Will Thailand become the first country to take Pfizer to court claiming fraud and declare the contracts null and void?
Professor Sucharit Bhakdi seems to think so. He claims to have talked to officials high up in government and told them that the contracts were fraudulent. According to him, the Thais want to be the first country in the world to declare the contracts null and void. If this goes ahead and found to be true in the courts, it will mean a significant sum of damages will have to be paid by Pfizer and set off a chain of events that will likely bankrupt the company.
23 days after the Thai King’s daughter had her booster, she collapsed and is still in a coma. Officially she has a bacterial infection but many claim she is the victim of vaccine damage. If the Thais do take Pfizer to court, will this have been the reason?
The National Institute of Health’s grant AI23946-08 issued to Dr. Ralph Baric at the University of North Carolina at Chapel Hill (officially classified as affiliated with Dr. Anthony Fauci’s NIAID by at least 2003) began the work on synthetically altering the Coronaviridae (the coronavirus family) for the express purpose of general research, pathogenic enhancement, detection, manipulation, and potential therapeutic interventions targeting the same. As early as May 21, 2000, Dr. Baric and UNC sought to patent critical sections of the coronavirus family for their commercial benefit.1 In one of the several papers derived from work sponsored by this grant, Dr. Baric published what he reported to be the full length cDNA of SARS CoV in which it was clearly stated that SAR CoV was based on a composite of DNA segments. “Using a panel of contiguous cDNAs that span the entire genome, we have assembled a full-length cDNA of the SARS-CoV Urbani strain, and have rescued molecularly cloned SARS viruses (infectious clone SARS-CoV) that contained the expected marker mutations inserted into the component clones.”2 On April 19, 2002 – the Spring before the first SARS outbreak in Asia – Christopher M. Curtis, Boyd Yount, and Ralph Baric filed an application for U.S. Patent 7,279,372 for a method of producing recombinant coronavirus. In the first public record of the claims, they sought to patent a means of producing, “an infectious, replication defective, coronavirus.” This work was supported by the NIH grant referenced above and GM63228.
In short, the U.S. Department of Health and Human Services was involved in the funding of amplifying the infectious nature of coronavirus between 1999 and 2002 before SARS was ever detected in humans.
This dossier is by no means exhaustive. It is, however, indicative the numerous criminal violations that may be associated with the COVID-19 terrorism.
US drugmaker Pfizer admitted on Friday that it “engineered” treatment-resistant variants of Covid-19 in order to test its antiviral medicine. The admission partially backs up earlier claims by an executive with the company who told an undercover reporter that Pfizer was deliberately “mutating” the virus to “preemptively develop new vaccines.”
In a statement posted on its website, Pfizer said that it “has not conducted gain of function or directed evolution research,” referring to the practice of amplifying a virus’ ability to infect humans and the process of selecting ‘desirable’ traits of a virus to reproduce, respectively.
However, the pharma giant said that it combined the spike proteins of new coronavirus variants with the original strain in order to test its vaccines, and that it created mutations of the virus to test Paxlovid, its antiviral drug.
“In a limited number of cases… such virus may be engineered to enable the assessment of antiviral activity in cells,” the company said, adding that this work was carried out in a secure laboratory. The work also sought to create “resistant strains of the virus,” it added, describing a process commonly understood as being ‘gain of function’ research.
Pfizer’s statement came two days after Jordon Trishton Walker, an executive involved in the firm’s mRNA division, told an undercover reporter that the company was “exploring” ways to “mutate [covid] ourselves so we could create, preemptively develop, new vaccines.” Walker said that scientists were considering infecting monkeys with the virus, who would then “keep infecting each other.”
“From what I’ve heard, they [Pfizer scientists] are optimizing it, but they’re going slow because everyone is very cautious,” he explained. “Obviously they don’t want to accelerate it too much. I think they are also just trying to do it as an exploratory thing because you obviously don’t want to advertise that you are figuring out future mutations.”
Pfizer’s statement makes no mention of the supposed plan to infect monkeys, instead explaining that any work on live viruses is carried out in vitro, meaning inside test tubes or other lab equipment.
Walker was told on camera that he was speaking to a journalist with Project Veritas, a conservative outlet known for its hidden-camera sting operations. After hearing this, Walker insisted that he was lying to impress his date, before attempting to steal an iPad from Project Veritas CEO James O’Keefe.
Many of us are familiar with the following conundrum: on one hand, highly credentialed scientists and doctors have written numerous research papers explaining the dangerous mechanisms of action underlying mRNA/DNA “platform” technologies. The papers are meticulously researched and depict, correctly in my opinion, many terrifying consequences of the technology that breaches the innate protective mechanisms of human cells. Furthermore, these theoretical papers are validated by the observed outcomes, such as for example, increases in all-cause mortality in high correlation with increases in rates of vaccination in a given territory, unprecedented increases in the adverse events and deaths recorded by various passive reporting (https://openvaers.com/), astonishingly high reports of the adverse events and deaths from the pharmas’ own pharmacovigilance systems, and autopsy findings in vaccinated post-mortem showing the mechanisms of mRNA technology damage in histopathologic evaluations. On the other hand, many who have received the injections report no adverse effects and deem the data points above a “crazy conspiracy”. The question from the uninjured seems to be – why don’t we see MORE deaths if what you say about mRNA products is true? Setting aside ethical limitations of this question, here is a possible answer why:
The mRNA shots do not conform to their label specifications. In practice both “blank” and “lethal” vials and anything in between is produced. Without full compliance, nobody, not even the manufacturers or regulators, know exactly what ends up being produced.
Vials of mRNA injections are not routinely tested by the manufacturers for conformity to the label. The only vial-level tests specified by Pfizer in leaked Chemistry Manufacturing and Controls (CMC) documents are the vial weight at filling, manual inspection for large visible particles, and some tests related to integrity such as vial capping. However, no vial or dose, i.e., “unit-level as dispensed” tests verifying the ingredients are described as routine. How is the public assured that each Pfizer dose contains 30 mcg of mRNA as stated on the label? What level of variability of this key ingredient and other ingredients is acceptable? The ingredient conformity tests described in Pfizer CMC package are based on the bulk product batch testing – an upstream manufacturing process step. It is a regulatory requirement to retain samples of each batch produced, and these samples of vials should exist and be available for examination. Per contracts with the US Government, the product is shipped to the DOD who retains the ownership of the vials until the product is injected into people. These contracts are very detailed and specify manufacturing data to be delivered to the DOD, however, I did not find any descriptions of sampling of the vials for purposes of verification of their contents vs the label. Furthermore, it is expressly forbidden by the international vaccine supply contracts to perform the vial tests for label conformity.
Despite the disturbing prohibition of the independent vial testing, covert random testing of the mRNA vials has been ongoing worldwide. Reported thousands of vials have been obtained and tested by dozens of research groups working independently of each other. The quality of these studies varies and depends on the conditions of the samples acquired, access to the lab equipment and the experience of the investigators. However, the consistent finding among all is that there is yet a single vial to be found in full conformance to the manufacturer’s label. A review of these independent testing efforts has been published recently. Another high-quality report summarizes experiences testing vials from various manufacturers in Germany. These studies use different techniques ranging from optical to electron microscopy, spectroscopy, as well as isolation of genetic and protein components and in some cases sequencing of the RNA.
Some vials contain RNA as well as high concentrations of DNA and protein impurities in quantities far exceeding allowed limits specified by the manufacturer. When RNA was sequenced, the sequences did not fully match the specified BNT162b2 sequence, and a large quantity of RNA fragments was found. In other instances, vials are found apparently without RNA or DNA in them (evidently absent nitrogen and phosphorus).
These results could depend on the methods used and more thorough testing may be needed. Nevertheless, I was able to confirm that the apparent “blank” vials from at least one researcher came from batches of Pfizer and Moderna that had almost no adverse events reports in VAERS: two batch numbers had 1 report each and one batch number had no reports. This should be contrasted with some batch numbers of Pfizer and Moderna associated with 5000+ adverse event reports in VAERS, and an average of ~1500 adverse event reports including ~700 serious reports and deaths across all CDC verified batch numbers.
Almost all vials examined contain high contamination levels of various metals that are toxic to human body. This finding is consistent across all groups and methodologies, and therefore should be deemed more conclusive. There is no explanation of the origin or purpose of these materials according to the known manufacturing processes. Additional findings include various forms of carbon, including, potentially graphene oxide which is a known toxin. Finally, almost all vials examined contain a variety nano- and micro-particulate contaminants – another conclusive finding with plenty of photo and video documentation. These appear under microscope examinations as shapes and structures of various sizes and include characteristic ribbons, fibers, and crystals. Several published reports by qualified and credentialed microscopy experts have excluded the possibility of environmental dirt on the microscope slides. Sometimes a process of movement and what can be described as “self-assembly” is visible and has been documented in a single take video. The researchers also take steps to maintain the chain of custody, examine unexpired product and keep the vials frozen per manufacturer’s instructions.
Below are some representative images from various manufacturers’ injection vials from many studies:
Dr. David Nixon – Australia, Pfizer
Another Dr. from Australia, Pfizer:
The images above are startling and remain unexplained to date. Some scientists insist these are all “salt and cholesterol”, and nothing to see here folks! I disagree. Images of salt and cholesterol under microscope may match some of these structures, but by far do not explain all of them, and seem especially poor explanations for assembly-disassembly processes that have been observed and video recorded. Sizes of these structures alone are problematic. Dismissing them as “manufacturing junk” is not a great way to instill confidence in anyone.
These contaminants and bizarre objects are not rare, in fact as the last image shows, at least some of the vials are teeming with them. While many speculations can be made, one overwhelming conclusion from all the vial tests by independent investigations is that the products are extremely “dirty”, do not conform to their labels and should thus be deemed adulterated. This is a clear indicator that the manufacture of these products is not compliant with the current Good Manufacturing Practices (cGMP).
Sloppy manufacturing process may result from numerous factors, including lack of accountability, negligence, incompetence and possibly fraud. Review of the contracts with the manufacturers made by the U.S. Department of Defense, BARDA and HHS shows that the main driver were the gigantic sums of money made available with no real accountability for quality or safety – all resulting from the forced extreme speed (“warp speed”) of the scale up of manufacturing. The U.S. DOD contracted Pfizer in May of 2020 for production of at least 100 million doses by October 31, 2020, and up to 500 million doses later. Pfizer’s initial contract award was for $10 billion, with many additional incentives for delivering more doses faster. Similar contracts were made with numerous other “vaccine” manufacturers, and hundreds of other suppliers, all under the guise of panic buying for covid countermeasures. No real accountability for product quality or consistency or safety was built into those contracts, in fact the manufacturers were explicitly exempt from all possible liability under the PREP Act, which is specified in a separate contract clause. The purchaser is the DOD, the distributor is the DOD (and not the licensed and accountable pharmaceutical distributors), and furthermore, the product is not serialized and hence open to both adulteration and falsification or mislabeling.
