A Complete Overhaul of the U.S. Financial System? No Longer a “Conspiracy Theory”

This story is about money and an alarming paper by Biden’s nominee Saule Omarova. For quite a while, we’ve been all discussing different aspects of the Great Reset and the treacherous plan to use the “happy” language of “public good” and “sustainable development” to push through an all-encompassing power grab by the largest institutional investors and the richest people of the world.

The end result of the power grab would be a fully mechanized society where the citizens’ bodies and minds are invaded by tech, managed by AI, and ultimately serve the financial and emotional interests of the self-appointed mad priests of the new normal. (And yes, they are mad.)

To our chagrin, the great resetters want to control our existence completely. They want to control our diets, our thoughts, and our sexuality. They want to control our feelings and relationships. And sure as hell, they want to control our money. The financial component of the Great Reset is at the foundation of how they hope to get from here to their mechanical dystopia.

The Financial Aspect of The Great Reset

This topic of finance in the light of this attempted reform has been explored by a number of great researchers and investigative journalists who have spoken and written about it very eloquently over the years. For example, here is a great conversation between Whitney Webb and John Titus called, “COVID-19 and Central Bank Digital Slavery.” Both of them have done pioneering research on the topic.

A core expert on the financial aspects of the Great Reset is Catherine Austin Fitts who was recently interviewed by Mercola on this very topic. In the interview, Catherine Austin Fitts pointed out that the aggressively promoted vaccine passports are connected to the attempted financial restructuring:

“If they get the passports, then I would argue, as a practical matter, we lose our ability to stop the Central Bank Digital Currencies. So, whatever we do, we need to stop the passports. The passports give them the kind of control they need of the digital and financial transactions that then leads into the CBDCs.” I also recently wrote about the Digital Financial Complex and Ernst Wolf:

“Wolff points out that currently, entities like BlackRock, Vanguard, and State Street Corporation hold more financial power than many governments — and hence, they have the ability to dictate their will to governments convincingly.

According to him, the destruction of the traditional Western social fabric and small businesses is intentional, and the purpose of the destruction is to create enough momentum in the form of desperation and impoverishment that when the central banks roll out the new financial system, the citizens will see it as a solution to horrible problems — as opposed to a new system that somebody wanted to roll out to begin with.”

“Per Wolff, the desired end result of the financial reform looks like this: Cash is out. Banks are we know them are out. All money is digital and transparent. Central banks generate digital money at will, as much as they want. Every citizen has one and only bank account, which is an account with a central bank.

Money is programmable, and our spending is not free-form, i.e. certain chunks of our money can be assigned for specific purposes, or we can only spend it in certain places, or we may be allowed to only buy certain types of food, etc. etc. Taxation’s easy. Censorship is easy. Fining people for bad behavior is easy.”

Very interesting analysis titled, “The Great Reset is a Social Carbon Credit Economy!” was published by Joseph Gonzalez, a game developer and a combat veteran with a lot of knowledge about blockchain and its role in the 4IR model.

“In this system, what you buy, consume, perform, etc., will be decided by your carbon footprint. You’ll be given a maximum allowance of carbon credits on your carbon credit crypto wallet. Each time you perform any action that has a carbon trace, carbon credits will be deducted from your carbon crypto account on the blockchain. What you can buy and do is decided by crypto/blockchain smart contracts, also known as programmable money.”

An Alarming Paper by Biden’s Nominee Saule Omarova

In that context, it is critical that we pay attention to the striking legal paper published last month in the Vanderbilt Law Review by Saule Omarova, Biden’s nominee to lead the Office of the Comptroller of the Currency (OCC).

What is OCC? The Office of the Comptroller of the Currency (OCC) is a bureau of the U.S. Department of the Treasury that charters, regulates, and supervises all national banks, federal savings associations, and federal branches and agencies of foreign banks. They are the “primary regulator of banks chartered under the National Bank Act and federal savings associations chartered under the Home Owners’ Loan Act.”

Who is Saule Omarova? Saule Omarova is a Kazakh-born Cornell University law professor who on November 2 was formally nominated to lead OCC by the Biden administration. Prior to 2014, Omarova was an Associate Professor at the University of North Carolina School of Law.

And before that, “she worked for the corporate law firm, Davis Polk & Wardwell, in their Financial Institutions Group. In 2006-2007, she served at the U.S. Department of the Treasury as a Special Advisor for Regulatory Policy to the Under Secretary for Domestic Finance.”

The paper is provocatively titled, “The People’s Ledger: How to Democratize Money and Finance the Economy.” It starts with the following intro:

“The COVID-19 crisis underscored the urgency of digitizing sovereign money and ensuring universal access to banking services. It pushed two related ideas — the issuance of central bank digital currency and the provision of retail deposit accounts by central banks — to the forefront of the public policy debate.

To date, however, the debate has not produced a coherent vision of how democratizing access to central bank money would — and should — transform and democratize the entire financial system.

This lack of a systemic perspective obscures the enormity of the challenge and dilutes our ability to tackle it. This Article takes up that challenge. It offers a blueprint for a comprehensive restructuring of the central bank balance sheet as the basis for redesigning the core architecture of modern finance.

Focusing on the U.S. Federal Reserve System (“the Fed”), the Article outlines a series of structural reforms that would radically redefine the role of a central bank as the ultimate public platform for generating, modulating, and allocating financial resources in a democratic economy — the People’s Ledger.”

Omarova’s thinking about finance is on the radical side. She seems to dislike Wall Street — which is fair — but then she also seems to believe that the central banks are our saviors. And while I agree with her assessment from an earlier interview that banks are “a**holes,” I also believe that her proposed solution to give all the control to central banks would hand the power not to the people — but to even bigger “a**holes,” while making a weird assumption that they are serving the people.

The “a**holes” theme comes from a documentary called, “A**holes: A Theory” (see this livestream with Omarova being interviewed at 34:16). What is also very enlightening to the understanding of her paper is a comment by her colleague at Cornell University, Professor Robert Hockett, who talks about “a**hole behavior” in finance and then states that central banks can be a “collective agent” to “regulate” it.

I think one has to have a lot of imagination to imagine central banks as protectors of peasants but that is none the less the belief they seem to espouse.

This kind of linguistic juggling — sincere or not — is a method that I am very familiar from my former homeland, the USSR. And no, I am not saying that the Great Reset is “communist,” or that Omarova is — I think that the entire thing is not about isms at all, and Omarova might mean well, albeit in a weird and dangerous way.

What I am saying though is that my former Soviet homeland has greatly perfected the method of masking abusive state practices with the fuzzy language about “the dignity of all workers,” and that I am alert to it. And just like the language of “worker dignity” was a lie in my Soviet childhood, it is an obvious lie in the context of the Great Reset.

What I suspect is going on here on the psychological level — I am merely guessing — is a combination of traditional opportunism and a sincere, deep, Soviet-rooted moral desire for theoretical “justice.”

Does she sincerely believe in the “sustainable rhetoric” or does she merely say what needs to be said to move ahead in the current insane and somewhat Soviet-like environment? I don’t know, but I would like to repeat what I said back in January, and stress that it applies to all bankers, including the central ones:

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For all those reasons, I find her recent legal paper completely horrifying as it pretty much describes the mother of all conspiracy theories — the conspiracy theory saying that we are currently going through a reform whose true purpose is to move all our money to central banks, make it digital, and allow the central banks to freeze people’s accounts.

The paper is 69 pages long. It was written about in detail by Wallstreet on Parade, which pointed out that Omarova’s proposed reform includes the following:

(1) Moving all commercial bank deposits from commercial banks to so-called FedAccounts at the Federal Reserve;

(2) Allowing the Fed, in “extreme and rare circumstances, when the Fed is unable to control inflation by raising interest rates,” to confiscate deposits from these FedAccounts in order to tighten monetary policy;

(3) Allowing the most Wall Street-conflicted regional Fed bank in the country, the New York Fed, when there are “rises in market value at rates suggestive of a bubble trend,” such as with technology stocks today, to “short these securities, thereby putting downward pressure on their prices”;

(4) Eliminate the Federal Deposit Insurance Corporation (FDIC) that insures bank deposits;

(5) Consolidate all bank regulatory functions at the OCC – which Omarova has been nominated to head.

And here is what Omarova’s paper has to say about freezing people’s money in case of an “emergency”:

“If and when the Fed injects monetary base into the system, each reserve sub-account would be credited with the appropriate “helicoptered” amount. If and when the Fed seeks to drain money from the system, the appropriate amount would be transferred from the transaction sub-account to the same holder’s reserve sub-account, where it would be effectively escrowed until the Fed ends its tightening policies.

These temporarily “reserved” funds would pay a higher interest than the regular interest paid by the Fed on money held in transaction sub-accounts. Importantly, raising this reserve interest rate would enable the Fed to incentivize depositors to move more of their money from transaction into reserve sub-accounts voluntarily.

Strategic use of this tool, therefore, may decrease the need for the mandatory “reserving” of people’s money, which would also help to counteract negative perceptions of this policy.142 In effect, the tightening of the money supply would be achieved through a compulsory but economically attractive investment scheme.”

For a bit of context, please see this 2018 IBM paper titled, “Programmable Money: Will Central Banks Take the Lead?” The IBM paper states: “The future of programmable money is dawning. While blockchain adoption is still in a formative stage, it offers tremendous potential to revolutionize the global financial system. No place on earth will be out of reach.”

For more context, here is the head of the Bank for International Settlements and his notorious speech about programmable currency in which he complains that with cash, they don’t know who is using the money and how — while with CBDC, central banks will have “absolute control over the rules and regulations that will determine the use of that expression of central bank liability and also … have the technology to enforce that.”

This man sounds and looks like a definite friend of the peasants. A poster child for protectors of the working people! We can relax, believe our leaders that the passports are about our health, and entrusts ourselves to people like this… or maybe not? I would like to finish this story with words by Catherine Austin Fitts:

“If we’re going to get out of this one, we need to just say no and refuse to go into the box.” There are more or us than there are of them. No box for the free people.

About the Author

To find more of Tessa Lena’s work, be sure to check out her bio, Tessa Fights Robots.

COVID-19: Moderna Gets Its Miracle

COVID-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their commercial candidate?

In late 2019, the biopharmaceutical company Moderna was facing a series of challenges that not only threatened its ability to ever take a product to market, and thus turn a profit, but its very existence as a company.

There were multiple warning signs that Moderna was essentially another Theranos-style fraud, with many of these signs growing in frequency and severity as the decade drew to a close. Part I of this three-part series explored the disastrous circumstances in which Moderna found itself at that time, with the company’s salvation hinging on the hope of a divine miracle, a “Hail Mary” save of sorts, as stated by one former Moderna employee.

While the COVID-19 crisis that emerged in the first part of 2020 can hardly be described as an act of benevolent divine intervention for most, it certainly can be seen that way from Moderna’s perspective. Key issues for the company, including seemingly insurmountable regulatory hurdles and its inability to advance beyond animal trials with its most promising — and profitable — products, were conveniently wiped away, and not a moment too soon.

Since January 2020, the value of Moderna’s stock — which had embarked on a steady decline since its IPO — grew from $18.89 per share to its current value of $339.57 per share, thanks to the success of its COVID-19 vaccine.

Yet, how exactly was Moderna’s “Hail Mary” moment realized, and what were the forces and events that ensured it would make it through the FDA’s emergency use authorization (EUA) process? In examining that question, it becomes quickly apparent that Moderna’s journey of saving grace involved much more than just cutting corners in animal and human trials and federal regulations.

Indeed, if we are to believe Moderna executives, it involved supplying formulations for some trial studies that were not the same as their COVID-19 vaccine commercial candidate, despite the data resulting from the former being used to sell Moderna’s vaccine to the public and federal health authorities.

Such data was also selectively released at times to align with preplanned stock trades by Moderna executives, turning many of Moderna’s highest-ranking employees into millionaires, and even billionaires, while the COVID-19 crisis meant economic calamity for most Americans.

Not only that, but — as Part II of this three-part series will show, Moderna and a handful of its collaborators at the National Institutes of Health (NIH) seemed to know that Moderna’s miracle had arrived — well before anyone else knew or could have known.

Was it really a coincidental mix of “foresight” and “serendipity” that led Moderna and the NIH to plan to develop a COVID-19 vaccine days before the viral sequence was even published and months before a vaccine was even considered necessary for a still unknown disease? If so, why would Moderna — a company clearly on the brink — throw everything into and gamble the entire company on a vaccine project that had no demonstrated need at the time?

The Serendipitous Origins of Moderna’s COVID-19 Vaccine

When early January 2020 brought news of a novel coronavirus outbreak originating in Wuhan, China, Moderna’s CEO Stéphane Bancel immediately emailed Barney Graham, deputy director of the Vaccine Research Center at the National Institutes of Health, and asked to be sent the genetic sequence for what would become known as SAR-CoV-2, allegedly because media reports on the outbreak “troubled” him.

The date of that email varies according to different media reports, though most place it as having been sent on either January 6th or 7th. A few weeks before Bancel’s email to Graham, Moderna was quickly approaching the end of the line, their desperately needed “Hail Mary” still not having materialized.

“We were freaked out about money,” Stephen Hoge would later remember of Moderna’s late 2019 circumstances.

Not only were executives “cutting back on research and other expenditures” like never before, but – as STAT News would later report – “cash from investors had stopped pouring in and partnerships with some drug makers had been discontinued. In meetings at Moderna, Bancel emphasized the need to stretch every dollar and employees were told to reduce travel and other expenses, a frugality there were advised would last several years.”

At the tail end of 2019, Graham was in a very different mood than Bancel, having emailed the leader of the coronavirus team at his NIH lab saying, “Get ready for 2020,” apparently viewing the news out of Wuhan in late 2019 as a harbinger of something significant.

He went on, in the days before he was contacted by Bancel, to “run a drill he had been turning over in his mind for years” and called his long-time colleague Jason McLellan “to talk about the game plan” for getting a head start on producing a vaccine the world did not yet know it needed.

When Bancel called Graham soon afterward and asked about this new virus, Graham responded that he didn’t know yet but that “they were ready if it turned out to be a coronavirus.” The Washington Post claimed that Graham’s apparent foreknowledge that a coronavirus vaccine would be needed before anyone officially knew what type of disease was circulating in Wuhan was a fortunate mix of “serendipity and foresight.”

congress lab

Dr. Barney Graham and Dr. Kizzmekia Corbett, VRC coronavirus vaccine lead, discuss COVID-19 research with U.S. legislators Sen. Chris Van Hollen, Sen. Benjamin Cardin and Rep. Jamie Raskin, March 6, 2020; Source: NIH

A report in Boston magazine offers a slightly different account than that reported by the Washington Post. Per that article, Graham had told Bancel, “If [the virus] is a coronavirus, we know what to do and have proven mRNA is effective.”

Per that report, this assertion of efficacy from Graham referred to Moderna’s early stage human-trial data published in September 2019 regarding its chikungunya vaccine candidate, which was funded by the Defense Advanced Research Projects Agency (DARPA), as well as its cytomegalovirus (CMV) vaccine candidate.

As mentioned in Part I of this series, the chikungunya vaccine study data released at that time included the participation of just four subjects, three of whom developed significant side effects that led Moderna to state that they would reformulate the vaccine in question and would pause trials on that vaccine candidate.

In the case of the CMV vaccine candidate, the data was largely positive, but it was widely noted that the vaccine still needed to pass through larger and longer clinical trials before its efficacy was in fact “proven,” as Graham later claimed.

In addition, Graham implied that this early stage trial of Moderna’s CMV vaccine candidate was somehow proof that an mRNA vaccine would be effective against coronaviruses, which makes little sense since CMV is not a coronavirus but instead hails from the family of viruses that includes chickenpox, herpes, and shingles.

Bancel apparently had reached out to Graham because Graham and his team at the NIH had been working in direct partnership with Moderna on vaccines since 2017, soon after Moderna had delayed its Crigler-Najjar and related therapies in favor of vaccines.

According to Boston magazine, Moderna had been working closely with Graham specifically “on [Moderna’s] quest to bring a whole new class of vaccines to market” and Graham had personally visited Moderna’s facilities in November 2019. Dr. Anthony Fauci, the director of the NIH’s infectious-disease division NIAID, has called his unit’s collaboration with Moderna, in the years prior to and also during the COVID-19 crisis, “most extraordinary.”

The year 2017, besides being the year when Moderna made its pivot to vaccines (due to its inability to produce safe multidose therapies, see Part I), was also a big year for Graham.

That year he and his lab filed a patent for the “2P mutation” technique whereby recombinant coronavirus spike proteins can be stabilized in a prefusion state and used as more effective immunogens. If a coronavirus vaccine were to be produced using this patent, Graham’s team would financially benefit, though federal law caps their annual royalties. Nonetheless, it would still yield a considerable sum for the named researchers, including Graham.

However, due to the well-known difficulties with coronavirus vaccine development, including antibody dependent enhancement risk, it seemed that commercial use of Graham’s patent was a pipe dream. Yet, today, the 2P mutation patent, also known as the ‘070 patent, is not just in use in Moderna’s COVID-19 vaccine, but also in the COVID-19 vaccines produced by Johnson & Johnson, Novavax, Pfizer/BioNTech, and CureVac.

Experts at New York University School of Law have noted that the 2P mutation patent first filed in 2016 “sounds remarkably prescient” in light of the COVID crisis that emerged a few years later while later publications from the NIH (still pre-COVID) revealed that the NIH’s view on “the breadth and importance of the ‘070 patent” as well as its potential commercial applications was also quite prescient, given that there was little justification at the time to hold such a view.

On January 10, three days after the reported initial conversation between Bancel and Graham on the novel coronavirus outbreak in Wuhan, China, Graham met with Hamilton Bennett, the program leader for Moderna’s vaccine portfolio.

Graham asked Bennett “if Moderna would be interested in using the new [novel coronavirus] to test the company’s accelerated vaccine-making capabilities.” According to Boston, Graham then mused, “That way … if ever there came a day when a new virus emerged that threatened global public health, Moderna and the NIH could know how long it would take them to respond.”

Graham’s “musings” to Bennett are interesting considering his earlier statements made to others, such as “Get ready for 2020” and his team, in collaboration with Moderna, would be “ready if [the virus then circulating in Wuhan, China] turned out to be a coronavirus.” Is this merely “serendipity” and “foresight”, as the Washington Post suggested, or was it something else?

It is worth noting that the above accounts are those that have been given by Bancel and Graham themselves, as the actual contents of these critical January 2020 emails have not been publicly released.

When the genetic sequence of SARS-CoV-2 was published on January 11, NIH scientists and Moderna researchers got to work determining which targeted genetic sequence would be used in their vaccine candidate. Later reports, however, claimed that this initial work toward a COVID-19 vaccine was merely intended to be a “demonstration project.”

