public. Obviously, public health authorities didn’t allow that to happen when reporting results of the Pfzier and Moderna COVID-19 mRNA vaccine trials, nor was the ARR reported when the FDA Advisory Committee granted authorization and approval of the vaccines.
Although an approximate 1% ARR represents 10,000 prevented infections per 1 million vaccinations, there are two problems with this point. First, the public has not been provided with sufficient information to consent to a treatment with a mere 1% ARR. Second, evidence of temporary anti-inflammatory and immunosuppressant effects from an ingredient used to stabilize the mRNA in the vaccines, polyethylene glycol (PEG), may account for the ultralow and waning vaccine ARR, and more investigations are needed in this area. Furthermore, after decades of failed attempts, there is still no clinical evidence proving the hypothesis that injecting mRNA into human cells in vivo is able to overcome cell defense mechanisms and successfully translate into ribosomal biogenesis of proteins that stimulate an immune response.
Preventing Severe Infections, Hospitalizations, and Deaths
Having established that the COVID-19 mRNA vaccines have ultralow efficacy in preventing infections with at least one mild or moderate symptom in clinical trials, how is it possible that the vaccines can prevent severe infections, hospitalizations, and deaths within the general public? Such claims are based on observational evidence of large numbers of healthy people within the general public who received the mRNA vaccines and who avoided severe infections, hospitalizations, and deaths.
But this evidence is not causative, and the evidence is flawed by selection bias. For example, to study clinical trial endpoints of severe infections, hospitalizations, and deaths, participants in a vaccine trial must be selected who are at greater risk for these conditions than healthy people. No such vaccine trials exist, and the claims cannot be substantiated.
Unvaccinated Hospitalizations and Threats to Others
Vaccine hesitancy is more common in people from minorities who have lower socioeconomic status (SES). People from Black and Hispanic minorities also have greater rates of obesity, chronic disease, and poor nutritional status which increase susceptibility to infection. People with lower SES generally have less access to primary healthcare providers and are more dependent on emergency room care. These social determinants, not lack of protection from a vaccine with an approximate 1% ARR, most likely account for higher rates of unvaccinated people in hospitals. Low Socioeconomic Status Mediates Vaccine Hesitancy and COVID-19 Hospitalizations.
Finally, with such low vaccine efficacy, people receiving the COVID-19 mRNA vaccines are susceptible to infection, reinfection, and transmission of viruses at the same rate as most unvaccinated people.
Summary of Evidence
A legal case against those who spread misinformation and enforce COVID-19 vaccine mandates on employees and the general public is based on the following points:
- Vaccine efficacy measures the COVID-19 mRNA vaccine’s ability to prevent an infection with a mild or moderate symptom in a randomized controlled trial, which is the gold standard for demonstrating causality, and which should not be confused with observation studies that only imply vaccine effectiveness.
- Vaccine efficacy, or the relative risk reduction (RRR), is calculated from clinical trial results by comparing the vaccine infection rate with the placebo infection rate.
- The method of calculating the RRR from the relative risk (RR) is a proportional measure used for population studies, but is not sensitive enough for use in a clinical trial to measure individual reductions in infections, known as the absolute risk reduction (ARR).
- The reciprocal of the ARR is the number needed to vaccinate (NNV), which is used to compare results of clinical trials.
- The absolute risk reductions of the COVID-19 mRNA vaccines are approximately 1% compared to RRRs of approximately 95%.
- Calculating the RRR with the risk reduction method statistically manipulates the ARR to increase the RRR, a method apparently familiar to Dr. Fauci.
- The U.S. Food and Drug Administration stated that both the RRR and ARR should be communicated to the public, which public health authorities and the FDA Advisory Committee that authorized and approved the vaccines ignored.
- An approximate 1% ARR should be reported to the public to provide necessary information before consenting to vaccination.
- Polyethylene glycol may account for the vaccine’s temporary anti-inflammatory and immunosuppressive effects, and, after decades of failed attempts, there is still no proof that mRNA injected into cells can overcome cell defenses and stimulate an immune response through translation of protein biogenesis.
- No clinical trial evidence exists that the vaccines can prevent severe infections, hospitalizations, and deaths in people at greater risk for these conditions than healthy people.
- Social determinants of poor health and higher susceptibility to infection accounts for higher hospitalization rates of unvaccinated people with lower socioeconomic status and vaccine hesitancy.
- Vaccinated people have no more protection against viral infection than most other unvaccinated people.
Based on this evidence, those who impose COVID-19 vaccine mandates must be held accountable for spreading false information and inflicting harm on employees and the general public.