Stop the Fraud

2021-08-26 07:00 by Karl Denninger in Editorial , 726 references ******nit, Stop The FRAUD

First, stop with the tin foil bull****: The FDA did grant a biologics license to the Pfizer jab.

Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

Second, under the law governing EUAs an EUA may only be issued and maintained if there is no LICENSED alternative.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities

For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need. A potential alternative product may be considered "inadequate" if, for example, there are contraindicating data for special circumstances or populations (e.g., children, immunocompromised individuals, or individuals with a drug allergy), if a dosage form of an approved product is inappropriate for use in a special population (e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may be resistant to approved and available alternative products.

There now is as of August 23rd, a licensed and available alternative so all of the other EUAs that were granted for the same indication are, under the law, void.

You see there is debate over whether the licensed product is identical to the EUA'd product. If it isn't -- that is, if chemically it is not identical (not similar, identical), different only in label then the licensed product at present does not exist which would permit the existing stock (and EUA's) to be used BUT renders any claim that you can be "mandated" moot as the licensed product does not, in fact, exist as of this time. Confused yet? That appears to be the direct intention of both the FDA and the Biden administration including but certainly not limited to Fauci and the CDC -- confusion and fraud.

But it does not matter because the process is corrupt, it has killed people in the past in the pursuit of money and if it does this time the body count is going to be ridiculous and not confined to a few druggies, butt****ing gay men or geriatric people with severe cognitive issues.

The FDA did not "magically become" corrupt since Biden came to office nor is this limited to Covid-19. Just a few months ago the FDA licensed an Alzheimer's medication that failed its trials. Specifically, it failed to demonstrate that it either (1) halted cognitive decline in Alzheimer's patients or (2) reversed said decline in those where it already existed.

https://www.sciencemag.org/news/2021/06/alzheimer-s-drug-approved-despite-doubts-about-effectiveness

All that the drug demonstrated was a reduction in plaque presence -- but there was no evidence that it reduced, treated or resolved disease.

This rank corruption has in fact been going on for decades. Vioxx was fully-approved in 2003 despite data being hidden and corrupted that was discoverable if anyone had bothered to, and nobody did. Tens of thousands of dead people and about five years later it was finally pulled off the market. The opiate scandal is another example with multiple "assurances" that formulations and reformations of these drugs made them impossible to abuse but there was no scientific proof that this was the case. Those assertions proved to be lies and tens of thousands of Americans died every year over a period of more than a decade including two in my extended family, both of whom started their personal road to ruin by prescription use of these "fully-approved" and "impossible to abuse" meds. The FDA deliberately sat back and allowed shipments of these drugs into certain counties in quantities sufficient to addict or even kill every single person who lived there, proof beyond reasonable doubt that the drugs were being illegally diverted and did nothing to stop it for years. That damage continues today while at the same time the FDA's "response" to it has been to deny those in chronic pain the medications they actually need.

In this case the FDA deliberately cherry-picked the data which, if looked at in full, appears to demonstrate that the all of the current jabs, all of which were formulated off the original "wild" Wuhan spike, are not only increasingly ineffective against the Delta variant but in fact Delta appears, under certain circumstances, to present binding, that is, enhancement of disease in someone inoculated with these jabs. https://www.biorxiv.org/content/10.1101/2021.08.22.457114v1.full.pdf

The signal for this is not real strong but the laboratory work has been done and it is evident that this is the case from the in-vitro data. That which you find in-vitro doesn't always translate over to in-vivo (in the body); in fact quite often it does not -- but when you've jabbed 200 million Americans with something that the evidence shows may, through ordinary natural mutation, not only evade the protection but have the severity of infection made worse in those who were vaccinated you had better wake the **** up and stop it until you can categorically exclude with 100% certainty that this may or will happen down the road. You have to be out of your ****ing mind to "license" something that has demonstrated in scientific work that this event may take place until it has been conclusively excluded. Doing so will take years which, of course, is contrary to both political and financial interests so the facts were, once again, deliberately ignored. This risk is global and there is no possible way for the US or any other nation to prevent said mutation from happening somewhere else in the world no matter what laws, regulations or actions they take -- and once it does, if it does, it will come here exactly as did Delta; that cannot be prevented.