To meet the contract obligations, Pfizer’s manufacturing batch size has increased from microgram scale for lab and animal study volumes to commercial batches of ~140 liters at the end of 2020 and ~300 liters by late 2021. In my experience commercializing biotechnologies from academia, failure to scale is one of the leading causes of failures of all new technology ventures. Showering this problem with money rarely accelerates the solution, and very often accelerates the demise of the whole venture. This is common sense. For example, placing an order today for 1,000,000 of a new type of vehicles with Ford Motor Company to be delivered in 6 months will likely fail no matter the dollars spent, since even obtaining the raw materials in time will be problematic. Complex manufacturing requires materials, systems, capacity, experienced staff, established processes, suppliers, and most importantly control systems at the correct scale to be successful and produce high quality consistent product. Now imagine simultaneously asking several direct competitors – Ford, GM and Toyota to produce 1,000,000 new cars each in the next 6 months.
Based on review of available literature on mRNA manufacturing and my discussions with experts who have made mRNA in the lab, it is not clear that mRNA can be manufactured at the scale that is estimated for these injections from known shipment numbers and disclosed manufacturing documentation: 200-300 liters of drug product per average batch, 700+ batches a year in the US alone. This is particularly unlikely if strict cGMP rules are applied to the manufacturing requirements, and we know that cGMP is not followed for production of these injections. Recently FDA found Catalent non-cGMP compliant. Catalent handles large volumes of fill-finish for Moderna, therefore batches processed through Catalent are non-cGMP compliant.
The generation of mRNA by in-vitro transcription (IVT) at large scale and under current good manufacturing practice conditions is challenging. For example, the specialized components of the in-vitro transcription IVT reaction must be acquired from certified suppliers that guarantee that all the material is animal component-free and GMP-grade. Furthermore, the availability of large amounts of these materials is limited and purchasing costs are high. This is true, for example, in the case of the enzymes used for translation and capping. Even the glass vials themselves were reported as a shortage. Additionally, the low yields and batch failure are a known problem. Conceptual process flow of making mRNA drug substance contains several steps:
The process is composed of a 2-step enzymatic reaction in continuous form, followed by enzyme recycling using tangential flow filtration strategies and two multimodal chromatography steps, one in bind-elute mode for the intermediate purification, and a second in flowthrough mode for polishing. Formulation is achieved using a third tangential flow filtration module. This means the mRNA needs to be made by chemical reaction, and then purified, and then capped and purified again. There are many variations of this process, and no standards exist. At the “formulation” step (last box in the picture), there are further multiple steps to create lipid nanoparticles, and get the mRNA encapsulated. Further, there are fill and finish steps that likewise are not problem free and decrease the yield. Finally, transportation and manual dose preparation add an extra variability layer.
Here is a simple heuristic to understand any manufacturing process flow and not get confused by the jargon: each arrow in the flowchart points to places where errors accumulate Each output-input point in a complex manufacturing flow is where the errors can be checked for and rectified or, if unsolved, will amplify and destroy the product quality and consistency. This is especially dangerous at the extreme speed and scale.
In science papers mRNA manufacturing is described with problem-free cartoons, it all works beautifully regardless of whether it is microgram or kilogram output, and not a single paper on this topic dwells much on low yields or process failures. This is because the academia never has to confront reality. However, the pesky reality of manufacturing mRNA (or anything else) at large scale is highly error prone. Each step has a yield of anywhere between 50% and 80%, and sometimes the whole batch fails, and that is especially true at the large scale of production. mRNA reaction fidelity is less than 100%, the caps and tails fall off, mRNA breaks into fragments, lipid nanoparticles do not form perfectly and PEGylation can be inhomogeneous leading to their breakage and subsequent escape and breakage of mRNA. Large mRNA breaks into smaller fragments, and these remain in the substance. At large scale of reaction, the enzymatic process for making mRNA was reported seizing at 37.5 liters of mRNA substance (before encapsulation into LNP and making drug product) according to the European Medicines Agency (EMA) documents. It is not clear how this was resolved and transitioned to 100’s of liters scale in a matter of few months, and for all suppliers. mRNA fragments were deemed process related impurities by the EMA who raised a significant concern, but they were dismissed by the FDA as a “theoretical problem” – as leaked emails from EMA have shown. mRNA “fragments” may or may not code for proteins, however micro-RNAs (miRNA) can interfere with endogenous cellular processes to detrimental health effects which is described in many scientific papers and even in a textbook on biological weapons published by the NIH in 2018. Chapter 6 of the book describes gene therapy as a class of biological weapons. Coincidentally, the DOD-pharma contracts for covid-19 shots also explicitly state that the product is being developed for both civilian and military applications.
Returning to mRNA manufacturing, multiplying even an optimistic 80% yield by, for example, 7 process steps results in 20% final yield, and if the in-process failures are larger, final yield is single digit percentage or a failure has occurred. Each step generates large amounts of impurities, which are never fully removed as aggressive purification will break the fragile product. Furthermore, the mRNA substance is never equally distributed in the batch volume as thorough mixing of the product is not possible due to its fragility, and lipids tend to float to the top of the vat as well as stick and congregate together. Dangerous possibly cytotoxic aggregates of broken LNPs and mRNA (mRNA adducts) can result and were reported by Moderna a full year after large scale deployment of their product. As a result, the larger the volume of the batch, the more inhomogeneity at the vial level. These conditions can create over-concentrated, toxic vials and the ones that could be “blanks”, or anything in between. The larger the batch volume the more duds it will produce, which in case of this product is largely good news for the injectees. Avoidance of specifying any product conformity tests at the vial level by the manufacturers seems to be intentional in this context.
Data from Pfizer’s own CMC documentation submitted to EMA at the end of November 2020 shows “failure to scale” beginning at approximately 25% of the current commercial scale of the batch (current scale = 600,000 vials = 3-4 million doses per batch). The graphs below were generated using exact sizes in vials and doses for each Pfizer batch manufactured between August and November 2020 (Figure 1) and all Pfizer shipped doses in the US up to end of April 2022 (Figure 2). I used reported deaths and adverse events in VAERS database associated with those batches as a measure of batch variability. This does not address vial variability but provides directional information especially for the scale of manufacturing. The batches in Figure 1 were the first ones to ship commercially and were likely all used close to 100% since at that time the demand for these injections was insatiable. As the “scale-up” of manufacturing proceeded in 2020, the batches were manufactured in a variety of sizes from 50,000 and up to 300,000 vials (~140 liters of drug product). During this time, several major changes were made to the manufacturing, for example, transition from the pilot facility at Polymun Scientific to Pfizer’s own plants and changing major manufacturing steps to new processes.
Figure 1.
First, the overall data indicate a statistical trend toward increased number of reported deaths with the increase in the batch size – the more this product is used, the more deaths are reported. This is not news for anyone who has been paying attention to the injection related adverse events and deaths. However, the variability batch-to-batch demonstrated by the vertical dispersion of the death reports associated with batches of the same size is already apparent at approximately 150,000 vial batch size (25% of the full commercial scale). Batches of the same size are 4-5 times different from each other in the number of reported deaths.
The “failure to scale” story gets larger at scale, no pun. Recently, the exact sizes of Pfizer lots shipped in the United States became known via a FOIA data release, including all doses with associated lot numbers shipped as of end of April 2022 to various vaccination centers. Figure 2 is the plot of all batches from Pfizer, by their reported size in doses on the x-axis and serious adverse events including deaths reported for those lot numbers on the y-axis. Data from VAERS was downloaded on September 24, 2022.
Figure 2.
This graph includes the “early” scale up batches from Figure 1, as well as what appears smaller shipments possibly for batches that were largely distributed overseas. What is immediately apparent from the data – the staggering inconsistency of the product batch-to-batch and the rapid decline of apparent toxicity measured by the adverse events with increase in batch size. The latter trend is the opposite of what was observed with the early batches. The product is causing fewer adverse events per dose when there are more doses available. This does not make sense, except if these doses are simply sitting on the shelves. Of note is batch FM0173 (only 26,700 doses shipped in the US) that generated the highest rate of serious adverse events (3.3/1000 doses), upper left dot.
The scale of manufacturing strains the credulity. A batch of 12 million doses translates to approximately 900+ liters of mRNA! Given the manufacturing steps involved, impurities generates and the amount of raw materials, and the scale of manufacturing equipment and disposables needed, it should be questioned whether this truly was a single production run.
Figure 3 is the same data as in Figure 2, with outlier batches removed for clarity (includes batch sizes from 100K to 4M doses):
Figure 3:
It is evident that the variability batch-to-batch is highly significant and remains unexplained. It is also strangely declining as the size of the batch is becoming larger. The only reasonable explanation to this is that the usage of this product per batch has plummeted. Most of what is produced later in the time period is sitting on the shelves. At the end of the time period in this graph (end of April 2022), an estimated 100M doses were manufactured but not administered in the United States. At the beginning of this graph, nearly all manufactured doses were administered. That is the only reasonable explanation – and it proves that these injections cause the injuries and deaths reported to VAERS!
Table below lists all batches >4 million doses, including their date of manufacture and the number of serious adverse events and deaths reported for them in VAERS:
Table 1:
The “mega” batches are not entirely benign. They are simply a larger lottery pool. The single death reported for batch FL0007 is for an 8-year-old girl who died in Texas from a multi-system organ failure (VAERS ID 2327226-1) – see Figure 4. While the first batch listed in her report RL0007 appears to be a typo (RL series do not exist for Pfizer), it is evident that she received both doses from the same FL0007 batch and passed away 3 months later.
Figure 4:
Here is my educated guess on what is going on with the batch variability: Pfizer’s (and other manufacturers’) contracts were for delivery of DOSES. Millions of them and fast. Contract scope is simply a “demonstration of large-scale manufacturing” and billion-dollar bonuses attached for shipping millions of doses by certain dates. No accountability, no checks, no liability, just ship the doses on time! The batches of 5 million+ doses should be questioned in this context. These appear largely benign from the adverse event perspective but, since the demand for these shots has plummeted coinciding with production of mega-batches, it is hard to say what the real driver of “safety” is – over-dilution of the product or refusal of the customers to be injected. I hope it is the latter.
Here is as close as I can get to answering the question “why aren’t MORE people dying?”: Too many people have died and have been injured by these injections, and plenty more will ultimately have their lives cut short. The manufacturers are making both – lethal shots and highly diluted “blanks” in a sloppy, uncontrolled, unaccountable, and ultimately fraudulent manner.
To know the truth, these products must be tested at the vial and dose levels, in a random sampling by independent 3rd party laboratories. In the meantime, the products must be recalled, and a proper investigation initiated.
Long before COVID-19 arrived, I was a close observer of the pharmaceutical industry. My great grandparents believed that pharmaceutical labs were at the forefront of progress, relieving suffering and extending life, and for the most part they were right. My paternal great grandfather owned a large chain of drugstores and was a benefactor of UT Southwestern Medical School. At the time of my birth, my maternal great grandmother gave me a generous gift of Pfizer stock. She had been impressed by Pfizer’s key role in discovering how to mass produce penicillin during World War II (in which her son was killed in action). Eighteen years later her gift paid for my university education. And then, in 1998, Pfizer received FDA approval to sell Viagra.
