On August 23, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) letter to pharmaceutical manufacturer, Pfizer, Inc. regarding licensed and unlicensed COVID-19 drugs. In that EUA letter, the FDA informed Pfizer, “The licensed vaccine has the same formulation as the EUA vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”
We can ascertain the true meaning of ‘interchangeability’ by reading Pfizer’s press release, “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.” (https://www.businesswire.com/news/home/20210823005499/en/)
Both political and corporate actors ignored the FDA’s statement concerning the legally distinct nature of the unlicensed vaccine and used the above ‘interchangeability’ statement of medical intent as the paradigm to deprive Americans of employment, health, and for many, life itself. Executive Branch leaders in federal and state governments engaged in the most comprehensive misinformation campaign ever devised to deny citizen rights and destroy the lives of the American people.
“Legally distinct” carries enormous weight in the context of the COVID-19 pandemic. Authorities at the FDA and other Executive Branch agencies intentionally obfuscated the distinction’s significance. The result of their gross negligence (willful conduct affecting the life or property or another) has led to the slaughter of thousands of Americans and harm to the financial, physical, and mental well-being of millions of others. Government actors and corporate employers NEVER had the right to penalize individuals who refused a 21 CFR 312.3 Investigational New Drug, such as Pfizer’s BioNTech COVID-19 Vaccine. This statement is irrefutable by statute.
Current COVID-19 vaccine mandates are illegal because they rely solely on the use of clinical research drugs for compliance.
COVID-19 VACCINE FACTS
To this date, the only available COVID-19 vaccines in the United States are still classified by the FDA as Investigational New Drugs (IND). For example, on August 23, 2021, the FDA informed pharmaceutical manufacturer Pfizer that BioNTech’s COVID-19 Vaccine had “not been approved or licensed by the FDA” and they “must submit to Investigational New Drug application number 19736.” The FDA has reissued and amended Pfizer’s EUA several times and the same language exists in them all. 3An IND is defined as “a new drug or biological drug that is used in a clinical investigation (21 CFR 312.3).” A clinical investigation is “any use of a drug except for the use of a marketed drug in the course of medical practice. (21 CFR 312.3)” Legally speaking, medical experimentation is to involve a human in an IND under any element of research (e.g., study of adverse events). Furthermore, all EUA medical products are legally regarded as experimental for their intended purpose. Adherence to the protocols resulting from the National Research Act (1974) strictly requires the free will and voluntary consent of individuals agreeing to participate in the administration of drugs or biologics classified as IND. To date, the FDA has assigned IND classification to each COVID-19 drug under an EUA, namely:
- Pfizer BioNTech COVID-19 Vaccine 19736
- Janssen IND 22657
- Moderna IND 19745
- Novavax IND 22430
LEGALLY EFFECTIVE INFORMED CONSENT
HHS codified a “set of adequate conditions” to obtain informed consent. Those conditions, when adhered to, provide the healthcare professional the ability to obtain the individual’s legally effective informed consent. 21 U.S. Code, SECTION 360bbb-3 564 (A)(i) is a congressional requirement for the Secretary (HHS) to “Appropriate conditions designed to ensure that individuals to whom the product is administered are informed.” This section of the law outlines the information required to be given in advance to the recipient. Once the individual is adequately informed of all relevant information, they must agree to accept or refuse based on their autonomous belief that the product may or may not benefit their personal health goals. This process is called ‘informed consent.’ However, federal law does not just require the informed consent of individuals involved in INDs under an EUA. More accurately, federal law requires the legally effective informed consent of individuals involved in EUA products. “Informed consent must be legally effective and prospectively obtained.” – U.S. Department of Health and Human Services The term “legally effective” means to obtain consent in accordance with all applicable laws and ethical guidelines in advance of the product’s administration.
To ensure the individual’s informed consent is legally effective, Congress defined the practical application of “the adequate standards for informed consent” as detailed in the Belmont Report.
(1) 45 CFR 46.116(a) (1) “Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject’s legally authorized representative.”
(2) 45 CFR 46.116(a) (2) “An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.” (3)45 CFR 46.116(a)
(3) “The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.”
(4) “The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.”
(5)45 CFR 46.116(a) “No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”
(6) “A description of any reasonably foreseeable risks or discomforts to the subject.”
(7) “A description of any benefits to the subject or to others that may reasonably be expected from the research.”
(8) “A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”
(9) “A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.” Combining the principles of the Belmont Report and the legal requirements of 45 CFR 46, informed consent is only legally effective if the offer to participate contains no coercion, undue influence, sanctions, or unjustifiable pressures.
The option to accept or refuse EUA products is a RIGHT bestowed upon the American people which no authority has the legal power to interfere. Both options have been granted equal protection and must be protected with equal force. The right to refuse is sacred. Never forget that!
Excellent summary. Parents should know there are still no FDA approved or licensed COVID vaccines available to current date. Those formulations were never manufactured. You have the legal right to refuse without exclusion from school or employment.
The Colorado Court of Appeals does not recognize’s people’s right to refuse. I was fired from my job due to the experimental jab and was denied unemployment benefits. I appealed and won however my former employer challenged the ruling and I ultimately lost in the Court of Appeals. The State of Colorado has no interest in protecting the rights and liberties of it’s citizens.
Well lookiee at all the lawyer speak. Ya it always ends up with dead people, lots of government daring the individual to do something.
Well I wish I had known this beforehand. Got 3 jabs !!!
Employment mandated. Now I am glad I’m old semi retired.
If I was young I’d be protesting and organizing. Well at least I’m armed.