COVID 19 "VACCINES"
IS A MANDATE CONSTITUTIONAL?
See Updated Sections
The Case Against Employer Mandates
The Limits of Jacobson
After Roman Catholic Diocese v. Cuomo
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 President Trump 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 contend Jacobson v Massachusetts gives government the police
power to forcibly 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 of Massachusetts 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 Covid 19 "vaccines" under and an Emergency Use Authorization (EUA)?
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 EUA and Phase III Covid 19 Investigational Drugs "vaccines" 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. Additionally, why do the legal experts who cite Jacobson as authority for mandating a novel "vaccine", sidestep that Court's reasoning which upheld a $5 fine, as opposed to forced vaccination? Is it possible those who cite Jacobson as authority for mandates are engaged in vaccine lawfare?
This question was addressed by the U.S. Supreme Court in Roman Catholic Diocese of Brooklyn v. Cuomo on November 25, 2020. In his conconcurrence, Judge Gorsuch explicitly demarcates the limits of Jacobson by stating that Jacobson provides no authority for forced vaccination. Gorsuch's concurrence and its impact
on Jacobson is discussed in this site's section on the Limits of Jacobson.
Given the Court's injunction in Roman Catholic Diocese, it now appears more likely Covid vaccine mandates will be by the "private sector." (See this site's section on Employer Mandates, where 21 U.S. Code's "Option
to Refuse" is discussed in detail). These mandates (if determined to be de facto state action) raise the issue of the constitutionality of a "private sector" warp speed end around of the 1st, 4th and 14th Amendments. While Jacobson is still germane to anti-choice advocates, to the extent it can be used as lawfare for private mandates and state action by authoritarian regimes, subsequent to Roman Catholic Diocese forced vaccination advocates are making a full pivot to private mandates by duress.
Independent of Jacobson, 21 U.S. Code raises an additional barrier to both private and public forced vaccination per an EUA, which provides the option to refuse an unapproved investigational drug.
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 Biologics.
Regardless of the sub-category under which these Next Generation Platforms are regulated, or what they end up being called due to political expediency, it is axiomatic that Emergency Use Authorization 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 unknown. While J&J may market their Ebola DNA 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 and/or
any of the myriad vaccine enhanced diseases, 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 and the absence of any long term in vivo data (previous world record was mumps at 4 years):
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 private or public mandates under 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 circumvention of Jacobson to support public and/or private mandates
Jacobson represents a Constitutional argument against forced vaccination. Under Jacobson a state mandate requires a common belief in vaccine safety and efficacy; and even if this pre-condition is satisfied, Jacobson does not support forced vaccination only fines. Thus, since a state cannot subject its citizens to forced medical experiments, state actors are now positioning the private sector to do what they cannot. By initially arguing Jacobson permitted forced vaccination, the state took a page from Sun Tzu's
Art of War - appearing strong when they were weak. The argument Jacobson permitted forced vaccination is legally weak, but it has now paved the way for proposed private mandates insulated from a Jacobson analysis. In other words, if the state can constitutionally mandate vaccination, then the private sector, which is free from constitutional restraint, could do so as well. This constitutes lawfare and is an end around the Constitution.
In the end, Jacobson becomes relevant not as an argument for forced vaccination, but as a Constitutional bulwark against it. But for this to take effect, Jacobson's reasoning must be imposed upon state actors as well as those who operate under the artifice of private industry, in concert with or directed by state actors.
Furthermore, even though the Jacobson Court did not consider the constitutionality of a novel "vaccine" mandate, its holding is prescient and provides a workable framework to determine whether the Constitution would permit it. 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 if given the facts? Without adequate knowledge to form a reasonable belief as to a novel "vaccine's" safety or efficacy, would the Court take judicial notice (which is the requisite test) that a majority would willingly and reasonably submit to a novel "vaccine" mandate? This issue of knowledge and the common belief must also take into consideration the abrogation of the 1st Amendment by state proxies and the wholesale censorship of those
who seek and disseminate information questioning experimental vaccines.
In conclusion, Jacobson's holding, must be reintroduced into the forced vaccine debate as written, so that the issue of a novel "vaccine" mandate can be analyzed in the proper context of U.S Constitutional Law,
the Law of Nations and the Nuremberg Code. But the gravamen of this undertaking is unwinding the gordian knot of state actors and the so called "private" scientific technological elites, that President Eisenhower warned us about 60 years ago. If our statesmen and women fail to mold, balance and
integrate these forces, we shall surely lose our Republic.
"Akin to, and largely responsible for the sweeping changes in our industrial-military posture, has been the technological revolution during recent decades. In this revolution, research has become central; it also becomes more formalized, complex, and costly. A steadily increasing share is conducted for, by, or at the direction of, the Federal government. Today, the solitary inventor, tinkering in his shop, has been overshadowed by task forces of scientists in laboratories and testing fields.
In the same fashion, the free university, historically the fountainhead of free ideas and scientific discovery, has experienced a revolution in the conduct of research. Partly because of the huge costs involved, a government contract becomes virtually a substitute for intellectual curiosity. For every old blackboard there are now hundreds of new electronic computers.
The prospect of domination of the nation's scholars by Federal employment, project allocations, and the power of money is ever present and is gravely to be regarded. Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that
public policy could itself become the captive of a scientific technological elite.
It is the task of statesmanship to mold, to balance, and to integrate these and other forces, new and old, within the principles of our democratic system -- ever aiming toward the supreme goals of our free society." President Dwight D. Eisenhower, Farewell Address.
* None of the Investigational New Drugs under a the 2020 EUA's 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 Sections: The Case Against Employer Mandates & The Limits of Jacobson -1.1.21]
This site and its contents are protected under 17 U.S. Code § 107. Limitations on exclusive rights: Fair use. Copyright Act of 1976