Pfizer initially developed the drug to treat high blood pressure and angina pectoris. However, as Pfizer’s researchers discovered in clinical trials, the drug was better at inducing erections than managing angina. And so, the company repurposed the drug for erectile dysfunction and launched a massive, global PR and marketing campaign—including seeking moral approval from Pope John Paul II and contracting the war hero and 1996 presidential candidate Bob Dole to be the brand’s poster gentleman—that succeeded in making Viagra a blockbuster. Fortunately for me, I still owned a large chunk of Pfizer stock. The price spiked in late 1998 and reached an all-time high in April of 1999. I sold my entire remaining position, which financed my early years as a freelance author, before my first book was published.
So, I learned firsthand why pharmaceutical companies seek to develop blockbuster drugs with fanatical zeal. Formulating a safe and effective new medicine to address a large, unmet need is very difficult and expensive. Performing clinical trials and obtaining FDA-approval is an arduous process that normally takes several years. Thus, if an opportunity for a new blockbuster presents itself, a big drug company like Pfizer will go to extreme lengths to seize it.
Three years after the release of Viagra, I learned that Pfizer was not the entirely respectable company my great grandmother had believed it to be. I arrived at this realization through my interest in British spy novels. In 2001 I lived in Vienna, around the corner from the Burgkino (Burg Cinema) which still played the 1949 film noir classic The Third Man on its big screen every weekend. I spent many a dreary winter Sunday afternoon watching the film. Based on the novella and screenplay by Graham Greene, The Third Man is a crime story about Harry Lime—an American running a medical charity in Vienna, who makes a killing selling penicillin on the bombed out, impoverished city’s black market. To increase his profits, he cuts the drug with other substances, thereby destroying its efficacy and causing the patients (including children) to die horribly from their infections.
In the film’s most iconic scene, the good guy (played by Joseph Cotton) meets his old friend Harry Lime (played by Orson Welles) on the Giant Ferris wheel in the Vienna Prater amusement park and tries to appeal to his conscience. At the wheel’s apex, the charismatic Harry opens the door, points down to people walking on the ground below, and says:
Look down there. Would you really feel any pity if one of those dots stopped moving forever? If I offered you twenty thousand pounds for every dot that stopped, would you really, old man, tell me to keep my money, or would you calculate how many dots you could afford to spare? Free of income tax, old man. Free of income tax. … Nobody thinks in terms of human beings. Governments don’t, why should we? They talk about the people and the proletariat; I talk about the suckers and the mugs. It’s the same thing. They have their five-year plans, and so have I.
I sensed that Graham Greene might have based the story on something he’d witnessed or heard about. Doing some research, I learned that Harry Lime was probably based on the British spy Harold “Kim” Philby, with whom Greene worked in British intelligence during World War II. Greene, it seems, discovered that Philby was a Soviet double agent long before he was exposed as such in 1963. Instead of ratting out his friend, he kept it to himself and left the intelligence service in 1944. Several pieces of evidence suggest that when he wrote The Third Man a few years later, he based it on his conflicted friendship with Philby.
John le Carré was also fascinated by Graham Greene and Kim Philby, and his thriller Tinker, Tailor, Soldier, Spy—one of my all-time favorites—was inspired by the Philby story. His novel The Constant Gardener was published in 2001, and I read it with great interest. The story wasn’t set in Cold War Europe, but in Kenya, where a British diplomat’s wife is brutally raped and murdered. Upon closer examination, the diplomat realizes that she was about to reveal a horrifying crime committed by a pharmaceutical company, which murdered her in order to prevent the exposure.
The novel’s plot was reminiscent of a controversial drug trial performed by Pfizer in Kano, Nigeria in 1996 during a meningococcal outbreak. For the trial of its new antibiotic, trovafloxacin, Pfizer gave 100 children this new drug. The control group of 100 other children received the standard anti-meningitis treatment at the time—a drug called ceftriaxone. However, for the control group, Pfizer administered a substantially lower dose of ceftriaxone than the drug’s FDA-approved standard.
When the reduced dosing in the control group was discovered, it raised the suspicion that Pfizer did this in order to skew the trial in favor of its new drug. Five of the children who received trovafloxacin died, while six who received the reduced dose of ceftriaxone died. Other children apparently suffered grave injuries from the administration of the experimental antibiotic without their informed consent. The investigation and litigation that ensued was the stuff of a thriller, involving private investigators, bribery, blackmail attempts, and disappearing records. Thirteen years later, in 2009, Pfizer settled out of court with the plaintiffs.
In his author’s note, le Carré claimed that nobody and no corporation in the novel was based on an actual person or corporation in the real world.
But I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.
In 2009, the same year that Pfizer settled with the trovafloxacin plaintiffs, the New York Times reported that a U.S. federal judge assessed Pfizer with the “largest health care fraud settlement and the largest criminal fine of any kind ever” for its illegal marketing of Bextra and three other drugs. The U.S. Department of Justice was unequivocal in characterizing Pfizer’s officers as guilty of grave criminal conduct at the expense of the American public.
Pfizer is “pausing advertising on Twitter” because it is “concerned that Mr. Musk could scale back content moderation, which they worry would lead to an increase in objectionable content on the platform.”
Pfizer was one of the most significant sources of revenue for Twitter. I constantly saw Pfizer ads and promoted posts, such as this one:
(If you are not sure why “the human brain” becomes so sweaty once pink “science” grabs it firmly from behind, neither am I)
What is interesting is that this advertising pause involves not only Pfizer but other large multinationals with no specific issues related to Twitter censorship, such as General Mills, a producer of popular but unhealthy breakfast cereals.
Who is behind this? Meet a new “action coalition” called “Accountable Tech” that is directing efforts to withhold advertising money from misbehaving technology companies. You may be very surprised, or not, but “Accountable Tech” is packed with Democratic operatives:
Accountable Tech is spearheading this letter to Twitter advertisers:
Accountable Tech joined more than 25 groups to deliver the below message in a letter to Twitter’s top advertisers to demand nonnegotiable requirements for their ad business in the midst of Elon Musk’s acquisition:
To whom it may concern:
Elon Musk’s takeover of Twitter will further toxify our information ecosystem and be a direct threat to public safety, especially among those already most vulnerable and marginalized.
The undersigned organizations believe that Twitter should continue to uphold the practices that serve as guideposts for other Big Tech platforms. We call on you – Twitter’s top advertisers – to commit to these standards as non-negotiable requirements for advertising on the platform:
Keep accounts including those of public figures and politicians that were removed for egregious violations of Twitter Rules – such as harassment, violence, and hateful conduct – off the platform
All these coalitions attempt to influence large advertisers into doing their bidding by withholding ad money from tech companies that “Accountable Tech” wants to punish.
I understand why Pfizer, a company selling fraudulent “Covid vaccine” and relying on censorship for continued sales, has a vested interest in Twitter continuing to censor vaccine skeptics. However, other companies mentioned above do not have such reasons.
General Mills should only care about selling its cereals. As such, they would advertise wherever the ads would bring future product buyers. So, the pecuniary interest of that company is certainly NOT in pausing their Twitter ads that go along with sports coverage and other non-controversial threads.
Thus, by stopping ads, General Mills acts against its own shareholders. Its management is not blind to this. However, over the years, the coalitions like Accountable Tech have acquired significant influence within these companies and boardrooms via various “diversity,” “equality,” and other “stakeholder” commissions intimidating corporate management.
I discussed this previously in a somewhat broader context after Musk made his first Twitter offer. I explained why “free speech” is a threat to very powerful interests:
Not all tech companies succumb to these “silencing coalitions.” Substack is a very successful, profitable platform that said no to all attempts to deplatform “misinformation superspreaders.” Rumble recently told France to bug off with its requests to close certain channels and blocked France. Other platforms like gab are doing just fine financially without these corporate advertisers.
These “fringe” platforms are resisting censorship but involve comparatively few users. What “Accountable Tech” is trying to do is keep the general masses on the largest social networks from learning the truth.
Will Elon Musk overcome this blackmail? Does he even care to have free speech on Twitter? Is he an ally of freedom? Will “Accountable Tech” win and silence us? What do you think?
The European Union prosecutor’s office has launched an investigation into the bloc’s procurement of billions of Covid-19 vaccine doses, amid allegations of corruption and secret backroom dealings from several members of the EU parliament.
EU officials announced the probe in a brief statement on Friday, confirming an “ongoing investigation into the acquisition of Covid-19 vaccines in the European Union.” They added that the case follows “extremely high public interest” around the issue, though declined to share any other details.
While prosecutors were tight-lipped about the exact nature of the probe, the announcement follows allegations from MEPs that European Commission President Ursula von der Leyen conducted vaccine negotiations with Pfizer CEO Albert Bourla in secret. Despite requests from journalists, lawmakers and an EU watchdog, von der Leyen’s office has failed to produce personal text messages sent to Bourla during talks for nearly 2 billion vaccine doses, prompting accusations of corruption.
Croatian MEP Mislav Kolakusic noted the new investigation later on Friday, saying the decision was made thanks to pressure from lawmakers. Though he was unable to shed additional light on the probe, Kolakusic has been highly critical of the EU’s vaccine procurement process, claiming deals for billions of doses were marred by “corruption” and secrecy.
“Today, 10 of us MEPs asked [von der Leyen] the following question: when will she present to us… the communication she had with Pfizer during the procurement of 4.5 billion doses of vaccines at a time when there was absolutely no proof of the effectiveness, and especially not of the harmfulness, of that product?” he said in a tweet earlier this week, calling the issue the “biggest corruption scandal in the history of mankind.”
Last month, the European Court of Auditors said it had asked the commission to provide information on “preliminary negotiations” for the EU’s largest Pfizer purchase – including “scientific experts consulted and advice received, timing of the talks, records of the discussions, and details of the agreed terms and conditions” – but added that “none was forthcoming.” The European Commission still has yet to make the information public, fueling corruption allegations from MEPs.
In Geneva in late May at the 75th meeting of the WHO’s decision-making body, the World Health Assembly (WHA), amendments to its International Health Regulations (IHRs) were debated and voted upon. If passed, they would grant the WHO the right to exert unconscionable pressure on countries to accept the WHO’s authority and health policy actions if the WHO decides that there is a public health threat that might spread beyond a country’s borders.
As Ramesh Thakur, the second man at the UN for years, noted, the amendments would mean “the rise of an international bureaucracy whose defining purpose, existence, powers and budgets will depend on outbreaks of pandemics, the more the better.”
This is the first clear instance of a globalist coup attempt. It would subvert national sovereignty worldwide by putting real power into the hands of an international group of bureaucrats. It has long been suspected that the authoritarian elites arisen during covid times would try to strengthen their positions by undermining nation states, and the this 75th jamboree is the first solid evidence of this being true.
What an opportunity then to see who is in the conspiring club. Who drafted the amendments? What was in them? Which individuals supported them or spoke out against them?
WHO were the conspirators?
