did the pfizer vaccine even really have a drug trial?
if the process is the product (and it is) then pfizer's product looks like it went to market untested
the discovery by brave fellow feline kevin mckernan (who actually did what should have been done right from the start and went out and gene sequenced the pfizer covid vaccines) that the vaccines were wildly impure, low integrity, and contained not only copious amounts of contaminants, but actual active compounds like plasmids that were, quite literally, spike protein factories was extraordinary.
the jab was literally full of the compounds used in its fabrication that had no place in a final product and these are not even just toxins, they are plasmids, actual factories for making pathogens. the idea of a “safe level” for such a thing seems fraught and they missed the alleged limits by an order of magnitude anyhow. from FEB substack
in decades of watching products like this, i have never seen anything like it from a standpoint of pure misrepresentation and negligence.
it is perhaps then small wonder that the top people in the FDA vaccine group resigned rather than keep having to rubber stamp this.
kevin’s result generated incredulity and dismissal all over the internet and among regulators. but it was valid. and it has now been replicated by an awful lot of people (though this list conspicuously fails to include any regulatory agency of which i am aware) and there is quite a lot of evidence that this process issue had been known for decades.
having been pinned with “well yes, this is obviously true” the pfizer apologists have pivoted to a new argument of “well, sure, that may be so, but they did a massive drug trial and it was proven “safe and effective” so whatever this is, it doesn’t matter.”
but this looks false as well. we clearly saw how the “effective” part went and the “safe” part looks to have fallen apart in the real world as well and the evidence of deliberate cover ups around even being able to count side effects (by CDC rigging the reporting process with malice aforethought) and suppressing data and studies, especially about myocarditis and other such “died of suddenly” or “mysteriously emergent lasting harm” topics.
but was it really even done? because it looks to me like it wasn’t and THAT is an entirely different kettle of fish with an altogether different aroma.
the key sleight of hand is this:
the pfizer BNT162b2 trial was performed using a compound produced using a very different manufacturing process from the one used to create the drug that was actually shipped and sold.
it was a small batch, high cost process that could not scale to make millions much less hundreds of millions of doses. and that is a VERY big deal because in this sort of biologic, the industry axiom has been constant for 100 years: “the process is the product.” make it a different way, and you have no idea if it’s the same thing. and the FDA knows this full well; it’s been a cornerstone of their approval process since the beginning.
when looking at something like a generic small molecule drug, the FDA will allow you to produce a clone (a generic drug) once the original drug is off patent if you can prove “bioequivalence.” you produce a copy, show that the molecule is the same, show that it has the same PK curves (pharmacokinetics), and off you go: ready for market without doing a drug trial. generally, this has worked out.
but this is most emphatically NOT so with biologics because they are too complex (molecules too big) and the manner in which things fold matters too much. you cannot show “this molecule is that” (not that pfizer would have even come close on the full drug if they had tried). this is why many biologic drugs (like acthar) have been off patent for generations but still have no generic. there is no way to prove equivalence without doing a trial because the process is the product and that process remains a trade secret.
the sort of change that pfizer made to manufacturing was not minor, it was massive. and that means, in simple terms, that the vaccine they shipped was a different drug than the one they got approved by the FDA by pretty much any reasonable standard.
and that is pfraud, pure and simple. it means that the drug they jabbed into a billion arms was never tested in any meaningful way.
“process 2” drug is not “process 1” drug and this raises some severe issues about regulatory diligence and quite literally whether anyone, politico, physician, parent, or citizen, could have made proper decisions, recommendations, or given anything resembling actual informed consent.
you could not possibly get anything statistically significant from this and it appears they never published it in any event. (hardly a surprise, recall that this is the company and the regulator that wanted 70 years to release their data under FOIA)
there is really no other sound conclusion here: this was a bait and switch and the drug pfizer shipped to the general public was not the one they used in the trial and that the FDA approved.
