COVID 19 "VACCINES"
IS A MANDATE CONSTITUTIONAL?
THE PUBLIC'S HEALTH
Is a Covid 19 "vaccine" mandate coming? According to Professor Kaminer at Buruch College, Department of Law, "States and the federal government have the law on their side if they needed to enact mandates." The New York Bar is on record in favor of mandates and State of Virginia Health Commissioner proclaimed he intends to use his authority to mandate a coronavirus vaccine. On 9.10.20, WUSA published the article, "States can Legally Mandate a Vaccine" (wusa9.com). WUSA cited its source as WHO Director Professor Lawrence Gostin, Georgetown University. As case law authority, WUSA cited Jacobson v Massachusetts, 1905.
Alan Dershowitz, Constitutional lawyer to the President and Harvard Law Professor declared with much fanfare, in his discussion with Jason Goodman on Crowdsource the Truth, that according to Jacobson v Massachusetts:
“You have no right not to be vaccinated, you have no right not to wear a mask, you have no right to open up your business… And if you refuse to be vaccinated, the state has the power to literally take you to a doctor's office and
plunge a needle into your arm.”
Dershowitz and other legal experts state Jacobson v Massachusetts gives government the police
power to mandate a Covid 19 "vaccine"*. Are they correct constitutionally or are they engaging in lawfare (see Links & Definitions).
The decision in Jacobson allowed the state to fine a defendant, who refused a smallpox vaccine, five
dollars. The Supreme Court's decision relied heavily on the common belief that smallpox vaccination, based on one hundred years of use, was safe and effective. Is the Court's holding in Jacobson, with respect to a smallpox vaccine, applicable to the Covid 19 "vaccines" currently in Phase III?
Vaccines are a unique class of pharmaceutical products that meet the statutory definition of both a drug and a biologic product (Food Drug and Cosmetic Act, 21 USC Sec. 321). Vaccines (such as smallpox, polio, MMR, measles) are regulated as Biologics by the FDA (CBER) under the sub-category Vaccine. Other FDA sub-categories under Biologics, are Gene Therapies, Cellular Products, Human Cells and Tissues.
The FDA defines a Biologic as a Vaccine regardless of its composition or method of manufacture, so long as its claimed intention is to induce or enhance a specific immune response to prevent or treat a disease or condition, or to enhance the activity of other therapeutic interventions. Therefore, even if a Biologic is a Genetic Therapy, if a manufacturer claims its end point satisfies the definition, it will be regulated by the FDA as a "vaccine."
The FDA however in its publications does distinguish between traditional and novel "vaccines":
"Advances in biotechnology have resulted in novel vaccines that are presently developed against global disease (e.g., nucleic-acid based (DNA) vaccines, viral-vectored vaccines, recombinant fusion protein vaccines and genetically altered attenuated live vaccines). These vaccines are frequently combined with novel adjuvants and administered using new delivery systems" (Guidance for Industry, Dec. 2011, fda.gov.).
All Covid 19 Investigational New Drugs "vaccines" currently in Phase III are novel, next generation platforms and not traditional vaccines.
J&J's Ad26.COV2.S and AstraZeneca's AZD1222 are DNA viral vectors. Moderna's 1273 and Pfizer/Biontech are mRNA viral vectors.
Therefore, is it reasonable to claim Jacobson (which addressed a traditional smallpox vaccine) gives government the power to mandate a novel "vaccine," when that question was not before the Court in 1905, nor any court since? In fact, the Jacobson Court's holding was explicitly based on the smallpox vaccine's 100 year safety record, which was common knowledge at the time. Have the legal experts who cite Jacobson as authority for mandating a novel "vaccine", fully considered the Jacobson's Court's reasoning underlying its decision to uphold a $5 fine against the Defendant. Conversely, is it possible these gatekeepers of the common law are engaged in vaccine lawfare?
According to the FDA, the investigational novel "vaccines" for Covid are at the forefront of biomedical experimentation.
"DNA vaccines represent a new frontier for molecular-based recombinant vaccines." fda.gov/media/81708
The mRNA "vaccines" are so novel, regulators in some countries (e.g. Japan) are unsure if mRNA vectors should be sub-categorized as a "vaccine" or under a completely new sub-category of biologic. Fueling this uncertainty, Moderna in its 8K SEC filing stated, mRNA vectors (in contrast to DNA vectors) should be regulated under a completely new sub-category of Novel Biologic.