The amendments on the table at the May WHA meeting had been transmitted to the WHO by the US Department of Health and Human Services on January 18, circulated by WHO to its member states (‘States Parties’) on January 20 and formally introduced to the WHA on April 12.
The proposals, according to an announcement on January 26, were co-sponsored by 19 countries plus the European Union. Even if some co-sponsors had little direct involvement in drafting them, they all would have approved in principle the overarching goal of tightening up the WHO’s authority over member states in the face of a public health event.
Loyce Pace, the HHS’s Assistant Secretary for Global Affairs – the leading US official nominally responsible for the proposed amendments – arrived at the Biden administration fresh from a stint as executive director of an advocacy organization called the Global Health Council.
That council receives funding from the Bill & Melinda Gates Foundation and its members include Eli Lilly, Merck, Pfizer, Abbott Labs, and Johnson & Johnson. You get the idea. Via one of the foxes-turned-chicken-guard, it appears the HHS ‘worked closely’ on these amendments with large pharmaceutical companies, who will be chomping at the bit for a more proactive (read: profitable) response to any public health emergency, real or imagined.
So the conspiring club consists primarily of the US government and its Western allies in lockstep with Big Pharma, and they are looking to undermine both the sovereignty of their own governments and that of other countries, presumably with the idea that the Western elites would do the running.
What was in them? A blizzard of acronyms and euphemisms
To understand what the US proposed at the WHA, we need first to understand how things have worked in the WHO to this point.
The IHRs in their current form have been in force as international law since June 2007. Among other things, they impose requirements on countries to detect, report and respond to ‘public health events of international concern,’ or PHEICs. The WHO Director-General consults with the state where a possible public health event has occurred, and within 48 hours they are meant to come to a mutual agreement on whether or not it actually is a PHEIC, whether or not it needs to be announced to the world as such, and what counter-measures, if any, should be taken. It’s essentially an early-warning system on major health crises. This is a good thing if it’s run by people you can trust and if it has checks and balances to rein in expansionary tendencies.
The proposed amendments would greatly strengthen the power of the WHO relative to this baseline, in a number of ways.
First, they lower the threshold for the WHO to declare a public health emergency by empowering its Regional Directors to declare a ‘public health event of regional concern’ (PHERC, italics ours) and for the WHO to put out a new thing called an ‘intermediate public health alert.’
Second, they permit the WHO to consider allegations about a public health event from non-official sources, meaning sources other than the government of the state concerned, and allow that government only 24 hours to confirm the allegations and a further 24 hours to accept the WHO’s offer of ‘collaboration.’
Collaboration is essentially a euphemism for on-site assessment by teams of WHO investigators, and concomitant pressure at the whim of WHO personnel to enact potentially far-reaching measures such as lockdowns, movement restrictions, school closures, consumption of medicines, administration of vaccines and any or all of the other social, economic, and health paraphernalia that we have come to associate with the covid circus.
Should the state’s government acceptance of the WHO’s ‘offer’ not be forthcoming, the WHO is empowered to disclose the information it has to the other 194 WHO countries, while continuing to pressure the state to yield to the WHO’s invitation to ‘collaborate.’ A non-collaborating country would risk becoming a pariah.
Third, the proposal includes a new Chapter IV, which would establish a ‘Compliance Committee’ consisting of six government-appointed experts from each WHO region tasked with permanently nosing around to ensure the member states are complying with IHR regulations.
There are more crossings-out of the existing IHR language and new language added in, but the flavour of what the US-led alliance is shooting for is a WHO that can unilaterally decide whether there is a problem and what to do about it, and can isolate countries that disagree.
Compliant WHO member states could act as a supporting cast in the isolation effort, through the distribution of their own health budgets and their ‘health-related’ policies, which would include travel and trade restrictions. The WHO would become a kind of command-and-control center for globalist agendas, pushing the produce of (Western) Big Pharma.
Why and how would this work?
We learned during covid times why it would make sense that the US and its allies are insisting on these amendments.
Lowering the bar for declaring a global (or regional) public health threat triggers a huge opportunity for Western pharmaceutical companies. As legal experts have observed: “WHO emergency declarations can trigger the fast-track development and subsequent global distribution and administration of unlicensed investigational diagnostics, therapeutics and vaccines.
This is done via the WHO’s Emergency Use Listing Procedure (EULP). The introduction of an ‘intermediate public health alert’ in particular will also further incentivise the pharmaceutical industry’s move to activate domestic fast-track emergency trial protocols as well as for advance purchase, production and stockpile agreements with governments before the existence of a concrete health threat to the world’s population has been detected, as is already the case under WHO’s EULP via the procedures developed for a ‘pre-public health emergency phase’.”
You can bet that the WHO ‘expert teams’ sent in to make on-the-ground assessments, under the banner of ‘collaboration’ with the host country experiencing the health event, will be chock-a-block with operatives from the CDC and who knows what other Western agencies, all poking around potentially sensitive facilities that a host government might justifiably claim a sovereign right to keep to itself. Likewise with the ‘Compliance Committee’ proposed by the US under the new Chapter IV of the IHRs: its government-appointed members have an open-ended brief, enshrined in international law, to be busybodies.
In layman’s terms, the WHO would be turned into an international thug, with its member states offered the role of backyard gang members.
As a bonus for Western elites, the proposals are a sneaky form of rewriting history. By cementing authority within an international organisation to determine the existence of public health crises and direct potentially draconian emergency responses, Western governments would get to enshrine and legitimise their own extreme responses to the covid outbreak, as we have pointed out previously. Their backsides would thereby be given some protection from legal challenges.
The refusniks: Developing countries
The proposals were pushed primarily by Western countries: the US was joined by Australia, the UK and the EU in arguing for passage. The resistance was led by developing countries who saw it as a colonialist ambush in which their ability to set policy and respond to health threats in a manner commensurate with their domestic situations would be overridden.
Brazil reportedly went so far as to threaten to withdraw from the WHO, and the African group of almost 50 countries, along with India, argued that the amendments were being rushed through without adequate consultation. Russia, China and Iran also objected.
Failure on the first try, but the US and its allies in the West will get more shots to push it through.
How do we expect them to do this? Well, when a proposal gets bogged down inside a giant bureaucratic machine like the WHO, the inevitable response is to set up committees to work in the background and circle back with a new set of proposals to be presented at a future meeting. True to form, a ‘working group’ and ‘expert committee’ are being assembled to accept member state proposals on IHR reform by the end of September this year. These will be ‘sifted through’ and reports will be prepared for review by the WHO’s executive board in January next year. The objective is to have a fresh set of proposals on the table when the WHA convenes for the 77th time in 2024.
Not all was lost
Salvaging something from the fact that the WHA failed to get a consensus around its biggest agenda item, the US and its allies got a small victory on the point of when they can try again – though in their desperation they needed to violate the IHRs’ own rules to accomplish it. Article 55 of the IHRs states unambiguously that a four-month notice period is required for any amendments.
In this instance, revised amendments were presented on May 24, the same day that the first lot were rejected. These were discussed, further amended on May 27 and then adopted on the same day. The approved amendments halve the two-year period for any (further) approved amendments to the IHRs to take effect. (The IHRs that came into force in 2007 were agreed to in 2005 – but under the new resolution, anything agreed to in 2024 would come into effect in 2025 rather than 2026.)
Yet, what was achieved in terms of fast-tracking the force of new amendments was lost in slow-tracking their implementation. Nations would have up to 12 months – double the previous suggestion of six months – to implement any IHR amendments that newly enter into force of law.
State of play
Where is all this going?
If the WHO takes the reins on decisions about what constitutes a health crisis, and can pressure every country into a one-size-fits-all set of responses that it, the WHO, also determines, that’s bad enough. But what about if its invitation to ‘collaborate’ with countries is backed up with teeth, such as sanctions against those who demur? And what about if it then broadens the definition of ‘public health’ by, for example, declaring that climate change falls under that definition? Or racism? Or discrimination against LBTQIA+ people? The possibilities thereby opened up for running the world are endless.
A global ‘health’ empire would bring huge harms to humanity, but a lot of power and money is pushing for it. Don’t think it can’t happen.
Paul Frijters is a Professor of Wellbeing Economics at the London School of Economics: from 2016 through November 2019 at the Center for Economic Performance, thereafter at the Department of Social Policy
The European Commission said it is unable to locate text messages sent between its president, Ursula von der Leyen, and Pfizer CEO Albert Bourla during talks for a massive vaccine deal last year, but denied prior charges of “maladministration” from an EU watchdog.
The commission issued a letter on Wednesday stating that an expanded search for the missing messages had “not yielded any results,” following months of dispute between the EU’s executive body and oversight officials. It argued that due to the “short-lived and ephemeral nature” of texts, they typically “do not contain important information” and are therefore rarely stored.
While von der Leyen revealed in an April 2021 interview that she and Bourla privately communicated for several weeks while negotiating a contract for nearly 2 billion vaccine doses, a journalist’s public information request for the texts was later shot down, with the commission claiming it could not find the messages in question.
The denial triggered a rebuke from the European ombudsman, Emily O’Reilly, who followed up with an investigation last year and blasted EU officials over poor administration and a lack of transparency, saying that “no attempt was made to identify if any text messages existed.” The ombudsman then urged the commission to “search again,” asking it to broaden its criteria in a way that might actually locate the records.
The commission doubled down in its latest response to O’Reilly, however, insisting it had handled the matter properly and made every effort to find the texts. It reiterated that it does not register material that contains no “important information,” and that such documents “are not kept, and, as a consequence, are not in the possession of the institution.”
“The European Commission is of the opinion that it has not treated this request in a ‘narrow way’ and that the search and handling of documents for the purpose of public requests for access to documents … is justified and follows the established practice,” it continued.
The body added that it intends to “issue further guidance on modern communication tools” in hopes of avoiding similar mix-ups in the future, but nonetheless held that its actions were “in line with the applicable legislation and the relevant case law on access to documents.”
The office of the ombudsman, which published the commission’s letter on Wednesday, declared that the response was “problematic on several points,” and noted that a “full analysis” of the case would follow in the coming weeks.
The controversy over the missing texts is not the first dispute regarding a lack of transparency in the EU’s vaccine dealings, as the commission was sued in April by several MEPs, who claimed the negotiations were overly secretive. Though contracts were eventually published, they were heavily redacted in a way that “made it impossible to understand the content of the agreements,” the lawmakers alleged, insisting secrecy “has no place in public agreements with pharmaceutical companies.”
The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.
The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.
The FDA on June 1 released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
CRFs show deaths, severe reactions to the vaccines during Phase 3 trials
The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants.
They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being “not related” to the vaccine.
For example:
A female in her early 50s (randomization number 86545) who participated in the trial at the Sterling Research Group in Cincinnati, Ohio, died of an apparent myocardial infarction on Nov. 4, 2020. She had received two doses of the vaccine, on Sept. 10 and Sept. 29, 2020.
The patient had a medical history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, osteoarthritis of the knees and attention deficit disorder. Her death was listed as “not related” to the vaccine, and was instead attributed to “hypertensive cardiovascular disease.”
