The Never Ending Emergency (USA): Part Two
The Relationship between Public Health Emergencies (PHE) and Emergency Use Authorizations (EUAs)
In Part One, I essentially summarized the relationship between PHEs and EUAs in one simple sentence:
No Emergency Declaration = No Emergency Use Authorizations.
*subsection (b) referenced in the above sentence, is titled “Declaration of emergency or threat justifying emergency authorized use.”
The goal of Part 2 is to show why the U.S. Government (USG), in collusion with BigPharma, has a vested interest to keep the Covid “emergency” going. Here’s a hint:
There Are No Fully Licensed Covid Injections Available in the United States. All Injections Are Still Under EUA, Hence the Need for the Emergency Declaration.
Believe it or not… it’s the reality. This reality is the basis for several on-going lawsuits against USG, DoD, DHS, FDA, HHS etc.
Now I will concede that there are “Comirnaty-labeled” vials located at some military installations. However, these vials are not available to the public and their validity is being contested in the courts. There is strong suspicion that the labels are fraudulent and the only reason they exist is due to hundreds of service members arguing that the DoD had issued an unlawful order since Comirnaty wasn’t available.
Using Fraudulent labels isn’t a new tactic for the DoD. DoD took similar actions during the days of the Anthrax Vaccination Immunization Program (AVIP). The Anthrax story will get its own post soon but here’s the key takeaway: Yesterday’s “Program” is today’s “Mandate.”
You can find the full list of current military lawsuits here covering a range of claims against the government related to the mandates. The lawsuits that contain claims regarding the bait-and-switch of EUA and licensed injections are listed below:
Coker et al. v. Austin; Northern District of Florida.
Wilson et al. v. Austin et al.; Eastern District of Texas
Bazzrea et al. v. Mayorkas et al.; Southern District of Texas
Navy Seal 1 v. Austin et al.; Middle District of Florida
Feds for Medical Freedom v Biden et al.; Southern District of Texas.*
*F4MF v. Biden challenges the President’s Executive Order (E.O.) 14043, requiring federal workers to receive a covid injection. While this lawsuit does not make a distinction between licensure and emergency use authorization, they are getting an honorable mention due to their recent, December 19th 2022, win in the 5th Circuit Court of Appeals:
V. Conclusion
We do not, and cannot, rule on the efficacy of any vaccine, the wisdom of the President’s action, or even whether or not this action would, in fact, increase economy and efficiency in federal contracting. Today, we are asked, where Congress has not authorized the issuance of this mandate, whether the President may nonetheless exercise this power. We hold that he may not. Accordingly, we AFFIRM the district court’s grant of an injunction.
The 5th Circuit Court affirmed the lower courts decision to enjoin the President from enforcing E.O 14043. and upheld the preliminary injunction.
A detail that warrants attention is the date that E.O 14043 was signed:
September 9th, 2021.
The Mandates Only Became a Requirement After the August 23, 2021 Approval Letter for COMIRNATY. Except, Comirnaty was never manufactured. Pfizer, NIH, CDC all admit this.
Jordan Schachtel wrote three articles about the bait-and-switch shell game. The first dating back to Dec 29, 2021 for Pfizer/Comirnaty. The second one in Jan 2022, when Moderna did the same move with their approved product called Spikevax. And the third one about 6 months ago in June, citing the NIH’s announcement that they have no intention of producing the supposed licensed versions. Everything Jordan wrote in those articles is still true today.
The Legal Right to Refuse
A product that is granted an “Emergency Use Authorization” is by definition an unlicensed product.
EUA can either be granted for an “unapproved" product or an “unapproved use of an approved product.”
Note: Comirnaty (yes the product that doesn’t exist) has been granted “unapproved use” as a booster. Notice the language in the hyperlinked homepage. Approved vs Authorized.
An “authorization” is not an approval or licensure. An “authorization” is in reference to the Emergency Use of that product.