Other odd features of the Moderna-NIH COVID-19 vaccine-development story emerged with Bancel’s account of the role the World Economic Forum played in shaping his “foresight” when it came to the development of a COVID-19 vaccine back in January 2020.

On January 21, 2020, Bancel reportedly began to hear about “a far darker version of the future” at the World Economic Forum (WEF) annual meeting in Davos, Switzerland, where he spent time with “two [anonymous] prominent infectious-disease experts from Europe” who shared with him data from “their contacts on the ground in China, including Wuhan.”

That data, per Bancel, showed a dire situation that left his mind “reeling” and led him to conclude, that very day, that “this isn’t going to be SARS. It’s going to be the 1918 flu pandemic.”

stephane bancel speaks

Stéphane Bancel speaks at the Breakthroughs in Cancer Care session at WEF annual meeting, January 24, 2020; Source: WEF

This realization is allegedly what led Bancel to contact Moderna cofounder and chairman, as well as a WEF technology pioneer, Noubar Afeyan. Bancel reportedly interrupted Afeyan’s celebration of his daughter’s birthday to tell him “what he’d learned about the virus” and to suggest that “Moderna begin to build the vaccine — for real.”

The next day, Moderna held an executive meeting, which Bancel attended remotely, and there was considerable internal debate about whether a vaccine for the novel coronavirus would be needed.

To Bancel, the “sheer act of debating” pursuing a vaccine for the virus was “absurd” given that he was now convinced, after a single day at Davos, that “a global pandemic was about to descend like a biblical plague, and whatever distractions the vaccine caused internally at Moderna were irrelevant.”

Bancel spent the rest of his time at the Davos annual meeting “building partnerships, generating excitement, and securing funding,” which led to the Moderna collaboration agreement with the Coalition for Epidemic Preparedness Innovations — a project largely funded by Bill Gates.

(Bancel and Moderna’s cozy relationship with the WEF, dating back to 2013, was discussed in Part I as were the Forum’s efforts, beginning well before COVID-19, to promote mRNA-based therapies as essential to the remaking of the health-care sector in the age of the so-called Fourth Industrial Revolution).

At the 2020 annual meeting attended by Bancel and others it was noted that a major barrier to the widespread adoption of these and other related “health-care” technologies was “public distrust.” The panel where that issue was specifically discussed was entitled “When Humankind Overrides Evolution.”

As also noted in Part I of this series, a few months earlier, in October 2019, major players in what would become the Moderna COVID-19 vaccine, particularly Rick Bright and Anthony Fauci, had discussed during a Milken Institute panel on vaccines how a “disruptive” event would be needed to push the public to accept “nontraditional” vaccines such as mRNA vaccines; to convince the public that flu-like illnesses are scarier than traditionally believed; and to remove existing bureaucratic safeguards in the vaccine development-and-approval processes.

That panel took place less than two weeks after the Event 201 simulation, jointly hosted by the World Economic Forum, the Bill & Melinda Gates Foundation, and the Johns Hopkins Center for Health Security.

Event 201 simulated “an outbreak of a novel zoonotic coronavirus” that was “modeled largely on SARS but … more transmissible in the community setting by people with mild symptoms.” The recommendations of the simulation panel were to considerably increase investment in new vaccine technologies and industrial approaches, favoring rapid vaccine development and manufacturing.

As mentioned in Part I, the Johns Hopkins Center for Health Security had also conducted the June 2001 Dark Winter simulation that briefly preceded and predicted major aspects of the 2001 anthrax attacks, and some of its participants had apparent foreknowledge of those attacks. Other Dark Winter participants later worked to sabotage the FBI investigation into those attacks after their origin was traced back to a US military source.

It is hard to imagine that Bancel, whose company had long been closely partnered with the World Economic Forum and the Gates Foundation, was unaware of the exercise and surprised by the closely analogous event that transpired within three months.

Given the accounts given by Bancel, Graham, and others, it seems likely there is more to the story regarding the origins of Moderna’s early and “serendipitous” push to develop a COVID-19 vaccine.

In addition, given that Moderna was in dire financial circumstances at the time, it seems odd that the company would gamble everything on a vaccine project that was opposed by the few investors that were still willing to fund Moderna in January/February 2020.

Why would they divert their scant resources towards a project born only out of Barney Graham’s “musings” that Moderna could try to test the speed of its vaccine development capabilities and Bancel’s doomsday view that a “biblical plague” was imminent, especially when their investors opposed the idea?

Moderna Gets to Bypass Its Long-Standing Issues With R & D

Moderna produced the first batch of its COVID-19 vaccine candidate on February 7, one month after Bancel and Graham’s initial conversation. After a sterility test and other mandatory tests, the first batch of its vaccine candidate, called mRNA-1273, shipped to the NIH on February 24. For the first time in a long time, Moderna’s stock price surged. NIH researchers administered the first dose of the candidate into a human volunteer less than a month later, on March 16.

Controversially, in order to begin its human trial on March 16, regulatory agencies had to allow Moderna to bypass major aspects of traditional animal trials, which many experts and commentators noted was highly unusual but was now deemed necessary due to the urgency of the crisis. Instead of developing the vaccine in distinct sequential stages, as is the custom, Moderna “decided to do all of the steps [relating to animal trials] simultaneously.”

In other words, confirming that the candidate is working before manufacturing an animal-grade vaccine, conducting animal trials, analyzing the animal-trial data, manufacturing a vaccine for use in human trials, and beginning human trials were all conducted simultaneously by Moderna. Thus, the design of human trials for the Moderna vaccine candidate was not informed by animal-trial data.

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Lt. Javier Lopez Coronado and Hospitalman Francisco Velasco inspect a box of COVID-19 vaccine vials at the Naval Health Clinic in Corpus Christi, TX, December 2020; Source: Wikimedia

This should have been a major red flag, given Moderna’s persistent difficulties in getting its products past animal trials. As noted in Part I, up until the COVID-19 crisis, most of Moderna’s experiments and products had only been tested in animals, with only a handful able to make it to human trials.

In the case of the Crigler-Najjar therapy that it was forced to indefinitely delay, toxicity concerns related to the mRNA delivery system being used had emerged in the animal trials, which Moderna was now greenlighted to largely skip. Given that Moderna had subsequently been forced to abandon all multidose products because of poor results in animal trials, being allowed to skip this formerly insurmountable obstacle was likely seen as a boon to some at the company.

It is also astounding that, given Moderna’s history with problematic animal trials, more scrutiny was not devoted to the regulatory decision to allow Moderna to essentially skip such trials. Animal studies conducted on Moderna’s COVID-19 vaccine did identify problems that should have informed human trials, but this did not happen because of the regulatory decision.

For example, animal reproductive toxicity studies on the Moderna COVID-19 vaccine that are cited by the European Medicines Agency found that there was reduced fertility in rats that received the vaccine (e. g., overall pregnancy index of 84.1% in vaccinated rats versus 93.2% in the unvaccinated) as well as an increased proportion of aberrant bone development in their fetuses.

That study has been criticized for failing to report on the accumulation of vaccine in the placenta as well as failing to investigate the effect of vaccine doses administered during key pregnancy milestones, such as embryonic organogenesis. In addition, the number of animals tested is unstated, making the statistical power of the study unknown.

At the very least, the 9 percent drop in the fertility index among vaccinated rats should have prompted expanded animal trials to investigate concerns of reproductive toxicity before testing in humans.

Yet, Moderna declined to further investigate reproductive toxicity in animal trials and entirely excluded reproductive toxicity studies from its simultaneous human trials, as pregnant women were excluded from participation in the clinical trials of its vaccine. Despite this, pregnant women were labeled a priority group for receiving the vaccine after Emergency Use Authorization (EUA) was granted for the Moderna and Pfizer/BioNTech vaccines.

Per the New England Journal of Medicine, this meant that “pregnant women and their clinicians were left to weigh the documented risks of Covid-19 infection against the unknown safety risks of vaccination in deciding whether to receive the vaccine.”

Moderna only began recruiting for an “observational pregnancy outcome study” of its COVID-19 vaccine in humans in mid-July 2021, and that study is projected to conclude in early 2024. Nevertheless, the Centers for Disease Control recommends the use of Moderna’s COVID-19 vaccine in “people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.”

This recommendation is largely based on the CDC’s publication of preliminary data on mRNA COVID-19 vaccine safety in pregnant women in June 2021, which is based on passive reporting systems in use within the United States (i. e., VAERS and v-safe).

Even in the limited scope of this study, 115 of the 827 women who had a completed pregnancy during the study lost the baby, 104 of which were spontaneous abortions before 20 weeks of gestation. Of these 827 pregnant women, only 127 had received a mRNA vaccine before the 3rd trimester.

This appears to suggest an increased risk among those women who took the vaccine before the 3rd trimester, but the selective nature of the data makes it difficult to draw any definitive conclusions.

Despite claims from the New England Journal of Medicine that the study’s data was “reassuring”, the study’s authors ultimately stated that their study, which mainly looked at women who began vaccination in the third trimester, was unable to draw “conclusions about spontaneous abortions, congenital anomalies, and other potential rare neonatal outcomes.”

This is just one example of the problems caused by “cutting corners” with respect to Moderna’s COVID-19 vaccine trials in humans and animals, including those conducted by the NIH.

Meanwhile, throughout February, March and April, Bancel was “begging for money” as Moderna reportedly lacked “enough money to buy essential ingredients for the shots” and “needed hundreds of millions of dollars, perhaps even more than a billion dollars” to manufacture its vaccine, which had only recently begun trials. Bancel, whose tenure at Moderna had long been marked by his ability to charm investors, kept coming up empty-handed.

Then, in mid-April 2020, Moderna’s long-time cooperation with the US government again paid off when Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) awarded the company $483 million to “accelerate the development of its vaccine candidate for the novel coronavirus.”

A year later, the amount invested in Moderna’s COVID-19 vaccine by the US government had grown to about $6 billion dollars, just $1.5 billion short of the company’s entire value at the time of its pre-COVID IPO.

BARDA, throughout 2020, was directly overseen by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), led by the extremely corrupt Robert Kadlec, who had spent roughly the last two decades designing BARDA and helping shape legislation that concentrated many of the emergency powers of HHS under the Office of the ASPR.

Conveniently, Kadlec occupied the powerful role of ASPR that he had spent years sculpting at the exact moment when the pandemic, which he had simulated the previous year via Crimson Contagion, took place. As mentioned in Part I, he was also a key participant in the June 2001 Dark Winter exercise.

In his capacity as ASPR during 2020, Kadlec oversaw nearly all major aspects of the HHS COVID-19 response and had a key role in BARDA’s funding decisions during that period, as well as in the affairs of the NIH and the Food and Drug Administration as they related to COVID-19 medical countermeasures, including vaccines.

On May 1, 2020, Moderna announced a ten-year manufacturing agreement with the Lonza Group, a multinational chemical and biotech company based in Switzerland. Per the agreement, Lonza would build out vaccine production sites for Moderna’s COVID-19 vaccine, first in the US and Switzerland, before expanding to Lonza’s facilities in other countries.

The scale of production discussed in the agreement was to produce 1 billion doses of Moderna’s COVID-19 vaccine annually. It was claimed that the ten-year agreement would also focus on other products, even though it was well known at the time that other Moderna products were “nowhere close to being ready for the market.”

Moderna executives would later state that they were still scrambling for the cash to manufacture doses at the time the agreement with Lonza was made.

The decision to forge a partnership to produce that quantity of doses annually suggests marvelous foresight on the part of Moderna and Lonza that the COVID-19 vaccine would become an annual or semiannual affair, given that current claims of waning immunity could not have been known back then because initial trials of the Moderna vaccine had begun less than two months earlier and there was still no published data on its efficacy or safety.

However, as will be discussed Part III of this series, Moderna needs to sell “pandemic level” quantities of its COVID-19 vaccine every year in order to avoid a return of the existential crises it faced before COVID-19 (for more on those crises, see Part I).

The implications of this, given Moderna’s previous inability to produce a safe product for multidosing and lack of evidence that past issues were addressed in the development of its COVID-19 vaccine, will also be discussed in Part III of this series.

It is also noteworthy that, like Moderna, Lonza as a company and its leaders are closely affiliated with the World Economic Forum. In addition, at the time the agreement was reached in May 2020, Moncef Slaoui, the former GlaxoSmithKline executive, served on the boards of both Moderna and Lonza.

Slaoui withdrew from the boards of both companies two weeks after the agreement was reached to become the head of the US-led vaccination-development drive Operation Warp Speed. Moderna praised Slaoui’s appointment to head the vaccination project.

By mid-May, Moderna’s stock price — whose steady decline before COVID-19 was detailed in Part I — had tripled since late February 2020, all on high hopes for its COVID-19 vaccine.

Since Moderna’s stock had begun to surge in February, media reports noted that “nearly every progress update — or media appearance by Moderna CEO Stephane Bancel — has been gobbled up by investors, who seem to have an insatiable appetite for the stock.”

Bancel’s tried-and-tested method of keeping Moderna afloat on pure hype, though it was faltering before COVID-19, was again paying off for the company thanks to the global crisis and related panic.

Some critics did emerge, however, calling Moderna’s now $23 billion valuation “insane,” especially considering that the company had posted a net loss of $514 million the previous year and had yet to produce a safe or effective medicine since its founding a decade earlier.

In January 2020, Moderna had been worth a mere $5 billion, $2 billion less than its valuation at its December 2018 IPO. If it hadn’t been for the onset of the COVID crisis and a fresh injection of hype, it seems that Moderna’s valuation would have continued to shrink.

Yet, thankfully for Moderna, investors were valuing Moderna’s COVID-19 vaccine even before the release of any clinical data. Market analysts at the time were forecasting Moderna’s 2022 revenue at about $1 billion, a figure based almost entirely on coronavirus vaccine sales, since all other Moderna products were years away from a market debut.

Yet, even with this forecasted revenue, Moderna’s stock value in mid-May 2020 was trading at twenty-three times its projected sales, a phenomenon unique to Moderna among biotech stocks at the time. For comparison, the other highest multiples in biotech at the time were Vertex Pharmaceutical and Seattle Genetics, which were then trading at nine and twelve times their projected revenue, respectively.

Now, with the implementation of booster shot policies around the world, revenue forecasts for Moderna now predict the company will make a staggering $35 billion in COVID-19 vaccine sales through next year.

Moderna’s surging stock price went into overdrive when, on May 18, 2020, the company published “positive” interim data for a phase 1 trial of its COVID-19 vaccine. The results generated great press, public enthusiasm, and a 20 percent boost in Moderna’s stock price.

Just hours after the press release, Moderna announced a new effort to raise $1.3 billion by selling more stock. It has since been revealed that that Moderna had hired Morgan Stanley to manage that stock sale on May 15.

However, left largely unmentioned by the press or Moderna itself was that the ostensibly “scientific study” only provided data from 8 of the 45 volunteers — 4 volunteers each from the 15- and 100-microgram dose cohorts — regarding the development of neutralizing antibodies.

The age of these mysteriously selected 8 volunteers was also not published, and other key data was missing, making it “impossible to know whether mRNA-1273 [Moderna’s COVID-19 vaccine] was ineffective [in the remaining 37 volunteers whose antibody data was not disclosed], or whether the results were not available at this point.”

Meanwhile, in the highest-dose cohort, in which volunteers received 250 micrograms, 21 percent of volunteers experienced a grade 3 adverse event, which is defined by the FDA as “preventing daily activity and requiring medical intervention.”

STAT published a report the next day that was skeptical of Moderna’s press release and seemed to imply the data release was aimed at boosting the company’s stock valuation, which hit $29 billion after the news. STAT reporter Helen Branswell called this jump in valuation “an astonishing feat for a company that currently sells zero products.”

Branswell’s report noted several things, including that several vaccine experts had noted that “based on the information made available [by Moderna], there’s really no way to know how impressive — or not — the vaccine may be.”

Moderna later defended its withholding of key data in the press release, claiming that it was done to respect “federal securities laws and the rules of scientific journals” and to prevent a potential leak of the data from insiders at the NIH.

Moderna executives have more recently claimed that the “timely” release of these selective data had been linked to their “desperate” fundraising efforts at the time and ultimately prevented them from “losing” the COVID-19 vaccine race.

The STAT report also noted that the National Institute of Allergy and Infectious Diseases (NIAID), which was running the trial referenced by Moderna in the press release, was completely silent on the matter, declining to put out a press release that day and declining to comment on Moderna’s announcement.

This was described as uncharacteristic for NIAID, especially considering they were the part of the NIH co-developing the vaccine with Moderna and running the trial. STAT noted that, normally, “NIAID doesn’t hide its light under a bushel. The institute generally trumpets its findings.” In this case, however, they declined to do so.

It emerged in early June 2020 that Dr. Anthony Fauci, who leads NIAID, had been displeased with Moderna’s decision to publish incomplete data on the trial, telling STAT that he would have preferred “to wait until we had the data from the entire Phase 1 … and publish it in a reputable journal and show all the data.”

tal zaks

Tal Zaks, Chief Scientific Officer at Moderna; Source: The Forward

It subsequently emerged that Moderna’s top executives, including chief financial officer Lorence Kim and chief scientific officer Tal Zaks, had used their insider knowledge of the coming press release to trade company stock that netted them several million each following the jump in Moderna’s stock that resulted from the press release’s positive buzz.

A little over a week after the press release had been published, STAT reported that the top five Moderna executives had cashed out $89 million in shares since the company’s stock price had begun to soar earlier in the year.

Per that report, the amount of trades by these five executives alone between January and May 2020 was “nearly three times as many stock transactions than in all of 2019.” By September 2020, the amount of stock shed by Moderna executives amounted to $236 million. Less criticized or even mentioned by the press was Moderna’s move, less than a month later, to create a tax haven in Europe for its European COVID-19 vaccine sales.

Though the trades were deemed slimy but legal, mainstream media reports essentially confirmed that the early release of the interim data was planned to “raise the share price of Moderna’s stock so that executives could cash in during the period of euphoria” that followed. Some watchdog groups called on the SEC to investigate Moderna executives for manipulating the stock market.

The critical reporting on executive stock trades and Moderna’s release of incomplete data led the company’s stock to temporarily trend downward throughout the rest of May. As previously mentioned, Moderna has repeatedly attempted to explain away the timing of this particular press release, offering new explanations as recently as this week.

Moderna’s Shocking Claim About Its Vaccine Candidate

In mid-June 2020, researchers at the NIH and Moderna published a manuscript preprint of preclinical data for Moderna’s COVID-19 vaccine. This preprint described the vaccine as employing a delivery system covered in a patent owned by the company Arbutus Biopharma and described the results of that vaccine in tests on mice.