A female in her late 50s (randomization number 220496), who participated in the trial at Cincinnati Children’s Hospital Medical Center, died of cardiac arrest on Oct. 21, 2020. Her death, however, was indicated as “not related” to her vaccinations (which occurred on July 30, 2020, and Aug. 20, 2020) as it “occurred 2 months after last receipt of study agent,” according to her CRF.
The participant’s medical history included obesity, placement of a gastric sleeve, gastroesophageal reflux, sleep apnea, supraventricular tachycardia, hypothyroidism, depression and asthma.
A male in his mid-60s (randomization number 221076) who participated in the trial operated by the Texas-based Ventavia Research Group died of an apparent myocardial infarction on Nov. 28, 2020. He had received the two doses of the vaccine on July 31, 2020, and Aug. 19, 2020.
The participant had a medical history that included a previous myocardial infarction, high blood pressure, high cholesterol, anxiety, bilateral hip pain, type 2 diabetes, fluid retention, angina (intermittent), restless leg syndrome, Vitamin D deficiency, tobacco dependency and the placement of a coronary arterial stent in 2017.
According to the CRF, he sustained the myocardial infarction on Oct. 27, 2020, and was diagnosed with pneumonia the following day. While both diagnoses were classified as “serious” in his CRF, they were both listed as “not related” to the vaccination, with his myocardial infection attributed to a “failed cardiac stent” and the pneumonia simply attributed to “infection.”
A female in her teens (randomization number 104650) was diagnosed with right lower extremity deep vein thrombosis on Nov. 15, 2020, which was still ongoing as of Mar. 29, 2021, the date of the CRF. She was hospitalized and her condition was classified as “serious,” but it was indicated as “not related” to the vaccine, instead attributed to a “fracture” occurring prior to her vaccination on Sept. 11, 2020.
The patient had a medical history including asthma, attention deficit hyperactivity disorder, Charcot-Marie-Tooth disease and obesity.
A male in his mid-70s (randomization number 227629) participating in the trial at Clinical Neuroscience Solutions Inc. (operating in Florida and Tennessee) sustained a series of adverse events following his vaccinations on Aug. 13 and Oct. 7, 2020.
He was diagnosed with COVID-19 on Aug. 30, 2020, which coincided with several other diagnoses classified as “serious,” including abdominal adhesions (Aug. 29, 2020), altered mental status (Aug. 29, 2020, lasting through Sept. 16, 2020), and acute hypoxic respiratory failure (Aug. 30, 2020). These diagnoses required his hospitalization.
He was also listed as having suffered from congestive heart failure on Aug. 30, 2020, but this diagnosis was listed as “not serious” and as “not related” to the vaccine, but to “prior surgery,” with no further details given. Similarly, his other serious adverse events were listed as being related to “prior” or “previous” surgery, or to “concomitant non-drug treatment.”
Other “non-serious” adverse events listed in this patient’s CRF include hypokalemia, anemia, acute renal failure, sepsis, hyponatremia, leukopenia, small bowel obstruction, aspiration pneumonia, mild concentric left ventricular hypertrophy (symptoms of which were still ongoing as of the CRF date of Mar. 29, 2021) and urinary tract infection.
The patient had a medical history encompassing ongoing hypertension, hypercholesterolemia, gastroesophageal reflux disease, constipation, hiatal hernia and previous diagnoses of small bowel resection, small bowel perforation, inguinal hernia, osteoarthritis in both knees and knee replacement (both knees).
A male in his mid-70s (randomization number 266982) participating in the trial at Boston Medical Center suffered a series of adverse events following vaccination, including pneumonia and peripheral edema. He had received two doses of the vaccine, on Oct. 2, 2020, and Oct. 27, 2020.
The patient was hospitalized for pneumonia on Jan. 20, 2021, in an event classified as “serious” but also as “not related” to the vaccine. However, the cause of his pneumonia was listed in the CRF simply as “un-related to vaccine,” while his peripheral edema diagnosis was attributed to “existing neuropathy.”
During his hospitalization with pneumonia, his blood pressure was measured as high as 179/72, with a heart rate reaching 105 beats per minute and an oxygen saturation level that fell to 92.0. In total, he had three emergency room visits during the observation period.
The patient had a medical history that included type 2 diabetes, alcoholic cirrhosis, hypothyroidism, asthma, sleep apnea, hypertension, diabetic neuropathy, congestive heart failure, generalized anxiety disorder, depression, insomnia, excessive urination, chronic obstructive pulmonary disease and HIV-positive status.
A protocol deviation also occurred involving this patient, as his diary was not activated following administration of the first dose of the vaccine.
A male in his early 40s (randomization number 68489) who participated in the trial at Cincinnati Children’s Hospital Medical Center sustained chronic myelogenous leukemia on Sept. 24, 2020, with the condition ongoing as of the date of the CRF on Mar. 29, 2021.
This was classified as a “serious” and “life-threatening” adverse event, albeit one that did not require hospitalization, but it was listed as “not related” to the vaccination but instead to a “genetic change in stem cells.”
The patient had been vaccinated on Aug. 26, 2020, and Sept. 17, 2020, and had a medical history of asthma and seasonal allergies. Other “non-serious” adverse events he sustained included leukocytosis and thrombocytosis.
A female in her mid-40s (randomization number 49018) who participated in the trial at Clinical Neuroscience Solutions Inc. was diagnosed with kidney stones on Jan. 4, 2021.
This was classified as a “serious” adverse event that required hospitalization, but was listed as “not related” to the vaccine, instead being related, again, to “kidney stone” (sic). She had received the two doses of the vaccine on Aug. 17, 2020, and Sept. 8, 2020.
The patient was diagnosed with COVID-19 on Jan. 27, 2021. Her prior medical history included migraine headaches, hypercholesterolemia and a Tarlov cyst.
A female approximately 30 years old (randomization number 53307) participating in the trial at Boston Medical Center, with nothing to report in her medical history, sustained a shoulder injury related to vaccine administration (SIRVA) on Sept. 9, 2020, with symptoms continuing until Feb. 8, 2021.
This injury was listed as being related to the second dose of the vaccine, which she received on Sept. 9, 2020 (she had previously received her first dose on Aug. 17, 2020).
A female in her late 50s (randomization number 260125) participating in the trial at Clinical Neuroscience Solutions Inc., suffered from acute exacerbation of asthma. The symptoms appeared in mid-December 2020, following her vaccination on Sept. 16, 2020, and Oct. 5, 2020.
Her symptoms were classified as serious but not life-threatening, and she was hospitalized. However, her asthma symptoms were listed as “not related” to the vaccine, instead being related to “asthma” with no further explanation provided. On Jan. 12, 2021, her blood pressure was recorded as 183/130, with a heart rate of 98 beats per minute.
Other less serious adverse events sustained by the patient included injection site pain, body pain, chills and a low-grade fever.
Her medical history included cholecystitis (and a cholecystectomy), herniated disc, total abdominal hysterectomy, bilateral oophorectomy, bilateral salpingectomy, endometriosis, hypertension, hypercholesterolemia, rheumatoid arthritis in remission, asthma, seasonal allergies, irritable bowel syndrome and obesity.
A male in his late 20s (randomization number 48413) who participated in the trial at Clinical Neuroscience Solutions Inc., sustained a bilateral pulmonary embolism on Dec. 14, 2020, with symptoms still ongoing as of the CRF date of Mar. 29, 2021.
This was listed as a “serious” adverse event that required hospitalization, but was attributed to the patient’s habit of vaping and his “sedentary lifestyle.” He had received the two doses of the vaccine on Aug. 13, 2020, and Sept. 2, 2020.
Other post-vaccination symptoms listed for the patient included fever, fatigue, headache, chills, vomiting, diarrhea, new/worsened muscle pain, new/worsened joint pain and swelling.
The patient had a medical history that included elevated triglycerides, genital herpes and seasonal allergies, in addition to a vaping habit.
The many serious adverse events – and several deaths – recorded during the Phase 3 trials are also apparent in a separate, massive document, exceeding 2,500 pages, cataloging such adverse events.
This document lists a wide range of adverse events suffered by trial participants classified as toxicity level 4 — the highest and most serious such level.
However, not one of the level 4 (most severe) adverse events listed in this particular document is classified as being related to the vaccination.
Level 4 adverse events listed in the document include but are not limited to the following, many of which occurred in multiple patients:
Acute cholecystitis
Acute respiratory failure
Adrenal carcinoma
Anaphylactic shock
Aortic valve incompetence
Appendicitis
Arrhythmia, supraventricular
Arteriosclerosis
Brain abscess
Cardiac arrest
Chronic myeloid leukemia
Complicated appendicitis/acute appendicitis with necrosis
Small bowel obstruction/small intestinal obstruction
Spontaneous coronary artery dissection
Subarachnoid hemorrhage
Suicidal ideation (and suicidal ideation with attempt)
Syncope
Type 2 diabetes
Worsening of abdominal pain
An “unevaluable event/“unknown of unknown origin”
Similarly, only a small number of toxicity level 3 adverse events were indicated as having been “related” to vaccination. Such adverse events included but are not limited to the following, some of which occurred in multiple trial participants:
Arthralgia
Blood glucose increase/glucose spike
Deafness/hearing loss
Dyspepsia
Hypotension
Lymph node pain
Lymphadenopathy/lymph node swelling
Musculoskeletal chest pain (non-cardiac)
Neutropenia
Pain in fingers/bilateral hands
Pruritus
Pyrexia/febrile syndrome
Severe headache
Shoulder injury related to vaccine administration
Sleep disorder/sleep disturbance
Tachycardia
Urticaria
Ventricular arrhythmia
Vertigo
Page 2,525 of the document in question also lists six trial participant deaths, with causes of death including arteriosclerosis, cardiac arrest, hemorrhagic stroke and myocardial infarction.
An additional document released in this month’s tranche catalogs patients who discontinued their participation in the Phase 3 trial, or whose participation was discontinued by physicians or other medical professionals.
While many patients were discontinued because they could not be located, because of a physician’s orders, because they moved to another region or for other personal reasons, numerous patients ended their participation due to adverse events, including but not limited to the following symptoms:
Acute myocardial infarction
Amnesia
Anorexia
Atrial fibrillation
Cerebral infarction
Congestive cardiac failure
Coronary artery disease
Deafness (unilateral)
Depression
Diabetic foot
Diverticular perforation
Exposure during pregnancy
Eye pain
Gait instability
Gastric adenocarcinoma
Gastrointestinal hemorrhage
Hypertension
Irregular heart rate
Loss of taste and smell
Myalgia
Paraparesis
Parkinsonism
Presyncope
Pulmonary embolism
Pyrexia
Swelling face
Tachycardia
Transient ischaemic attack
Urticaria
Vaccine allergy
Vertigo
In other instances, subjects withdrew because of fears connected to safety concerns related to the vaccine, or discomfort in receiving the second dose.
