Dr. Robert Malone
All posts tagged Dr. Robert Malone
Dr. Robert Malone writes that ‘In my past professional life – probably a decade ago, I had a client named Dr. Charlton Brown. Dr. Brown, at the time, was CEO and co-innovator at Immune Targeting Systems Ltd (UK). I always enjoyed working with Charlton, as we share a certain curiosity for science/knowledge and a dry wit. It turns out, that Charlton has been part of the medical freedom resistance and has been working to get the word out about the risks of mRNA vaccines. Up until his email to me earlier this week, I had no idea.
This isn’t the first time that people from my “former” professional life have emailed me to let me know that they are supportive of what I have been doing. In fact, I had a former colleague from my time at the Salk Institute in the 1980s write to me to express their support for me this week. These emails always lift my spirits as sometimes this seems like a very lonely fight, although the people writing in the comments section of this Substack also let me know that Jill and I are not alone – and this community often saves me from my own dark musings about the state of the world.
I have no idea how many scientists and physicians are quietly, sometimes secretly questioning the public health policies in this country and globally. But I do know that dissidents of the new normal are slowly finding their voice and are speaking out.
Anyway, Dr. Brown emailed me ask if I could share this document with people who might find it useful. As a trained scientist, Dr. Brown has conducted a deep analysis of the mRNA vaccines and origins of the virus and has created an “evidentiary document” (analysis) that is incredibly powerful.
Published below is Dr. Brown’s open letter sent to the prime minister and all ministers in New Zealand. Be sure to click on the link to read and save his full analysis for future reference.
From: Dr. Charlton Brown
Dear: Rt Hon Jacinda Ardern, Prime Minister, Hon Andrew Little, Minister of Health, Hon Dr. Ayesha Verrall, Minister of COVID-19 Response, and Hon Peeni Henare and Hon Aupito William Sio, Associate Ministers of Health
In this Open Letter and evidentiary document, I share my research results on overseas government and Ministry of Health (MoH) COVID-19 vaccine surveillance and pharmacovigilance data indicating irreparable vaccine-induced harm. Furthermore, I share important evidence that SARS-CoV-2 originated from gain-of-function research, remind you that no evidence exists for an animal-to-human origin, and highlight that its potential source lay beyond Wuhan, China. A series of requests for investigations are made below linked to this evidence, including the statistical biases evident in the Ministry of Health and other healthcare agencies’ calculable unvaccinated COVID-19 case rates. These biases essentially eliminated the negative vaccine effectiveness harm signal from ready public view. This evidentiary document is provided by a former European corporate venture capital-funded CEO/vaccine innovator (“Vaccines for Mutating Viruses”), veterinarian with 36 years of vaccine use experience, and a private researcher. It is supported by 525 unique data, scientific, and other citations.
According to New Zealand, England, Scotland, and Canada healthcare agencies and Global surveillance data (77 nations), these vaccines failed to prevent SARS-CoV-2 infection as initially touted. Significant negative vaccine effectiveness and vaccine failure were evident with the emergence of antigenically distinct strains (i.e., Delta, Omicron). The vaccine industry experienced antibody-dependent enhancement of virus infection (ADE) and vaccine-associated enhanced disease (VAED) with three other different coronaviruses and their spike protein vaccine prototypes in the last 30 years, giving my study results a predictable context. Furthermore, one year of US lot-numbered COVID-19 vaccine-associated deaths and hospitalizations equaled 32x (Comirnaty 15.4x) and 20x (Comirnaty 10.5x) of all US vaccine-associated deaths and hospitalizations, respectively. These adverse outcomes were highly skewed and peaked across vaccine lots and were associated with a minority of lots sent to a larger number of US States. This data highlights that there was an urgent need for investigation by the US and other regulatory and healthcare agencies before expanded population use.
