The Never Ending Emergency (USA) Part Three (Final)

The Fully-Licensed Product That Never Was

If you’re just now tuning in to the “The Never Ending Emergency” Saga, here’s the recap of the main points from both Part 1 and Part 2:

Part 1 - HHS Secretary, as an unelected official, has the sole authority, without Congressional or Executive approval or oversight, to declare, end, and renew a Public Health Emergency (PHE). PHE’s are temporary measures that auto-expire within 90 days if not ended prior by the HHS Secretary. Source: Title 42 U.S. Code § 247d - Public health emergencies

Part 2 - An Emergency Declaration is required before any product may be granted an “emergency use authorization” by the HHS Secretary. An EUA is granted for two reasons: for an “unapproved” product - or - “unapproved use of an approved product.” Recipients of EUA products have the right to accept or refuse the product and, upon acceptance of the product, must provide their informed consent. Source: Title 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies

Part 3 is going to dive into Title 42 U.S. Code § 262 - Regulation of biological products. This statute governs both labeling and interchangeability.

Foreshadow: Interchangeability requires two licensed products. Unlicensed EUA’s legally CANNOT be interchangeable with licensed products.

Let’s Talk About Labels

Title 42 U.S. Code § 262 is very clear about the required information for labels:

(a) Biologics license

(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with—

(i) the proper name of the biological product contained in the package;

(ii) the name, address, and applicable license number of the manufacturer of the biological product; and

(iii) the expiration date of the biological product.

For Comparison here are the labels:

Source: https://dailymed.nlm.nih.gov/dailymed/index.cfm

The labels are accurate in their description of the product as being an EUA, however the issue is the persuasive marketing campaign of an unlicensed product as if it were licensed.

The Government then mandated an unlicensed product based on a manipulation of the law. The labeling laws require that a biological product is plainly marked with the proper name. In this case it would be Comirnaty. Comirnaty is the product that was on the Biologics License Application (BLA) package which was approved on August 23rd, 2021. However, that BLA expired the same day it was signed.

It was this approval, lasting for less than 24 hours, that became the legal basis on which the mandates were enforced.

The first mandate coming from Secretary Austin on August 24th, 2021…

The Fully-Licensed Product That Never Was

Dept of Defense Fraud?

Within a week of Siri’s August 4th, 2021 Rebuttal to Dawn Johnsen’s July 6th, 2021 Slip Opinion, SECDEF produced a strange “Message to the Force” memorandum on August 9th, 2021 which said the following:

I want you to know that I will seek the President's approval to make the [unlicensed] vaccines mandatory no later than mid-September, or immediately upon the U.S. Food and Drug Administration (FDA) licensure, whichever comes first…

By way of expectation, public reporting suggests the Pfizer-BioNTech vaccine could achieve full FDA licensure early next month.

Requesting the Presidents approval to make EUA vaccines mandatory is in reference to Title 10 U.S. Code § 1107a - Emergency use products. However, SECDEF’s statement is a misapplication of the law. US Code §1107a authorizes the President to provide a written waiver of the condition that requires the recipient to be “informed of the option to accept or refuse.” If the President signs the waiver, service members never lose the right to refuse, only the right to be informed of the option to refuse—a Presidential waiver was never signed.

Exactly two weeks after the SECDEFs Message to the Force, on August 23rd, 2021, the FDA granted Pfizer’s BLA approval for the product called COMIRNATY, license number #2229.

The Application Package had the same marketing start and end date. BLA125742 expired the same day it started:

This fact did not stop Secretary Austin from issuing the DoD mandate the following day on August 24th, 2021. The order stated:

Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance. Service members voluntarily immunized with a COVID-19 vaccine under FDA Emergency Use Authorization…

By the time Secretary Austin’s signature dried, his order was already impossible to comply with, as COMIRNATY’s BLA approval had expired the previous day.

Within weeks of the DoD Mandate, NIH announced on September 13, 2021 that Pfizer was not going to produce any licensed products— they didn’t need to as they were operating using the expired BLA approval.

Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.

September 13, 2021, however, happens to also be the same day that I and many other military members, from various service branches, were ordered to receive mandatory Covid-19 injections.

Here’s what mine looked like:

What you won’t see on this list is the option for Comirnaty.

Are you following the legal manipulation?

Timeline Review:

• 6 July 2021 - Dawn Johnsen’s Slip Opinion arguing unlicensed EUA product can be mandated

• 4 August 2021 - Rebuttal by Aaron Siri, Esq.

• 9 August 2021 - SECDEF’s Message to the Force Memo

• 23 August 2021 - Single-day BLA124752 approval

• 24 August 2021 - SECDEF Mandate

• 13 September 2021 - NIH Announcement; No Intention to Produce Licensed Products

Sept 14th, 2021 - The Interchangeability Memo

The day after the NIH announcement and after I received the order to get injected, then Assistant Secretary of Defense, Terry Adirim published her infamous interchangeability memo.

The memo stated:

On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the biologics license application for the Comirnaty vaccine, made by Pfizer-BioNTech, as a two­ dose series for prevention of coronavirus disease 2019 (COVID-19) in persons aged 16 years or older.

Previously, on December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, which has the same formulation as the Comirnaty vaccine. Per FDA guidance, these two vaccines are 'interchangeable' and DoD health care provider should "use doses distributed under the EUA to administer he vaccination series as if the doses were the licensed vaccine.'

(Emphasis added)

Did you catch that? Here’s what they are saying in a nutshell:

*Inject this unlicensed product into your arm “as if” it was the licensed version because yesterday, Pfizer said they aren’t making the licensed version*

FYI: FDA guidance is not, and does not qualify as, law.

Legal Definition of “Interchangeability”

As soon as Comirnaty was approved, the EUA’s should have been dead in the water:

Source: Title 21 U.S. Code § 360bbb–3

Rather than actually produce a licensed product—which takes years to do—the Administration continued to push EUA products as if they were fully licensed based on the idea they have the “same formulation" and can be used interchangeably.

However, interchangeability has a legal requirement. Legally, interchangeability requires two licensed products. Here’s what Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) had to say about interchangeability to a Federal Judge on October 21, 2021:

In other words, this idea that an EUA product can be interchangeable with a licensed product simply due to formulation is completely false.

FDA has an online database for licensed interchangeable products. Here are the results when you search Comirnaty:

“No interchangeable products at this time”

Where Are We Today?

The non-profit coalition called Feds for Medical Freedom went looking for Comirnaty. They called pharmacies around the country and produced a short 90-second video to capture their results.

Comirnaty was no where to be found.

To this day, the military and the American people do not have access to a licensed vaccine to prevent the spread of Covid-19.

While there may be room to debate the efficacy of the currently available injections, there is no sensible objection to the fact that these injections were advertised and mandated on false legal pretenses. Whatever your ends may be, molestation of the law and Constitution are not a historically advisable route to take.

Here’s what a Federal Judge had to say about it:

…the United States Supreme Court has recognized that, while the public indisputably “has a strong interest in combating the spread of [COVID-19],” that interest does not permit the government to “act unlawfully even in pursuit of desirable ends.”

The U.S. Government robbed the American people their right to choose. They led people to believe that a licensed product was made available. They ignored natural immunity. They shutdown any discourse through social media portals. They violated First Amendment rights.

The worst of it, is that many people felt they no choice. Pandemic or not, do we truly want to be a society that is subject to ultimatums from its government? What ever happened to consent of the governed?

“Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship to restrict the art of healing to one class of Men and deny equal privileges to others; the Constitution of the Republic should make a Special privilege for medical freedoms as well as religious freedom”

Benjamin Rush, a Founding Father.