COMMON BELIEF OF THE PEOPLE
THE FOUNDATION OF JACOBSON v MASSACHUSETTS
According to Jacobson, "if a statute purporting to have been enacted to protect the public health, the public morals, or the public safety has no real or substantial relation to those objects... it is the duty of the courts to so adjudge, and thereby give effect to the Constitution. Mugler v. Kansas, 123 U. S. 623, 123 U. S. 661; Minnesota v. Barber, 136 U. S. 313, 136 U. S. 320; Atkin v. Kansas, 191 U. S. 207, 191 U. S. 223."
In Jacobson, the Court held the common belief and knowledge of the people was the core determining factor as to whether a smallpox vaccine had a real and substantial relation to the prevention of smallpox. Per Justice Harlan, the Court took judicial notice that people commonly believed the smallpox vaccine was preventive of smallpox, therefore the legislative decision to invoke police power was reasonable.
"While we do not decide, and cannot decide, that vaccination is a preventive of smallpox, we take judicial notice of the fact that this is the common belief of the people of the state, and, with this fact as a foundation, we hold that the statute in question is a health law, enacted in a reasonable and proper exercise of the police power." (Jacobson).
According to Gostin, the Jacobson Court determined the smallpox vaccine had a real or substantial relation to the prevention of smallpox, by means of a 3 part test, which included (1) necessity, (2) means-ends and (3) proportionality.
Each factor in Gostin's 3 part restatement of the standard enunciated in Jacobson, is determined by the common belief and knowledge of the people.
The Common Belief & Knowledge Standard
The terms "common knowledge", "common belief" and "what people believe is for the common welfare" are referenced 11 times in the Jacobson opinion. As the Court states,
"In a free country, where the government is by the people, through their chosen representatives, practical legislation admits of no other standard of action; for what the people believe is for the common welfare must be accepted as tending to promote the common welfare, whether it does in fact of not."
"...it had become the duty of the judge, in accordance with the law as stated in Commonwealth v. Anthes, 5 Gray, 185, to instruct the jury as to whether or not the statute is constitutional, he would have been obliged to consider the evidence in connection with facts of common knowledge, which the court will always regard in passing upon the constitutionality of a statute. He would have considered this testimony of experts in connection with the facts that for nearly a century most of the members of the medical profession have regarded vaccination, repeated after intervals, as a preventive of smallpox; that while they have recognized the possibility of injury to an individual from carelessness in the performance of it, or even in a conceivable case without carelessness, they generally have considered the risk of such an injury too small to be seriously weighed as against the benefits coming from the discreet and proper use of the preventive; and that not only the medical profession and the people generally have for a long time entertained these opinions, but legislatures and courts have acted upon them with general unanimity." (Jacobson).
To the Court, common belief and knowledge were fundamental to the constitutionality of a vaccine mandate. Thus, the Jacobson Court set forth with the requisite specificity how it determined the common belief and knowledge and how that common belief and knowledge (per Gostin's restatement) supported its finding of necessity, means/end and proportionality in the case of Henning Jacobson. Thus, the question before the Court today would be whether it was common knowledge and belief that an experimental mRNA vaccine prevented Covid 19 and rendered it less dangerous.
As the Court decided in Jacobson, "The common belief, is that it [the smallpox vaccine] has a decided tendency to prevent the spread of this fearful disease, and to render it less dangerous to those who contract it."
Determining the Common Belief and Knowledge
While Gostin's restatement sets forth the factors to which common knowledge and belief are dispositive, it was the Jacobson Court which set out the methodology for determining that common belief and knowledge.
"The common belief, is that it [the smallpox vaccine] has a decided tendency to prevent the spread of this fearful disease, and to render it less dangerous to those who contract it. While not accepted by all, it is accepted by the mass of the people, as well as by most members of the medical profession. It has been general in our state, and in most civilized nations for generations. It is generally accepted in theory, and generally applied in practice, both by the voluntary action of the people, and in obedience to the command of law...the legislature has the right to pass laws which, according to the common belief of the people, are adapted to prevent the spread of contagious diseases." (Jacobson).