As discussed in Part I, Moderna has long been locked in a bitter legal dispute with Arbutus, which has threatened Moderna’s ability to ever turn a profit on any product that relies on Arbutus-patented technology regarding lipid nanoparticle (LNP) delivery systems for its mRNA products. Moderna has claimed for years it was no longer using the Arbutus-derived system on which it once entirely relied, with Bancel even going so far as to publicly call it “not very good.”

However, Moderna has provided no real evidence that it no longer relies on the technology covered in the Arbutus patents. The June 2020 manuscript preprint from the NIH and Moderna provided evidence indicating that the same Arbutus-derived technology that had caused major toxicity issues in multidose products Moderna had previously attempted to develop was also being used in Moderna’s COVID-19 vaccine candidate.

Yet, when Moderna’s chief corporate affairs officer, Ray Jordan, was challenged on this point by Forbes, Jordan asserted that the preprint’s data had been generated using a formulation of a COVID-19 vaccine that is not the same as the vaccine itself, stating, “while the authors of the preprint used the term ‘mRNA-1273’ for convenience of the reader, the preprint does not describe the cGMP process by which we make our messenger RNA and LNP or the final drug product composition in our commercial candidate (mRNA-1273).”

When Forbes asked Jordan if he could provide any specifics, including the LNP molar ratio of the new LNP technology to prove that the LNPs in use in the COVID-19 vaccine were in fact different from those covered by the Arbutus patent, Jordan flat out refused.

arbutus biopharmas office

Arbutus Biopharma’s office in Warminster, Pennsylvania; Source: Philadelphia Business Journal

Despite Jordan’s claims, a Moderna preclinical study regarding its COVID-19 vaccine was published a month later, and that July study noted that the Moderna vaccine used LNPs as described in a 2019 paper, which in turn reveals that the LNPs in question were the same as those used in the June study. This paper included the results from the study originally promoted by Moderna in May that led to a jump in Moderna’s stock price.

Now published in full, the study generated lots of positive press, including a statement from the NIAID’s Fauci that “no matter how you slice this, this is good news.” A jump in US government funding of Moderna’s COVID-19 vaccine also shortly followed the study’s publication.

At the time, CBS News remarked that Moderna’s stock price, which had been sliding since its late 2018 IPO, had been essentially rescued by the COVID-19 crisis, as “shares of Moderna — which has never brought a product to market over its ten-year existence — have soared as much as 380 percent since the start of the year as news emerged [in January] of its promising potential for producing a vaccine.

[Moderna’s] stock price was less than $20 in early January and around $95 on Friday [July 17, 2020].” Today, by comparison, Moderna has consistently been trading above $300 a share.

Yet, if we take Ray Jordan at his word with respect to the preprint published in June, Moderna appears to have been engaged in rather slimy behavior. If Jordan was telling the truth, it appears that this July study, which appears to use the vaccine candidate containing the same LNPs as those described in the June 2020 preprint, also used a formulation not consistent with the company’s commercial vaccine candidate.

If so, given that the July study was the same study referenced by Moderna’s controversial May press release tied to insider stock trades, Moderna appears to have used “positive” data generated by a vaccine candidate other than its commercial vaccine candidate to boost stock prices and ameliorate the company’s financial situation while also generating millions for executives.

This, of course, says nothing about the separate but critically important issue that the vaccine candidate used in these studies, including the NIH study, is not necessarily the same as the commercial candidate used in clinical trials.

It seems that the only reason that Moderna would make such an outrageous claim to Forbes would be to distance its COVID-19 vaccine from its past controversies that largely have their root in Moderna’s LNP-related problems, which it had claimed to have already resolved. It is not clear if the motive behind such a gambit is principally related to the legal dispute with Arbutus or the past safety issues Moderna encountered with multidose therapies.

Adding to the confusion about the LNPs in use in Moderna’s products is that, a few days earlier in July, Moderna had published results on a separate vaccine candidate, this one for HIV, that appeared to use the exact same LNP technology that is covered by the Arbutus patent. The LNPs described in that study included the same components as those described in the Arbutus patent and the same molar ratio.

Moderna appeared to be referencing this issue in their August 6, 2020, SEC filing, which states: “There are many issued and pending third-party patents that claim aspects of oligonucleotide delivery technologies that we may need for our mRNA therapeutic and vaccine candidates or marketed products, including mRNA-1273, if approved.”

By the end of 2020, Moderna claimed in a December filing with the SEC that, while it had “initially used LNP formulations that were based on known lipid systems,” that is, the Arbutus LNPs, it had “invested heavily in delivery science and ha[s] developed LNP technologies, as well as alternative nanoparticle approaches.”

Despite the claims it made in this filing, however, it remained unclear as to whether the company’s COVID-19 vaccine was using Arbutus technology or the technology it purported to have developed on its own without infringing on Arbutus’s intellectual property.

Moderna’s claims that it now uses a different LNP system than the one that caused such major issues is based on the company’s development and implementation of a lipid structure now known as SM-102. This lipid structure was first revealed by Moderna in a 2019 publication under the name Lipid H, and, in that paper and since, Moderna has claimed that its LNP system is now superior to that which it previously used because it is using SM-102 instead of the original Arbutus lipids.

However, it is critical to note that Moderna’s use of SM-102 does not necessarily mean the company is not violating the Arbutus patents, which cover the use of LNPs that combine cationic and PEGylated lipids in specific proportions.

Despite claims from Moderna that SM-102 resolved both the company’s patent-related and toxicity issues with its LNP system (as discussed in Part I), Moderna has declined to disclose SM-102’s exact structure or whether it carries a net positive charge at physiological pH, the latter of which could lead to proof of continued infringement on the Arbutus patent.

In addition, there are no studies on the distribution, degradation, and/or elimination of SM-102 from the body, meaning that the accumulation of the lipids or their capacity to damage organs is not documented.

The obvious lack of study of SM-102’s properties and effects on the human body was largely circumvented by public health authorities during the emergency approval process by using the same criteria for the Moderna vaccine candidate that is used for traditional vaccines that do not utilize the novel mRNA approach. These “traditional” criteria therefore do not include any requirements for data on LNP safety.

Overall, the evidence seems to point toward Moderna’s claims that its COVID-19 vaccine doesn’t use Arbutus-derived LNPs as being false. The other possibility is that Moderna attempted to modify the LNP system but only slightly so that potential identifiers, such as the molar ratio, remained the same.

In this case, Arbutus could still claim that the LNPs currently in use by Moderna and in its COVID-19 vaccine infringe on their patent. It is also thus likely that the safety issues Moderna had acknowledged with this LNP system were largely unaffected if the potential modifications were indeed minor.

Yet, if either of these scenarios is correct, the question becomes – Why wouldn’t Arbutus challenge Moderna once again to obtain royalty payments stemming from its COVID-19 vaccine?

The answer seems to lie mostly in optics and public relations. As STAT wrote last July, were Arbutus to sue Moderna over patent infringement in the midst of the COVID-19 crisis, “that would mean taking the substantial risk that it would be perceived as a company holding up a desperately needed medicine out of concern for its bottom line.”

This also seemed to be part of the motive behind Moderna’s altruistically framed promise not to enforce its own COVID-19–related patents until the pandemic is declared over.

Observers have noted that this move by Moderna was not only a public relations boon for the company but also “set a disarming tone in the space that may serve to deter others in the space [e.g., Arbutus] from acting too defensively or aggressively,” largely due to “fear of the potential public relations backlash.”

While July 2020 brought a surge in valuation and positive press for Moderna and its COVID-19 vaccine candidate, it also brought an unfavorable ruling for Moderna in its long-running dispute with Arbutus, one that opened the door for Arbutus to file an injunction against Moderna’s COVID-19 vaccine, if they chose, to force the negotiation of a license with Moderna.

The news led to Moderna’s stock price falling by 10 percent, wiping out $3 billion in value. However, most likely for the reasons outlined above, Arbutus ultimately declined to jump on the decision to block Moderna’s COVID-19 vaccine from advancing in the hopes of securing royalties. Yet, they reserve the ability to do so, if and when the perceived urgency of the COVID-19 crisis fades.

ray jordan moderna

Ray Jordan, Chief Corporate Affairs Officer at Moderna; Source: PRSA

Moderna has asserted that the decision would not affect its COVID-19 vaccine as the company was “not aware of any significant intellectual property impediments for any products we intend to commercialize.”

Thus, Ray Jordan’s assertions and the lack of “clear and convincing” evidence that Moderna’s COVID-19 vaccine relies on Arbutus-patented technology appears to have been sufficient for Moderna to make this claim.

This seems to be due to a lack of interest by the mainstream media or federal agencies/regulators in demanding concrete evidence that Moderna’s LNP system used in its COVID-19 vaccine does not rely on Arbutus-patented technology.

Despite the issues raised above in relation to the vaccine study data published in June and July, the positive press attention — particularly after the July publication — translated just a month later into the US government entering into a significant supply agreement with Moderna on August 11, 2020.

Per that agreement, the government would pay $1.525 billion for 100 million doses with the option to purchase an additional 400 million doses in the future, all of which it has since purchased. Per Moderna’s press release, the agreement meant that the US government had, by that point, paid $2.48 billion for “early access” to Moderna’s COVID-19 vaccine.

Roughly a month later, it was revealed that the US government had been paying for much more. On September 10, 2020, BARDA joined long-time Moderna funder and “strategic ally” DARPA in scrutinizing contracts that had been awarded to the company due to Moderna’s failure to disclose the role government support had played in its numerous patent applications.

The announcement came after Knowledge Ecology International (KEI), which advocates for protecting taxpayer investments in patents, found that none of the patents or applications assigned to Moderna in the company’s entire history had disclosed the considerable US government funding it had received at the time those patents were filed, which is required by the 1980 Bayh-Doyle Act and by the regulations of the Patent and Trademark Office.

Per KEI, this translates into the US government owning certain rights over the patents, and thus US taxpayers may have an ownership stake in vaccines made and sold by Moderna.

Despite the clear evidence that Moderna failed to disclose the considerable amount of US government funding prior to and during the COVID crisis in its patent applications, Moderna responded to KEI and the BARDA/DARPA “scrutiny” by stating that it was “aware of and consults with our agency collaborators regarding our contractual obligations under each of these agreements, including those with respect to IP [intellectual property], and believe we comply with those obligations.”

As of the writing of this article, BARDA and DARPA have taken no action against Moderna for their illegal omission about having received substantial government funding in their patent applications and filings.

Instead, a month after DARPA claimed to be “scrutinizing” Moderna’s patent applications, it awarded the company up to $56 million to develop small-scale mobile means of manufacturing its products — namely, its COVID-19 vaccine and its personalized cancer vaccine.

Moderna: “Just Trust Us”

What quickly stands out about Moderna’s COVID-19 vaccine candidate over the course of its rapid development in 2020 was the willingness of federal agencies like NIH, BARDA, and others, as well as the mainstream press, to take Moderna at its word concerning critical aspects of its vaccine and its development, even when the evidence appeared to contradict its claims.

This is particularly evident in Moderna claiming that it resolved its LNP issues, both in terms of toxicity and patent infringement, and those claims — despite the company’s refusal to release clear supporting evidence — being taken at face value.

This is even more striking when one considers the multiple factors that Moderna was facing before COVID-19 and how the company faced collapse without the success of its COVID-19 vaccine, as this means Moderna was under considerable pressure to have its vaccine succeed.

While the controversial simultaneous conducting of animal and human trials was publicly justified in the name of the urgency of the COVID-19 crisis, can the other examples explored in this article be similarly justified in the name of urgency? Instead, several issues explored above appear to have been driven by conflicts of interest and corruption.

Adding to the ridiculousness is that Moderna got away with claiming that the NIH was conducting safety tests on a COVID-19 vaccine product different from their commercial candidate, without causing a major backlash in either the mainstream media or from the NIH itself.

This is particularly telling as the May 2020 press release and suspiciously timed stock trading by Moderna executives and insiders did garner negative press attention.

However, the subsequent revelation, per Moderna, that its press release was based on the study of a vaccine candidate that was not “necessarily the same” as their commercial COVID-19 vaccine candidate received essentially no coverage, despite raising the unsettling possibility that Moderna could have used another product to essentially rig preliminary data to be positive in order to advance their product to market and make millions through insider stock sales.

How can the claims made by such a company be trusted at face value without independent verification? Furthermore, how can NIH studies of Moderna be trusted when Moderna has claimed that some of the studies that were ultimately factors in the vaccine’s emergency use authorization approval by the FDA utilized a different product than that which Moderna later successfully commercialized?

Moderna and the NIH were, nevertheless, taken at their word in November 2020 when they said that their COVID-19 vaccine candidate was 94.5 percent effective. At the time, the main promoters of this claim were Moderna’s Bancel and NIAID’s Fauci.

The claim came shortly after Pfizer’s press release claiming its COVID-19 vaccine candidate was 90 percent effective. Not to be outdone by Moderna, Pfizer revised the reported efficacy of its vaccine just two days after Moderna’s November press release, stating that their vaccine was actually 95% effective to Moderna’s 94.5%.

In the case of these claims, it was indicative of the now-established yet troubling practice of “science by press release” when it comes to touting the benefit of certain COVID-19 vaccines currently on the market. Since then, real-world data has shattered the efficacy claims that were used to secure emergency use authorization, for which Moderna applied at the end of November 2020 and received only a few weeks later in mid-December of that year.

As Part III of this series will explore, the EUA for the Moderna vaccine got around the issues raised in this article by treating the entire Moderna formulation as a traditional vaccine, which it is not, as traditional vaccines do not utilize mRNA for inducing immunity, and their safety and efficacy depend on several criteria that are entirely different from those of the more novel mRNA.

Thus, the LNP issue, a perpetually sticky one for Moderna that it struggled to circumvent before the onset of the COVID-19 crisis, was largely evaded when it came down to, not just research and development, but receiving EUA.

It appears that this sleight-of-hand by federal regulators was necessary for Moderna, after ten years, to finally get its first product on the market. As noted in Part I, were it not for the COVID-19 crisis and its fortuitous timing, Moderna might not have survived the severe challenges that threatened its entire existence as a company.

Part III will also examine how Moderna’s “Hail Mary” moment in the COVID-19 crisis was only the beginning of its miraculous rescue from a Theranos-like fate, as the company has not only expanded its partnership with the government but now with a CIA-linked firm.

This shows that Moderna and key power players in Big Pharma and the US national-security state envision Moderna’s COVID-19 vaccine being sold in massive quantities for several years to come. As previously noted, without annual or semiannual sales of booster doses, Moderna’s pre-COVID crisis will inevitably return.

The push for Moderna booster-dose approval has advanced despite real-world data not supporting Moderna’s past claims of safety and efficacy for its COVID-19 vaccine, the recent decision of several European governments to halt the vaccine’s use, and the FDA’s own infighting and recent admissions that the Moderna COVID-19 vaccine is one of the more dangerous currently in use, particularly in terms of adverse effects on the cardiovascular system.

The obvious question here then becomes – How costly will Moderna’s “Hail Mary” save ultimately be, not just in terms of the $6 billion US taxpayer money already spent on it, but also in terms of public health?

Secret Military Experiments and Our Health

This story is about secret experiments on people. It is also about the reality of living inside a Machine that plays games with us. Sometimes the Machine selectively shows its face — and sometimes it selectively hides it — and based on that, it plays its favorite game called, “Confuse, Divide and Conquer.”

The story was specifically inspired by the fact that as I am typing this, a biosecurity experiment is taking place in my home town of New York. All safe, allegedly …

Of course it’s safe. It’s always safe when the television says so! We in the West are used to being mostly spared by the Machine, and so we think that our bureaucracies are mostly under control. We believe that yes, there is corruption — and yes, there are bad apples here and there — but they cannot go very far because we have a Democracy. A Machine that is working for us. A working Machine.

And while our levels of trust do vary from person to person and from community to community — based on the fact that some people get to see the Machine more up close than others — overall, up until last year, we’ve been living in relative comfort, taught to generally trust our bureaucracies like sweet puppies generally trust their owners with their open-for-petting bellies (including those owners who, on a side note, sterilize their pets at the beginning of their life journeys and then potentially euthanize the mat the end of it, in order to prevent greater suffering; such is our culture).

Relationships of love inside the Machine can be puzzling at times. And so, we’ve been living in relative comfort and relative trust of our bureaucracies, and feeling okay. And then last spring, we were asked to lockdown for two weeks to flatten the curve — and here we are.

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The blood-chilling dehumanization is in vogue. It’s 2021, and we are marching straight into the Great Reset. Everything is “fine.”

And what about the Machine? The Machine is showing its face to most of us at last. It demands that we stop being human, stop touching each other, and bury our faces and our children’s faces under The Mask, “to be good citizens.” It demands that we don’t think and comply. It proclaims that we have no bodily freedom and need to obey.

But another thing that is happening is that we the people are becoming awake. Many people are becoming “mechanics,” looking under the hood — and discovering things we have not thought about before.

For example, how many of us just recently found out that during the Prohibition era, the U.S. government purposely poisoned alcohol to ween the unruly Americans off the forbidden habit?

That particular story went like this: At the time, there was a black market for re-distilled industrial alcohol — and, unhappy with the state of affairs, federal officials “ordered manufacturers to make their products far more deadly.”

According to Slate, “In 1926, President Calvin Coolidge’s government decided to turn to chemistry as an enforcement tool … By mid-1927, the new denaturing formulas included some notable poisons … The Treasury Department also demanded more methyl alcohol be added — up to 10 percent of total product. It was the last that proved most deadly.”

“In 1926, in New York City, 1,200 were sickened by poisonous alcohol; 400 died. The following year, deaths climbed to 700. These numbers were repeated in cities around the country.” (In 1926, the population of the United States was about 117 million people.) “Officially, the special denaturing program ended only once the 18th Amendment was repealed in December 1933.”

And how many of us remember that in 1931, Dr. Cornelius Rhoads, a 1945 recipient of Legion of Merit, infected people with cancer cells while working with the Rockefeller Institute for Medical Investigations in Puerto Rico, “under the auspices of studying hookworm-caused anemia and tropical sprue anemia“?

How many of us know that fourteen years after the Tuskegee experiment started, the U.S. also conducted syphilis experiments in Guatemala, purposely infecting Guatemalan men and women with syphilis?

How many of us know that during the Cold War, MIT researchers and the Quaker Oats Company fed the mentally disabled children at the Walter E. Fernald School in Waltham, MA, doses of radiation in their cereal?

How many of us know that in 1950, in San Francisco, the Navy intentionally hosed a “cloud of microbes into the air and into the city’s famous fog”? The microbe was Serratia marcescens. According to Discover, over a period of six days, “members of the US Navy sprayed clouds of Serratia from giant hoses aboard a Navy minesweeper drifting two miles along the San Francisco coastline.”