Clinical review document glosses over adverse events during trials
Also included in June’s FDA document dump was a 334-page “clinical review” document, which appears to have been approved by the FDA on Apr. 30, 2021, and which presents “pivotal data” from Phase 1/2/3 Study C4591001, conducted in the U.S., along with “supporting” Phase 1/2 data from Study BNT162-01, performed in Germany.
This document refers to both Pfizer-BioNTech vaccine, which received an EUA from the FDA, and the Pfizer Comirnaty vaccine, which received full FDA approval but is reportedly almost impossible to find at vaccination locations in the U.S.
“BNT162b2 has received temporary authorizations for emergency supply in 28 countries and conditional marketing authorizations in 39 countries globally.
“The name of the product supplied under emergency/temporary use authorization for all applicable regions is Pfizer-BioNTech COVID-19 Vaccine.
“The name of the product supplied under conditional marketing authorization for all applicable regions is COMIRNATY [COVID-19 mRNA Vaccine (nucleoside modified)].”
The document states that trial participants were administered one of two candidate vaccines, labeled BNT162b1 and BNT162b2 (the latter of which ultimately received an EUA from the FDA), or a placebo. A variety of dosage levels were also tested, ranging from 10 μg to 100 μg for BNT162b1, and 10 μg to 30 μg for BNT162b2.
In Phase 1 of Study BNT162-01, the clinical review reports that “40% to 45% of participants who received BNT162b1 and BNT162b2 across age groups and across dose levels reported one or more AEs [adverse events] from Dose 1 through 28 days (i.e., 1 month) after Dose 2.”
In what will turn out to be a general pattern throughout the clinical review, we are told that “most AEs were considered by the investigator as not related to study intervention and mild to moderate in severity, and all AEs were reported as resolved.”
Some specific adverse events highlighted in this part of the clinical review include:
“Among BNT162b1 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of malaise (considered as not related to study intervention) after Dose 1 and 1 younger participant in the 60 μg group discontinued due to a dose-limiting toxicity of pyrexia after Dose 1.
“One older participant in the 20 μg group had an SAE of severe syncope (considered as not related to study intervention) after Dose 1 and study treatment was withdrawn.
“Among BNT162b2 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of nasopharyngitis (considered as not related to study intervention) after Dose 1.
“One older participant in the 20 μg group had an SAE of ankle fracture (considered as not related to study intervention) after receiving both doses, was listed as recovering, and remains in follow-up.”
The clinical review also states “no deaths occurred in the Phase 1 part of Study BNT162-01.”
The review adds that “from Dose 1 of BNT162b2 30 μg to the unblinding date, 6 (50.0%) participants in the younger age group and 3 (25.0%) participants in the older age group reported at least 1 AE.”
Specifically, in this portion of the study, “two (16.7%) participants in the BNT162b2 30 μg younger age group and 1 (8.3%) participant in the BNT162b2 30 μg older age group reported at least 1 severe AE,” and “in the BNT162b2 30 μg younger age group, 3 (25.0%) participants reported at least 1 related AE and 1 (8.3%) participant reported 1 severe SAE.”
These specific adverse events, according to the review, were reported in “the system organ class (SOC) of nervous system disorders (3 [25.0%] participants in the younger age group and 1 [8.3%] participant in the older age group), followed by musculoskeletal and connective tissue disorders (1 [8.3%] participant in each age group). All AEs by preferred term (PT) were reported by no more than 1 participant.”
The review adds, “from Dose 1 to the unblinding date, 1 participant in the BNT162b2 30 μg younger age group reported a severe SAE (neuritis) that was assessed by the investigator as not related to study intervention,” and “there were no Phase 1 participants randomized to BNT162b2 30 μg or corresponding placebo who died through the data cutoff date of 13 March 2021.”
Review of results from Study C4591001
While “incidences in the BNT162b2 and placebo were similar within the age groups for younger (9.1% vs 11.1%) and older (4.3% vs 8.9%) participants, among those who received BNT162b2 instead of the placebo, “two severe events of myalgia and gastric adenocarcinoma (which was also an SAE) were reported for 2 participants in the … younger age group, both assessed by the investigator as not related to study intervention.”
It is further mentioned that “the only discontinuation due to an AE during this time was the participant in the BNT162b2 younger age group who reported an SAE of gastric adenocarcinoma (discontinued from the study on Day 23 after Dose 1 of BNT162b2).”
Ultimately, from dose 1 to 1 month after dose 2 for participants during the blinded safety follow-up of study C4591001, “the numbers of overall participants who reported at least 1 AE and at least 1 related AE were higher in the BNT162b2 group (30.2% and 23.9%, respectively) as compared with the placebo group (13.9% and 6.0%, respectively).”
Specifically, “severe AEs were reported by 1.2% and 0.7% in in the BNT162b2 and placebo groups respectively, and life-threatening AEs were similar (0.1% in both groups),” and “SAEs and “AEs leading to withdrawal were reported by ≤0.6% and ≤0.2%, respectively, in both groups,” while “discontinuations due to related AEs were reported in 13 participants in the BNT162b2 group and 11 participants in the placebo group (0.1% in both groups).”
Overall, as reported for this part of the study, “in the younger age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 4233 (32.6%) and 1871 (14.4%) in the BNT162b2 and placebo groups, respectively. In the older age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 2384 (26.7%) and 1177 (13.2%) in the BNT162b2 and placebo groups, respectively.”
The review specifies that “the most frequently reported AEs in the BNT162b2 group … were injection site pain (2915 [13.3%]), pyrexia (1517 [6.9%]), fatigue (1463 [6.7%]), chills (1365 [6.2%]), headache (1339 [6.1%]), and myalgia (1239 [5.7%]),” however, some more serious adverse events that were reported during this stage of the trial included facial paralysis, cardiac disorders, hepatic cirrhosis, cholecystitis/cholecystitis acute, biliary colic, bile duct stone, biliary dyskinesia, lymphadenopathy, appendicitis, optic neuritis and hypersensitivity/anaphylaxis.
Overall, according to the review, “from Dose 1 to 1 month after Dose 2, severe AEs reported during the blinded follow-up period were low in frequency, reported in 1.2% of BNT162b2 recipients and 0.7% of placebo recipients.”
During the “open-label follow-up period,” referring to the period when the initial trial has been completed but participants are invited to continue taking the study drug for an additional period, the review states “three participants originally randomized to BNT162b2 died during open-label follow-up.”
While one of these deaths was reportedly due to a road accident, the other two were attributed to lung metastases and myocardial infarction. However, none of these deaths “were assessed by the investigator as related to study intervention.”
Furthermore, according to the report, during this period “there were 12,006 participants who had at least 6 months of follow-up. Among these, 3,454 participants (28.8%) reported at least 1 AE and 2245 participants (18.7%) reported at least 1 related AE. Severe AEs and SAEs were reported by 2.1% and 1.6%, respectively.”
The review provides data for participants from dose 3 (first dose of BNT162b2) to the data cutoff date. The severe adverse event incidence rate (IR) was 6.0 per 100 PY (patient-years), with specific conditions reported including pulmonary embolisms, thrombosis, urticaria, a cerebrovascular accident and COVID-19 pneumonia.
Here, the review adds that the IR for original placebo participants who had at least 1 life-threatening AE from Dose 3 to the data cutoff date was 0.5 per 100 PY. Only one such life-threatening event, an instance of anaphylactoid reaction, was considered to be related to the vaccination. Other life-threatening, serious adverse events included cardio-respiratory arrest, gastrointestinal necrosis, deep vein thrombosis and pulmonary embolism.
The report also notes, “There were 15 deaths in the BNT162b2 group and 14 deaths in the placebo group from Dose 1 to the unblinding date during the blinded placebo-controlled follow-up period.”
However, the report does not appear to go into detail about the causes of death for either group, other than to state, “None of these deaths were assessed by the investigator as related to study intervention.”
In the “Blinded Follow-Up Period from Dose 1 Through 1 Month After Dose 2,” in the BNT162b2 group, “SAE [serious adverse events] was similar in the BNT162b2 group (0.6%) and in the placebo group (0.5%),” with three SAEs in the non-placebo group deemed to be related to the vaccine. These included ventricular arrhythmia, lymphadenopathy and SIRVA.
During the “open-label follow-up period” for “original BNT162b2 participants,” the report states “one younger participant with no past medical history had a life-threatening SAE of myocardial infarction 71 days after Dose 2 that was assessed by the investigator as related to study intervention.”
However, despite its life-threatening nature, this condition “lasted 1 day and resolved the same day.”
Overall, “from Dose 1 to 6 months after Dose 2, during the blinded and open-label follow-up periods, 190 (1.6%) participants in the BNT162b2 group reported at least 1 SAE,” and “the number of participants who reported at least 1 SAE was 73 (1.1%) and 117 (2.2%) in the younger and older age groups, respectively.”
These SAEs were categorized as neoplasms, infections and infestations, gastrointestinal disorders, hepatobiliary disorders, respiratory/thoracic/mediastinal disorders and injury/poisoning/procedural complications.
An original placebo participant who received BNT162b2 for Dose 3 experienced a severe adverse event that “was assessed by the investigator as related to study intervention; specifically, “an anaphylactoid reaction 2 days post Dose 3” leading to the participant’s withdrawal from the study, despite a reported resolution.
A separate subsection in the report specifically addressed cases of Bell’s palsy and facial paralysis among trial participants. Specifically, “during the blinded placebo-controlled follow-up period, 6 participants developed one-sided facial paralysis (Bell’s palsy): 4 were randomized to BNT162b2 (all male) and 2 were randomized to placebo (1 male; 1 female),” according to the review.
Regarding the four vaccinated trial participants, their ages ranged from 40 to 70, with symptoms appearing three to 48 days after their last dose. Their symptoms were recorded as “mild to moderate in severity,” with duration ranging “from 3 to 68 days,” and with two of these cases “considered by the investigator to be related to study intervention.”
Moreover, “during the open-label follow-up period, 3 participants who received BNT162b2 as Dose 3 or Dose 4 (after originally being randomized to placebo) experienced facial paralysis,” according to the review. These patients were all female, with an age range between 19 and 34. Events were recorded as beginning two to eight days after administration of the third dose, and “were mild to severe.” One case had a duration of 12 days, while the other two cases were ongoing as of the cutoff date of the trial.
Notably, according to the review, “all these events of facial paralysis were considered by the investigator as related to study intervention.”
The review adds, “during the open-label follow-up period for participants originally randomized to BNT162b2, a male participant 51 years of age developed Bell’s Palsy 154 days after receiving Dose 2.” No indication is given as to whether this was deemed to be related to the vaccination or not.
From dose 1 to the unblinding date, heart-related adverse events included “6 acute myocardial infarctions, 4 myocardial infarctions group, and 1 acute coronary syndrome” in the BNT162b2 group.
According to the review, “most of these events had onset distant (ie, >30 days following) to receipt of vaccine or placebo. None of these events were assessed by the investigator as related to study intervention.”
Moreover, “there was 1 participant in the older BNT162b2 age group with pericarditis. The event had an onset of 28 days after Dose 2, was ongoing at the data cutoff date, and was assessed by the investigator as not related to the study intervention.”
