Do C-19 Vax Manufacturers Violate cGxP?

A master class in pharmaceutical regulations: the difference between EAU and EUA that no one on Earth has noticed. Including me until November 2023.

This is a slightly updated post, originally published on November 4, 2023. I am reposting it, because this information will be important very shortly.

Let’s look at the clip related to JJ Couey’s debunking the Debunk guy debunking Kevin McKernan. I hope you can keep track of all the debunking. All of this centers around the CHD video “Intent to Deceive” where Kevin discussed his finding the SV40 promoter sequence in Pfizer’s vials and the fact that someone inside Pfizer or inside its contractor or ultimately at the DOD (where all contracts and most active substances originate) went into trouble of deleting that sequence so it does not show up in the documents that Pfizer submitted to the regulators like FDA, EMA, TGA, etc. He claims that there was an “intent to deceive the regulators”, vaccinators and the public about the presence of this well-known nuclear localizing, cancer-inducing piece of code in the injections. We know that the regulators were not at all deceived, they were in on this from the start.

However, let’s proceed with what’s going on in this clip. JJ Couey is not really debunking the Debunk guy, but rather using his line of argument to trash Kevin and CHD, which is Couey’s operational task. He is being paid to sit in his garage producing acid trip of a powerpoint all day by somebody. I assure you, it’s not his 20 cat lady subscribers, drunk on white zinfandel and throwing quarters into Couey’s slot who pay his garage heating bill. Couey is likely mentally disturbed due to his escalated attacks on just about everyone in the so-called “health freedom”, and I wish him full recovery from whatever plagues him. This article is not endorsing him in any way, I am using it for illustration only.

Both positions in the video are not correct IMO. Let’s review.

The Debunk Bro is easy - he is a paid propagandist and simply repeats the FDA/CDC/HHS/DOD prescribed narrative. The narrative goes like this:

• Kevin got vials from who knows where, we don’t know if they came from Pfizer and Moderna or maybe they are fake!

• Lengthy discussion of existing cGxP laws - every pharmaceutical must be in compliance, look at all the quality checks, and tests and quality control procedures that must be in place before approval, then all the batch-release testing for each batch, so many rules everyone must comply, yada, yada, therefore what Kevin says he found in the vials cannot happen! Because cGxP.

JJ Couey’s position can be condensed to the following:

• Because cGxP, FDA will use the “contamination” finding to remove the product from the market and maybe superficially punish Pfizer.

• The mRNA poison will be cleaned up from SV40 and DNA plasmids and put it back on the market and continue.

• The mRNA is poison with or without SV40, because it is transfecting cells and nothing positive to health can happen that way. Only damage can result from this.

I agree with the last bullet point.

What’s wrong about both positions - the highlighted part. Both rely on the assumption that covid jabs are pharmaceutical products subject to cGxP laws and FDA regulations, and therefore finding and proving a cGxP violation may result in recall or another pharmaceutical law enforcement action. That’s a profound lie on which this whole situation hinges. I am not at all surprised that both the Debunk Bro and Couey promote it. They are probably on the same entity’s payroll.

Now, what is the truth?

Covid-19 poison marketed as “vaccine” is NOT a pharmaceutical product subject to cGxP laws and FDA enforcement powers under 21CFR 312.

Let’s recall:

21 USC 360bbb-3(k): use of EUA-covered medical countermeasure (MCM) products, once designated as such by the Secretary of Health and Human Services “shall not be considered to constitute a clinical investigation.” 

The definition of clinical investigation from cGxP (21CFR part 312):

Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

There are 3 mutually exclusive categories of pharmaceuticals regulated by cGxP laws:

• FDA approved/marketed;

• In clinical trials under IND exemption;

• “Expanded Access Use” products (EAU, colloquially referred to as “emergency use” or “EUA”)

There is a 4th category of things imagined and fabricated more recently (after 9/11 and anthrax letters) that is mutually exclusive with these 3 categories above, by way of legal magic and word confusion:

• EUA Countermeasure under Public Health Emergency which is waved through with smoke and mirrors under para 564 of the Food, Drug and Cosmetics Act.

This “EUA” is not the same “EAU” (are you following this?) as it requires the situation of total global panic because of a few false-positive PCR tests primed with some code from a post-it note and about 40 Chinese murdered in Wuhan with remdesivir and ventilators under the supervision of Robert Malone’s dear friend the CIA agent Dr. Michael Callaghan, aka Indiana Virus-Jones. EUA exists when PHE and PREP Act declaration are in force:

More about the legal status of EUA Countermeasures here.

Here is a slide from “Legal Preparedness” deck of the FDA from August 2020, discussing the same concept. EUA (no IND) is not EAU (which requires IND).

In the same presentation the FDA lawyers state that “certain [pandemic] preparedness activities [without EUA + PREP Act shield] would otherwise violate the FD&C Act”.

“Legal preparedness” is exactly what it sounds - they write new illegal-laws that allow them to break actual laws. If you still need evidence that all of the covid atrocities were premeditated and intentional, look no further. Law making is a series of intentional acts over time. If these acts lead to legalizing murder, as long as it is committed by a “covered person” with a “covered countermeasure”, then that was the original intent. They fully planed to poison people and anticipated massive numbers of injured potential plaintiffs. And they knew that they need to build many walls of their legal fortress so that no actual justice can occur. And that wall worked as designed! Read about the success of the PREP Act in preventing any justice from happening here.