Consistent with this holding in Jacobson, the reasonableness of any health law mandating a covid experimental genetic "vaccine" must focus on the common belief and knowledge of the people, as determined by the 5 factors the Court found dispositive:
1) Accepted by the mass of people
2) Accepted by most members of the medical profession
3) In general [use] in our state, and in most civilized nations for generations;
4) Generally accepted in theory
5) Generally applied in practice, by the voluntary action of people, and in obedience to law
Factor 1: The mRNA Vaccine is not Accepted by the Mass of People
Because the mRNA vaccine has never been deployed and is being administered as part of an experiment, there is no reasonable basis to claim the mass of people accept mRNA vaccines prevent Covid nor that this novel gene therapy renders Covid 19 less dangerous.
Factor 2: The mRNA Vaccine is not Accepted by Most Members of the Medical Profession
The majority of the quotes* (see below) regarding lack of acceptance by the medical profession are not from random practitioners, but from those responsible for regulating and developing Covid vaccines. The majority of these quotes are warnings and include direct quotes from three of the largest Covid vaccine manufacturers and their military funders. They are demonstrative of the skepticism and concern shared by most members of the profession.
Factor 3: The mRNA Vaccine is Not in General [use] Anywhere in the United States, nor in Most Civilized Nations for Generations
The mRNA vaccine is a novel unprecedented genetic therapy and should be distinguished from
a 100 year old smallpox vaccine. The mRNA vaccines are not in general use
anywhere in the world and these experimental biologics are being deployed pursuant to an Emergency Use Authorization. Additionally, (based on observations of adult populations for less than 1 year) there is no data on inter-generational use which would allow people to determine the likelihood of birth defects and other neonatal adverse events. Also, because no Pre-Phase 1 standardized animal testing has been performed, regulators have not been able to provide the public with any reliable data from animal models to quantify the probability of mutagenesis or long term adverse events in human subjects.
Finally, given the unique handling and administration requirements of genetic vaccines, during the initial roll out, there have been multiple reports of issues, resulting in people receiving wrong dosages and spoiled product. Most problematic has been the use of the second dose (as a first dose) contra to FDA approval protocols, in order to get as many people as possible vaccinated.
Factor 4: The mRNA Vaccine is Not Generally Accepted in Theory
In order to determine if an mRNA genetic therapy is generally accepted in theory as safe and effective, we turn to key excerpts of Moderna's 8K Securities Exchange Commission Filing.
The quotes below** are taken directly from Moderna's filing. The upshot is that the theory of
experimental mRNA genetic vaccines is novel and unprecedented. Theoretical safety risks and lack of efficacy is not just related to the vaccine itself, but involve the lipid carrier which has never been tested in humans for medium and long term synergistic impact. In its 8K, Moderna raises the probability its vaccines carry some theoretical risk for mutagenesis. Additionally, the unprecedented scale required for worldwide storage, handling, distribution and administration, adds unprecedented complex levels of theoretical risk never before seen and for which short term limited testing has not been able to address.
Factor 5: The mRNA Vaccine (Under an Emergency Use Authorization) is not Generally Applied in Practice, by the Voluntary Action of People, and in Obedience to Law
The term "generally applied in practice" is not a reference to an equal protection analysis, since equal protection was explicitly addressed in Jacobson in a different section of that opinion. Here the term "generally accepted" should be interpreted per its plain meaning, as defined by Oxford Dictionary as "usually" with "usually" defined by Oxford as " under normal conditions." Given these experimental mRNA "vaccines" are being administered under an Emergency Use Authorization (EUA), it is axiomatic that they are not being administered under normal conditions, since the Code of Federal Regulations explicitly requires a "life-threatening situation" for an EUA.
"Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]."
Per Jacobson, the above 5 Factor Test is determinative as to whether the people commonly believe a Covid "vaccine" has a decided tendency to prevent the spread of this fearful disease, and to render it less dangerous to those who contract it. Given these factors are dispositive of the common belief and knowledge and that this belief and knowledge is foundational to the reasonable and proper exercise of the police power," there is no basis for the Court to hold forcible injection of an mRNA vaccine is constitutional.
