was convincing soldiers they weren’t study subjects Part 1
Let’s get into it!
The FDA and the DoD are at the forefront of one of the biggest scams in history. Ok, maybe that’s hyperbole, but maybe not. The Anthrax vaccine program clearly taught them nothing, so now for round two of the ongoing handshakes between the FDA and DoD.
August 23, 2021 is the pivotal date of the scams inception. This represents the first FDA approval of the Pfizer-BioNTech COVID 19 vaccine, proprietary name Comirnaty. But on this day two announcements were made at the same time that has (purposefully) created confusion and the opportunity for deception.
- The Biologics Licensing Application (BLA) for Comirnaty was approved and subsequent guidance was issued for its use and distribution for those 16 and over
- The Emergency Use Authorization was continued for those 12-15 and for those 16 and over for logistical reasons (Comirnaty Q&A Page, FDA)
What this means, is that at the time of the approval there was no licensed and properly labeled vaccine available for distribution. While this is understandable under the current situation in dealing with a global pandemic, it does not eliminate the requirements of the distribution of an Emergency Use Authorization (EUA) product. However, this was the green light many businesses and (more importantly to me) the military needed to drop mandates to vaccinate against Covid. The only hiccup, there was no licensed product, just an application approval.
To date, there is no licensed product that meets the requirements laid out in the Public Health Service Act. The Act requires that for a product to be deemed licensed it must be manufactured in certain approved facilities and the label must possess: the proprietary name, license number, name and address of manufacture and the expiration date.
On August 24, 2021, after probably what was mostly likely a few seconds of consideration Secretary of Defense La Lloyd Austin da Tres, put out a memo to the combatant commands to begin the Covid 19 vaccination as expeditiously as possible. Yet, homeboy’s memo had some words in it that have created some problems legally.
This line, “Receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance,” is incredibly important for a few reasons, but most importantly the military has specific DoD Instructions, regulations and US Code that set policy for administration of immunizations.
First DODI 6205.2 that is referenced in Austin’s memo states in Section 3.3 (3)b, “Requests to use non-FDA-approved immunizations will be processed as outlined in DoDI 6200.02.” Sure let me just hunt that down.
Found it. DODI 6200.02
10 USC 1107a? This is a goose chase.
Alright. Seems pretty clear. If there is no licensed product, all we need is that waiver right? Checks for waiver. Oh what? There is no waiver? How will the military proceed if there is no EUA waiver from the President and no licensed product?
BRING IN TERRY ADIRIM!!
What is she even saying? This memo is directing the services to use the EUA doses “AS IF” they are the licensed doses. Interchangeable with what? Is this the land of make believe? Are we just pretending now? Using our imagination “AS IF” the laws and regulations no longer exist?
Tomorrow we will unpack this. It’s almost 9 a.m. and I need a drank.