A vast chasm exists between the vaccine safety and efficacy experienced in 2021-2022 and the falsifiable 95% vaccine efficacy and safety proclaimed by governments with Comirnaty’s first Emergency Use Authorization in 2020 (USA). This document reviews critical pharmacotoxicology and clinical safety package deficiencies evident in overseas regulatory reviews. This helps explain why Pfizer then struggled to cope with the sheer volume of Comirnaty adverse event reports in the first 90 days post-launch. This was uncharacteristic of a safe vaccine. Numerous vaccine-associated enhanced disease mechanisms are evident by which vaccine spike proteins can cause disease or exacerbate comorbidities common to severe COVID-19 outcomes. These mechanisms place upregulated furin and angiotensin-converting enzyme-2 receptors (ACE2) and prevalent co-morbidities in tissues and organs common to all three center-stage. At the same time, SARS-CoV-2’s spike protein provides its uniquely encoded furin cleavage site for the furin to cleave its S1 and S2 sub-units and activate its ACE2-receptor-mediated infectivity and pathogenicity.
Of grave concern for global public health is a gain-of-function origin to SARS-CoV-2 is indicated by its spike protein incorporating human infectivity and pathogenicity enhancing features unprecedented in nature while synthetic biology left its fingerprints. Furthermore, there is no evidence supporting a Wuhan Huanan market zoonosis because no virus progenitor or animal host was ever identified. There are two reasons for detailing a coronavirus gain-of-function origin to SARS-CoV-2. Firstly, the negative vaccine effectiveness evident in governments’ COVID-19 surveillance data could have been enhanced by a genetically modified SARS-CoV-2. Secondly, the world will be left vulnerable to future pandemics if there was no accidental release from the Wuhan Institute of Virology. At least two other potential SARS-CoV-2 origins exist beyond Wuhan, with one of these potentially involving a WHO, Five Eyes, and NATO-spearhead member nation connected with Ukraine.
The US Department of Defense (DoD) and National Institutes of Health (NIH) funding of EcoHealth Alliance (EHA, $69 million) and its connections one-degree-removed were scrutinized because EHA’s leader led a failed attempt to cover up SARS-CoV-2’s gain-of-function origin. EHA directed research that genetically modified bat SARSr-CoVs that could not infect humans so that they could. EHA’s $14.2 million funding application to the DoD in 2018 showed its intent to insert a codon-optimized furin cleavage site (FCS) into bat SARSr-CoVs. A uniquely encoded Arginine-doublet containing FCS now sits between SARS-CoV-2’s spike protein S1 and S2 sub-units, which has no precedent in known viruses and may have infringed patents. Besides EHA’s long-standing collaborations with two coronavirus gain-of-function research epicenters in the USA and China, it had another with Metabiota. Metabiota’s Series-A lead investor was a Hunter Biden part-owned investment firm. The DoD-funded Metabiota operated in Pentagon Biolabs in Ukraine and US-funded Biolabs in Cameroon and researched corona-, monkeypox-, influenza-, and Ebola viruses. Metabiota has implemented major DoD and Homeland Security contracts across Central Africa while its surveillance role in Sierra Leone’s Ebola outbreak in 2014 created significant controversies.
You are requested to investigate:
- (1) this New Zealand and overseas evidence for negative vaccine effectiveness, vaccine failure, and toxic vaccine lots,
- (2) the statistical biases evident in the MoH and other healthcare agencies’ calculable unvaccinated COVID-19 case rates, which essentially eliminated the negative vaccine effectiveness signal,
- (3) the role of COVID-19 vaccination in exacerbating comorbidities most frequently associated with serious-severe COVID-19 outcomes,
- (4) SARS-CoV-2’s gain-of-function origin while internationally championing a punitive global ban on gain-of-function R&D, and
- (5) the conduct of the WHO during COVID-19 linked to seven critical points detailed in section 2.7.
Would you please ensure New Zealanders are updated on their recently acquired life-long health risks and that informed consent guidelines associated with COVID-19 vaccination be urgently amended?
Would government please prioritize clinical research into COVID-19 antibody-dependent enhancement of virus infection, vaccine-associated enhanced disease, and antigenic imprinting in the New Zealand population?
Thank you.