Because the Jacobson Court never addressed the question of non consensual injections of a novel "vaccine", nor the right of states to force an experimental procedure on unwilling participants,
Dershowitz's position that "the state has the power to literally take you to a doctor's office and plunge a needle into your arm” cannot be supported. In fact, based on both Jacobson's holding, and on J Gorsuch's concurrence in Roman Catholic Diocese, Dershowitz's opinion is arguably lawfare.
Factor 2: Quotes from the Medical Profession*:
"You can't spend your time figuring out is it going to work or not going to work, you just have to commit." AstraZeneca CEO Pascal Soriot
"mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of medicines"
Moderna's 8K Securities Exchange Commission Filing
Col. Nelson Michael, director of the U.S. Army's Center for Infectious Disease Research who is working on the government's "Warp Speed" project to deliver a vaccine at scale by January, said companies usually have years to figure this stuff out. "Now, they have weeks."
"This is the biggest logistical challenge the world has ever faced," said Toby Peters, an engineering and technology expert at Britain's Birmingham university. "We could be looking at vaccinating 60% of the population."
J&J has partnered with the U.S. government on a $1 billion investment to speed development and production of its vaccine, even before it's proven to work. "Never in history has so much vaccine been developed at the same time - so that capacity doesn't exist," said Paul Stoffels, J&J's chief scientific officer, who sees filling capacity as the main limiting factor.
The speed of pre-clinical development for COVID-19 vaccines has been unprecedented — Moderna’s innovative m-RNA platform moved from receiving the coronavirus genome to having a testable vaccine in 44 days. But as Dr. Fauci emphasized, even if everything goes perfectly during clinical trials, there are another 6-12 months to go until approval, and additional time will be needed to ramp up production.
"As I have outlined elsewhere, we know that risk of hospitalization and death from COVID-19 is concentrated in the elderly and people with underlying medical problems, and it is largely a mild, even asymptomatic disease for the young." Dr Joel M. Zinberg is a senior fellow with the Competitive Enterprise Institute in Washington, D.C. He is also an associate clinical professor of surgery at the Mount Sinai Icahn School of Medicine and was senior economist and general counsel at the Council of Economic Advisers from 2017 to 2019.
“A lot of optimism is swirling around a 12- to 18-month time frame, if everything goes perfectly,” Rick Bright, the former head of the Biomedical Advanced Research and Development Authority, told lawmakers in May. “We’ve never seen everything go perfectly. I think it’s going to take longer than that.”
For example, said Offit, most vaccines work by triggering an immune response inside the body without making a person sick. But for this novel coronavirus, scientists still haven't had time to adequately study the body's immune response to infection -- meaning we don't know whether an immune system response necessarily protects against a future infection.
Dr. Paul Goepfert, professor of medicine at the University of Alabama at Birmingham (UAB) and an expert in vaccine design, said a vaccine by January would only be possible "if everything works out perfectly."
The speed with which researchers and pharmaceutical companies have responded to the coronavirus epidemic has been described as "unprecedented" by Dr Jerome Kim, Director-General of the International Vaccine Institute.
