Civilian Employer COVID-19 Violations - 1974 Congress Nat'l Research Act *Save This Info*

been sayn this since day 1 - you cant force vaccinate a non-fda approved vaccine. you also cant force vax if theres known cures n therapies which there is, regeneron, hcq, ivermectin et al in addition trump signed the right to try act in 20 - its a felony to use coercion under us code 50.23 + 50.24. **In Pennsylvania, on Oct 11/2017 Gov Tom Wolf signed EO whereas anyone wanting to participate in a clinical trial it is deemed a VOLUNTARY PROGRAM. California has a similar law.

If you were fired from your job - SUE!! you have grounds. cant trump congress.

Did you know federal law explicitly states that “participation [in experimental COVID-19 drugs] is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled?” Congress passed the National Research Act in ’74, declaring that an individual may not be administered an experimental drug if they are under “sanctions,” “coercion,” or “undue influence.”


Government agencies (e.g., VA, ICE, FSA) administrators and supervisors are at risk of prosecution by State Attorneys General for violating international treaties, federal statutes, state statutes and regulations for penalizing employees who refuse to participate in a COVID-19 experimental substance.

Private corporations are also at risk of significant remedial actions in civil courts for violating the federally protected rights of citizens to refuse COVID-19 experimental substance administration without incurring a penalty or losing a benefit to which citizens are otherwise entitled.

Both aforementioned entities have assaulted the fundamental 14th Amendment rights of citizens to be treated equally before the law. They have also potentially committed felonies under health privacy statutes. This document will present the facts to substantiate these claims so that authorities may take appropriate action to remedy the injustice perpetrated against law-abiding citizens.

Please note there are several statutory laws involved in products authorized for access under an Emergency Use Authorization (EUA). The author’s desire is to provide a basic understanding of those statutes to better understand how they interconnect, as well as the indisputable right to refuse an experimental substance without incurring a penalty.

COVID-19 VACCINE FACTS
An IND is legally defined as “a substance that has been tested in the laboratory and approved by the U.S. Food and Drug Administration (FDA) for testing in people. Also
called an experimental drug, IND, investigational agent, and investigational new drug (National Cancer Institute (NCI) Dictionary of Cancer Terms, 2022).” To involve a
human in an investigational new drug under any element of research is legally considered medical experimentation. No FDA-licensed and approved vaccines are known to be available to individuals subjected to the COVID-19 vaccine mandate. As of August 15, 2022, only COVID-19 Investigational New Drugs (IND) are commercially available to American citizens.

UNDERSTANDING SECTION 564
21 U.S. Code contains a set of statutes providing the Health and Human Services (HHS) Secretary authority to grant Americans access to experimental medical products
when certain conditions warrant. Some of those conditions might be the medical requirements of an individual; small investigatory research group; or under emergency
access protocols. 21 U.S. Code §360bbb-3 (Section 564) provides the HHS Secretary authority to grant Americans access to experimental medical products under a provision
known as “broad access” when a medical emergency has been declared.

Congress requires the HHS Secretary to assign a classification to each medical product before access is granted (§360bbb-2) so that government entities understand the regulatory framework for legal purposes. Without such classification, government entities have no authority over those substances. Furthermore, courts could not adjudicate litigation for respective administrative duties because the source of authority is derived from drug classification statutes and regulations.

Congress requires the HHS Secretary to issue an EUA letter to the pharmaceutical company requesting one of their products to be utilized for emergency purposes if the
Secretary believes the product “may have benefit” for its intended purpose.

Congress restricts the HHS Secretary from issuing an EUA if a FDA-licensed and approved product already exists in the market. Therefore, once a COVID-19 FDA-licensed product reaches the market, the authority to issue an EUA for the current pandemic automatically ends by statute.

REQUIRED CONDITIONS OF SECTION 564 AUTHORIZATION
1) Congress requires the HHS Secretary to issue a Scope of
Authorization outlining the regulatory requirements to be followed by all parties that “volunteer” to participate (e.g., emergency stakeholders, pharmaceutical companies, distributors, health care providers).

2) Congress requires the following information to be provided to
individuals participating in the medical product:
a) That HHS Secretary has authorized access
b) Risks and benefits of the product
c) The option to accept or refuse the product (informed
consent)
d) Consequences (health) of not taking the product
e) Alternatives to the product
f) Risks and benefits of those alternatives
3) Congress requires the HHS Secretary to ensure “appropriate
conditions on who may administer the product with respect to the emergency use of the product, and on the categories of individuals to whom, and the circumstances under which, the product may be administered with respect to such use.”

4) Congress requires the HHS Secretary to guarantee “appropriate conditions with respect to collection and analysis of information
concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.”

5) Congress notified the nation that, “nothing in this section provides the HHS Secretary any authority to require any person to carry out any activity that becomes lawful pursuant to an authorization
under this section.” This is a required statement because of liability immunities granted to participating entities including pharmaceutical companies.

Section 564 only grants the HHS Secretary authority to provide Americans access to experimental products during a declared emergency; Congress made no other claim.
Congress requires the Secretary to establish the circumstances under which Section 564 COVID-19 vaccines may be administered and denies authority to the Secretary to
require anyone to participate in those products.
No Governor, CEO, or federal agency Director will be able to declare any statute in Section 564 provides them authority to require participation under duress in EUA substances.