Yours sincerely
Dr. Carlton Brown – BVSc (1986, Massey University), MBA (1997, London Business School). Former CEO and co-innovator at Immune Targeting Systems Ltd (UK), “Vaccines for Mutating Viruses.”
- Dr. Brown’s Linked-in Profile
- Dr. Brown’s Orcid Profile
- Download the evidentiary document
- Download “Toxic COVID-19 Vaccine Lots (VAERS)”
- Download “Negative vaccine effectiveness and vaccine failure associated with COVID-19 vaccination”’ https://rwmalonemd.substack.com/p/irreparable-vaccine-induced-harm?publication_id=583200&post_id=88962247&isFreemail=true
‘As we begin to emerge from the tunnel of the COVID crisis and all of the biowarfare, information warfare, WHO, WEF and US Department of Homeland Security mismanagement which has caused so much damage, we are being presented with a “Great Reset” vision of a fourth industrial revolution, transhumanism, and a new class structure of Physicals, Virtuals, Machines and “Davos Man” Overlords which is being globally pitched by the World Economic Forum and its acolytes as the inevitable outcome.
Pointing out the naivety and flaws in the reasoning of Klaus Schwab and his wingman Yuval Noah Harari is a favorite trope of those writing from an alternative perspective. This recent essay, titled “The Dangerous Populist Science of Yuval Noah Harari” (06 July 2022, Current Affairs) provides an example of the ease with which Harari’s popularized dark visions can be dissected and revealed as sensationalist tripe. As author Darshana Narayanan summarizes, “The best-selling author is a gifted storyteller and popular speaker. But he sacrifices science for sensationalism, and his work is riddled with errors”. Based on my reading, the same critiques apply to the books “COVID-19: The Great Reset” and “The Great Narrative” by Klaus Schwab and Thierry Malleret. But the power of the WEF and its global army of trained agents to direct public policy at both national and transnational levels forces us all to take their poorly reasoned arguments and dark musings seriously.
It is one thing to criticize someone else’s vision of the future, but quite another to develop a compelling alternative. I have been traveling the world, trying to advance the cause of medical freedom and help others make sense out of what we have all experienced over the last three years. During these travels, I have found that many leaders from the various independently developed resistance groups often speak of similar things; a rejection of centralized authority, a need to build organizational structures which will not merely recapitulate the same leadership failures of present social, political, and corporate structures, and a vague sense of a more decentralized world. This is often posited as the alternative to the globally centralized, utilitarian/marxist/command economy, Malthusian corporatist/fascist vision promoted by the WEF, and increasingly by the United Nations, World Trade Organization, Bank of International Settlements/Central banks and the World Health Organization.
Is the dark vision of the fourth industrial revolution, transhumanism, fusion of man and machine, and total centralized control by a small group of unelected elite Overlords inevitable, as Klaus Schwab and Yuval Noah Harari would have us believe?
I recently learned of Christopher Michael Langan, who has been quietly developing one alternative vision which incorporates many aspects of what I have heard many global leaders within the medical freedom movement beginning to explore. Mr. Langen refers to this vision and model of an alternative future as “The Cognitive-Theoretic Model of the Universe” (CTMU). When I first read about these ideas, they struck me as truly transformational in the same way that my first introduction to Mattias Desmet’s “Mass formation” theories have been. It is useful to remember that this theory of Mr. Langan was developed well before the COVIDcrisis, even though much of what he envisions and describes is prescient in retrospect.
By all accounts, Mr. Langen may be one of the most intelligent currently living individuals on the planet, and like many with an IQ measured greater than 150, it can be a challenge for the vast majority of us to follow some of his more advanced logic and writing. In his commitment to living a “double-life strategy”, on one side a regular guy, doing his job and exchanging pleasantries, and on the other side coming home to perform equations in his head and working in isolation on his Cognitive-Theoretic Model of the Universe, I find many similarities with the way I have chosen to live my own life. Plus, he lives with his wife Gina (née LoSasso), a clinical neuropsychologist, in northern Missouri where they own and operate a horse ranch. I don’t know about you, but this sounds like someone I would like to meet and spend some time with.