As a result, “a week after the spraying, eleven patients were admitted to the now defunct Stanford University Hospital in San Francisco with severe urinary tract infections, resistant to the limited antibiotics available in that era. One gentlemen, recovering from prostate surgery, developed complications of heart infection as Serratia colonized his heart valves.” Unfortunately, he passed away.

According to WJS, in 1950s, “Army researchers dispersed Serratia on Panama City, Fla., and Key West, Fla., with no known illnesses resulting. They also released fluorescent compounds over Minnesota and other Midwestern states to see how far they would spread in the atmosphere. The particles of zinc-cadmium-sulfide — now a known cancer-causing agent — were detected more than 1,000 miles away in New York state.”

Another bacterium, Bacillus globigii, “was released in San Francisco, while still others were tested on unwitting residents in New York, Washington, D.C., and along the Pennsylvania Turnpike, among other places, according to Army reports released during the 1977 hearings.”

How many of us know that in 1966, in New York, military researchers dispersed Bacillus subtilis variant Niger, believed to be harmless at the time and currently considered to be a pathogen, in the subway system, by dropping lightbulbs filled with the bacteria onto tracks in stations in midtown Manhattan?

WSJ wrote that the bacteria were carried for miles throughout the subway system. In a 1968 report, Army officials concluded: “Similar covert attacks with a pathogenic [disease-causing] agent during peak traffic periods could be expected to expose large numbers of people to infection and subsequent illness or death.”

Also notable is the reaction from the public to being fumed over. At the time, in a report titled “A Study of the Vulnerability of Subway Passengers in New York City to Covert Attack with Biological Agents,” the team noted: “When the cloud engulfed people, they brushed their clothing, looked up at the grating and walked on. People in the big city are moving too fast to see what is going on around them.” Sounds familiar?

To further quote WJS, “army officials also found widespread dispersal of bacteria in a May 1965 secret release of Bacillus globigii at Washington’s National Airport and its Greyhound bus terminal, according to military reports released a few years after the Senate hearings. More than 130 passengers who had been exposed to the bacteria traveling to 39 cities in seven states in the two weeks following the mock attack.”

“The Army kept the biological-warfare tests secret until word of them was leaked to the press in the 1970s. Between 1949 and 1969, when President Nixon ordered the Pentagon’s biological weapons destroyed, open-air tests of biological agents were conducted 239 times, according to the Army’s testimony in 1977 before the Senate’s subcommittee on health.

In 80 of those experiments, the Army said it used live bacteria that its researchers at the time thought were harmless, such as the Serratia that was showered on San Francisco. In the others, it used inert chemicals to simulate bacteria.”

In 1975, the New York Times published an article detailing various military experiments that took place in 1960s. In particular, it talked about the 1966 subway experiment in New York and various other “exotic” experiments and weapons.

The New York Times story focused on the testimony by Charles Senseney, “a project engineer who developed weapons such as an electric poison dart gun and a system to spread biological poison from a fluorescent bulb.”

Charles Senseney told the Senate Select Committee on Intelligence that he “took part in the New York ‘vulnerability study’ as one of many such efforts aimed at testing the dangers of biological warfare … Mr. Senseney said the studies [were] conducted by the staff of the Army laboratories at Fort Detrick, Md … They included tests at the White House, the Pentagon, a Food and Drug Administration building in Washington and McGuire Air Force Base in New Jersey.”

Additionally, Mr. Senseney confirmed that “the Fort Detrick labs had secretly placed a colored dye into the water system of a Washington building used by the Food and Drug Administration to test how fast the occupants could be killed or incapacitated by introducing a biological agent into the water system. Mr. Senseney said he had developed a special drill that allowed the dye to be punched into a water pipe without leakage or change in the water pressure.”

A question: How many Americans at the time had any idea that all this was happening? I would bet that even today, this might come as a shock to many. Stay safe?

And how many of us are aware that from 1963 to 1973, under Project SHAD, numerous sets of tests were performed, “many involving multiple releases of biological or chemical agents in locations as far-ranging as the Deseret Test Center (80 miles from Dugway), Hawaii, the Panama Canal Zone, and off the coast of San Diego?”

Among the substances and organisms released were F. tularensis, Coxiella burnetti, Staphylococcal enterotoxin B), as well as the nerve agents sarin, tabun, soman, and VX. “One or more of these potential biological or chemical weapons were used in 26 SHAD tests.

Biological simulants were also released: B. globigii in 24 tests, S. marcescens in 7 tests, and E. coli in 5 tests.” This list of experiments is incomplete and doesn’t even touch on Fauci or Daszac — but even an incomplete list should make us stop and ponder why we are living in a world like this.

Speaking of experiments, here is a thought-provoking interview with Dr. Lee Merritt in which she and Mike Adams discuss the possibility of spikes having been scattered over target cities.


And then my mind comes back to the experiment happening right now in the open in my city, where they are releasing “harmless substances” on the New York subway and in various populous locations. Among those substances are DNATrax, amorphous silica, sulfur hexafluoride, and perfluorocarboms.

Will we hear in ten or twenty or fifty years that it was a really bad idea, and that whatever they thought was harmless (wink, wink) was toxic? If history is any proof, we probably will. That is, if Mother Nature saves us again and we survive mad science and mad feudal owners for the millionth time.

If we do, I hope, we will wake up to our senses and stop accepting abuse. Just stop accepting abuse. Abuse is not cool. The end.

Destruction of Medicine? A Bill to Allow Prescriptions by AI

On September 30, 2021, David Schweikert (R-Ariz.) introduced a bill (HR5457) that, if enacted, would qualify AI as a medical practitioner, eligible to prescribe drugs.

Whoa there. That puts the conversation about the professional sovereignty of physicians in a whole different context — and sadly, that reformist context has been there all along. Let’s first look at the text of the bill. It says the following:

“To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administration, and for other purposes.”

The part where it says “for other purposes” is interesting. What if AI determines that something is safe and effective — and it should be mandated? It’s hard to debate with AI. The safe and effective thing could be a therapy, a nutritional system to fight climate change, a mental hygiene regime — anything, really. Drug prescription is just a foot in the door but the sky is the limit. And who do we sue?

And who is David Schweikert? Currently, he is serving his sixth term in the United States Congress. At the moment, he “sits on the Ways and Means Committee, having previously served on the Financial Services Committee.

He also sits on the bicameral Joint Economic Committee, serving as the Senior House Republican Member, Co-Chairs the Valley Fever Task force with House Minority Leader Kevin McCarthy, is the Republican Co-Chair of the Blockchain Caucus, Co-Chair of the Tunisia Caucus, and Co-Chair of the Tele Health Caucus.”

According to his website, he “championed key reforms such as the Secret Science Reform Act, which has passed the House of Representatives.” That particular reform was interesting as it used the “good” language of scientific transparency to limit the powers of the already not very useful EPA.

Interestingly, his website also calls him a “national leader on tribal policy,” working with Arizona’s tribal communities on important priorities. Lots to ponder.

So let’s talk about why this bill is significant — regardless of whether it passes or not. The bill serves the obvious practical purpose and a psychological purpose. If it passes and stays, then we can kiss our medical sovereignty goodbye for some time — since arguing with a robot is much harder than arguing with the most menacing and unmovable Soviet cashier of my childhood (a personal memory; I was terrified of cashiers)!

But whether it passes of not, it’s a sign of where the wind is blowing and an act of widening of what’s psychologically acceptable. In other words, an act of eating at our sanity. And of course, the desire to possibly replace the current medical system with AI and telemedicine predates COVID. Let’s go back in time.

The year was 2019. The name of the committee was National Security Commission on Artificial Intelligence (NSCAI). The committee, chaired by Eric Schmidt of Google, issued a report called, “Chinese Tech Landscape Overview.”

In that report, obtained by EPIC through a FOIA request, the committee talked about the AI race between the U.S. and China, and what kind of “legacy systems” in the U.S. were in the way of winning. (If you want to see their most recent report — which is very long and, unlike the 2019 FOIA-obtained report, was meant for public display and thus was worded far more diplomatically — you can find it here.)

Now, an important note. I personally believe that the competition between different countries is not what drives this trend — and that Eric Schmidt, out of all people alive today, is using “international competition” as an excuse to attempt installing his favorite AI on top of the people (but underneath his friends, of course).

Which is not to say that international competition does not exist — of course it does — but the attempted reform that goes under the names of the Great Reset, 4IR, or Happytalism, is supranational, in my opinion. However, using a bogeyman (be it “China,” “America,” “Russia,” or “COVID”) is a proven strategy.

(Speaking of using the “crisis mode,” here is a very interesting 2015 paper titled, “Rapid Medical Countermeasure Response to Infectious Diseases: Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary.” It talks about coronaviruses. This bit below mentions a quote by Peter Daszak talking about the development of pan-influenza and pan-coronavirus vaccines.)

quote by peter daszak

Going back to the 2019 NSCAI report, the committee, first written about in detail by Whitney Webb on Last American Vagabond, “was created by the 2018 National Defense Authorization Act (NDAA) and its official purpose is ‘to consider the methods and means necessary to advance the development of artificial intelligence (AI), machine learning, and associated technologies to comprehensively address the national security and defense needs of the United States.'”

To further quote Whitney, who did an outstanding job two years ago covering this development, the report “says that ‘creation,’ followed by ‘adoption’ and ‘iteration’ are the three phases of the ‘life cycle of new tech’ and asserts that failing to dominate in the ‘adoption’ stage will allow China to ‘leapfrog’ the U.S. and dominate AI for the foreseeable future.”

three phases of the life cycle of new tech

The report mentions that while the United States is leading in the “creation” phase of AI development, China is leading in the “adoption” phase due to specific “structural factors,” framed in the report as very advantages to winning the AI race.

To be clear, the report does not directly say anything like, “it would be great if we were a little more like China in terms of those structural factors.” It does not say that directly. But it seems to imply it as it describes winning the AI race as absolutely desirable and then lists the American “legacy” systems as obstacles on the way.

legacy systems
good enough hinders adoption

What does the report says about medicine? It seems to frown at the medicine of today and to favor AI and telemedicine. Please see below:

AI for medical diagnosis

Conclusion?

My subjective conclusion is that perhaps putting AI in charge of medicine has always been the goal? Perhaps the illogical and abysmal state of “human” medicine in 2021 is not coincidental? 

So far, we’ve seen scientific and medical censorship, unhelpful official protocols, forced closures of hospitals, artificially created staffing shortages — and perhaps at least in part we are seeing it because it helps the advancement of 4IR?

Perhaps?

It looks like the things that we consider generally good for people, such as having in-person access to a caring doctor — or the “regulatory barriers” protecting our privacy — all those natural things are viewed as undesirable by our aspiring masters.

Their proverbial New Normal is not for people. It’s for the people’s “owners.” (By the way, AI is not human or conscious, no matter how hard they spin it. AI is software. Somebody owns the software, including medical software. Somebody pays for it, somebody writes it, somebody patents it, somebody owns it. This whole “AI going conscious” thing is a well-funded con job in my opinion — just like the sale of “immortality” via converting to a data bundle.)

When it comes to medicine, in the New Normal, sovereign physicians (and sovereign patients) are a liability and an inconvenience. The New Normal does not fancy human subjectivity — not philosophically and not economically. The New Normal is about effective asset management, where regular citizens are a class of assets, just like machines or minerals.

Assets are supposed to be useful and are not supposed to think. The entire foundation of the New Normal social system is the denial of free will.

The New Normal does not account for privacy or personal space. It’s a new digital order — with citizens united in homogeneity, under AI. It’s not about balance or sustainable frolicking in the grass while the robot toils — it’s about converting our creative energy into the fuel for the machine. It’s essentially anti-life.

Another tangential but very curious window into how the crazies think is this 2001 report titled, “Future Strategic Issues/Future Warfare [Circa 2025]“. It has every dystopian trick on the book, even “co-opted insects.” And I suppose it’s possible to weaponize insects, viruses, or art. It’s all been tried. But no matter what the broken ones think or do, their abuse is temporary.

Dysfunction produces pain. Pain produces questions. Questions produces resistance. Resistance produces change. And then it breaks. This time around, too, life will prevail — and that’s regardless of what the technocrats desire.

A note: Philosophy and emotions are important at the time of the Great Reset because they remind us of who we are and help us to fight for life. The maniacs can think up a world in which we are soulless assets. They can pass bills in which we report to AI. But if we refuse to shut down our hearts, in the end we win.

I’d like to finish this story with an open question from the beautiful film called “A Hidden Life.” In this film, the protagonist asks a priest, “If our leaders, if they are evil, what does one do?” What does one do? I am thinking, maybe we have a duty to our hearts and the generations past. And maybe this time around, we get to live.

Moderna: A Company “In Need of a Hail Mary”

Before COVID-19, Moderna was in danger of hemorrhaging investors, as persistent safety concerns and other doubts about its mRNA delivery system threatened its entire product pipeline. Fear caused by the pandemic crisis made those concerns largely evaporate, even though there is no proof that they were ever resolved.

Those analyzing the COVID-19 crisis and its effects have mostly focused on how its disruptive nature has led to major shifts and recalibrations throughout society and the economy. Such disruption has also lent itself to a variety of agendas that had required an event of “reset” potential in order to be realized.

In the case of the vaccine industry, COVID-19 has led to dramatic changes in how federal agencies manage the approval of medical countermeasures during a declared crisis, how trials for vaccine candidates are conducted, how the public perceives vaccination, and even how the term “vaccine” is defined.

Such shifts, though obvious, have provoked praise from some and sharp criticism from others, with the latter category being largely censored from public discourse on television, in print, and online. However, in objectively analyzing such seismic changes, it’s clear that most of these shifts in vaccine development and vaccine policy dramatically favor speed and the implementation of new and experimental technology at the expense of safety and thorough study.

In the case of vaccines, it can be argued that no one benefitted more from these changes than the developers of the COVID-19 vaccines themselves, particularly the pharmaceutical and biotechnology company Moderna.

Not only did the COVID-19 crisis obliterate hurdles that had previously prevented Moderna from taking a single product to market, it also dramatically reversed the company’s fortunes. Indeed, from 2016 right up until the emergence of COVID-19, Moderna could barely hold it together, as it was shedding key executives, top talent, and major investors at an alarming rate.

Essentially, Moderna’s promise of “revolutionizing” medicine and the remarkable salesmanship and fund-raising capabilities of the company’s top executive, Stéphane Bancel, were the main forces keeping it afloat.

In the years leading up to the COVID-19 crisis, Moderna’s promises — despite Bancel’s efforts — rang increasingly hollow, as the company’s long-standing penchant for extreme secrecy meant that — despite nearly a decade in business — it had never been able to definitively prove that it could deliver the “revolution” it had continually assured investors was right around the corner.

This was compounded by major issues with patents held by a hostile competitor that threatened Moderna’s ability to turn a profit on anything it might manage to take to market, as well as major issues with its mRNA delivery system that led them to abandon any treatment that would require more than one dose because of toxicity concerns.

The latter issue, though largely forgotten and/or ignored by media today, should be a major topic in the COVID-19 booster debate, given that there is still no evidence that Moderna ever resolved the toxicity issue that arose in multi-dose products.

In this first installment of a two-part series, the dire situation in which Moderna found itself immediately prior to the emergence of COVID-19 is discussed in detail, revealing that Moderna — very much like the now disgraced company Theranos — had long been a house of cards with sky-high valuations completely disconnected from reality.

Part 2 will explore how that reality would have come crashing down sometime in 2020 or 2021 were it not for the advent of the COVID-19 crisis and Moderna’s subsequent partnership with the US government and the highly unusual processes involving its vaccine’s development and approval.

Despite the emergence of real-world data challenging the claims that Moderna’s COVID-19 vaccine is safe and effective, Moderna’s booster is being rushed through by some governments, while others have recently banned the vaccine’s use in young adults and teens due to safety concerns.

As this two-part series will show, safety concerns about Moderna were known well before the COVID crisis, yet they have been ignored by health authorities and the media during the crisis itself. In addition, in order to stave off collapse, Moderna must keep selling its COVID-19 vaccine for years to come. In other words, without the approval of its booster, which has caused great controversy even among the country’s top vaccine officials, Moderna faces a massive financial reckoning.

While the COVID-19 crisis threw the company a lifeboat, the administration of its COVID-19 vaccine, in which the US government has now invested nearly $6 billion, must continue into the foreseeable future for the bailout to be truly successful. Otherwise, a company now worth $126.7 billion, with major investments from the US government, US military, and ties to the world’s wealthiest individuals, will crumble in short order.

A New Theranos?

In September 2016, Damian Garde, the national biotech reporter for the medical media company STAT, wrote a lengthy exposé of the “ego, ambition, and turmoil” plaguing “one of biotech’s most secretive startups.” The article focused on the company Moderna, which had been founded in 2010 to commercialize the research of Boston Children’s Hospital cell biologist Derrick Rossi.

The effort to turn a profit by creating Moderna, which intimately involved controversial scientist and close Bill Gates associate Bob Langer as well as Cambridge, Massachusetts–based Flagship Ventures (now Flagship Pioneering), began soon after Rossi published a report on the ability of modified RNA to turn skin cells into different types of tissue.

Between the time of Moderna’s founding and Garde’s 2016 investigation, the buzz around Rossi’s research and its potential to create medical breakthroughs had waned, as had the buzz around its potential to make its investors very wealthy.

Despite teaming up with pharmaceutical giants like AstraZeneca and raising record amounts of funding, Moderna still had no product on the market six years after its founding, and, as STAT revealed, the “company’s caustic work environment” had led to a persistent hemorrhaging of top talent, though little of its internal conflicts was publicly known due to “its obsession with secrecy.”

Most troubling for the company that year, however, was that Moderna appeared to have “run into roadblocks with its most ambitious projects.”

moderna ceo stephane bancel
Moderna CEO Stéphane Bancel

Aside from the scientific obstacles that Moderna had encountered, one major “roadblock” for the company, per Garde, was none other than Stéphane Bancel, Moderna’s top executive, who still heads the company. According to Garde, Bancel was squarely at the center of many of the company’s controversies due, in part, to his “unwavering belief that Moderna’s science will work — and that employees who don’t ‘live the mission’ have no place in the company.”

Between 2012 and 2016, Bancel was allegedly a key factor in the resignation of at least a dozen “highly placed executives,” including those who directed Moderna’s product pipeline as well as its vaccine projects.

Bancel, prior to joining Moderna, had spent much of his career in sales and operations, not science, making a name for himself at pharmaceutical giant Eli Lilly before heading a French diagnostics firm called bioMérieux. His performance there, as well as his ambition, caught the attention of Flagship Ventures, a Moderna cofounder and top investor, which then connected him with the company he would go on to lead.