The potential benefits are to have a vaccine against Covid-19 ready for general use as soon as possible. That won’t happen for a year at least. That timeline, Lynch went on, is “insanely fast,” Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania
Factor 4: Quotes from Moderna's 8K SEC filing**:
"Currently, mRNA is considered a gene therapy product by the FDA. In certain countries, mRNA therapies have not yet been classified or any such classification is not known to us...mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of medicines...There have been few approvals of gene therapy products in the United States or foreign jurisdictions, and there have been well-reported significant adverse events associated with their testing and use...Our mRNA development candidates and investigational medicines are based on novel technologies and any development candidates and investigational medicines we develop may be complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release, shelf life, testing, storage, and supply chain management or shipping... We are utilizing a number of raw materials and excipients that are either new to the pharmaceutical industry or are being employed in a novel manner... As a potential new category of medicines, no mRNA medicines have been approved to date by the FDA or other regulatory agency. Successful discovery and development of mRNA medicines by either us or our strategic collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control...The number and design of the clinical and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict...In addition, the biology risk across the majority of our pipeline represents targets and pathways not clinically validated by one or more approved drugs. Only our H10N8 vaccine (mRNA-1440), H7N9 vaccine (mRNA-1851), phenylketonuria, or PKU, (mRNA-3283), and Fabry disease (mRNA-3630) programs pursue pathways where an approved pharmaceutical product has validated the vaccine and therapeutic intervention points. While we believe we have made progress in seeking to reduce biology risk in certain settings, such as for vaccine targets for which we and others have shown the utility of neutralizing antibodies, the risk that the targets or pathways that we have selected may not be effective will continue to apply across the majority of our current and future programs...Gene therapies and mRNA based medicines may activate one or more immune responses against any and all components of the drug product (e.g., the mRNA or the delivery vehicle, such as a lipid nanoparticle) as well as against the encoded protein, giving rise to potential immune reaction related adverse events...We must also complete extensive work on Chemistry, Manufacturing, and Controls, or CMC, activities (including yield, purity and stability data) to be included in the IND filing. CMC activities for a new category of medicines such as mRNA require extensive manufacturing processes and analytical development, which is uncertain and lengthy...As a result, we cannot be sure that we will be able to submit INDs or similar applications for our preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin...The manufacturing processes for our development candidates and investigational medicines are novel and complex. There are no mRNA medicines commercialized to date or manufactured at such scale. Due to the novel nature of this technology and limited experience at larger scale production, we may encounter difficulties in manufacturing, product release, shelf life, testing, storage and supply chain management, or shipping. These difficulties could be due to any number of reasons including, but not limited to, complexities of producing batches at larger scale, equipment failure, choice and quality of raw materials and excipients, analytical testing technology, and product instability...The process to generate mRNA investigational medicines encapsulated in LNPs is complex and, if not developed and manufactured under well-controlled conditions, can adversely impact pharmacological activity. Furthermore, we have not manufactured mRNA medicines at commercial scale. We may encounter difficulties in scaling up our manufacturing process, thereby potentially impacting clinical and commercial supply...Our investigational medicines may have undesirable side effects, such as the immunogenicity of the LNPs or their components, the immunogenicity of the protein made by the mRNA, or degradation products, any of which could lead to serious adverse events, or SAEs, or other unexpected characteristics...Although our mRNA development candidates and investigational medicines are designed not to make any permanent changes to cell DNA, regulatory agencies or others could believe that adverse effects of gene therapies products caused by introducing new DNA and irreversibly changing the DNA in a cell could also be a risk for our mRNA investigational therapies...There is typically an extremely high rate of attrition for product candidates across categories of medicines proceeding through clinical trials. These product candidates may fail to show the desired safety and efficacy profile in later stages of clinical trials despite having progressed through nonclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in later-stage clinical trials due to lack of efficacy or unacceptable safety profiles, notwithstanding promising results in earlier trials...Most of our investigational medicines are formulated and administered in an LNP which may lead to systemic side effects related to the components of the LNP which may not have ever been tested in humans. While we have continued to optimize our LNPs, there can be no assurance that our LNPs will not have undesired effects. Our LNPs could contribute, in whole or in part, to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation reactions, antibody reactions including IgA, IgM, IgE or IgG or some combination thereof, or reactions to the PEG from some lipids or PEG otherwise associated with the LNP. Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events in one or more of our clinical trials. Many of these types of side effects have been seen for legacy LNPs. There may be resulting uncertainty as to the underlying cause of any such adverse event, which would make it difficult to accurately predict side effects in future clinical trials and would result in significant delays in our programs...In addition to serious adverse events or side effects caused by any of our investigational medicines, the administration process or related procedures also can cause undesirable side effects...To date, our investigational medicines including RSV vaccine (mRNA-1777), CMV vaccine (mRNA-1647), hMPV+PIV3 vaccine (mRNA-1653), H10N8 vaccine (mRNA-1440), H7N9 vaccine (mRNA-1851), Zika vaccine (mRNA-1325), Chikungunya vaccine (mRNA-1388), PCV (mRNA-4157), OX40L (mRNA-2416), and VEGF-A (AZD8601) have been tested in fewer than 1,000 subjects in the aggregate...Our product and product intermediates are extremely temperature sensitive, and we may learn that any or all of our products are less stable than desired."
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