Christopher Langen, weightlifter, construction worker, cowboy, forest service firefighter, farmhand, for over twenty years, a bouncer on Long Island, New York, and a super genius.
Here is a lightly edited transcript of the video clip attached above:
We’re approaching a juncture, and this is really a bifurcation into possible futures. One of those futures will take us toward a centralized form of government. It’s more or less like a hive. A certain cohort of elites are going to be in charge and everybody else is going to be… They’ll be the overclass and everybody else will be a kind of underclass, which serves them and does pretty much what they’re told.
On the other hand, we can go in another direction, which is to distribute responsibility and decision making power over everybody. And of course, that takes enhanced intelligence and responsibility. So there’s a certain challenge associated with this. We have to make up our minds very quickly how we’re going to do this. If we want to distribute responsibility, then the first thing that we need is a sound understanding of human nature and the nature of reality, and this is what I propose to bring to bear on the problem.
Mr. Langen refers to the two alternative futures which he has focused on as involving singularities, alternative nodes through which humanity will pass. His language for describing these two consists of “Metareligion as the human singularity” and the “Technology singularity”. The technology singularity which he envisions is very aligned with the fourth industrial revolution/transhumanism dystopian corporatist/fascist government described by Schwab, Malleret, and Harari.

What I find particularly relevant to the current challenge of visualizing an alternative to the mutterings of the WEF and its acolytes is Christopher’s vision of a separate reality from the one that they wish to use in “shaping” a future.
Mr. Langen’s 2002 publication “The Cognitive-Theoretic Model of the Universe: A New Kind of Reality Theory” provides an example of the densely reasoned complex explanations which he often provides, in which he discusses concepts which rely on language and terms which he has had to personally develop because the English language is not sufficient to allow him to adequately express his ideas and insights. Fortunately for neophytes such as myself, his 2018 essay “Metareligion as the Human Singularity” (published in the journal “Cosmos and History: The Journal of Natural and Social Philosophy”, vol. 14, no. 1) is much more accessible.
If, like me, you find the vision, thought and insights which I have tried to capture with the quotes below to be useful in imagining a better, decentralized future which offers a more desirable vision of the future, I recommend reading the entire work and then venturing a journey into the many podcast interviews and writings of this home grown American genius and philosopher.
To understand his own identity, man requires a coherent and therefore monic self-model reflecting its psychological coherence and relating it to all levels of reality. That is, man requires a valid interpretation of the human individual in society, and of the individual and society in reality at large. This interpretation must take the form of an unbroken correspondence spanning the extended relationship between man, as an inhabitant of reality, and reality in its most basic and universal form; man must see himself as an integral part of reality, and reality as an extension of his own being within a single unified ontology or metaphysics. In short, man and reality must share a common metaphysical identity.
Where metaphysics is a language expressing the relationship between mental and physical reality, spirituality can be understood as the metaphysical essence of human identity, and religion as its organizational manifestation. In its various benign forms, religion provides man with self-understanding and a sense of community … a model of the individual and his or her relationship to other people, society, and reality at large. Religion tells people who they are, and mankind what it is, by establishing their relationship to the global environment on the spiritual level; it is a binary relationship of man to his real environment, and where the global environment of each human being includes all others, the relationship of mankind to itself.
The spiritual model of self, the extended man-reality relationship required by religion, is thus a stratification of human identity from the individual to ultimate reality, the level of reality that cannot be explained in terms of anything prior to itself or any sort of exterior embedment. This follows from the fact that man is embedded in reality and thus shares all of its most general and ubiquitous properties, up to human limitations of structure and dynamics. Parallel to this degree of extension is the outward extension of self that is sought in certain Asian religious traditions; the self becomes ever more expansive as its hidden depths are plumbed.
But here we must note that the phrase “ultimate reality” is necessarily a partial description of God, incorporated in the (otherwise variously defined) identity of all viable monotheistic religions. Any God not incorporating ultimate reality could exist only in a properly inclusive reality partially beyond His influence and creative power, and would thus come up short in virtually every major strain of monotheism. On the other hand, this description holds regardless of any more specific properties incorporated in various definitions of God.