Although lacking a background in mRNA and the science behind its use as a therapeutic, Bancel has made up for it by becoming Moderna’s salesman par excellence. Under his leadership, Moderna became “loath to publish its work in Science or Nature, but enthusiastic to herald its potential on CNBC and CNN.”

In other words, under Bancel, the company came to promote its science through media publicity and public relations rather than by publishing actual data or scientific evidence. When two of its vaccine candidates entered phase 1 human trials in 2016 (trials that ultimately went nowhere), the company declined to list them on the public federal registry ClinicalTrials.gov.

The decision not to list, which deviates from common practice by Moderna’s competitors and other more traditional vaccine companies, meant that the information on the safety of these vaccine candidates would likely never be publicly available after the trial’s conclusion. Moderna also refused to publicly comment on what diseases these vaccines were meant to target.

Such secrecy became commonplace at Moderna after Bancel took the helm, with the company having published no data “supporting its vaunted technology” by the time STAT’s 2016 exposé was published. Insiders as well as investors that had committed millions to the company were only granted “a peek” at the company’s data.

According to former Moderna scientists who spoke to STAT, the company was “a case of the emperor’s new clothes.” Former employees further charged that Bancel was actually “running an investment firm” and “then hop[ing] it also develops a drug that’s successful.”

Perhaps this is why Bancel was deemed the best executive to steer Moderna. As an ambitious salesman running a highly overvalued company, he would prioritize the company’s image and its finances regardless of any issues with the science underpinning it all. Perhaps it was for that reason that Bancel, per former employees, “made it clear [from the beginning] that Moderna’s science simply had to work. And that anyone who couldn’t make it work didn’t belong.”

As STAT noted in 2016, the people who were tasked with making “the science work” were those who most frequently resigned, which led to Moderna losing two heads of chemistry within a single year, followed shortly by losing its chief scientific officer and its head of manufacturing. Many top executives, including the heads of its cancer research and rare disease research branches, ended up lasting fewer than eighteen months in their respective positions.

The abrupt resignations weren’t exclusive to Moderna’s science-focused executive positions either, as the chief information officer and top financial executive role were also affected. Bancel ultimately sought advice from the human resources departments of Facebook, Google, and Netflix on employee retention.

Particularly telling was the abrupt and mysterious resignation of Moderna’s head of research and development, Joseph Bolen, after about two years at the company. A company insider at the time told STAT that the only reason Bolen would have resigned was if “there was something wrong with the science or the personnel.”

In other words, Bolen either left because the science underpinning Moderna’s massive valuation did not live up to the hype or Bancel had forced him out, with the additional possibility that both were key in Bolen’s resignation.

Speculation at the time pointed the finger at Bancel, though it’s not clear why the rift between the two men emerged. Bancel asserted that he tried to convince Bolen to stay, though there were contrasting assertions from anonymous employees, and that Bolen had “voted himself off the island.”

Whatever the exact cause of the resignation of the head of R & D, it only added to the mystique around Moderna’s inner workings and its ability to deliver on its promise to “revolutionize” medicine. It also reveals more than a few similarities between Moderna and the now-disgraced company Theranos.

Theranos, whose former top executive, Elizabeth Holmes, is now on trial for fraud, was known for its extreme culture of secrecy that kept investors and business partners in the dark, forced nondisclosure agreements on everyone who came in contact with the company, and kept employees “siloed” through an extremely strict need-to-know policy.

Like Moderna, Theranos had been praised as revolutionary and poised to “change the medical industry forever.” Similarly, its top executive had no professional health-care or science experience, yet both fired or forced the resignations of employees who disagreed with their perspective or were unable to provide “positive” results.

Both companies also failed to publish any evidence in peer-reviewed journals that the science behind their multibillion-dollar valued companies was more than just fantasy and a well-devised sales pitch.

Arguably, the most critical difference between Moderna and Theranos is that Moderna, whose numerous issues and challenges only came to light after the collapse of Theranos had begun, has never faced the same degree of scrutiny from the US government or mainstream investigative journalists.

There are many possible reasons for this, including Moderna’s close relationship with the US Department of Defense through the Defense Advanced Research Projects Agency (DARPA), or concern that its exposure post-Theranos would bring scrutiny to any company existing at the intersection of Silicon Valley and the health-care industry.

However, such a reckoning would likely have been inevitable for Moderna had it not been for the COVID-19 crisis, which could not have come at a more convenient time for the company.

Moderna’s “Software” Encounters Bugs

Many of the problems with Moderna that Garde identified in 2016 continued to plague the company right up until the beginning of the COVID-19 crisis. Chief among these was Moderna’s struggle to prove that its technology worked and that it was safe.

Concerns about the safety and efficacy of the company’s products, which were publicly reported beginning in 2017, evaporated in the wave of panic surrounding COVID-19 and the simultaneous “Warp Speed” race for a vaccine that would “end the pandemic.”

Yet, there is little, if any, evidence that these once-well-recognized concerns were addressed prior to the US government’s emergency use authorization of Moderna’s COVID-19 vaccine and its now widespread use in many countries around the world. To the contrary, there is evidence that these concerns were covered up both prior to and during the development of its vaccine.

moderna office in cambridge massachusetts
Moderna’s office in Cambridge, Massachusetts

The reports that emerged in January 2017 noted that Moderna had “run into troubling safety problems with its most ambitious therapy” and that the company was “now banking on a mysterious new technology to keep afloat.”

The “ambitious therapy” in question was meant to treat Crigler-Najjar syndrome and “was to be the first therapy using audacious new technology that Bancel promised would yield dozens of drugs in the coming decade.” Bancel had specifically used the Crigler-Najjar therapy as a major selling point to investors, particularly in 2016 when he touted it at the JP Morgan Healthcare Conference.

Yet, employees of Alexion, the company co-developing the drug with Moderna, blew the whistle on the project in 2017, revealing that it “never proved safe enough to test in humans” and that the failure of this therapy and the technology platform it sought to use had been responsible for prompting Moderna to abandon the class of drug therapies that, for years, had justified its sky-high valuation and attracted hundreds of millions in investor cash.

As a result of the problem with the Crigler-Najjar drug, media outlets asserted that Moderna was now “in need of a Hail Mary” that would keep its valuation from imploding and its investors from fleeing. The persistence of problems first noted in the 2016 STAT investigation, such as Moderna’s failure to publish meaningful data supporting its mRNA technology, were only exacerbating the company’s increasingly precarious position.

Indeed, not long before the indefinite delay of the Crigler-Najjar therapy, Bancel had dismissed questions about Moderna’s promise by painting mRNA as an easy way to quickly develop novel treatments for a variety of diseases. He stated that “mRNA is like software: You can just turn the crank and get a lot of products going into development.”

If that were the case, why did the company have no products on the market after nearly seven years, and why had its most touted project experienced such obstacles? Clearly, in keeping with Bancel’s “software” metaphor, Moderna’s technology had encountered bugs, bugs that were potentially ineradicable.

It turns out that the Crigler-Najjar drug therapy that Moderna had bet on so heavily had failed because of the lipid nanoparticle delivery system it used to transport mRNA into cells. Crigler-Najjar had been chosen as a target condition because Moderna scientists deemed it to be “the lowest-hanging fruit.”

First, the syndrome is caused by one specific genetic defect; second, the affected organ, the liver, is among the easiest to target with nanoparticles; and third and most important for the company, treating the disease with mRNA would require frequent doses, ensuring a steady stream of income for the company.

Thus, given the first two motives behind the company’s focus on Crigler-Najjar, if Moderna couldn’t develop a therapy for that condition, it meant they wouldn’t be able to develop a therapy for other conditions that, for example, were caused by multiple genetic defects or affected multiple organs or those more resistant to nanoparticle-based treatments.

In other words, that “Moderna could not make its therapy [for Crigler-Najjar] work” meant that it was unlikely to make therapies of that entire class work either.

Indeed, media reports on the indefinite delay of this particular therapy noted that “the indefinite delay on the [Moderna] Crigler-Najjar project signals persistent and troubling safety concerns for any mRNA treatment that needs to be delivered in multiple doses.”

This issue would soon lead Moderna to only pursue treatments that could be delivered as a single dose — that is, until the emergence of COVID-19 and the advent of the COVID-19 vaccine booster debate. It is also worth mentioning that, due to the extreme rarity of Crigler-Najjar syndrome, even if the therapy had been successfully taken to market by Moderna, it would have been unlikely to bring in enough money to sustain the company.

The specific problem Moderna encountered with the Crigler-Najjar treatment was related to the lipid nanoparticle delivery system it was using. According to former Moderna employees and their collaborators at Alexion, “The safe dose was too weak, and repeat injections of a dose strong enough to be effective had troubling effects on the liver [the target organ of this particular therapy] in animal studies.”

This was an issue Moderna had apparently run into with its nanoparticle delivery system in other cases too, according to reports published at the time. Per STAT, the delivery system employed by Moderna had consistently “created a daunting challenge: Dose too little, and you don’t get enough enzyme to affect the disease; dose too much, and the drug is too toxic for patients.”

Moderna attempted to offset the bad press over having to delay the Crigler-Najjar drug with claims that they had developed a new nanoparticle delivery system called V1GL that “will more safely deliver mRNA.” The claims came a month after Bancel had touted another delivery system called N1GL to Forbes.

In that interview, Bancel told Forbes that the delivery system they had been using, licensed to them by Acuitas, “was not very good” and that Moderna had “stopped using Acuitas tech for new drugs.” However, as will be explored in detail in this report as well as Part II of this series, it appears that Moderna continued to rely on the Acuitas-licensed technology in subsequent vaccines and other projects, including its COVID-19 vaccine.

Former Moderna employees and those close to their product development were doubtful at the time that these new and supposedly safer nanoparticle delivery systems were of any consequence. According to three former employees and collaborators close to the process who spoke anonymously to STAT, Moderna had long been “toiling away on new delivery technologies in hopes of hitting on something safer than what it had.”

All of those interviewed believed that “N1GL and V1GL are either very recent discoveries, just in the earliest stages of testing — or else new names slapped on technologies Moderna has owned for years.” All spoke anonymously due to having signed nondisclosure agreements with the company, agreements that are aggressively enforced.

One former employee, commenting on the alleged promise of N1GL and V1GL, stated that these platforms “would have to be a miraculous, Hail Mary sort of save for them to get to where they need to be on their timelines … Either [Bancel] is extremely confident that it’s going to work, or he’s getting kind of jittery that, with a lack of progress, he needs to put something out there.”

stephen hoge melissa moore
Stephen Hoge, Moderna’s president, and Melissa Moore, Moderna’s CSO for Platform Research Source: Moderna

It seems that those former employees who believed that N1GL and V1GL were new names put on existing technology and that Bancel was overselling their promise were correct, as Moderna appears to have returned to the troubled lipid nanoparticle delivery system it had licensed from Acuitas for subsequent therapies, including its COVID-19 vaccine.

As will be explored in this report and Part II of this series, there is no evidence that Moderna ever got their “Hail Mary” save when it came to acquiring the rights for or developing a safe mRNA delivery system.

On top of the much-touted promises of N1GL and V1GL as safer treatments, Moderna additionally vowed to create “new and better formulations” for the Crigler-Najjar therapy that could potentially make it to human trials at a later time. This helped to stave off more bad press, but only for a few weeks.

One month after the troubles with the Crigler-Najjar therapy were publicly reported, the head of Moderna’s oncology division, Stephen Kesley, left the company. This was just as Moderna was moving toward its first human trials for its cancer treatment, which forced “a senior leadership team with little experience in developing drugs to sort out the company’s future in the field.”

Just weeks before Kesley’s departure, Bancel had boldly claimed in a bid to woo new investors at the JP Morgan Healthcare Conference, held in January 2017 in San Francisco, that oncology was Moderna’s “next big opportunity after vaccines.”

The same month as Kesley’s departure, Moderna was able to draw media attention elsewhere, as for the very first time they published data in a peer-reviewed journal. In Cell, its scientists published data on an animal trial for its Zika vaccine candidate that positively demonstrated both efficacy and safety in mice.

While animal trial results do not necessarily translate into equivalent results in humans, the results were deemed to “bode well” for Moderna’s planned clinical trial of that vaccine candidate in humans. In addition, the results were like the animal trial results published by Moderna competitor BioNTech for their mRNA vaccine candidate for Zika a month earlier.

However, for Moderna, the positive news was muted by a negative ruling on a legal dispute that threatened Moderna’s ability to ever turn a profit on the Zika vaccine or any other mRNA vaccine it developed, a threat that Moderna’s competitors, such as BioNTech, didn’t have to contend with.

That ruling, discussed in greater detail later in this report, greatly restricted Moderna’s use of the lipid nanoparticle delivery system licensed to it through Acuitas and directly threatened the company’s ability to create a for-profit product using intellectual property tied to the relevant patents.

It would also kick off a years-long legal dispute that has suggested at various times that the promises of V1GL and N1GL were either completely invented or greatly exaggerated, as former Moderna employees and collaborators had stated.

Not long afterward, in July 2017, Moderna was hit with yet another wave of bad press as their partner in the Crigler-Najjar venture, Alexion, cut ties with the company completely. Moderna downplayed Alexion’s decision and claimed it had acquired “extensive knowledge” that would allow it to continue to develop the troubled therapy on its own.

Nonetheless, Alexion’s decision came at an inopportune time for the company, as one of Moderna’s top investors had just two weeks earlier slashed its valuation of the company by almost $2 billion, allegedly because Moderna had “struggled to live up to its own hype.” Reports began to circulate claiming that “Moderna’s investors might be losing faith in the company’s future.”

Indeed, the Crigler-Najjar syndrome drug was not the only one that, at that point, had proven “too weak or too dangerous to test in clinical trials,” according to former employees and partners.

The persistent issue, which again lay with the nanoparticle delivery system Moderna had licensed from Acuitas, had forced the company, beginning with the delay of the Crigler-Najjar therapy, to “prioritize vaccines, which can be dosed just once and thus avoid the safety problems that have plagued more ambitious projects.”

Yet, these single-dose “vaccines” or therapies were considered not as lucrative as the drug therapies Moderna had long promised and that underpinned its multibillion-dollar valuation, thereby forcing the company to “bet big on a loss-leader.” Also problematic was that Moderna lagged behind its mRNA vaccine competitors and that the supposed promise of its technology to produce viable vaccines was only “proven” at that point by a single, small trial.

That trial, as noted by the Boston Business Journal, was an “early-stage human trial that was primarily meant to assess the safety of an avian flu vaccine.” Moderna had claimed, despite the trial being designed to assess safety, that it had “provided evidence that the vaccine is effective, with no major side effects” as well.

Furthermore, as will be discussed in a later section of this report, the legal dispute over the Acuitas-licensed lipid nanoparticle system threatened Moderna’s ability to ever turn on a profit on any mRNA vaccine it managed to get through trials and the federal approval process, making the company’s future appear quite grim.

Despite Positive Press, Lingering Questions Remained

In September 2017, at a closed-door investor event meant to prevent more major investors from devaluing the company or jumping ship, Moderna provided more insight into a recently published press release on the trial results of a therapy meant to regrow heart tissue by boosting production of a protein known as VEGF.

The press release, which generated positive media headlines, noted that the therapy had been proven safe in a study with a sample size of 44 patients. However, neither the press release nor the data Moderna disclosed to investors at the closed-door meeting revealed how much protein the therapy caused patients to produce, leaving its efficacy a mystery.

Indeed, media reports on the investor meeting noted that “since Moderna did not release that crucial data point, outsiders can’t judge how much therapeutic potential there may be.”

The results, though they seemed to mitigate the concerns over the safety of Moderna’s technology, failed to inspire confidence in many attendees. Several attendees later told reporters that they “were not overly impressed” with Moderna’s presentation, which only “underlined lingering questions about whether it can live up to its own hype.”

One of the issues here, yet again, is that Moderna’s valuation was and is underpinned by its promise to produce products for rare diseases that require repeated injections over a patient’s lifetime. The VEGF therapy promoted by Moderna at this meeting was meant to be a one-time-only injection, and, thus, evidence of its safety did not resolve the problem of none of Moderna’s multi-dose products having proven safe enough to test on humans.

The closed-door investor event made it clear that Moderna was aiming to avoid that persistent problem by prioritizing single-dose vaccines. As STAT noted at the time:

“The presentation to investors also made clear that Moderna is prioritizing vaccines. They are easier to develop from mRNA because patients need just one dose, which eliminates some of the safety issues that have plagued more ambitious projects such as therapies for rare diseases.”

The pivot to vaccines remained a sore point with many investors, however, as vaccines are viewed as “low-margin product[s] that can’t generate anywhere near the profits seen in more lucrative fields like rare diseases and oncology.” These, as previously mentioned, are the very fields on which Moderna’s massive valuation had been based but for which it had been unable to produce safe and effective therapies.

Moderna was clearly aware of these concerns among its current and potential investor base and attempted to speak promisingly of its oncology-related efforts at this same event. However, it was silent on trial timing and other key data points, maintaining the company’s long-standing reputation for secrecy towards both insiders and the general public.

It is certainly telling that Moderna remained so secretive about key data at an event not only closed to the public and the press, but meant to reassure existing investors and to entice new ones. If Moderna declined to show important data to investors at a time when it was desperately seeking to keep them onboard, it implies that the company either had something to hide or nothing to show.

Moderna’s increasingly troubled internal situation, despite its consistently rosy PR, escalated a month later when reports emerged of the abrupt resignations of its head of chemistry, the leader of its cardiovascular division, and the head of its rare diseases division. These resignations, which occurred toward the end of 2017, followed the high-profile resignations the company suffered that were mentioned in the 2016 STAT exposé by Damian Garde.

A few months later, in March 2018, the chief scientific officer of Moderna’s vaccine business, Giuseppe Ciaramella, also left.

This resignation signaled further internal troubles at the company, even more because Moderna had recently and very publicly pivoted to vaccines; and Ciaramella, in addition to leading vaccine development at this critical juncture, had been the first Moderna executive to suggest that the company’s technology could be useful in developing vaccines, a suggestion that the company was now betting everything on.

One can’t help but wonder if Bancel’s tendency to force out employees and executives who “couldn’t make the science work” was a factor in any of these high-profile resignations, including that of Ciaramella.

A Years-Long Legal Snafu

Thus far, this report has largely focused on how Moderna’s extreme secrecy appears to have been used to obfuscate and mitigate major issues with its technology and product pipeline and how those issues were reaching a climax following the company’s IPO and immediately prior to the COVID crisis.

However, the challenge of creating products that work and can be proven to work in clinical settings is but one of at least two major issues facing Moderna as a company. Indeed, during the same timetable explored above, Moderna was embroiled in aggressive disputes related to intellectual property and patents.