Regardless of the sub-category under which these Phase III Next Generation Platforms are regulated, or what they end up being called based on political expediency, it is axiomatic that any near term Emergency Use Authorization (EUA) would be based on the collection and analysis of short term data only. The regulatory question then becomes, how does the FDA construct its required Probability-Impact Matrix, in order to determine if an investigational novel "vaccine" is safe?
A Probability-Impact Matrix requires the FDA to assign a probability to the likelihood of harm occurring and then multiplying that probability, by the severity of harm should it occur.
Given only short term data is available (1 year or less), it is tautological that calculating the probability of long term harm from an investigational novel "vaccine" is an unknown. While J&J may market their Ebola viral vector "vaccine" as proven, credible sources disagree.
"It is not proven until it is licensed...to say it is proven without peer- reviewed efficacy data is a stretch."
Professor Hildegund C.J. Ertl, M.D., Vaccine & Immunotherapy Center
What is foreseeable however, is that if long term harm does occur, such as mass mutagenesis, the severity of harm to billions of people and future generations could be catastrophic and potentially the worst medical (iatrogenic) disaster in human history.
Given a truncated investigation measured in months (2 month follow up) and the absence of any long term in vivo data:
1) Can the FDA construct a Probability-Impact Matrix, reasonably sufficient to perform the requisite risk-benefit analysis that addresses important identified risks, important potential risks and important missing information.
2) Given a formula which requires the FDA to determine the product of an unknown multiplier (likelihood of harm) and a potentially infinite multiplicand (severity of harm), can the FDA legally justify an EUA?
If the FDA does authorize a "vaccine" as an Investigational New Drug under an EUA, would this preempt individual states from asserting their police powers to mandate injections? If so, would an unapproved EUA Investigational New Drug, be subject to the Right of Refusal set forth in Sec. 564 of the Federal Food, Drug & Cosmetic Act?
The Jacobson Precedent - 115 Years Later. Is it still good law?
The Jacobson Court never considered the constitutionality of a novel "vaccine" mandate. Nevertheless, the reasoning underlying the Court's holding is prescient and provides a workable framework to determine whether the Constitution permits mandating a novel "vaccine." Foundational to this analysis is the common belief of the medical profession and the public, not the science per se.
"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 v Mass.
While it is beyond dispute some individuals will willingly volunteer their bodies for "vaccine" research regardless of risk, can this be said for the majority of people? Without having adequate knowledge to form a reasonable belief as to a novel "vaccine's" safety, would the Court take judicial notice (which is the requisite test) that a majority would willingly submit to a novel "vaccine" mandate?
In addition to the Jacobson holding, the issue of an novel "vaccine" mandate shall be analyzed in the context of other applicable constitutional precedents, statutes, cases, regulations and law. This site's review will include, but not be limited to, The Model State Emergency Health Powers Act, International Health Regulations 2005 and the Pandemic and All Hazards Preparedness Act ( PAHPA).
* None of the Investigational New Drugs in Phase III trials are traditional vaccines. Nevertheless, these next generation platforms are being referred to as "vaccines" because of their intended end point. Therefore, in order to introduce clarity into the discussion, when an Investigational New Drug is a Next Generation Platform (e.g., nucleic-acid based (DNA) vaccine, viral-vectored vaccine, recombinant fusion protein vaccine and/or genetically altered attenuated live vaccine) it shall be distinguished from a traditional platform by the use of quotation marks around "vaccine." When not in quotes, vaccine refers to a traditional vaccine (e.g. smallpox, measles, MMR, tetanus).
Editor's Note: The reader's indulgence is requested. Confounding the terms Experimental, Investigational New Drug, Next Generation Platform, Novel Biologic, Novel Vaccine, Genetic Therapy and Traditional Vaccine is at the heart of vaccine lawfare and it is important the reader unpack this conceptual confusion.
**The common law of traditional vaccines is well established. Therefore, this website will not address traditional vaccines developed and deployed consistent with longstanding regulatory process and believed by the majority of medical professionals and the public to be safe and effective.
THIS WEBSITE IS UNDER DEVELOPMENT
[See updated Home Page & Statement of Concern -10.27.20]
This site and its contents are protected under 17 U.S. Code § 107. Limitations on exclusive rights: Fair use. Copyright Act of 1976