DUALISM: REALITY TORN IN TWO
In mainstream social and economic theory, a human being is understood as a mechanistic automaton driven by individual self-interest and governed by impersonal laws of nature and rules of behaviorism. Human automata are subject to conditioning on the basis of individual self-interest, which is a function of the individual’s pleasure and happiness, freedom from want, pain, and sadness, and standards of biological fitness including survival and reproduction, all of which inhabit a standardized economy with a monetary metric. Man is thus simplistically viewed as an economic agent subject to monetary control, through centralization of which the entire future of mankind can in principle be mechanistically determined by the calculated pushing of buttons. Obviously, this dualistic view of man represents a complete negation of human dignity and sovereignty, reducing the human race to cattle. It is also incompatible with any kind of religion other than that referred to by Marx as an “opiate of the masses”.
Sound familiar? This is the vision which unites the writings of Schwab, Malleret, and Harari, and by extension the World Economic Forum. This “man as economic agent” is essentially the fundamental unifying model currently shared by the WEF and its globalist affiliate organizations.
Langen then launches into some definitions before describing his alternative.
For present purposes, a “singularity” is a point at which a system must undergo a directional break, jump through a limit, or be redefined in order to survive regardless of how it may evolve before or after. Accordingly, it can be understood as a kind of systemic destiny, an inevitable convergence of possible paths or trajectories of systemic evolution. Paths converge on points, and where such a point marks a sharp change in the smooth overall trajectory of a system, it comprises a kind of systemic “metapoint” which can be seen as marking a systemic mutation or change of inertia. This provides a tentative mathematical conceptualization of “singularity” for social systems.
The related forms of dualism thus far discussed — Cartesian dualism, naturalism, NOMA [the “non-overlapping magisteria” of science and religion], and so on — are opposed to the human need for a coherent spiritual identity. This implies a bifurcation or divergence, a human evolutionary choice between two possible adaptations or destinies respectively corresponding to the anthropic and technological aspects of an impending “singular” transformation. Each possible destiny corresponds to the dominance of one aspect over the other, and may be associated with its own conventional type of singularity.
On one side is the Human Singularity, a mass realization of the expansive spiritual identity of the human species. Basically, this is the mass spiritual awakening that we have been led to expect by, e.g., certain currents in “New Age” thought. The prototype for this kind of singularity is the Omega Point of Pierre Teilhard de Chardin, representing an evolutionary terminus and divine spiritual unification event through which mankind, and reality itself, will achieve “Christ-Consciousness” and be forever transformed.
On the other side is the Tech Singularity, seminally formulated by the celebrated mathematician John von Neumann as the approaching juncture at which “technological progress will become incomprehensively rapid and complicated”, prior to which “the ever-accelerating progress of technology … gives the appearance of approaching some essential singularity [italicized for emphasis] in the history of the race beyond which human affairs, as we know them, could not continue” (Ulam, 1958). In short, von Neumann foresaw an uncontrollable technological quickening, a sudden acceleration of complexity followed by the transformation (or extinction) of humanity.
Most discussions of the Tech Singularity have been naive to the point of disingenuity, boiling down to starry-eyed encomiums to the power of human intelligence to inventively couple with reality on the physical level of being using technological marvels both real and imagined, including implants, prosthetics, genetic engineering, virtual realities, and above all, a merging of human intelligence with AI. The problem with such discussions is that they seem to inhabit a socioeconomic and political vacuum, whereas in fact, the singularity concept is fraught with worrisome complications involving economic and sociopolitical factors apart from which it cannot be properly evaluated.