Notably, these same legal issues deal with the lipid nanoparticle system that was also reportedly at the root of Moderna’s safety and product-pipeline issues.

As mentioned earlier, the lipid nanoparticle delivery system used in many Moderna therapies was licensed to them by Acuitas. Acuitas, however, had licensed that system from a separate company, Arbutus, which sued in 2016 claiming that Acuitas’s sublicense to Moderna was illegal. Arbutus won the case, which lead to a temporary injunction in 2017 that stopped Acuitas from further sublicensing the lipid nanoparticle technology.

A settlement reached between Acuitas and Arbutus in 2018 terminated Acuitas’s license and restricted Moderna’s use of the technology to four vaccine candidates that targeted already identified viruses.

Moderna’s Bancel told Forbes in 2017 that the Acuitas/Arbutus system was barely mediocre and that Moderna was developing its own improved delivery system that would not infringe on Arbutus’s intellectual property (the aforementioned N1GL and V1GL systems).

However, soon after Bancel made those claims, Arbutus’s leadership challenged them, stating that the company had reviewed all of Moderna’s patents, publications, and presentations regarding these “new” delivery systems and had found nothing that didn’t involve their own intellectual property.

Even former Moderna employees, as mentioned previously, were very doubtful that N1GL and V1GL were any different than the Acuitas/Arbutus system, meaning that — despite Bancel’s claims — Moderna had unresolved legal woes related to these nanoparticles that, along with the toxicity issues, was stalling Moderna product candidates.

It is important to note at this point that, while only Moderna has been locked in a legal battle with Acuitas/Arbutus for years over LNP intellectual property, the other main producers of mRNA COVID-19 vaccines, Pfizer/BioNTech and CureVac, also use major aspects of the same Arbutus-derived technology. However, BioNTech licensed the LNPs in such a way as to avoid the issues that have entangled Moderna for years.

Moderna’s legal dispute, in addition to the already discussed safety issues, greatly threatened Moderna’s ability to survive as a company. Having already been forced to settle on the vaccines market and reject the more lucrative and “revolutionary” mRNA therapies it had long promised, Moderna was steadily moving toward a position where it had “no right to sell” vaccine products that depended on the Arbutus-patented and Acuitas-sublicensed technology.

This situation has placed pressure on Moderna to negotiate a new license with Arbutus directly, negotiations in which the company would have very little leverage.

Since the first legal case in 2016, Moderna and Arbutus have remained locked in disputes about the nanoparticles and who owns them. Moderna challenged three Arbutus patents with the US Patent and Trademark Office, with mixed results.

Yet, simultaneously, Moderna also claimed that its tech was “not covered by the Arbutus patents,” which prompted numerous observers and reporters to ask questions such as — “In that case, why did [Moderna] initiate the legal action against Arbutus to begin with?”

Moderna answered that query by claiming that it targeted Arbutus only because of Arbutus’s past “aggression” against them. However, despite such claims, the effort and cost inherent in the legal challenge reveals that, at the very least, Moderna takes the threat of Arbutus’s intellectual property claims very seriously.

The actual answer seems to lie in Moderna being willing to publicly claim that their LNP technology is different enough from the Arbutus-derived system covered by the patents but unwilling to release any proof — whether in court, to its own investors, or to the public — that it is in fact different. The more recent twists and turns of this protracted legal battle, including a pivotal 2020 decision that was very unfavorable for Moderna, are discussed in Part II of this series.

Anything to Aid a Slumping Stock Price

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Nasdaq building on the day of Moderna’s 2018 IPO. Source: Nasdaq

Just previous to Ciaramella’s resignation, Moderna had claimed to have “solved the scientific issues that made its earlier mRNA treatments too toxic for clinical trials,” according to media reports. Those reports also claimed that, as a result, “Moderna believes it has steered back on course,” though the company did not provide evidence to support that claim.

Nevertheless, the promise allowed the company to complete a new round of financing, during which it raised an additional $500 million from “an investor syndicate uncommon in biotech” that included the governments of Singapore and the United Arab Emirates.

Some observers were puzzled as to how Moderna had managed to raise so much money despite the outstanding questions about the science underpinning its high valuation.

The answer came with the publication of Moderna’s confidential investor slide deck by STAT’s Damian Garde, which showed that the company had predicted that drugs that they had only been tested in mice would soon be worth billions and that its vaccine revenue would amount to $15 billion annually.

The slide deck, deemed “pretty absurd” and “geared at hopeful generalists that can dream big” per one skeptical investor, made it clear why the company’s last funding round had appealed to “unconventional” biotech investors rather than veteran investors focused on the industry.

A veteran biotech investor, who spoke anonymously due to the slide deck’s confidentiality, stated that “it’s a deck designed to tell the ‘we’re going to be huge’ story to a group of rather unsophisticated investors — and it does that beautifully … Just enough science and platform stuff to convey the ‘We know what we’re doing’ sentiment, but not enough to engender technical questions.”

Per those who sat through Moderna’s pitch, the company was “very generous on the market-size assumptions for their programs,” with one former Moderna collaborator placing the real-world value of a treatment the company had claimed was worth billions annually at closer to “$100 million to 250 million.”

Of course, that revenue estimate comes with the caveat that the treatment, tested thus far only in mice, would someday prove to work in humans. A former Moderna employee in its rare diseases division stated at the time that Moderna “continue[s] to rush forward and over-promise the potential for broad use of mRNA prior to any evidence beyond vaccines or very early experiments in mice.”

Despite Moderna’s ability to convince “unsophisticated” and/or “unconventional” investors to back its early 2018 funding round, it appears that one of its most important promises used to attract investors — that it had solved the nanolipid particle toxicity issue — was not true.

In a filing with the Securities and Exchange Commission dated November 2018, months after Moderna had claimed to have fixed the issues with its lipid nanoparticle delivery system, the company made several claims that appear to contradict its purported development of a new, safer nanoparticle technology. For example, the filing states on page 33:

Most of our investigational medicines are formulated and administered in an LNP [lipid nanoparticle] which may lead to systemic side effects related to the components of the LNP which may not have ever been tested in humans. While we have continued to optimize our LNPs, there can be no assurance that our LNPs will not have undesired effects.

Our LNPs could contribute, in whole or in part, to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation [sic] reactions, antibody reactions including IgA, IgM, IgE or IgG or some combination thereof, or reactions to the PEG from some lipids or PEG otherwise associated with the LNP.

Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events in one or more of our clinical trials. Many of these types of side effects have been seen for legacy LNPs.

There may be resulting uncertainty as to the underlying cause of any such adverse event, which would make it difficult to accurately predict side effects in future clinical trials and would result in significant delays in our programs. (emphasis added)

Based on these statements, Moderna appeared to be uncertain as to whether its current lipid nanoparticle delivery system was any safer than that which led to the indefinite delay of its Crigler-Najjar therapy. In addition, the reference to “adverse reactions within liver pathways,” one of the main issues that triggered the specific delay of the Crigler-Najjar therapy, suggests a continued reliance on technology sublicensed from Acuitas.

As will be noted in Part II, the Moderna COVID-19 vaccine also appears to use the controversial Acuitas technology that had prompted significant safety, legal, and financial concerns for Moderna for years.

The November 2018 SEC filing makes other statements regarding its supposedly fixed lipid nanoparticle delivery system that are worth noting:

If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting trial participants to any of our clinical trials, trial participants may withdraw from trials, or we may be required to abandon the trials or our development efforts of one or more development candidates or investigational medicines altogether …

Even if the side effects do not preclude the drug from obtaining or maintaining marketing approval, unfavorable benefit risk ratio may inhibit market acceptance of the approved product due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition, and prospects.

These statements are significant in that they openly suggest at least one reason for Moderna’s long-standing tendency toward secrecy in publishing data about its treatments, as public knowledge of its technology’s persistent challenges would threaten its ability to attract trial participants, investors, and, later, consumers.

About a month after these troubling admissions were made in fine print, Moderna succeeded in pulling off a record-setting initial public offering (IPO) in December 2018. For that IPO, Moderna had retained the services of eleven investment banks, which is reportedly around “twice the number normally seen in biotech offerings.”

However, its stock value tumbled just hours afterward, “a sign the company and its underwriters might have over-estimated demand for the richly valued company.”

A month after the IPO, Moderna’s stock continued its downward slide, “doing exactly the opposite of what private investors look for in an IPO.” Those who had predicted this post-IPO outcome before Moderna went public had also warned that this downward trend would likely continue through early 2020 if not longer.

Skeptics such as STAT’s Damian Garde had warned right before Moderna’s IPO that that the company’s sliding stock value would likely continue throughout 2019 due to “a seeming lack of impending news,” given that “momentum in biotech, positive or negative, is driven by catalysts” and “Moderna is in for a fairly quiet 2019.”

Meanwhile, media reports warned, as they had for years, that Moderna “is still in the early days of proving [their] technology’s potential,” despite being a nine-year-old company. Such reports also noted that Moderna’s inability to prove its technology’s worth after nearly a decade in business was hampered by its “struggl[e] in its initial efforts to turn mRNA into drugs that can be repeatedly dosed, leading it to pivot to vaccines, which can be administered just once or twice.”

Investors at the 2019 JP Morgan health-care conference spoke of concerns that “Moderna [has] yet to rule out the lingering risks tied to mRNA, and, even at its depressed valuation, the company is simply too expensive.” Others confided in reporters that they would be “sitting on the sidelines until Moderna either changes the narrative with promising human data or gets substantially cheaper.”

A few weeks later, Moderna’s Bancel attended the World Economic Forum’s 2019 annual meeting alongside Johnson & Johnson executive Paul Stoffels and other pharmaceutical and biotech leaders in order to “rub elbows with world leaders and one-percenters — and talk about the future of healthcare.”

Other health-care figures in attendance included head of the World Health Organization, Tedros Adhanom Ghebreyesus, and “global health philanthropist” Bill Gates, whose foundation entered into “a global health project framework” with Moderna in 2016 to “advance mRNA-based development projects for various infectious diseases.”

The Bill & Melinda Gates Foundation is the only foundation listed as a “strategic collaborator” on the Moderna website. Other “strategic collaborators” include the US government’s Biomedical Advanced Research and Development Authority (BARDA), the US military’s DARPA, and pharmaceutical giants AstraZeneca and Merck.

Moderna first teamed up with the WEF just a few years after its founding back in 2013, when it was named to the Forum’s community of Global Growth Companies (GGC). That year, Moderna was one of just three North American health companies to receive the honor and was additionally recognized by the Forum as “an industry leader in innovative mRNA therapeutics.”

“We are honored to be recognized for our efforts to advance our platform and ensure its potential is realized on a global scale, and we look forward to being a member of the World Economic Forum community,” Bancel said at the time.

stephane bancel at the world economic forum annual meeting
Stéphane Bancel at the World Economic Forum Annual Meeting, January 2020. Source: WEF

As a WEF Global Growth Company, Moderna has closely and regularly engaged with the Forum since 2013 at both the Chinese-hosted Annual Meeting of the New Champions and the WEF’s regional meetings, while also having access to the WEF’s exclusive networking platform that provides the company privileged access to the world’s most powerful business and government leaders.

Additionally, such carefully selected companies are given opportunities by the Forum “to shape global, regional and industry agendas and engage in meaningful exchanges about ways to continue on a sustainable and responsible path of growth.”

Essentially, the roster of such companies constitutes a consortium of corporations that are promoted and guided by the Forum because of their commitment to “improving the state of the world,” that is, their commitment to supporting the Forum’s long-term agendas for the global economy and for global governance.

In April 2019, Moderna published some information on modifications to its lipid nanoparticles (discussed in more detail in Part II). A month later, in May 2019, Moderna published positive results in the journal Vaccine for phase 1 data on mRNA vaccine candidates for “two potential pandemic influenza strains” administered as two doses three weeks apart.

The company’s press release on the study stated that “future development of Moderna’s pandemic influenza program is contingent on government or other grant funding,” suggesting that it would use the trial results to lobby the government for funds for a continuation of this particular program.

Notably, at the same time as these results were published, the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, then filled by Robert Kadlec, was in the midst of conducting Crimson Contagion, a multimonth simulation of a global pandemic involving an influenza strain that originates in China and spreads globally through air travel.

The strain at the center of the simulation, called H7N9, is one of the very strains used in the Moderna study.

Moderna published those results on May 10, just four days before the Crimson Contagion simulation hosted its federal interagency seminar. BARDA, which the ASPR office oversees, is a major strategic ally of Moderna and was co-developing these “potential pandemic influenza” vaccines that are mentioned in this timely press release, that is, for H10N8 and H7N9 influenza infections.

Crimson Contagion is notable for several reasons, most significantly for Kadlec’s own history with the Dark Winter simulations that preceded and eerily predicted the 2001 anthrax attacks. As has been discussed in detail in a previous TLAV – Unlimited Hangout investigation, the 2001 anthrax attacks conveniently rescued anthrax vaccine manufacturer BioPort, now Emergent Biosolutions, from certain ruin, much like the way the COVID crisis did for Moderna.

A month later, in June 2019, Moderna again managed to generate positive headlines on making its debut at the American Society of Clinical Oncology annual meeting, where it sought to promote its ability to produce the personalized cancer treatments that had been key to wooing investors both before and after its record-setting IPO.

It was the first time the company had publicly presented data on a cancer treatment, and this particular treatment was being co-developed with Merck. The data showed positive results in preventing relapses in cancer patients whose solid tumors had been removed via surgery, but the trial failed to show any definitive effect in cancer patients whose tumors had not been removed.

Thus, the early data seemed to indicate that Moderna’s treatment would only help cancer patients stay in remission after other medical interventions had been performed. Though the news allowed Moderna to bask in some much-needed positive press and to promote its oncology products in development, some reports rightly noted that it was “still too early for any definitive judgment” on the cancer treatment’s clinical benefit.

Despite this apparent advance, by September 2019, Moderna’s stock price continued to decline, leading to a loss of about $2 billion in market value from the company’s $7.5 billion valuation at the time of its record-setting IPO.

The main factors for this were the same persistent problems the company had been facing for years — lack of progress, including lack of products on the market; persistent safety problems with its mRNA technology; and the lack of data showing that advances were being made to make that technology commercially feasible.

In mid-September 2019, Moderna gathered investors together to showcase scientific evidence it claimed would finally prove that its mRNA technology could “turn the body’s own cells into medicine-making factories” and hopefully “turn skeptical investors into believers.” This data, which was derived from a very preliminary study that involved only four healthy participants, had complications.

Three of the four participants had side effects that prompted Moderna to state at the meeting that they would need to reformulate the mRNA treatment to include steroids, while one of the participants suffered heart-related side effects, including a rapid heart rate and an irregular heartbeat.

Moderna, which asserted that none of the heart-related side effects was serious, could not “definitively pinpoint the cause of the heart symptoms.” Yet, as previously mentioned, it was likely related to the safety issues that had been plaguing its experimental products for years.

The company’s preliminary data, which was promoted in yet another bid to keep investors from leaving, also included the caveat that Moderna had decided to pause trials for this particular product, which was a single-injection mRNA treatment for the chikungunya virus. That treatment was being developed in partnership with the Pentagon’s DARPA.

Other more positive data from a preliminary trial were also released at this meeting. That trial, however, was for an mRNA treatment for cytomegalovirus, “a common virus that is usually kept in check by the body’s immune system and rarely causes problems in healthy people,” meaning its mRNA vaccine for that condition was unlikely to ever be lucrative.

Not long after this lackluster investors meeting, on September 26, 2019, the once highly secretive Moderna announced it would collaborate with researchers at Harvard University “in hopes that the research will spur new drugs,” as its product pipeline appeared to have stalled.

Moderna president Stephen Hoge described the collaboration as select Harvard researchers receiving “a package of stuff that we put our blood, sweat, and tears in, and then someone’s going to do something with it. We’ll find out afterward how that went.” For a company long known for its extreme secrecy in an already secretive industry, Moderna’s arrangement with Harvard, which it admitted was “unusual,” came across as somewhat desperate.

A month later, at the 2019 Milken Institute Future of Health Summit, there was a panel discussion on universal flu vaccines and how a “disruptive” event would be needed to upset the long-existing bureaucratic vaccine-approval process to facilitate wider adoption of “nontraditional” vaccines, such as those produced by Moderna.

Panel speakers including former FDA commissioner Margaret Hamburg, a veteran of the 2001 Dark Winter exercise and scientific advisor to the Gates foundation, as well as Anthony Fauci of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and Rick Bright of BARDA, who previously worked for the Gates-funded PATH.

The panel discussion notably took place shortly after the controversial coronavirus pandemic simulation called Event 201, whose moderators and sponsors had been intimately involved in 2001’s Dark Winter.

2019 milken institute universal flu vaccine panel
Screengrab from the 2019 Milken Institute Universal Flu Vaccine panel. Full video available here.

During the panel, the moderator — Michael Specter of the New Yorker — asked the question: “Why don’t we blow the system up? Obviously, we just can’t turn off the spigot on the system we have and then say ‘Hey! everyone in the world should get this new vaccine we haven’t given to anyone yet,’ but there must be some way.”

Specter then mentioned how vaccine production is antiquated and asked how sufficient “disruption” could occur to prompt the modernization of the existing vaccination development and approval process. Hamburg responded first, saying that as a society we are behind where we need to be when it comes to moving toward a new, more technological approach and that it is now “time to act” to make that a reality.

Several minutes later, Anthony Fauci stated that the superior method of vaccine production involves “not growing the virus at all, but getting sequences, getting the appropriate protein and it sticking in on self-assembling nanoparticles,” essentially referring to mRNA vaccines.

Fauci then stated: “The critical challenge … is that in order to make the transition from getting out of the tried and true egg-growing [method] … to something that has to be much better, you have to prove that this works and then you have got to go through all of the critical trials — phase 1, phase 2, phase 3 — and show that this particular product is going to be good over a period of years. That alone, if it works perfectly, is going to take a decade.”

Fauci later stated that there is a need to alter the public’s perception that the flu is not a serious disease in order to increase urgency and that it would be “difficult” to alter that perception along with the existing vaccine development and approval process unless the existing system takes the posture that “I don’t care what your perception is, we’re going to address the problem in a disruptive way and an iterative way.”

During the panel, Bright stated that “we need to move as quickly as possible and urgently as possible to get these technologies that address speed and effectiveness of the vaccine” before discussing how the White House Council of Economic Advisers had just issued a report emphasizing that prioritizing “fast” vaccines was paramount.

Bright then added that a “mediocre and fast” vaccine was better than a “mediocre and slow” vaccine. He then said that we can make “better vaccines and make them faster” and that urgency and disruption were necessary to produce the targeted and accelerated development of one such vaccine.