this was the literal equivalent of building a perfect pinto by hand with master craftsmen for NHTSA and consumer reports to test and then shipping a bunch of junk made in a dysfunctional factory with massive defect rates and a different gas tank to your customers.
this was a lie, pure and simple and pfizer knew it and so did the FDA. there is just no way you miss this and this wild presumption that “oh, we can just switch to a radically new production process for a biologic drug without testing” is, as far as i know, unprecedented in FDA history.
the process is the product and therefore they had no idea what this new product was.
and they shipped it anyway.
astonishingly, regulators do not even appear to have tried to find out. it would have been both sensible and trivial for them to sequence this. but they didn’t (or if they did, they sure kept quiet about it).
they literally responded to this issue by lowering their standards. (read the whole piece including links to kevin mckernan’s key work HERE.
building on the idea that the mRNA integrity in the covid vaccines had dropped to a shockingly low 55% in commercial batches and that the regulators had responded to this by simply lowering standards to make that a passing grade while accepting a set of implausible looking western blots as “evidence” that all was OK with wildly low fidelity copies of CG enriched protein coding instructions the fearless feline anadamide went out and actually did what any real regulator should have done and sequenced the drug in the vaccine vials. what emerged was terrifying.
having a regulator that lies to you and papers over problems is worse than having no regulator at all. it’s the equivalent of thinking you have a seatbelt on when you don’t. it’s no basis for sound decisions.
this is an important idea to internalize, especially for those who tend to default to “bad things would happen if we did not have regulators to watch out for us.” did they do so here? did they even try? because it looks to me like they suited up against us and pretty much all the discovery and revelation here comes from private actors who the regulators tried to suppress, malign, and gaslight.
i have spoken in the past about how it’s the low energy path for the politicians who cheer led this mess to turn on pfizer and throw them under the bus for having committed fraud in their drug trials. this was always a bit hard to prove and frankly, i have thus far been disappointed in the failure of this trend to emerge. perhaps i underestimated the extent to which “campaign sponsored by pfizer” and the desperate instinct to double down and brazen out of mistakes too big to admit to would tilt the scales.
but this one is simple and obvious: the drug they shipped was not the drug from the trials.
it was stunningly low integrity and full of truly dangerous contaminants and sequencing it next to some of the trial batches is an easy, objective process that will yield definitive results.
anyone at FDA could do it. so why don’t they?
perhaps they need a little help.
this is where lawsuits, FOIA, and maybe, just maybe, congress can be of help if they ever decide to get serious.
this is a simple, provable matter: was the drug you shipped the one you used in the drug trials or were the contents of the vials significantly different?
and if it wasn’t, then heads need to roll. the FDA needs to be gutted and real safeguards put in place (or honestly, perhaps flat out eliminated and replaced with competitive private market accreditation agencies not paid by pharma companies who must compete on reputation for accuracy, not monopoly). this outcome was obscene.
if the drug shipped was not the one tested, pfizer (already one of the most fined companies in human history) needs to be have its EUA protections yanked for pfraud and then get sued into bankruptcy as the gates open for class action suits by all those harmed. frankly, these protections (and similar for being on childhood vaxx schedules) should not exist at all.
governments and companies that imposed jab mandates for this product should be likewise opened up to civil action. this is how you create the liability that will make a group like the FAA or OSHA or departments of education/school boards think twice in the future about mandating experimental drugs to retain certification.
if this is found to be willful and deliberate, then the corporate veils at places like pfizer need to be pierced and folks like bourla need to be personally liable both civilly and criminally. this sort of pfraud needs to be a pfelony for pfizerians and FDA alike.
we cannot allow the age of “pay a $1 billion fine for a calamity that netted us $20bn” as though it were some sort of gratuity to persist. that’s a recipe for the most egregious of misbehavior and under such a system, neither regulator nor corporation has any incentive to protect the consumer.
it’s time to step up and go after the EUA on the grounds of fraud and willful misrepresentation.
because this is no basis for regulatory regimes or corporate accountability and it’s not going to change until those seeking to misbehave face incentives not to.