The Human and Tech Singularities relate to each other by a kind of duality; the former is extended and spacelike, representing the even distribution of spiritual and intellectual resources over the whole of mankind, while the latter is a compact, pointlike concentration of all resources in the hands of just those who can afford full access to the best and most advanced technology. Being opposed to each other with respect to the distribution of the resources of social evolution, they are also opposed with respect to the structure of society; symmetric distribution of the capacity for effective governance corresponds to a social order based on individual freedom and responsibility, while extreme concentration of the means of governance leads to a centralized, hive-like system at the center of which resides an oligarchic concentration of wealth and power, with increasing scarcity elsewhere due to the addictive, self-reinforcing nature of privilege. (Note that this differs from the usual understanding of individualism, which is ordinarily associated with capitalism and juxtaposed with collectivism; in fact, both capitalism and collectivism, as they are monopolistically practiced on the national and global scales, lead to oligarchy and a loss of individuality for the vast majority of people. A Human Singularity is something else entirely, empowering individuals rather than facilitating their disempowerment.)
The existence of two possible singularities presupposes a point of bifurcation or divergence beyond which the evolutionary momentum of mankind must carry it. Presently, all of the momentum belongs to the Tech Singularity; it is preferred by the financial, corporate, and governmental interests which drive the general economy. This momentum is reinforced by the seeming unavailability of alternatives, i.e., the nonexistence of any other track onto which society might be steered in order to escape an oligarchical AI lockdown. It is one thing for humankind to awaken en masse to its impending enslavement through a seemingly inevitable Tech Singularity; it is quite another to have a superior alternative clearly in view.
In order to reach any alternate destination whatsoever, humanity must understand what has been driving it toward the Tech Singularity. At this point, the reason is clear: the virtually automatic concentration of wealth and power, which has been observed to occur under both capitalism and socialism, fractionates humanity into an overclass and an underclass between which all else is crushed out of existence as though by the jaws of a vise. That is, the top and bottom levels of society become the jaws of a vise which, due to the screwing down of the upper jaw against the anvil-like lower jaw, crushes the middle class and all meaningful competition out of existence, thus normalizing the hive through the economic, physical, and psychological standardization of its drones and workers.
For reasons that should by now be evident, let us call this process a “parasitic divergence” — i.e., an organized divergence of humanity into a parasitic overclass and a relatively impoverished underclass serving as its mind-controlled host, mirroring the gruesome effects of certain obligate parasites on the organisms they attack — and acknowledge that it is driven by the self-reinforcing and therefore accelerating acquisition of wealth, power, and technological control by the rich. Left to run away with itself, this process ultimately leads to a “singular” concentration of wealth and power … a kind of sociopolitical-economic “black hole” that never stops gravitating. As the top jaw of the vise grows smaller, denser, and stronger, the bottom jaw grows larger and weaker; and as human utility becomes increasingly concentrated, every significant increase in the wealth of the overclass translates into a greater amount of misery for the underclass, arbitrarily diminishing the net utility of mankind.
Parasitic divergences have occurred many times in history, but the present one is different. Due to the double whammy of globalization and powerful surveillance and coercion technology, the one now in progress is geographically ubiquitous and quite possibly irreversible. If humanity is to save itself from the insectile, hive-like future associated with a Tech Singularity, the Human Singularity must prevail, empowering mankind to exert sufficient control over the production, distribution, and application of technology to prevent its unlimited oligarchical abuse. To bring this about, it is not enough to merely distribute a cognitive avoidance mechanism out of which the moneyed elite can buy and bribe their way as usual, given the absence of a well-defined alternative direction in which humanity can proceed; rather, an alternative direction must be defined and universally distributed in cognitive and attitudinal form. In short, in order to have a meaningful mass awakening, the content of the awakening must be defined and distributed to the members of humanity, thus immunizing them against parasitic mind control. Because this content must be spiritual, the involvement of religion is unavoidable.
I think that these words and vision speak for themselves. I once again remind that they were first published in 2018. As far as I am concerned, this essay gets the closest to the emergent sense of an alternative future consistent with what many in the medical freedom movement have been groping towards of any that I have ever read.’https://rwmalonemd.substack.com/p/two-possible-futures-for-humanity#play
‘Esteemed Virologist Dr. Theo Schetters wrote me this evening, with a troublesome message.
After we had had the interview at De Nieuwe Wereld in Leiden (Netherlands), censorship became harsh.
De Nieuwe Wereld was not allowed to upload new items to YouTube for a week.
