COMIRNATY Vanishing or Was It Ever Really There?

The COVID-19 vaccine legal definitions are a Schrödinger's Cat-style menagerie of nonsense -- by design.

There hasn't been much discussion on the topic of the "FDA approved" Pfizer vaccine. There were quite a few articles that tried to explain why the Comirnaty trademarked vaccine was "chemically" the same as the vaccines used under the EUA (Emergency Use Authorization). But something didn't sit right with me.

Now the issue over Comirnaty has gone to court. The judge seems to question the validity of this claim as well. Look at the Pfizer explanation.

“The licensed vaccine has the same formulation as the EUA-authorized 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.”

It's a difference without a distinction. The EUA vaccine and Comirnaty are different enough for legal separation, and identification, but somehow interchangeable? This is something that can have a lasting effect on someone's wellbeing, it's not New Coca-Cola, the "New Coke" we're talking about!

There are key differences between fully licensed vaccines and those authorized under EUA. EUA products are considered experimental under U.S. law. This means they cannot be mandated, and everyone has the right to refuse such vaccines without consequences.

There is another aspect to this. The judge pointed out the most important aspect of this as it relates to pharma and regulations. The location of manufacture. The facility that produced the EUA vaccines was not validated to produce FDA approved vaccines. While this might not seem important to some people, it is a huge deal in the pharma world.

It's not just the product's approval that is required. Information throughout the manufacturing process must be stored for a number of years through a validated system. Data on manufacturing will include, the raw materials used (their lot numbers and identifying information) the equipment used, all the way down to the conditions in the facility. Even how frequently the equipment requires calibration, and records of that as well. Pretty much every aspect of the manufacturing process is tracked.

This data is not tracked in a R&D (Research and Development) environment. And the facility that produced the EUA vaccines couldn't have been properly validated, because the product wasn't approved yet. Meaning that the specific information needed to track the production of the EUA vaccines was not in place. Pfizer can't provide all of the supporting documentation required for any FDA approved product. Therefore, there is no way to validate that the two products are the same.

As recognized by the judge, “[u]nder the EUA statute, recipients of EUA drugs must be ‘informed … of the option to accept or refuse administration of the product.”

The judge further noted that with regard to the administration of an EUA product to members of the armed forces, such a right of refusal may be waived only by the president.

As noted, “[t]he DOD acknowledges that the president has not executed a [waiver], so as things now stand, the DOD cannot mandate vaccines that only have an EUA.”

Judge Winsor also pointed out that “DOD’s guidance documents explicitly say only FDA-licensed COVID-19 vaccines are mandated.”

While this would be applicable to the Comirnaty vaccine, the judge noted “the plaintiffs have shown that the DOD is requiring injections from vials not labeled ‘Comirnaty.’ Indeed, defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all.”

The judge also noted that the DOD “later clarified that it was mandating vaccines from EUA-labeled vials,” adding that “[i]n the DOD’s view, this is fine because the contents of EUA-labeled vials are chemically identical to the contents of vials labeled ‘Comirnaty’ (if there are any such vials).”

The judge found this argument “unconvincing,” stating that “FDA licensure does not retroactively apply to vials shipped before BLA approval.”

He further noted that EUA provisions suggest “drugs mandated for military personnel be actually BLA-approved, not merely chemically similar to a BLA-approved drug,” not just in terms of labeling, but also in terms of being produced at BLA-compliant facilities.

As the judge stated, “there is no indication that all EUA-labeled vials are from BLA-approved facilities,” adding that “the DOD cannot rely on the FDA to find that the two drugs are legally identical.”

The FDA is not following their own guidelines as it pertains to the Pfizer vaccines. The approval for these vaccines would equate to an R&D biologic being sold to the public because it had not yet expired --even though it was not produced in an FDA regulated environment. That's what they are tying to do here. That's why the judge said, “FDA licensure does not retroactively apply to vials shipped before BLA approval.”

It's plainly spelled out in the specification.

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

* Applicant information
* Product/Manufacturing information
* Pre-clinical studies
* Clinical studies
* Labeling

The lawyers for the government do not have proof that the vaccines are the same, why not? That is the entire basis of their claim to mandate them. Wouldn't their defense be so much easier if they could prove in court that the two vaccines are indeed the same? But then, they didn't do that. And they won't be able to either. The FDA says that Comirnaty and the EUA vaccines are "legally different."

UPDATE 06/03/22

Brook Jackson filed a False Claims Act lawsuit against Pfizer in the United States District Court for the Eastern District of Texas, Beaumont Division. The following was revealed during the court case against Pfizer.

Pfizer has asked a U.S. court to throw out a whistleblower’s lawsuit on the basis that the company can’t be guilty of fraud, abuse, and protocol violations in its COVID Vaccine clinical trials because its contract with the U.S. government allowed them to skirt regulations and federal laws that typically apply to government contracts.

In other words, Pfizer was allegedly able to make false statements to the government, and lie about the safety and efficacy of its product, “because the government was in on it with them!” according to Robert Barnes, the lead lawyer in the case.

007 has a license to kill — Pfizer has a license to kill and lie.

What do you think?

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