The FDA declares that informed consent is not “generally” required under Section 564 –
a legal fallacy. Suppose a chemical, biological, radiological, and or nuclear (CBRN) event releases an unknown agent causing significant harm to a large population who are all seeking immediate health care. In that case, the HHS Secretary can remove the “informed” part of the equation if not practical, but is never authorized to remove the
right of consent from any individual.

Some attorneys unethically construe the word “consequences” to mean civil violation. However, this is judicial heresy of the highest order. Section 564 does not authorize any
person to enforce participation under duress. Such arguments conflict with Congress providing individuals with the “option to accept and refuse” emergency-use products.
Furthermore, civil infractions and/or criminal violations must be authorized by a legislative body and pre-published to have the force of law. Congress did not legislate
penalties for non-participation. In 2007 the FDA guided authorities to notify individuals of the “consequences of not taking / using [product], including possible health effects...and of stopping the use of [product] against the recommendation of the
health care provider.”

PFIZER EUA
On August 23, 2021, the FDA issued an EUA letter to Pfizer for their BioNTech
COVID-19 Vaccine. Some of the FDA listed requirements under its Scope of
Authorization include:

1) “Pfizer Inc. must submit an Investigational New Drug application (IND) number 19736.” This was the HHS Secretary assigning an IND classification to Pfizer’s experimental substance complying with Section 564 requirements.
2) All printed matter relating to the use of the Pfizer-BioNTech COVID-19 Vaccine shall clearly and conspicuously state that: “This product has not been approved or licensed by the FDA.”
3) That “product-specific information required to be made available to vaccination providers and recipients” known as the Drug Fact Sheet.

INTERCHANGEABILITY
The FDA provided notice to Pfizer on August 23, 2021, that both of their COVID-19 vaccines (i.e., COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine) have the same formulation and may be used interchangeably to fulfill the vaccination series. That same day, Pfizer issued a press release echoing that statement saying, "the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine
to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2."

Pfizer, Inc. defines interchangeably as an option to use either the experimental or the approved vaccine to fulfill the same medical purpose. Therefore, this scientific
statement is explicitly related to their products and may not be utilized by authorities as the legal basis to bypass statutes protecting human subjects involved in INDs under an
EUA.

Neither private business (e.g., Pfizer, Inc.) nor government entities (e.g., FDA) have the authority to exempt themselves from congressional statutes governing the administration of EUA substances. COVID-19 vaccines classified by the FDA as an IND require the informed consent of the individual before their administration. This requirement is based on drug classification irrespective of another drug sharing the same formula. Congress did not provide a statute allowing an experimental substance to be used as a full licensure drug based on formulation.

Health care providers must administer the Pfizer-BioNTech COVID-19 Vaccine according to the Scope of Authorization outlined in the FDA’s EUA (i.e., during a declared public health emergency). However, those health care providers are not under such requirements when administering the FDA-approved COMIRNATY despite both vaccines sharing the same formulation. This legal fact demonstrates the requirement of
Congress for authorities to abide by a drug label and not a drug’s formulation.

The Department of Justice (DOJ) will not be able to produce a single federal statute providing an exemption from informed consent requirements based on a formula. All
such statutes are based on the product’s labeling, which is why the Centers for Disease Control (CDC) only provided guidance based on voluntary participation.

The CDC never issued guidance requiring compliance under threat of penalty and conspicuously stated, “...with vaccine being provided by the federal government ─ to ensure all people in the United States who wish to be vaccinated can receive vaccines without barriers, to the greatest extent possible.” The declaration of “who wish” is required by statute because their recommendations include both FDA-licensed and FDA-classified experimental substances.

Neither government nor corporate leaders are able to produce a single statute or FDA
guidance legally authorizing utilization of classified experimental substances “as if” they
are full licensure drugs for legal purposes of vaccine mandates.

Pfizer and BioNTech’s COVID-19 vaccines may share the same formulation, but they do not share the same classification. On August 23, 2021 the FDA informed governments
and corporations of the two drugs’ legal distinctions because these have significant legal consequences for citizens depending on their choice.

Can statutes associated with Pfizer COMIRNATY be used interchangeably with statutes that govern Pfizer/BioNTech COVID-19 Vaccine in a court of law because they share
the same formulation? Absolutely not! A competent judge would immediately dismiss such a claim. Lawyers guiding governmental and corporate entities to use a non-approved substance as if it is a full-licensure drug for purposes of legal mandates should be disbarred for abject failure to distinguish the proper course of action as written.


Legal Fact #1: Congress explicitly provided Americans with the absolute right to refuse participation in EUA experimental products. There does not exist a legal means by which authorities can mandate participation under threat of penalty. The interchangeable argument was pre-planned to confuse an entire nation about their right to refuse COVID-19 IND vaccines. Simply because the FDA and Pfizer declare that both substances fulfill the same medical purpose does not confer authority by statute to
subject Americans to medical experimentation without their free will and voluntary consent. Furthermore, Pfizer has yet to ship COMIRNATY, so it is physically impossible to use both substances ‘interchangeably’ for any purpose.

the rest of the pdf IS HERE [link to covidpenalty.com]



Last Edited by Phennommennonn on 08/19/2022 11:44 PM