The new media Blckbx.tv channel was blocked from streaming their programs using YouTube for two weeks after I appeared in one of their programs where I presented the same results.
In that particular show, I asked for suspension of the upcoming autumn vaccination campaign. They didn’t.
So, I have written this short update to present this to a broader audience.
I would appreciate if you could post it and spread the message on your substack.
For additional context and detail, please see the prior substack post on this topic which can be found here.
UPDATE CORRELATION VACCINATION AND MORTALITY IN THE NETHERLANDS OCTOBER 30TH 2022

In the Netherlands, the autumn vaccination campaign started in week 37 of 2022 (triangles). As scheduled, the elderly (>80 years old) and subjects that belong to the high-risk population, were the first to receive the vaccinations (mRNA corona vaccines). Immediately after the onset of the campaign, there was a rise in mortality (red line). This temporal relationship between vaccination and increase in mortality appeared similar to that found earlier during the spring vaccination campaign that was started in week 9 earlier this year (blue line). Although the data lack sufficient detail to firmly establish causality, these results call for immediate suspension of the vaccinations. Detailed investigation into the cause of increased mortality is paramount.
A presentation that explains which data were used, where they can be found and how they were analyzed can be found here.’https://rwmalonemd.substack.com/p/update-coronavax-safety-in-the-netherlands?publication_id=583200&post_id=81614697&isFreemail=true
‘Whatever you may currently think about the SARS-CoV-2 vaccines, it is a fact that more than 5.41 billion people worldwide have received a dose of some type of COVID-19 vaccine, equal to about 70.5 percent of the world population. In the United States as of October 17, 2022, 494.74 million “initial protocol doses” of SARS-CoV-2 vaccine have been administered, together with 138.16 million “booster” doses. 265.59 million US residents have received at least one dose, and 226.59 million have completed the initial vaccination protocol (see this link), out of a total population of 335.49 million (67.5%). In terms of the logistics of development, manufacturing and deployment of a novel injectable biologic product, this is undeniably a major achievement. Of the SARS-CoV-2 mRNA vaccine doses administered in the United States as of October 19, 2022, 375.64 million were manufactured by Pfizer/Bio-N-Tech, and 237.61 doses by Moderna, for a total of 613.25 million mRNA vaccine doses administered. In the European Union, the corresponding numbers are 641.89M doses of Pfizer/Bio-N-Tech and 153.16M doses of Moderna for an EU total of 795.05M mRNA vaccine doses, and a grand total of 1 Billion, 408.3 million doses of mRNA vaccines in these two regions. All this involves a novel technology, product and large scale manufacturing process which was created, passed non-clinical and clinical development and was massively manufactured, distributed and globally deployed in less than three years.
At a meeting of the Special Committee of the European Union Parliament held on 11 October 2022 to discuss the findings regarding COVID-19 pandemic and recommendations for the future, a Pfizer executive confirmed that the vaccine had never been tested for its ability to prevent the transmission of SARS-CoV-2 virus before being put on the market. Data emerging since the introduction of the vaccine indicates that it is in fact unable to do so, thereby refuting the claim that the COVID-19 Passports provide any guarantee of protection. In other words, although governments throughout the world employed a wide range of propaganda and censorship methods to promote these products as both safe and effective at stopping the spread of SARS-CoV-2 infection, there were no studies performed prior to this distribution which even tested how well the products would prevent the spread of COVID-19 disease. It is not an exaggeration to state that this massive deployment has been the largest clinical experiment performed on human beings in the history of the world.
All of the mRNA vaccine doses administered in the United States (to both citizens and military personnel) have been provided under “Emergency Use Authorization” (EUA), which is to say that although the FDA has licensed the Pfizer/Bio-N-Tech and Moderna vaccines for some age cohorts, the firms have elected to not manufacture, distribute, or market these licensed products in the United States. The reason for this is not clear, but appears to relate to both liability issues as well as conditions placed by the FDA involving additional clinical studies, safety monitoring (pharmacovigilance) and product disclosures once the products begin to be marketed.