When the effect of the enhancing antibodies was analyzed, the infectivity enhancement of the Delta pseudovirus by some of the enhancing antibodies was more than that of the wild-type pseudovirus (Figure 1D). These data suggested that the Delta variant completely escaped from anti-NTD neutralizing antibodies while maintaining functional enhancing antibody epitopes.

What's worse is that there are other mutations already known in the wild that go even further in terms of escape. Whether those will "win" in the circulating realm of Covid-19 is not known at this time; evolutionary selection is a complex process in that the virus only gets one crack at a host; if you get infected and develop an effective response that response is typically durable and protective for years if not decades and is conserved across future mutations. Were this not to be the case humans, say much less other animals, would have all become extinct millions of years ago.

This exact mechanism of mutational dynamics, incidentally, is what has derailed all other coronavirus (and RSV, for that matter) vaccine attempts over the previous decades. It is not a function of Covid-19 being "unique" in some fashion (even though we know it is, and it was almost-certainly engineered complements of Dr. Fauci, EcoHealth and of course the CCP) but rather is a function of how beta coronaviruses are structured, what parts of their protein structure perform the various functions and the mutational affinity -- that is, what can mutate and still have a virus that infects humans -- of those structures.

Never mind the very real risk of the Chinese or some other malevolent government with biological lab capacity deliberately causing that next, one final remaining mutation to take place on purpose and then releasing it, knowing damn well what will happen -- a risk I pointed out in early February before we started jabbing people en-masse. https://market-ticker.org/akcs-www?post=241577

The FDA knows this. The CDC knows this. The NIH knows this. The research has been done for decades to try to crack this code and it has failed.

Not once has durable immunity been demonstrated in such a trial in the past against these classes of virus and now the same signal is evident with the current jabs which were permitted to be used despite not demonstrating said durable, sterile immunity first.

What we do not know is whether immunity caused by infection prior to vaccination is damaged by the jab. It might be through the mechanism of shifting the balance of antigens the body produces. Maybe. Or maybe not.

Here's a very well-balanced article that points out a whole bunch of other facts that nobody wants to discuss when it comes to the "vaccines" for Covid-19. https://www.realclearscience.com/articles/2021/08/23/lets_stop_pretending_about_the_covid-19_vaccines_791050.html It's from an MD and I can find little to quarrel with, save the above -- yet it exactly that risk that, from my point of view, was the worst of all because you can't do anything about it and the harm may be lifetime in duration.

When the jabs first came out I made a very clear statement: For people at very high risk they were probably worth it even with all the unknowns, which, at the time, were numerous. Why? For the same reason we compute the decision to take a cancer drug differently than for a Tylenol. If you have cancer and do nothing you will die. If the drug kills you 5% of the time that's acceptable provided you actually have the cancer since a 5% risk of death is reasonable when the alternative is a 100% risk of death.

There are people for whom the risk of dying if they get Covid-19 reaches or even exceeds a 5% threshold. That is a very high risk. It is within spitting distance to SARS-1 in the general population and is, by any set of standards, considered "extremely high." I would happily take a 1% risk of a stroke or heart attack in the ensuing 8 weeks if doing so meant that a 5% risk of dying would be avoided with reasonable scientific certainty, provided I only had to take that risk of the heart attack or stroke once. There's no argument for forcing someone to take such a decision but there certainly is a clean mathematical argument for doing it on a personal, informed-consent basis.

But as the unknowns have filled in, and to a large extent they have, in those people with a lower baseline risk the odds ratios have gotten much worse over time. For example myocarditis isn't a "sure thing" if you take the jab but in young people it is especially dangerous, particularly in young males. That risk may be as high as 1 in 10,000 or worse. That's 0.01% and sounds like a tiny risk except such a person only had a 1/30,000 risk of getting seriously harmed or killed by Covid-19 -- that is, 0.003% -- in the first place. While most myocarditis cases appear to resolve at present the long-term impact of that is a complete unknown simply because the time has not yet passed to figure it out.

And remember: It is not certain you will get the virus; you may have already had it, be immune, and not know. If you take the jab you are guaranteed to take whatever risks are associated with it. One must adjust the risk numbers for these facts.

Then there is a very high associated "all cause" death rate compared with other vaccines. Again, the per-shot risk is very low but if it's you the odds do not matter. And again, the question is simply this: On a personal risk basis which is the more-dangerous option? To get infected and gain durable immunity or take a jab that, on the science, was never tested for durable immunity at all?