Later in the panel, Bright said the best way to “disrupt” the vaccine field in favor of “faster” vaccines would be the emergence of “an entity of excitement out there that’s completely disruptive, that’s not beholden to bureaucratic strings and processes.” He later very directly said that by “faster” vaccines he meant mRNA vaccines.

The Bright-led BARDA and the Fauci-led NIAID in just a few months’ time became the biggest backers of the Moderna COVID-19 vaccine, investing billions and co-developing the vaccine with the company, respectively.

As will be explained in Part II of this series, the partnership between Moderna and the NIH to co-develop what would soon become Moderna’s COVID-19 vaccine was being forged as early as January 7, 2020, long before the official declaration of the COVID-19 crisis as a pandemic and before a vaccine was proclaimed as necessary by officials and other individuals.

Not only did the COVID-19 vaccine quickly become the answer to nearly all Moderna’s woes but it also provided the disruptive scenario necessary to alter the public’s perceptions of what a vaccine is and eliminate existing safeguards and bureaucracy in vaccine approval. (Watch the 2019 Universal Flu Vaccine event here.)

As Part II of this series will show, it was an alleged mix of “serendipity and foresight” from Moderna’s Stéphane Bancel and the NIH’s Barney Graham that propelled Moderna to the front of the “Warp Speed” race for a COVID-19 vaccine.

That partnership, along with the disruptive effect of the COVID-19 crisis, created the very “Hail Mary” for which Moderna had been desperately waiting since at least 2017 while also turning most of Moderna’s executive team into billionaires and multi-millionaires in a matter of months.

However, Moderna’s “Hail Mary” won’t last – that is, unless the mass administration of its COVID-19 vaccine becomes an annual affair for millions of people worldwide. Even though real-world data since its administration began challenges the need for as well as the safety and efficacy of its vaccine, Moderna – and its stakeholders – cannot afford to let this opportunity slip through fingers. To do so would mean the end of Moderna’s carefully constructed house of cards.

The Great New Normal Purge

olbermann

So, the Great New Normal Purge has begun … right on cue, right by the numbers. As we “paranoid conspiracy theorists” have been warning would happen for the past 18 months, people who refuse to convert to the new official ideology are now being segregated, stripped of their jobs, banned from attending schools, denied medical treatment, and otherwise persecuted.

Relentless official propaganda demonizing “the Unvaccinated” is being pumped out by the corporate and state media, government leaders, health officials, and shrieking fanatics on social media. “The Unvaccinated” are the new official “Untermenschen,” an underclass of subhuman “others” the New Normal masses are being conditioned to hate. You can see the hatred in the New Normals’ eyes …

consent factory twitter

But it isn’t just a purge of “the Unvaccinated.” Anyone deviating from the official ideology is being systematically demonized and persecuted.

In Germany, Australia, and other New Normal countries, protesting the New Normal is officially outlawed. The New Normal Gestapo is going around to people’s homes to interrogate them about their anti-New Normal Facebook posts. Corporations are openly censoring content that contradicts the official narrative. New Normal goon squads roam the streets, checking people’s “vaccination” papers.

And it’s not just governments and corporations carrying out the New Normal Purge. Friends are purging friends. Wives are purging husbands. Fathers are purging children. Children are purging parents. New Normals are purging old normal thoughts. Global “health authorities” are revising definitions to make them conform to New Normal “science.”

And so on … a new official “reality” is being manufactured, right before our eyes. Anything and anyone that doesn’t conform to it is being purged, unpersoned, memory-holed, erased. None of which should come as a surprise.

Every nascent totalitarian system, at some stage of its takeover of society, launches a purge of political opponents, ideological dissidents, and other “anti-social deviants.” Such purges can be brief or open-ended, and they can take any number of outward forms, depending on the type of totalitarian system, but you cannot have totalitarianism without them.

The essence of totalitarianism — regardless of which costumes and ideology it wears — is a desire to completely control society, every aspect of society, every individual behavior and thought.

Every totalitarian system, whether an entire nation, a tiny cult, or any other form of social body, evolves toward this unachievable goal … the total ideological transformation and control of every single element of society (or whatever type of social body it comprises). This fanatical pursuit of total control, absolute ideological uniformity, and the elimination of all dissent, is what makes totalitarianism totalitarianism.

Thus, each new totalitarian system, at some point in its evolution, needs to launch a purge of those who refuse to conform to its official ideology. It needs to do this for two basic reasons: (1) to segregate or otherwise eliminate actual political opponents and dissidents who pose a threat to the new regime; and (2) and more importantly, to establish the ideological territory within which the masses must now confine themselves in order to avoid being segregated, or eliminated.

The purge must be conducted openly, brutally, so that the masses understand that the rules of society have changed, forever, that their former rights and freedoms are gone, and that from now on any type of resistance or deviation from official ideology will not be tolerated, and will be ruthlessly punished.

The purge is usually launched during a “state of emergency,” under imminent threat from some official “enemy” (e.g., “communist infiltrators,” “counter-revolutionaries,” or … you know, a “devastating pandemic”), such that the normal rules of society can be indefinitely suspended “for the sake of survival.” The more terrified the masses can be made, the more willing they will be to surrender their freedom and follow orders, no matter how insane.

The lifeblood of totalitarianism is fear … fear of both the system’s official enemy (which is constantly stoked with propaganda) and of the totalitarian system itself. That the brutality of the system is rationalized by the threat posed by the official enemy doesn’t make it any less brutal or terrifying. Under totalitarian systems (of any type or scale) fear is a constant and there is no escape from it.

The masses’ fear is then channeled into hatred … hatred of the official “Untermenschen,” whom the system encourages the masses to scapegoat. Thus, the purge is also a means of allowing the masses to purge themselves of their fear, to transform it into self-righteous hatred and unleash it on the “Untermenschen” instead of the totalitarian system, which, obviously, would be suicidal.

Every totalitarian system — both the individuals running it and the system, structurally — instinctively understands how all this works. New Normal totalitarianism is no exception. Just reflect on what has happened over the last 18 months.

Day after day, month after month, the masses have been subjected to the most destructive psychological-terror campaign in the history of psychological terror. Sadly, many of them have been reduced to paranoid, anus-puckering invalids, afraid of the outdoors, of human contact, afraid of their own children, afraid of the air, morbidly obsessed with disease and death … and consumed with hatred of “the Unvaccinated.”

Their hatred, of course, is utterly irrational, the product of fear and propaganda, as hatred of “the Untermenschen” always is. It has absolutely nothing to do with a virus, which even the New Normal authorities admit. “The Unvaccinated” are no more of a threat to anyone than any other human being … except insofar as they threaten the New Normals’ belief in their delusional ideology.

No, we are way past rationality at this point. We are witnessing the birth of a new form of totalitarianism. Not “communism.” Not “fascism.” Global-capitalist totalitarianism. Pseudo-medical totalitarianism. Pathologized totalitarianism. A form of totalitarianism without a dictator, without a definable ideology. A totalitarianism based on “science,” on “fact,” on “reality,” which it creates itself.

I don’t know about you, but, so far, it has certainly made quite an impression on me. So much so that I have mostly set aside my satirical schtick to try to understand it … what it actually is, why it is happening, why it is happening now, where it is going, and how to oppose it, or at least disrupt it.

The way I see it, the next six months will determine how successful the initial stages of the roll-out of this new totalitarianism will be. By April of 2022, either we’ll all be showing our “papers” to the New Normal Gestapo to be able to earn a living, attend a school, dine at a restaurant, travel, and otherwise live our lives, or we will have thrown a monkey wrench into the machinery.

I do not expect GloboCap to abandon the roll-out of the New Normal over the longer term — they are clearly committed to implementing it — but we have the power to ruin their opening act (which they’ve been planning and rehearsing for quite some time).

So, let’s go ahead and do that, shall we? Before we get purged, or unpersoned, or whatever. I’m not sure, as I haven’t seen a “fact-check” yet, but I believe there are some commercial airline pilots in the USA who are showing us the way.

About the Author

C.J. Hopkins is an award-winning American playwright, novelist and political satirist based in Berlin. His plays are published by Bloomsbury Publishing and Broadway Play Publishing, Inc. His dystopian novel, Zone 23, is published by Snoggsworthy, Swaine & Cormorant.

Volumes I and II of his Consent Factory Essays are published by Consent Factory Publishing, a wholly-owned subsidiary of Amalgamated Content, Inc. He can be reached at cjhopkins.com or consentfactory.org.

Moderna: A Company “In Need of a Hail Mary”

Before COVID-19, Moderna was in danger of hemorrhaging investors, as persistent safety concerns and other doubts about its mRNA delivery system threatened its entire product pipeline. Fear caused by the pandemic crisis made those concerns largely evaporate, even though there is no proof that they were ever resolved.

Those analyzing the COVID-19 crisis and its effects have mostly focused on how its disruptive nature has led to major shifts and recalibrations throughout society and the economy. Such disruption has also lent itself to a variety of agendas that had required an event of “reset” potential in order to be realized.

In the case of the vaccine industry, COVID-19 has led to dramatic changes in how federal agencies manage the approval of medical countermeasures during a declared crisis, how trials for vaccine candidates are conducted, how the public perceives vaccination, and even how the term “vaccine” is defined.

Such shifts, though obvious, have provoked praise from some and sharp criticism from others, with the latter category being largely censored from public discourse on television, in print, and online. However, in objectively analyzing such seismic changes, it’s clear that most of these shifts in vaccine development and vaccine policy dramatically favor speed and the implementation of new and experimental technology at the expense of safety and thorough study.

In the case of vaccines, it can be argued that no one benefitted more from these changes than the developers of the COVID-19 vaccines themselves, particularly the pharmaceutical and biotechnology company Moderna.

Not only did the COVID-19 crisis obliterate hurdles that had previously prevented Moderna from taking a single product to market, it also dramatically reversed the company’s fortunes. Indeed, from 2016 right up until the emergence of COVID-19, Moderna could barely hold it together, as it was shedding key executives, top talent, and major investors at an alarming rate.

Essentially, Moderna’s promise of “revolutionizing” medicine and the remarkable salesmanship and fund-raising capabilities of the company’s top executive, Stéphane Bancel, were the main forces keeping it afloat.

In the years leading up to the COVID-19 crisis, Moderna’s promises — despite Bancel’s efforts — rang increasingly hollow, as the company’s long-standing penchant for extreme secrecy meant that — despite nearly a decade in business — it had never been able to definitively prove that it could deliver the “revolution” it had continually assured investors was right around the corner.

This was compounded by major issues with patents held by a hostile competitor that threatened Moderna’s ability to turn a profit on anything it might manage to take to market, as well as major issues with its mRNA delivery system that led them to abandon any treatment that would require more than one dose because of toxicity concerns.

The latter issue, though largely forgotten and/or ignored by media today, should be a major topic in the COVID-19 booster debate, given that there is still no evidence that Moderna ever resolved the toxicity issue that arose in multi-dose products.

In this first installment of a two-part series, the dire situation in which Moderna found itself immediately prior to the emergence of COVID-19 is discussed in detail, revealing that Moderna — very much like the now disgraced company Theranos — had long been a house of cards with sky-high valuations completely disconnected from reality.

Part 2 will explore how that reality would have come crashing down sometime in 2020 or 2021 were it not for the advent of the COVID-19 crisis and Moderna’s subsequent partnership with the US government and the highly unusual processes involving its vaccine’s development and approval.

Despite the emergence of real-world data challenging the claims that Moderna’s COVID-19 vaccine is safe and effective, Moderna’s booster is being rushed through by some governments, while others have recently banned the vaccine’s use in young adults and teens due to safety concerns.

As this two-part series will show, safety concerns about Moderna were known well before the COVID crisis, yet they have been ignored by health authorities and the media during the crisis itself. In addition, in order to stave off collapse, Moderna must keep selling its COVID-19 vaccine for years to come. In other words, without the approval of its booster, which has caused great controversy even among the country’s top vaccine officials, Moderna faces a massive financial reckoning.

While the COVID-19 crisis threw the company a lifeboat, the administration of its COVID-19 vaccine, in which the US government has now invested nearly $6 billion, must continue into the foreseeable future for the bailout to be truly successful. Otherwise, a company now worth $126.7 billion, with major investments from the US government, US military, and ties to the world’s wealthiest individuals, will crumble in short order.

A New Theranos?

In September 2016, Damian Garde, the national biotech reporter for the medical media company STAT, wrote a lengthy exposé of the “ego, ambition, and turmoil” plaguing “one of biotech’s most secretive startups.” The article focused on the company Moderna, which had been founded in 2010 to commercialize the research of Boston Children’s Hospital cell biologist Derrick Rossi.

The effort to turn a profit by creating Moderna, which intimately involved controversial scientist and close Bill Gates associate Bob Langer as well as Cambridge, Massachusetts–based Flagship Ventures (now Flagship Pioneering), began soon after Rossi published a report on the ability of modified RNA to turn skin cells into different types of tissue.

Between the time of Moderna’s founding and Garde’s 2016 investigation, the buzz around Rossi’s research and its potential to create medical breakthroughs had waned, as had the buzz around its potential to make its investors very wealthy.

Despite teaming up with pharmaceutical giants like AstraZeneca and raising record amounts of funding, Moderna still had no product on the market six years after its founding, and, as STAT revealed, the “company’s caustic work environment” had led to a persistent hemorrhaging of top talent, though little of its internal conflicts was publicly known due to “its obsession with secrecy.”

Most troubling for the company that year, however, was that Moderna appeared to have “run into roadblocks with its most ambitious projects.”

moderna ceo stephane bancel
Moderna CEO Stéphane Bancel

Aside from the scientific obstacles that Moderna had encountered, one major “roadblock” for the company, per Garde, was none other than Stéphane Bancel, Moderna’s top executive, who still heads the company. According to Garde, Bancel was squarely at the center of many of the company’s controversies due, in part, to his “unwavering belief that Moderna’s science will work — and that employees who don’t ‘live the mission’ have no place in the company.”

Between 2012 and 2016, Bancel was allegedly a key factor in the resignation of at least a dozen “highly placed executives,” including those who directed Moderna’s product pipeline as well as its vaccine projects.

Bancel, prior to joining Moderna, had spent much of his career in sales and operations, not science, making a name for himself at pharmaceutical giant Eli Lilly before heading a French diagnostics firm called bioMérieux. His performance there, as well as his ambition, caught the attention of Flagship Ventures, a Moderna cofounder and top investor, which then connected him with the company he would go on to lead.

Although lacking a background in mRNA and the science behind its use as a therapeutic, Bancel has made up for it by becoming Moderna’s salesman par excellence. Under his leadership, Moderna became “loath to publish its work in Science or Nature, but enthusiastic to herald its potential on CNBC and CNN.”

In other words, under Bancel, the company came to promote its science through media publicity and public relations rather than by publishing actual data or scientific evidence. When two of its vaccine candidates entered phase 1 human trials in 2016 (trials that ultimately went nowhere), the company declined to list them on the public federal registry ClinicalTrials.gov.

The decision not to list, which deviates from common practice by Moderna’s competitors and other more traditional vaccine companies, meant that the information on the safety of these vaccine candidates would likely never be publicly available after the trial’s conclusion. Moderna also refused to publicly comment on what diseases these vaccines were meant to target.

Such secrecy became commonplace at Moderna after Bancel took the helm, with the company having published no data “supporting its vaunted technology” by the time STAT’s 2016 exposé was published. Insiders as well as investors that had committed millions to the company were only granted “a peek” at the company’s data.

According to former Moderna scientists who spoke to STAT, the company was “a case of the emperor’s new clothes.” Former employees further charged that Bancel was actually “running an investment firm” and “then hop[ing] it also develops a drug that’s successful.”

Perhaps this is why Bancel was deemed the best executive to steer Moderna. As an ambitious salesman running a highly overvalued company, he would prioritize the company’s image and its finances regardless of any issues with the science underpinning it all. Perhaps it was for that reason that Bancel, per former employees, “made it clear [from the beginning] that Moderna’s science simply had to work. And that anyone who couldn’t make it work didn’t belong.”

As STAT noted in 2016, the people who were tasked with making “the science work” were those who most frequently resigned, which led to Moderna losing two heads of chemistry within a single year, followed shortly by losing its chief scientific officer and its head of manufacturing. Many top executives, including the heads of its cancer research and rare disease research branches, ended up lasting fewer than eighteen months in their respective positions.

The abrupt resignations weren’t exclusive to Moderna’s science-focused executive positions either, as the chief information officer and top financial executive role were also affected. Bancel ultimately sought advice from the human resources departments of Facebook, Google, and Netflix on employee retention.

Particularly telling was the abrupt and mysterious resignation of Moderna’s head of research and development, Joseph Bolen, after about two years at the company. A company insider at the time told STAT that the only reason Bolen would have resigned was if “there was something wrong with the science or the personnel.”

In other words, Bolen either left because the science underpinning Moderna’s massive valuation did not live up to the hype or Bancel had forced him out, with the additional possibility that both were key in Bolen’s resignation.

Speculation at the time pointed the finger at Bancel, though it’s not clear why the rift between the two men emerged. Bancel asserted that he tried to convince Bolen to stay, though there were contrasting assertions from anonymous employees, and that Bolen had “voted himself off the island.”

Whatever the exact cause of the resignation of the head of R & D, it only added to the mystique around Moderna’s inner workings and its ability to deliver on its promise to “revolutionize” medicine. It also reveals more than a few similarities between Moderna and the now-disgraced company Theranos.

Theranos, whose former top executive, Elizabeth Holmes, is now on trial for fraud, was known for its extreme culture of secrecy that kept investors and business partners in the dark, forced nondisclosure agreements on everyone who came in contact with the company, and kept employees “siloed” through an extremely strict need-to-know policy.

Like Moderna, Theranos had been praised as revolutionary and poised to “change the medical industry forever.” Similarly, its top executive had no professional health-care or science experience, yet both fired or forced the resignations of employees who disagreed with their perspective or were unable to provide “positive” results.

Both companies also failed to publish any evidence in peer-reviewed journals that the science behind their multibillion-dollar valued companies was more than just fantasy and a well-devised sales pitch.

Arguably, the most critical difference between Moderna and Theranos is that Moderna, whose numerous issues and challenges only came to light after the collapse of Theranos had begun, has never faced the same degree of scrutiny from the US government or mainstream investigative journalists.

There are many possible reasons for this, including Moderna’s close relationship with the US Department of Defense through the Defense Advanced Research Projects Agency (DARPA), or concern that its exposure post-Theranos would bring scrutiny to any company existing at the intersection of Silicon Valley and the health-care industry.

However, such a reckoning would likely have been inevitable for Moderna had it not been for the COVID-19 crisis, which could not have come at a more convenient time for the company.