Credit to David Wiseman for fishing out this absolute gem from a 400 page transcript of the VRBPAC meeting on October 22, 2020. Here Doran Fink (then at FDA, currently enjoying his reward for the job well done at Moderna) explains why EUA and not EAU regulatory pathway was used for Poison-19 injections. Annotations and emphasis are mine:

P201/408 of transcript:

“DR. KURILLA: And then for Doran [FINK], did you consider at all the possibility of an expanded access protocol for those specific groups that you would issue the indication for the EUA instead of an EUA? [notice they are themselves confused between EAU and EUA!]

P203 Dr. FINK: Yeah. So to answer your question about an expanded access protocol [EAU or Expanded Access], that is another regulatory mechanism for providing access to investigational vaccine. I think if we were to consider an expanded access protocol of the same size and scope as what is being considered for an Emergency Use Authorization, then the benefit/risk considerations and the data to inform those benefit/risk considerations and allow that type of use would be highly similar. The differences between expanded access use and Emergency Use Authorization are that expanded access use is done -- or is carried out under FDA's investigational new drug regulations. So among many other things, those regulations require use of an institutional review board and also obtaining informed consent from recipients of the investigational vaccine according to regulations for clinical investigations -- research use of investigational vaccines. And so operationally speaking, an expanded access protocol would add some complexity, and that is why Emergency Use Authorization is being considered primarily as the mechanism for addressing the public health emergency that has been declared.”

I think it’s time to put the issues of the informed consent and the need to follow cGxP regs to rest, isn’t it? The FDA officials clearly explained here that the reason they went with EUA is specifically NOT to follow any investigational drug rules or cGxP, and NOT to provide informed consent. And it is legal for them to do so for EUA under a declared PREP Act emergency!

This explains many things, but still does not explain the curious Schroedinger cat-like phenomenon of both EUA and the FDA’s assertion of “full approval” co-existing for covid poisons, unless of course we realize that the “approval” is a fake. There cannot be an FDA approval per 21 CFR 312 if IND and clinical trials are not relevant to it.

From the same FDA lawyer presentation, observe the entire process of issuing an EUA:

This process consists entirely of “determinations” (opinions of a bunch of bureaucrats) and declarations that “circumstances exist”. Did you see a box on this chart that said “open IND and complete a clinical trial, it’s ok to do it badly but you still must do it”? Was there any box saying “safety/efficacy/manufacturing compliance review”? No? I don’t see those either. Clinical trials were IMMATERIAL. Judge Truncale said so when dismissing Brook Jackson’s case under allegations of serious fraud that nobody disputed.

Let’s not forget, that an extra precaution of PREP Act must be in place for this scheme of conducting illegal experiments without informed consent can take place. It is in fact so critical that it is prominently specified in the Emergent Biosolutions-DOD contract for manufacturing Poison-19 injections (they were the manufacturer for AstraZeneca and Janssen):

On page 49, you can read :

"In the event the Contractor delivers vaccine under this contract which is not covered by the aforementioned declaration (PREP ACT) because of the expiration of the aforementioned declaration (PREP ACT) and any renewals or amendments thereof, the Government agrees that the medical countermeasure delivered by the Contractor under this contract will not be administered for use in humans."

They were fully aware that without the PREP Act the Medical Countermeasures cannot be used in humans. None of the real pharmaceutical products have this requirement.

Do fentanyl dealers violate cGxP? Rhetorical question.

If a substance cannot be subject to clinical investigation, the Investigational New Drug (IND) exemption for it is meaningless, and so are the clinical trials, and review and approval in compliance with cGxP. The best part of this: if you cannot really comply with cGxP, violations of cGxP cannot happen either!

Here is the thing about SV40 finding, it’s not the only evidence of contamination, adulteration or violation of cGxP for these products. I can list perhaps hundreds of examples of severe violations of cGxP, many I have reported on since 2021, and many that were documented by dozens of people worldwide. Clear and undeniable violations of all laws that relate to consumer safety and pharmacy distribution in the US and other countries. That’s because NONE of them apply to “EUA Countermeasure under PHE”.

Can cGxP violation/contamination argument still be used to remove this poison from the market?

This theoretical possibility of this remains, as hope is the last one to die on this planet. However, I am pretty certain at this point that the FDA has dug themselves into a very deep hole via rigorously not noticing any severe cGxP violations that continue to exist in reality over the past 2-3 years. They use capricious methods to occasionally “notice” things that help them solidify their ability to further engage in this crime by creating useful case law - such as the case of them “noticing” glass shards in remdesivir and allowing the one injury lawsuit to proceed which will simply help the HHS/DOD to defend PREP Act legitimacy in the future. “See, the injured do have recourse! We regulate quality and cGxP applies!”

Let’s recall the DOD-lead Operation Warp Speed and BARDA’s own slides explaining how these stable geniuses were never planning to comply with cGxP in the first place (yellow box is my annotation):

The Debunk Bro is simply spewing the prescribed narrative of the criminal FDA-DOD-Pharma cartel describing all the regulations that exist (cGxP) “forgetting” to mention that they do not apply to the “EUA Countermeasures”. In fairness, he probably doesn’t know this, and that makes him sound more assured and convincing as a paid actor that he is.

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Art for today: Vikingholm, watercolor