Additionally, “there were 8 cases of pulmonary embolism in the BNT162b2 group,” in addition to four hemorrhagic strokes and “2 ischemic strokes, 4 cerebral vascular accidents, 2 transient ischemic attacks” in this group, plus “1 case of thrombocytopenia and 1 case of platelet count decreased.”
Furthermore, “there were 9 thrombotic events in the BNT162b2 group,” including seven instances of deep vein thrombosis, one case of coagulopathy and one case of ophthalmic vein thrombosis.
Regarding autoimmune issues in the BNT162b2 group, the review states “there were 10 autoimmune disease cases identified,” with one case each of “autoimmune thyroiditis, ulcerative colitis, Crohn’s disease, reactive arthritis, fibromyalgia, systemic lupus erythematosus, alopecia areata, psoriasis,” and two cases of psoriatic arthropathy.
Pregnancies were largely glossed over in the review, which states:
“At the time of the data cutoff date (13 March 2021), a total of 50 participants who had received BNT162b2 had reported pregnancies, including 42 participants originally randomized to the BNT162b2 group and 8 participants originally randomized to the placebo group who then received BNT162b2.”
“In total, 12 participants (n=6 each in the randomized BNT162b2 and placebo groups) withdrew from the blinded placebo-controlled vaccination period of the study due to pregnancy, and 4 participants originally randomized to placebo who then received BNT162b2 withdrew from the open-label vaccination period due to pregnancy.
“These participants continue to be followed for pregnancy outcomes. No births have been reported from individuals who have become pregnant in Study C4591001 as of the time of this submission.
“All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Available data on BNT162b2 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
Pfizer concludes vaccines are ‘safe and well-tolerated’
Overall, despite the incidence of severe adverse events — some of which were admitted to be related to the vaccine — and deaths, as well as an admitted lack of data regarding outcomes for pregnant women who participated in the trial, the “safety conclusions” of the review indicate the following:
“Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings … and the AE profile and clinical laboratory results did not suggest any safety concerns.
“Based on Phase 1 data from Study C4591001 and Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in younger healthy adults 18 to 85 years of age, with no unanticipated safety findings … and the AE profile did not suggest any safety concerns, including up to approximately 6 months after Dose 2 for BNT162b2 30 μg groups.
“Based on Phase 2/3 data from approximately 44,000 participants ≥16 years of age with up to at least 6 months of follow-up after Dose 2 in Study C4591001, BNT162b2 at 30 μg was safe and well-tolerated across age groups … and the AE profile did not suggest any serious safety concerns. The incidence of SAEs and deaths were low in the context of the number of participants enrolled and comparable in BNT162b2 and placebo. The incidence of discontinuations due to AEs was also generally low and similar between BNT162b2 and placebo groups.
“Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 Phase 2/3 participants originally randomized to BNT162b2, comprising the combined blinded and open-label periods, showed no new safety signals or suggested [any] new safety concerns arising from this period of follow-up.
“Similarly, open-label follow-up of participants originally randomized to placebo from the time of unblinding to receive BNT162b2 until the data cutoff date showed no new safety signals or concerns.
“The AE profile among approximately 44,000 participants ≥16 years of age enrolled to date as of the most recent safety cutoff date (13 March 2021), was mostly reflective of reactogenicity events with low incidences of severe and/or related events. The incidence of SAEs was low and similar in the vaccine and placebo groups. Few participants withdrew from the study due to AEs. Few deaths occurred overall in both the vaccine and placebo groups with no imbalance.
“For participants randomized to placebo and then unblinded to receive BNT162b2 vaccination, open-label data from the time of unblinding to the data cutoff date (13 March 2021) showed no new safety findings or signals.
“Taken together, efficacy and immunogenicity data suggest the BNT162b2 (30 μg) 2-dose regimen induces a strong immune response and provides durable protection from COVID-19 across a spectrum of individuals representative of the population at large for individuals ≥16 years of age: those with or without prior exposure to SARS-CoV-2 and those in higher-risk categories based on age, race, ethnicity, and/or comorbidity.”
As a result, and based on the above data, the review makes a case for the approval of BNT162b2:
“A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course. Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.
“The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (i.e., individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).
“Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control.
“Overall, the potential risks and benefits, as assessed by the safety profile and the efficacy and immunogenicity of BNT162b2 (30 μg), are balanced in favor of the potential benefits to prevent COVID-19 in immunized individuals.
“Likewise, the BNT162b2 30 μg benefit and risk profile support further development in pediatric, maternal, and other at-risk populations.”
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
They want the COVID-19 vaccine approval for children so bad, Peter Marks himself and his cronies published the very study he has to use to evaluate for approval.
As promised, the FDA has ginned up a report that ostensibly will be used to try to justify “approval” (whatever they mean by that now) of COVID-19 vaccines for infants and toddlers (children < 5 years old). Here’s the report for your reference.
This report comes after a torrent of massive reports from Moderna and Pfizer that claim to review studies of the safety and efficacy of COVID-19 vaccines in children. It is not hard to see what shenanigans the FDA has been up to to try to bolster a vaccine that fewer and fewer adults want. It’s more of the same: exaggerate the apparent risk of the virus and minimizing the perception of risk. In other words, lies.
There is no evidence of clinical urgency. Infants and toddlers (and children in general) do not get COVID-19; they do not (yet) die from COVID-19. All that can change when antibody dependent enhancement kicks in for the vaccinated. FDA’s own reports cites 1,086 deaths “from COVID-19” and 10,700,000 “cases” of COVID-19 in children aged 0-17. There have been 832 days since April 1, 2020 when diagnoses started for COVID-19. For the entire population of children in the US (73,000,000), the risk of COVID-19 infection since the onset of COVID is 10,700,000/73,000,000 = 0.14657. The risk of a child dying if they have a diagnosis is 1,086/10,700,00 or 1086/10700000 = 0.00010149532. The risk of any child dying of COVID-19 over this time period is 1,086/73000000 = 0.00001487671. The per-day risk is on the order of 1.78806611e-8 (0.000000001788). There is no real unmet clinical need and the FDA needs to go back to college to understand how to use RT-PCR correctly. Children do not get COVID-19, and they do not die.
Inconsistent use of the idea “vaccinated”. This has been the pattern from the very first study. FDA, CDC, Moderna, Pfizer, and others pull out whatever definition of “vaccinated” they want. Examples: “Vaccinated” is defined in the original trials as people who received both doses and who did not develop COVID-19 before two weeks passed after the second exposure to the vaccine. In fact, that means that people who developed COVID-19 due to disease enhancement were dropped from the study calculations. First, this is the first time people were dropped from a vaccine trial for getting infected with the pathogen targeted by the vaccine up to 13 or 14 days after being vaccinated. Second, it’s actually five entire weeks – one month and one week – 44 days – after the first exposure. ALL of the vaccine efficacy being cited by FDA is suspect. Moderna’s and Pfizer’s vaccines never achieved >90% true vaccine efficacy; the best estimate is more like 75%.
Inconsistent use of the idea “vaccine efficacy”. Over the time period since the first COVID-19 vaccine trials, various definitions of “vaccine efficacy” have been used. Decreased transmission. Reduction in infection rates. Reduced hospitalization. Presence of neutralizing antibodies. Presence of antibodies. All are used and cited in FDA’s report whenever convenient, all in an ad-hoc manner. It’s more than irritating. It’s moving the goal post and represents reckless (and ineffective) attempts to manipulate public perception. This practice continues in the reports and studies that are cited by FDA. I do not trust the efficacy data FDA cites in their report (why would we given Point 1?).Further evidence of the futility of the evidence used to claim efficacy comes from Moderna’s Sponsor Briefing report to the FDA:“3.3 Regulatory Considerations for Clinical Development of COVID-19 Vaccines in Children
Effectiveness
Regulatory precedent with other preventive vaccines provides a basis for inference of vaccine effectiveness in pediatric populations based on immunobridging to a young adult population in which clinical disease endpoint vaccine efficacy has been demonstrated for the same prototype vaccine. The immune marker(s) used for immunobridging do not need to be scientifically established to predict protection but should be clinically relevant to the disease. Based on available data in humans and animal models, FDA considers neutralizing antibody titers (a functional measure of the vaccine immune response against SARS-CoV-2) to be clinically relevant for immunobridging to infer effectiveness of COVID-19 vaccines in pediatric age groups. Because no specific neutralizing antibody titer has been established to predict protection against COVID-19, two immunogenicity endpoints (GMT and SRR) are considered appropriate for comparing the range of neutralizing antibody responses elicited by the vaccine in pediatric versus young adult populations.
Also embedded in this piece of work is the fact that FDA does not need evidence of long-term immunity; they are settling for something called “immunobridging” – guessing at the efficacy of a vaccine in one clinical population from measurements made from other clinical populaton.
They also are making people dependent on vaccines… expecting patients to have antibodies from one vaccine to the next. This makes no sense immunologically. We don’t need continuously high antibody levels against any pathogen. We have memory B-cells and T-cells. In accepting this paradigm, FDA is completely off its rocker and will cause immune exhaustion with constant vaccinations every 3-4 months.
Incomplete consideration of the scientific data (Barnstable County, Israel, Ontario). We know that months after vaccination, those who are vaccinated are at higher risk of infection and now of hospitalizations. Data actually show negative vaccine efficacy in children (per Jeremy Hammond). See: “Evidence for Negative COVID-19 Vaccine Effectiveness in Children”. From that article:“vaccine effectiveness (VE) in children becomes(sic) negative within several months since receipt of the second dose.Researchers from the New York State Department of Health published a study on the preprint server medRxiv on February 28 noting that the evidence for vaccine effectiveness in children, particularly those aged five to eleven, was “limited”. So, they aimed to provide data to inform policymaking.“During Omicraon variant predominance,” the authors concluded, “VE against infection declined rapidly” for young children in the state of New York, “with low protection by one month following full-vaccination.”Comparing COVID-19 cases during January between unvaccinated and vaccinated children, they estimated initial vaccine effectiveness for children aged twelve to seventeen to be 76 percent, but this dropped to below 50 percent after just five weeks since receipt of the second dose.Moreover, for young children (aged five to eleven), they observed a drop from 65 percent to just 12 percent after only one month.Thereafter, their estimate indicated significantly negative effectiveness for this age group, as shown in Figure 2 of their paper: by 35 to 41 days, VE reached negative 10 percent, and by 42 to 48 days, it reached negative 41 percent.
Jeremy goes on to report (correctly) that the authors of the article misinterpreted their own data. History will remember Jeremy as a reporter with great integrity.
Moderna and Pfizer reports fail to study long-term risks. Like I said, more of the same shenanigans. In this report, for example, Moderna offers data on myocarditis only up to Day 28 after the vaccine. Why Day 28? Why not “since the vaccine has been administered” to more accurately reflect the real-world clinical situation? They also state that myocarditis in a large concern in people infected with SARS-CoV-2 – but the comparison is to the uninfected, not the vaccinated, and we know that the spike protein is the cause (syncytia among heart muscles caused by the spike protein). The spike protein, of course, is the basis of their mRNA vaccines.
