Originally published @ HopingForJustice.org
- SERVICE MEMBERS HAVE THE PRIOR CONSENT RIGHT TO ACCEPT OR REFUSE EMERGENCY USE AUTHORIZED (EUA) IMMUNIZATIONS
- SENIOR LEADERS MUST ENSURE IMMUNIZATIONS COMPLY WITH GOVERNMENT REGULATORY STANDARDS
- IF THE RULES ARE NOT FOLLOWED THE BOTTOM OF THE CHAIN OF COMMAND SHOULD NOT BE PUNISHED
- IT IS COMMON SENSE TO HALT AND REVERSE ALL PUNISHMENTS AND DISCHARGES RELATED TO EUA COVID VACCINES
EUA PRECEDENT BEGAN WITH ANTHRAX VACCINE
1ST EVER EUA & LEGAL PRECEDENT AFTER THE DOD ANTHRAX VACCINE WAS DECLARED ILLEGAL IN 2003
“You may refuse anthrax vaccination under the EUA, and you will not be punished. No disciplinary action or adverse personnel action will be taken. You will not be processed for separation, and you will still be deployable. There will be no penalty or loss of entitlement for refusing anthrax vaccination.”
FDA CONFIRMS THE AVAILABLE PFIZER-BIONTECH VACCINE IS AUTHORIZED UNDER A REISSUED EUA
“In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would remain in place for the Pfizer-BioNTech COVID-19 Vaccine for the previously-authorized indication and uses.”
PFIZER AFFIRMS THEIR AVAILABLE VACCINE IS UNDER AN EUA
Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2). This product information is intended only for residents of the United States. This product is exclusively distributed within the U.S. under an Emergency Use Authorization from FDA.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.
LEGAL AND REGULATORY DEVELOPMENTS
FEDERAL JUDGE QUESTIONS PFIZER’S INTERCHANGEABILITY AND IF COMIRNATY VACCINE IS AVAILABLE
Judge affirms: “the FDA nowhere claims that EUA vaccine had been licensed as ‘interchangeable’ with Comirnaty.”
Judge clarifies on interchangeability: “medical claim, rather than a regulatory claim”
Judge states: “If the FDA’s goal were to ‘retroactively license’ the EUA vaccine, it had an odd way of doing so—in the same footnote describing the EUA vaccine and Comirnaty as ‘interchangeabl[e],’ the FDA clarifies that the two products are ‘legally distinct.'”
Judge finds: “Thus, as a legal matter, vaccines sent before August 23—and vaccines produced after August 23 in unapproved facilities—remain ‘product[s] authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.'”
Judge upheld: “Section 1107a’s explicit cross-reference to the EUA provisions suggests a concern that drugs mandated for military personnel be actually BLA-approved, not merely chemically similar to a
BLA-approved drug. And the distinction is more than mere labeling: to be BLA compliant, the drug must be produced at approved facilities.”
Judge adds: “Moreover, the DOD concedes that some of its current vials are not BLA-compliant, and that there is no policy to ensure that servicemembers get only BLA-compliant vaccines.”
Judge concludes: “the DOD cannot mandate vaccines that only have an EUA.”
FDA CONFIRMS NO PRODUCTS ARE INTERCHANGEABLE WITH COMIRNATY
FDA Search Results for Comirnaty — includes all biological products that share a core name (i.e., biosimilar, interchangeable, reference, and related biological products).
No biosimilar data at this time.
No interchangeable data at this time.
EUA LAW REFERENCES TO “CONSEQUENCES” RELATES TO INFORMED CONSENT AND THE PROTECTION OF HUMAN SUBJECT
In the above cited 2005 EUA precedent troops were informed “of the option to accept or refuse administration of AVA; of the consequences, if any, of refusing administration of the product; and of the alternatives to AVA that are available, and of their benefits and risks.”
The above military legal precedent related to 10 USC 1107 and the Code of Federal Regulations (CFRs) both mention the word “consequences.” The CFR on informed consent for clinical trials relates to “The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.” Consequences clearly relate to medical issues and informed consent.
In item (a)(8) the CFR on informed consent specifically states: “participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.” This is almost identical language as the 2005 anthrax vaccine EUA precedent above.
NO WHERE in EUA precedent, in EUA law, or in the CFRs on informed consent, is punishment, penalty or loss of entitlements mentioned. Instead, any such consequences should be strictly prohibited based on the express wording and intent of the laws and precedent.
Current mandates hinge on the misinterpretation of the word of consequences to the peril of our troops, and at the risk of tarnishing the integrity of our military institutions and public health officials, similar to the pre-2006 illegal use of anthrax vaccine.
Misinterpretations of the word consequences in EUA law impact all mandates for all Americans. The parallel laws under Title 21 for EUA products are available at: 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III).
MANUAL FOR COURTS-MARTIAL / UCMJ: ARTICLE 90— …WILLFULLY DISOBEYING SUPERIOR COMMISSIONED OFFICER
MCM / UCMJ 14(d)(2)(a) Lawfulness of the order. (i)
“Inference of lawfulness. An order requiring the performance of a military duty or act may be inferred to be lawful and it is disobeyed at the peril of the subordinate. This inference does not apply to a patently illegal order, such as one that directs the commission of a crime.”
If threatened with punishment over a mandate to submit to a EUA product, in violation of the prior consent rights upheld in 10 USC 1107a, it may be valuable to cite this section of the UCMJ and MCM, since military justice strips the “inference of lawfulness” away from any patently illegal order. If the DoD executes a patently illegal order, the institution does so at its peril.