As a recipient of an EUA product you must be informed of three things:
That it’s EUA (not approved or licensed)
Significant known risks and potential benefits and risks; and of the extent to which such benefits and risks are unknown
and of the option to accept or refuse administration of the product
This is a required condition by law. There’s no way around it.
However that doesn’t mean the Biden Administration didn’t try…
What’s the Definition of “Required”?
I’m not being funny…
An Assistant Attorney General from the Dept. of Justice argued that the President could mandate an EUA product. Is that logical given the legally required conditions? The Ass. Attorney General goes as far as stating that the required condition of having the “option to accept or refuse” is discretionary.
Importantly, however, and consistent with FDA’s views, we also read section 564 as giving FDA some discretion to modify or omit “the option to accept or refuse” notification, or to supplement it with additional information, if and when circumstances change.
These qualifiers indicate that FDA’s responsibility to impose the “option to accept or refuse” condition is not absolute and that the agency has some discretion to modify or omit the condition when the agency finds the notification would not be “practicable” given the emergency circumstances
The full Slip Opinion dated 06 July 2021 from Dawn Johnsen can be found here. It’s a gross, borderline hostile, misapplication of the law. Here’s another quote:
Our reading of section 564(e)(1)(A)(ii)(III) does not fully explain why Congress created a scheme in which potential users of the product would be informed that they have “the option to accept or refuse” the product.
Created a scheme? Interesting word choice. I’ll come back to this.
The Rebuttal (for piece of mind…sort of)
The attorneys at the Siri | Glimstad law firm counter Dawn Johnsen’s slip opinion with the proper application and interpretation of the law. I recommend reading the rebuttal dated 4 August 2021 in it’s entirety. Here’s a preview:
In your Slip Opinion, you assert that expulsion from a job, school, and civil society are only “secondary consequences” which does not remove the “option to accept or refuse.” Not only does this argument defy common sense, but Section 564’s history, statutory framework, and implementation all reflect that “the option to accept or refuse” was intended to continue the longstanding principle that it is not permissible to coerce anyone to receive an unlicensed medical product.
The interpretation of Section 564 that you apply in your Slip Opinion is therefore incorrect…The Slip Opinion runs directly counter to Section 564 and the FDA’s guidance by permitting additional conditions on a person’s refusal to receive an EUA product.
Your Slip Opinion cites to the dictionary definition of “inform” but ignores the definition of the more important word “option” in Section 564 which the dictionary defines as “the power or right to choose; freedom of choice.”
In sum, your reading of Section 564 as a requirement that an individual be informed that they have a “choice” while at the same time allowing the product to be mandated is illogical and contrary to the plain meaning, intent, and history of Section 564.
It’s a fantastic read and an honest interpretation of the statutes.
Unfortunately the rebuttal changed nothing. It fell on deaf ears, especially to an administration hellbent on violating the law…
“Interchangeability”- an introduction to Part 3
The July 6th 2021 slip opinion arguing that EUAs can be mandated was weak at best.
The August 4th 2021 rebuttal dispelled any notion that unlicensed EUAs can be mandated.
However, rather than produce a fully-licensed product, which would have taken years to do, the administration continued to find ways around the law.
Enter scene: “Interchangeability”
The administration pressed ahead with unlawful mandates based on the flimsy argument that the unlicensed version and licensed version had the same formulation and therefore could be used interchangeably.
Regardless of formula, the bottom line is that the legal distinction between unlicensed and licensed is indisputable. As long as the labels continue to say Emergency Use Authorization on them… they are unlicensed, they have not met any licensure regulations, and you have the legal right to refuse them.
In the words of Dawn Johnsen, my reading of the statues does not fully explain why the Administration would “create a scheme” to mandate unlicensed emergency use injections.
Here’s the label from the most recently produced Bivalent injections:
Part 3 (In-progress): “Interchangeability;” The Licensed Product That Never Was
Well written. Thank you, David.
Our government that is allowed to break the law during an emergency will create an emergency in order to break the law.