It's not so simple, and now to add to this we have evidence that the virus is mutating as every other coronavirus has through history and is extremely close to not only complete evasion of the protective quality from the jabs but worse, is on the verge of, if not already here, in being enhanced in those who were vaccinated.

That means in the best case you must repeatedly take the risk of strokes and heart attacks, along with other serious adverse effects, in order to maintain protection. If the risk is 1/10,000 to do it once then the risk is 1/5,000 to do it twice, assuming the risk is linear which we do not know. If its exponential, and there is a strong suggestion that is the case because most of these events occurred after the second jab in the series, then the risk from taking three jabs may be 1/1,000 instead of 1/10,000 which is ridiculously higher and makes the decision to risk infection rather than vaccination simple for most people since only the quite-morbid are at higher risk from infection than 1/1,000 (0.1%) even if we assume the risk of eventual infection, if you do nothing, is 100%.

Note that if there is no end to these jabs then eventually even the most-morbid are stupid to take them since the risk of the jab killing them will rapidly exceed that of the virus doing so and this assumes that vaccine-induced enhancement does not show up and wildly multiply the risk of serious disease and death from the virus itself.

There is no way to know whether these risks will converge either naturally or by forced action of a malevolent party but that they exist and are independently present is now known with scientific certainty as all of those mutations have now been found in the gene banks from sampled patients. If that "next mutation" winds up being of benefit to "being first" in an uninfected, non-recovered host and worse, if being vaccinated makes the person who gets it more-infectious then being jabbed is not only personally dangerous it is dangerous to public health and will cause a wave of serious illness and death to tear through the vaccinated population and if that happens there is nothing that can be done to stop it.

The FDA knows all of this as they have the same access to the published scientific work I do. They didn't hold a hearing or take public comment, as they are supposed to, because then people like myself could submit into the formal, government record papers like the one I cited above.

In addition the FDA cut off the data far enough back to deliberately ignore the most-recent few weeks, which show crazy deterioration in the percentage of people who die of Covid-19 and are vaccinated. In some counties (e.g. Clark, NV) the vaccinated are now the majority of the deaths. Does this prove vaccine-induced enhancement is here and raging? No; the data is too thin. But what it does prove is that being jabbed doesn't stop you from getting sick nor does it stop you from giving the virus to others and that by itself reduces the decision to be vaccinated to one of personal choice at best.

And finally even Pfizer admits that they can't get ahead of such a mutational event whether it occurs naturally or is forced and released by a malevolent actor. https://www.foxnews.com/health/pfizer-bourla-covid-19-vaccine-resistant-variant-likely-emerge They say they can turn around a new version of the jab within 95 days but then you have to get it into the hundreds of millions of Americans and that can't happen any faster the second time than the first. Assuming you immediately can ramp up production and distribution expecting that you can get effective coverage within less than another three to six months is fantasy-level bull**** as we didn't manage that the first time and the virus mutates faster than you can accomplish it, making the attempt a game of whack-a-mole which you will inevitably lose. Never mind the risk that the reformulated version may produce immediate and extremely dangerous adverse events at a wildly-elevated rate: Without trials, which again will add months or years to the time required to deploy, there is no way to know! It is sheer arrogance to presume none of this will happen when we now have hard proof that least some of it did with the first go-around.

While you're at it stop lionizing "health care workers." I know, factually, that there are plenty of hospitals that 18 months into this still do nothing other than stick you on low-flow oxygen, fill you full of Remdesivir which not only doesn't work it has a risk of destroying your kidneys (that will kill you outright in the hospital, by the way) and perhaps give you dexmethasone. This despite the fact that we knew in the spring of 2020 that when Covid-19 screwed you it was not bacterial pneumonia but rather organizing viral immune dysregulation and we knew how it killed you too. To not hit an infection that becomes pulmonary and systemic with immediate testing for d-Dimer and ferratin levels to detect clotting problems and immediately treat those, along with immediately hitting indications of inflammatory dysfunction in the lungs as soon as you find them well before someone is in the hospital at all is flat-out insane. We know how to treat those conditions and have known how to do so for decades. Yet even today, 18 months into this, hospitals are not doing any of it and collecting their $30,000 bounty for shoving a tube down your throat and then sticking a toe tag on you when it inevitably fails to help as it leaves the actual cause of the problem unaddressed.