From the standpoint of the vaccine manufacturers, EUA is a preferred pathway for marketing their products. A single purchaser (the US Government) provides complete liability indemnification, a guaranteed market with very little oversight, and manages both the distribution and marketing. In the case of all unlicensed products, the manufacturers are prohibited from marketing them, but under EUA the US Government has been doing this for them, and has been acting in coordination with corporate media, social media, and large technology firms to suppress any discussion of risks or limitations of the products. From the standpoint of the vaccine manufacturers, this is all profit and no risk; a perfect business model. Why would they ever want to consider taking up the burden of actually producing and marketing the licensed version of these products?
EUA is a process defined by US federal law (21 U.S. Code § 360bbb–3 – Authorization for medical products for use in emergencies) which in the case of these mRNA-based products involves biological products which are not approved, licensed, or cleared for commercial distribution. Specifically, the statute authorizes “the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency.” Continued “Emergency Use Authorization” of these vaccines requires “a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents”. Once the domestic emergency has passed (ergo “a determination by the Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances described in paragraph (1) have ceased to exist”), “A declaration under this subsection shall terminate”. In other words, when there is no longer an emergency, the “Emergency Use Authorization” for the product will cease, and the vaccine products will return to their status as not approved, licensed, or cleared for commercial distribution. These products remain experimental, and are only to be used for a limited amount of time during an ongoing emergency.
Regarding the consequences for the incorporation of pseudouridine in mRNA as a drug for therapeutic or vaccine purposes, Borchardt et al conclude that:
“Pseudouridine likely affects multiple facets of mRNA function, including reduced immune stimulation by several mechanisms, prolonged half-life of pseudouridine-containing RNA, as well as potentially deleterious effects of Ψ on translation fidelity and efficiency.”
Based on the currently available information, it appears to me that the extensive random incorporation of pseudouridine into the synthetic mRNA-like molecules used for the Pfizer/BioNTech and Moderna SARS-CoV-2 vaccines may well account for much or all of the observed immunosuppression, DNA virus reactivation, and remarkable persistence of the synthetic “mRNA” molecules observed in lymph node biopsy tissues (Roltgen et al. 2022). Many of these adverse effects were reported by Kariko, Weissman et al in their 2008 paper “Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability” (Kariko et al. 2008) and could have been anticipated by regulatory and toxicology professionals if they had bothered to consider these findings prior to allowing emergency use authorization and widespread (global) deployment of what is truly an immature and previously untested technology. Therefore, neither the FDA, NIH, CDC, nor BioNTech (which employs Dr. Kariko as a Vice President) nor Moderna can claim true ignorance. To my eyes, what we have seen is more appropriately classified as “willful ignorance”.
Based on my review of the scientific data, it is my opinion that the random and uncontrolled insertion of pseudouridine into the manufactured “mRNA”-like molecules creates a population of polymers which may resemble natural mRNA, but which have a variety of properties which are clinically relevant. These characteristics and activities may account for many of the unusual effects, unusual stability, and striking adverse events associated with this new class of vaccines. These molecules are not natural mRNA, and they do not behave like natural mRNA.
The question that most troubles and perplexes me at this point is why the biological consequences of these modifications and associated clinical adverse effects were not thoroughly investigated before widespread administration of random pseudouridine-incorporating “mRNA”-like molecules to a global population.
Biology, and particularly molecular biology, is highly complex and interrelated. Change one thing over here, and it is really hard to predict what might happen over there. That is why one must do rigorously controlled non-clinical and clinical research. Once again, it appears to me that the hubris of “elite” high status scientists, physicians and governmental “public health” bureaucrats has overcome common sense, well established regulatory norms have been disregarded, and patients have unnecessarily suffered as a consequence. These products do not use natural mRNA, and referring to them as mRNA vaccines is misleading. I recommend that, in the future, these products which employ a synthetic unnatural polymer which is not natural mRNA, should be designated using a different term, such as Ψ-mRNA genetic medicines.’https://rwmalonemd.substack.com/p/mrna-vaccines-and-eua?publication_id=583200&post_id=80795186&isFreemail=true