Incestuous COIs/Unjustified Influence by Regulators. Peter Marks is charged with setting the decisions at FDA whether to consider vaccines for specific populations. Why the hell is he involved in a study conducted to bolster the vaccines he is going to have to decide upon? See “Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16–29 years”. That “study” is also guilty of all of the same loose logic as above; it is noteworthy that the study assumes as “worst case scenario” of zero deaths from myocarditis following COVID-19 vaccination (Credit: Toby McDonald, who wrote this to me:“I’m reading the Moderna “Sponsor Briefing Document” and they built their benefit-risk assessment off of Funk et al. (2022). So I looked up Funk and it’s a recent paper by six staffers at the FDA including Peter Marks, Richard Forshee, and Hong Yang (who wrote the dreadful benefit-risk assessment for kids 5 to 11 back in October). Quite literally in their “worst-case scenario” they predict 0 deaths from myocarditis in the vaccine group. It’s a stunning work of fiction.”
I’m on an email thread with Steve Kirsch (he considers me part of his “debate team”. Last week, Steve challenged Peter Marks to a debate:“Hi Peter,You are right about the vaccine uptake problem. According to independent survey we just commissioned, only 33% of Americans opted to go further than the first 2 doses.You were quoted in that CNN article:“We do have a problem with vaccine uptake that is very serious in the United States and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research.Isn’t it time for you to end the misinformation problem by debating us in a public forum?My colleagues and I look forward to hearing from you.
The only way to end the misinformation is to debate the top misinformation spreaders. You will never win by trying to censor us.
To my knowledge, Marks has not replied. I replied to Steve and the entire email thread, including Marks, though:
“Steve,
History is going to remember one person on this email thread in a manner in which I would not ever care to be seen associating with.
I would therefore decline to participate in such a debate.
Sincerely,
James Lyons-Weiler, PhD
I could continue and debate dozens more points in the report dump by the FDA. I don’t have to. Marks himself provides evidence of being way off-target immunologically and lying about the “need” for COVID-19 vaccines for children.
Here’s an old video of Prevaricating Peter lying about the need for “high antibody titres” for immunity, and that children’s immune response is “not enough for some of these variants” (no data on that, just words):
The comments in that video have not aged well. Call your Senator and Congressional Reps and demand that Peter Marks resign. Email them this article. Marks and the FDA are NOT basing their considerations on independent fact, science and logic. He and his cronies are either incompetent or working for the industry. Either way, he and his cronies have to go.
The August 23, 2021 FDA approval of Pfizer’s Comirnaty vaccine was a cause for celebration. Marked as a turning point in the battle against COVID19, the announcement was highly publicized by the Biden Administration with the clear intention to extinguish “vaccine hesitancy” and boost uptake.
It was celebrated as a cause for national relief, and many Americans arrived at their local pharmacies under the impression, via government and pharmaceutical propaganda, that they were receiving an FDA-approved COVID vaccine. Yet that legally distinct product, as we know it, never existed. And now we know, via Pfizer, that it will never exist.
For the uninitiated:
Comirnaty is a legally distinct product from the emergency use authorization (EUA) shots, and It has never made its way to market. For months on end, no such vaccine has ever become available. Those who received the “Pfizer shot(s)” have been injected with the emergency use authorization (EUA) version of the shots. See my piece in The Dossier for more info:
The information operation succeeded. There was indeed an FDA approved vaccine, at least on paper, but you couldn’t get it.
When originally confronted with this ordeal, Pfizer labeled this issue an inventory question that had nothing to do with the legal distinction between an experimental EUA product and an FDA-approved vaccine. Up until just weeks ago, this was the statement up on the CDC website via Pfizer:
“Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.
At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”
In May, Pfizer updated its statement to mention a December 2021 licensed Comirnaty product, which was granted a license four months after the highly-publicized August FDA press release.
And just last week, Pfizer finally acknowledged that its original licensed product will never be distributed. In an unreported update on the CDC website, Pfizer told the agency:
“Pfizer received initial FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename. These NDCs will not be manufactured. Only NDCs for the subsequently BLA approved tris-sucrose formulation will be produced.”
The key distinction between the originally approved formulation and the tris-sucrose formulation is that — according to manufacturers — the latter can be held for a much longer period of time outside of an ultra cold freezer. These freezers cost over $10,000 a piece and each unit uses as much energy per day as an average American household. Improper storage can render the mRNA unstable.
Notably, the clinical trials for the Pfizer shot were conducted without the modified tris-sucrose ingredient. Given the partisan nature of Pfizer, the corporate media, government health bureaucracies, and your correspondent’s lack of expertise in this area, it is unclear whether this is significant.
Another notable thing to look out for in the coming days and weeks is the possibility that the subsequently FDA approved product finally becomes available in the United States. In recent days, the CDC removed the language of “not orderable at this time” above the description of both Comirnaty and Moderna’s Spikevax.
Additionally, as reported by Uncover DC, the Defense Department appears to be in the early stages of ordering what it has interpreted as a legally required minimum of Comirnaty in order to continue its mRNA mandate of American service members.
You may have heard the disturbing story of Maddie de Garay, who in July 2020, aged 12, participated in Pfizer’s Covid vaccine trial of adolescents aged 12-15. Within 24 hours of receiving the second dose in early January 2021, Maddie experienced “zapping pain up and down her spine with severe abdominal pain… her toes and fingers turned white and were ice cold”. She now can barely see, suffers from tinnitus, mobility issues, vomiting, blood in her urine, numbness in her body and has at least 10-20 seizures a day. Yet her injury was recorded in the vaccine trial data as “abdominal pain” and it was asserted without investigation to be not related to the vaccine.
Another case, similarly disturbing, has now emerged of an adverse reaction during a Pfizer trial that was not recorded in the trial data, raising concerns about the integrity of the trial data and the possibility of fraud.
Augusto Roux is a 35-year old lawyer from Buenos Aires, Argentina who volunteered for Pfizer’s Covid vaccine phase 3 trial. He did so to protect his mother, who has emphysema.
On the way home after his second dose on September 9th 2020, he began feeling unwell, developed a high fever and felt very ill. He fainted on September 11th and went to the hospital on September 12th. The hospital ran tests, including a CAT scan of his chest, which showed an abnormal collection of fluid around the outside of the heart, indicating pericarditis (a form of heart inflammation).
On September 14th he was discharged, with the doctor writing in his discharge note that he had suffered an adverse reaction to the vaccine. Augusto was also told by hospital staff that there had been a considerable number of people from the clinical trial coming to the hospital – one nurse estimated staff had seen around 300 people – so his experience was not new to them. Around 3,000 trial participants had been enrolled before Augusto, so, if the nurse’s estimate is accurate, this would be a hospitalisation rate of 10%.
Following his adverse reaction, Augusto asked to see his trial clinical records, but those running the trial refused. Being a lawyer, Augusto went to law to get access to his records, which took over a year. Once he saw them, he could well imagine why someone might not want them to be released.
In hospital, Augusto had tested negative for Covid, and the doctor at the hospital had written that his condition was due to the vaccine. However, when Augusto contacted the trial site on September 14th to notify the investigators he had been in hospital, they wrote down in his clinical trial record that he had been admitted for a “bilateral pneumonia” that had nothing to do with the “investigational product” – the vaccine – even though that was not what he told them or what the doctor who examined him had stated.
For obvious reasons, Augusto was keen to know whether he’d had the vaccine or not. However, the principal investigator for the trial, Fernando Polack (pictured below), had inaccurately claimed that he could only be unblinded if his life were in danger. Augusto appealed to ANMAT, the Argentinian equivalent of the FDA, and following a formal hearing on October 9th 2020 it forced the trial investigators to tell Augusto that he had, indeed, received the vaccine.
The clinical trial notes reveal that two days prior to this hearing, on October 7th, “at the request of the sponsor” (Pfizer), the adverse event code was updated from pneumonia to “COVID-19 disease”. This is despite Augusto testing negative at the time of his admission. (Conveniently for Pfizer, the COVID-19 ‘diagnosis’ would not be included in the trial vaccine efficacy calculations due to the negative test.)
Even more disturbing, on October 8th, Polack wrote in Augusto’s clinical trial records that he had had an attack of “severe anxiety” starting on September 23rd (not caused by the vaccine, naturally). Polack added that Augusto suspected a conspiracy between the two hospitals, described his anxiety as “constitutional”, and noted that it was ongoing, evidenced by his pursuing his appeal to ANMAT. On October 11th, Polack had this mental health diagnosis added to his actual medical records.
Dr. David Healy, who has interviewed Augusto and seen the medical records in question, comments that “there is nothing in any record that indicates that Dr. Polack or any other doctor attempted on September 23rd to establish whether Augusto had a mental disorder”. He adds:
Augusto points to the notes of October 8th and 11th as evidence that this idea was invented just around the time the ANMAT hearing was about to happen. He states that it is in breach of Argentinian law for Dr. Polack to have diagnosed someone with a medical condition that the person does not have – and to have entered it into his medical record.
Note that Polack is a paediatrician so lacks the qualification to make mental health diagnoses, especially without any formal assessment.
Polack is a key player in the Pfizer Covid vaccine trials. He was the lead author on the December 2020 NEJM paper on the safety and efficacy of the vaccine. Israeli academic Josh Guetzkow notes that he is also one of the directors of i-trials, the site management organisation “paid handsomely by Pfizer to run the trial in Argentina (the largest site of the trial by far)”. Guetzkow adds:
If he raised an alarm about the vaccine safety, his company would have lost a ton of money and would be an unlikely choice by any company to run any trials in the future. So to say that he had an interest in achieving a positive trial outcome would be quite an understatement. There may be other conflicts we’re not aware of.
The evidence of malpractice and possible fraud in the Pfizer Covid vaccine trials is certainly stacking up now. But very few people are aware of it as it is mostly only being reported in alternative media. When will mainstream outlets start following up properly on this potentially massive story?
By Joe Giambrone | Dissident Voice | November 22, 2019
Did you know that Donald Trump had the State Department, USAID, NED, and the CIA fund and train Neo-Nazi, fascist militias to overthrow the government of Ukraine? These riot mobs, primarily Svoboda and Right Sector, stormed the capital, firebombed and shot the police, and destroyed democracy inside Ukraine. When the legitimately elected president was forced out by the rioters, the population which had supported him in the east seceded from the country, tearing the entire nation into pieces and sparking a civil war. The Ukraine civil war has cost the lives of over 13,000 Ukrainians. There is so much blood on Donald Trump’s hands.
Oh, wait a minute! That was Barack Obama. Change that paragraph, please.
Since 2014, it’s been glaringly obvious to astute (and honest) observers that the Administration of Barack Obama and Joe Biden supported the most vicious street mobs in Europe, people who considered themselves proud fascists. Western media routinely censored this part of the story.… continue
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The word “alleged” is deemed to occur before the word “fraud.” Since the rule of law still applies. To peasants, at least.
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While prosecutors were tight-lipped about the exact nature of the probe, the announcement follows 
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