I'm here because instead of listening to the idiots in the health care system when I got infected with Delta I did the right thing. I hit the virus hard with meds and won. I have multiple objective measurements of its impact on my body and, while it wasn't fun, what got me in January of 2020 (likely H1N1) was objectively worse in every metric.

Having been infected and recovered I'm now broadly immune to this monster including all currently-known and suspected mutations and thus have no fear of it. I will walk, right now, into a Covid-19 ICU with zero PPE. I challenge anyone who has not been infected and trusts the vaccines to do the same right next to me. You know damn well you won't because you don't believe your own bull****; it is that very refusal which forms the premise of any and all attempted mandates in this regard.

I believe in science, I believe in millions of years of evolution, I believe in the body's immune system which in my person is functional and has proved it works including my B and T-cells, immune recall and the broad, demonstrated immunity that natural infection and recovery confers. I have confirmed that I actually was infected (not "tested positive") as I now have an IgG titer for Covid-19 antibodies and that presence, in the absence of vaccination, is conclusive scientific proof of infection and recovery. A huge percentage of those who allegedly "tested positive" almost-certainly never had Covid at all because if that was not true then there could have been no surge in either last winter or now because on the CDC's claims herd suppression has long been surpassed yet clearly it did and is occurring. This means a huge percentage of people claimed to have been infected by alleged PCR test never had Covid-19 at all but rather had something else, or in the case of an "asymptomatic infection" were never infected with anything. Fortunately today for about $25 you can personally find out by running an IgG antibody test, assuming you have not been vaccinated (you'd expected vaccination to read positive on said test -- unfortunately that positive reading does not mean you have protection as discussed above) whether you truly had Covid-19 and thus are presumably sterile to the virus and safe both personally and with respect to others.

As the science has continued an irrefutable line of studies has shown repeatedly that the vaccines do not work compared against natural infection. The latest shows as much as a 13 fold increased risk for those who were vaccinated .vs. previously infected. https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1 That is, vaccination is for all intents and purposes on a personal protective basis worthless compared against being previously infected.

In other words one of the biggest frauds of all is that if you had Covid-19 and recovered you "need a jab." Bull****. Not only does infection confer sterile immunity it does so at a much higher rate than vaccination. Period.

I will never take a jab because to demand I do so is identical to demanding that someone who had chicken pox, which I also had, be vaccinated against it and unlike the flu and even the varicella (chicken pox) shot, which would almost-certainly simply do nothing as there is decades of data on both of their safety these shots are demonstrably and directly dangerous and the evidence is extremely strong that at best viral evasion is in process right now and at worst vaccine-induced enhancement of viral binding is starting to occur, that wildly increases the risk of death, and there is zero data one way or the other on whether infection prior to vaccination prevents those bad effects, does nothing or, and this is quite possible, makes them more-likely.

yeah, this BS that the FDA didn’t REALLY approve the current Pfizer covid vaccine is exactly the same kind of garbage that fools and/or trolls recently kept posting here about the vaccines being chock-a-block full of graphene oxide ...

there’s enough legitimate concern about what’s in these vaccines, how they function in the body, the serious detrimental effects they cause in so many people, and their lack of efficacy, that it’s seriously counterproductive to keep posting garbage conspiracy nonsense here, thereby diluting the credibility of legitimate concerns ...

i posted the following on another thread:

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine?fbclid=IwAR3YfGMw2mJ14XVKK7OA8N_tNzgSIag5cfE3t5CVECyBp5D5rnBvR99j8y0

“On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”

The EUA is only for a subset of usage NOT included in the initial FDA approval ...

and Comirnaty, which is nothing more than a new name for the Pfizer covid vaccine, IS of course available because it’s just a new name, not a new vaccine:

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full

to quote from the press release:

the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.

The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 Vaccine). The EUA permitted essential rollout of vaccine doses across the U.S. to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial.”

once again, it couldn’t be more clear than that the FDA approved the original Pfizer vaccine but with a new marketing name (COMIRNATY) that Pfizer chose to call it instead of calling it the Pfizer-BioNTech vaccine.

NOT a new vaccine, simply a new name ... this is actually pretty much S.O.P. for new drug approval, namely when a trial drug with some name like “compound xyz-310” gets approved it gets a new marketing name like “CureAllWondaStuff” ...

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