Moderna’s “Software” Encounters Bugs

Many of the problems with Moderna that Garde identified in 2016 continued to plague the company right up until the beginning of the COVID-19 crisis. Chief among these was Moderna’s struggle to prove that its technology worked and that it was safe.

Concerns about the safety and efficacy of the company’s products, which were publicly reported beginning in 2017, evaporated in the wave of panic surrounding COVID-19 and the simultaneous “Warp Speed” race for a vaccine that would “end the pandemic.”

Yet, there is little, if any, evidence that these once-well-recognized concerns were addressed prior to the US government’s emergency use authorization of Moderna’s COVID-19 vaccine and its now widespread use in many countries around the world. To the contrary, there is evidence that these concerns were covered up both prior to and during the development of its vaccine.

moderna office in cambridge massachusetts
Moderna’s office in Cambridge, Massachusetts

The reports that emerged in January 2017 noted that Moderna had “run into troubling safety problems with its most ambitious therapy” and that the company was “now banking on a mysterious new technology to keep afloat.”

The “ambitious therapy” in question was meant to treat Crigler-Najjar syndrome and “was to be the first therapy using audacious new technology that Bancel promised would yield dozens of drugs in the coming decade.” Bancel had specifically used the Crigler-Najjar therapy as a major selling point to investors, particularly in 2016 when he touted it at the JP Morgan Healthcare Conference.

Yet, employees of Alexion, the company co-developing the drug with Moderna, blew the whistle on the project in 2017, revealing that it “never proved safe enough to test in humans” and that the failure of this therapy and the technology platform it sought to use had been responsible for prompting Moderna to abandon the class of drug therapies that, for years, had justified its sky-high valuation and attracted hundreds of millions in investor cash.

As a result of the problem with the Crigler-Najjar drug, media outlets asserted that Moderna was now “in need of a Hail Mary” that would keep its valuation from imploding and its investors from fleeing. The persistence of problems first noted in the 2016 STAT investigation, such as Moderna’s failure to publish meaningful data supporting its mRNA technology, were only exacerbating the company’s increasingly precarious position.

Indeed, not long before the indefinite delay of the Crigler-Najjar therapy, Bancel had dismissed questions about Moderna’s promise by painting mRNA as an easy way to quickly develop novel treatments for a variety of diseases. He stated that “mRNA is like software: You can just turn the crank and get a lot of products going into development.”

If that were the case, why did the company have no products on the market after nearly seven years, and why had its most touted project experienced such obstacles? Clearly, in keeping with Bancel’s “software” metaphor, Moderna’s technology had encountered bugs, bugs that were potentially ineradicable.

It turns out that the Crigler-Najjar drug therapy that Moderna had bet on so heavily had failed because of the lipid nanoparticle delivery system it used to transport mRNA into cells. Crigler-Najjar had been chosen as a target condition because Moderna scientists deemed it to be “the lowest-hanging fruit.”

First, the syndrome is caused by one specific genetic defect; second, the affected organ, the liver, is among the easiest to target with nanoparticles; and third and most important for the company, treating the disease with mRNA would require frequent doses, ensuring a steady stream of income for the company.

Thus, given the first two motives behind the company’s focus on Crigler-Najjar, if Moderna couldn’t develop a therapy for that condition, it meant they wouldn’t be able to develop a therapy for other conditions that, for example, were caused by multiple genetic defects or affected multiple organs or those more resistant to nanoparticle-based treatments.

In other words, that “Moderna could not make its therapy [for Crigler-Najjar] work” meant that it was unlikely to make therapies of that entire class work either.

Indeed, media reports on the indefinite delay of this particular therapy noted that “the indefinite delay on the [Moderna] Crigler-Najjar project signals persistent and troubling safety concerns for any mRNA treatment that needs to be delivered in multiple doses.”

This issue would soon lead Moderna to only pursue treatments that could be delivered as a single dose — that is, until the emergence of COVID-19 and the advent of the COVID-19 vaccine booster debate. It is also worth mentioning that, due to the extreme rarity of Crigler-Najjar syndrome, even if the therapy had been successfully taken to market by Moderna, it would have been unlikely to bring in enough money to sustain the company.

The specific problem Moderna encountered with the Crigler-Najjar treatment was related to the lipid nanoparticle delivery system it was using. According to former Moderna employees and their collaborators at Alexion, “The safe dose was too weak, and repeat injections of a dose strong enough to be effective had troubling effects on the liver [the target organ of this particular therapy] in animal studies.”

This was an issue Moderna had apparently run into with its nanoparticle delivery system in other cases too, according to reports published at the time. Per STAT, the delivery system employed by Moderna had consistently “created a daunting challenge: Dose too little, and you don’t get enough enzyme to affect the disease; dose too much, and the drug is too toxic for patients.”

Moderna attempted to offset the bad press over having to delay the Crigler-Najjar drug with claims that they had developed a new nanoparticle delivery system called V1GL that “will more safely deliver mRNA.” The claims came a month after Bancel had touted another delivery system called N1GL to Forbes.

In that interview, Bancel told Forbes that the delivery system they had been using, licensed to them by Acuitas, “was not very good” and that Moderna had “stopped using Acuitas tech for new drugs.” However, as will be explored in detail in this report as well as Part II of this series, it appears that Moderna continued to rely on the Acuitas-licensed technology in subsequent vaccines and other projects, including its COVID-19 vaccine.

Former Moderna employees and those close to their product development were doubtful at the time that these new and supposedly safer nanoparticle delivery systems were of any consequence. According to three former employees and collaborators close to the process who spoke anonymously to STAT, Moderna had long been “toiling away on new delivery technologies in hopes of hitting on something safer than what it had.”

All of those interviewed believed that “N1GL and V1GL are either very recent discoveries, just in the earliest stages of testing — or else new names slapped on technologies Moderna has owned for years.” All spoke anonymously due to having signed nondisclosure agreements with the company, agreements that are aggressively enforced.

One former employee, commenting on the alleged promise of N1GL and V1GL, stated that these platforms “would have to be a miraculous, Hail Mary sort of save for them to get to where they need to be on their timelines … Either [Bancel] is extremely confident that it’s going to work, or he’s getting kind of jittery that, with a lack of progress, he needs to put something out there.”

stephen hoge melissa moore
Stephen Hoge, Moderna’s president, and Melissa Moore, Moderna’s CSO for Platform Research Source: Moderna

It seems that those former employees who believed that N1GL and V1GL were new names put on existing technology and that Bancel was overselling their promise were correct, as Moderna appears to have returned to the troubled lipid nanoparticle delivery system it had licensed from Acuitas for subsequent therapies, including its COVID-19 vaccine.

As will be explored in this report and Part II of this series, there is no evidence that Moderna ever got their “Hail Mary” save when it came to acquiring the rights for or developing a safe mRNA delivery system.

On top of the much-touted promises of N1GL and V1GL as safer treatments, Moderna additionally vowed to create “new and better formulations” for the Crigler-Najjar therapy that could potentially make it to human trials at a later time. This helped to stave off more bad press, but only for a few weeks.

One month after the troubles with the Crigler-Najjar therapy were publicly reported, the head of Moderna’s oncology division, Stephen Kesley, left the company. This was just as Moderna was moving toward its first human trials for its cancer treatment, which forced “a senior leadership team with little experience in developing drugs to sort out the company’s future in the field.”

Just weeks before Kesley’s departure, Bancel had boldly claimed in a bid to woo new investors at the JP Morgan Healthcare Conference, held in January 2017 in San Francisco, that oncology was Moderna’s “next big opportunity after vaccines.”

The same month as Kesley’s departure, Moderna was able to draw media attention elsewhere, as for the very first time they published data in a peer-reviewed journal. In Cell, its scientists published data on an animal trial for its Zika vaccine candidate that positively demonstrated both efficacy and safety in mice.

While animal trial results do not necessarily translate into equivalent results in humans, the results were deemed to “bode well” for Moderna’s planned clinical trial of that vaccine candidate in humans. In addition, the results were like the animal trial results published by Moderna competitor BioNTech for their mRNA vaccine candidate for Zika a month earlier.

However, for Moderna, the positive news was muted by a negative ruling on a legal dispute that threatened Moderna’s ability to ever turn a profit on the Zika vaccine or any other mRNA vaccine it developed, a threat that Moderna’s competitors, such as BioNTech, didn’t have to contend with.

That ruling, discussed in greater detail later in this report, greatly restricted Moderna’s use of the lipid nanoparticle delivery system licensed to it through Acuitas and directly threatened the company’s ability to create a for-profit product using intellectual property tied to the relevant patents.

It would also kick off a years-long legal dispute that has suggested at various times that the promises of V1GL and N1GL were either completely invented or greatly exaggerated, as former Moderna employees and collaborators had stated.

Not long afterward, in July 2017, Moderna was hit with yet another wave of bad press as their partner in the Crigler-Najjar venture, Alexion, cut ties with the company completely. Moderna downplayed Alexion’s decision and claimed it had acquired “extensive knowledge” that would allow it to continue to develop the troubled therapy on its own.

Nonetheless, Alexion’s decision came at an inopportune time for the company, as one of Moderna’s top investors had just two weeks earlier slashed its valuation of the company by almost $2 billion, allegedly because Moderna had “struggled to live up to its own hype.” Reports began to circulate claiming that “Moderna’s investors might be losing faith in the company’s future.”

Indeed, the Crigler-Najjar syndrome drug was not the only one that, at that point, had proven “too weak or too dangerous to test in clinical trials,” according to former employees and partners.

The persistent issue, which again lay with the nanoparticle delivery system Moderna had licensed from Acuitas, had forced the company, beginning with the delay of the Crigler-Najjar therapy, to “prioritize vaccines, which can be dosed just once and thus avoid the safety problems that have plagued more ambitious projects.”

Yet, these single-dose “vaccines” or therapies were considered not as lucrative as the drug therapies Moderna had long promised and that underpinned its multibillion-dollar valuation, thereby forcing the company to “bet big on a loss-leader.” Also problematic was that Moderna lagged behind its mRNA vaccine competitors and that the supposed promise of its technology to produce viable vaccines was only “proven” at that point by a single, small trial.

That trial, as noted by the Boston Business Journal, was an “early-stage human trial that was primarily meant to assess the safety of an avian flu vaccine.” Moderna had claimed, despite the trial being designed to assess safety, that it had “provided evidence that the vaccine is effective, with no major side effects” as well.

Furthermore, as will be discussed in a later section of this report, the legal dispute over the Acuitas-licensed lipid nanoparticle system threatened Moderna’s ability to ever turn on a profit on any mRNA vaccine it managed to get through trials and the federal approval process, making the company’s future appear quite grim.

Despite Positive Press, Lingering Questions Remained

In September 2017, at a closed-door investor event meant to prevent more major investors from devaluing the company or jumping ship, Moderna provided more insight into a recently published press release on the trial results of a therapy meant to regrow heart tissue by boosting production of a protein known as VEGF.

The press release, which generated positive media headlines, noted that the therapy had been proven safe in a study with a sample size of 44 patients. However, neither the press release nor the data Moderna disclosed to investors at the closed-door meeting revealed how much protein the therapy caused patients to produce, leaving its efficacy a mystery.

Indeed, media reports on the investor meeting noted that “since Moderna did not release that crucial data point, outsiders can’t judge how much therapeutic potential there may be.”

The results, though they seemed to mitigate the concerns over the safety of Moderna’s technology, failed to inspire confidence in many attendees. Several attendees later told reporters that they “were not overly impressed” with Moderna’s presentation, which only “underlined lingering questions about whether it can live up to its own hype.”

One of the issues here, yet again, is that Moderna’s valuation was and is underpinned by its promise to produce products for rare diseases that require repeated injections over a patient’s lifetime. The VEGF therapy promoted by Moderna at this meeting was meant to be a one-time-only injection, and, thus, evidence of its safety did not resolve the problem of none of Moderna’s multi-dose products having proven safe enough to test on humans.

The closed-door investor event made it clear that Moderna was aiming to avoid that persistent problem by prioritizing single-dose vaccines. As STAT noted at the time:

“The presentation to investors also made clear that Moderna is prioritizing vaccines. They are easier to develop from mRNA because patients need just one dose, which eliminates some of the safety issues that have plagued more ambitious projects such as therapies for rare diseases.”

The pivot to vaccines remained a sore point with many investors, however, as vaccines are viewed as “low-margin product[s] that can’t generate anywhere near the profits seen in more lucrative fields like rare diseases and oncology.” These, as previously mentioned, are the very fields on which Moderna’s massive valuation had been based but for which it had been unable to produce safe and effective therapies.

Moderna was clearly aware of these concerns among its current and potential investor base and attempted to speak promisingly of its oncology-related efforts at this same event. However, it was silent on trial timing and other key data points, maintaining the company’s long-standing reputation for secrecy towards both insiders and the general public.

It is certainly telling that Moderna remained so secretive about key data at an event not only closed to the public and the press, but meant to reassure existing investors and to entice new ones. If Moderna declined to show important data to investors at a time when it was desperately seeking to keep them onboard, it implies that the company either had something to hide or nothing to show.

Moderna’s increasingly troubled internal situation, despite its consistently rosy PR, escalated a month later when reports emerged of the abrupt resignations of its head of chemistry, the leader of its cardiovascular division, and the head of its rare diseases division. These resignations, which occurred toward the end of 2017, followed the high-profile resignations the company suffered that were mentioned in the 2016 STAT exposé by Damian Garde.

A few months later, in March 2018, the chief scientific officer of Moderna’s vaccine business, Giuseppe Ciaramella, also left.

This resignation signaled further internal troubles at the company, even more because Moderna had recently and very publicly pivoted to vaccines; and Ciaramella, in addition to leading vaccine development at this critical juncture, had been the first Moderna executive to suggest that the company’s technology could be useful in developing vaccines, a suggestion that the company was now betting everything on.

One can’t help but wonder if Bancel’s tendency to force out employees and executives who “couldn’t make the science work” was a factor in any of these high-profile resignations, including that of Ciaramella.

A Years-Long Legal Snafu

Thus far, this report has largely focused on how Moderna’s extreme secrecy appears to have been used to obfuscate and mitigate major issues with its technology and product pipeline and how those issues were reaching a climax following the company’s IPO and immediately prior to the COVID crisis.

However, the challenge of creating products that work and can be proven to work in clinical settings is but one of at least two major issues facing Moderna as a company. Indeed, during the same timetable explored above, Moderna was embroiled in aggressive disputes related to intellectual property and patents.

Notably, these same legal issues deal with the lipid nanoparticle system that was also reportedly at the root of Moderna’s safety and product-pipeline issues.

As mentioned earlier, the lipid nanoparticle delivery system used in many Moderna therapies was licensed to them by Acuitas. Acuitas, however, had licensed that system from a separate company, Arbutus, which sued in 2016 claiming that Acuitas’s sublicense to Moderna was illegal. Arbutus won the case, which lead to a temporary injunction in 2017 that stopped Acuitas from further sublicensing the lipid nanoparticle technology.

A settlement reached between Acuitas and Arbutus in 2018 terminated Acuitas’s license and restricted Moderna’s use of the technology to four vaccine candidates that targeted already identified viruses.

Moderna’s Bancel told Forbes in 2017 that the Acuitas/Arbutus system was barely mediocre and that Moderna was developing its own improved delivery system that would not infringe on Arbutus’s intellectual property (the aforementioned N1GL and V1GL systems).

However, soon after Bancel made those claims, Arbutus’s leadership challenged them, stating that the company had reviewed all of Moderna’s patents, publications, and presentations regarding these “new” delivery systems and had found nothing that didn’t involve their own intellectual property.

Even former Moderna employees, as mentioned previously, were very doubtful that N1GL and V1GL were any different than the Acuitas/Arbutus system, meaning that — despite Bancel’s claims — Moderna had unresolved legal woes related to these nanoparticles that, along with the toxicity issues, was stalling Moderna product candidates.

It is important to note at this point that, while only Moderna has been locked in a legal battle with Acuitas/Arbutus for years over LNP intellectual property, the other main producers of mRNA COVID-19 vaccines, Pfizer/BioNTech and CureVac, also use major aspects of the same Arbutus-derived technology. However, BioNTech licensed the LNPs in such a way as to avoid the issues that have entangled Moderna for years.

Moderna’s legal dispute, in addition to the already discussed safety issues, greatly threatened Moderna’s ability to survive as a company. Having already been forced to settle on the vaccines market and reject the more lucrative and “revolutionary” mRNA therapies it had long promised, Moderna was steadily moving toward a position where it had “no right to sell” vaccine products that depended on the Arbutus-patented and Acuitas-sublicensed technology.

This situation has placed pressure on Moderna to negotiate a new license with Arbutus directly, negotiations in which the company would have very little leverage.

Since the first legal case in 2016, Moderna and Arbutus have remained locked in disputes about the nanoparticles and who owns them. Moderna challenged three Arbutus patents with the US Patent and Trademark Office, with mixed results.

Yet, simultaneously, Moderna also claimed that its tech was “not covered by the Arbutus patents,” which prompted numerous observers and reporters to ask questions such as — “In that case, why did [Moderna] initiate the legal action against Arbutus to begin with?”

Moderna answered that query by claiming that it targeted Arbutus only because of Arbutus’s past “aggression” against them. However, despite such claims, the effort and cost inherent in the legal challenge reveals that, at the very least, Moderna takes the threat of Arbutus’s intellectual property claims very seriously.

The actual answer seems to lie in Moderna being willing to publicly claim that their LNP technology is different enough from the Arbutus-derived system covered by the patents but unwilling to release any proof — whether in court, to its own investors, or to the public — that it is in fact different. The more recent twists and turns of this protracted legal battle, including a pivotal 2020 decision that was very unfavorable for Moderna, are discussed in Part II of this series.

Anything to Aid a Slumping Stock Price

nasdaq building
Nasdaq building on the day of Moderna’s 2018 IPO. Source: Nasdaq

Just previous to Ciaramella’s resignation, Moderna had claimed to have “solved the scientific issues that made its earlier mRNA treatments too toxic for clinical trials,” according to media reports. Those reports also claimed that, as a result, “Moderna believes it has steered back on course,” though the company did not provide evidence to support that claim.

Nevertheless, the promise allowed the company to complete a new round of financing, during which it raised an additional $500 million from “an investor syndicate uncommon in biotech” that included the governments of Singapore and the United Arab Emirates.

Some observers were puzzled as to how Moderna had managed to raise so much money despite the outstanding questions about the science underpinning its high valuation.

The answer came with the publication of Moderna’s confidential investor slide deck by STAT’s Damian Garde, which showed that the company had predicted that drugs that they had only been tested in mice would soon be worth billions and that its vaccine revenue would amount to $15 billion annually.

The slide deck, deemed “pretty absurd” and “geared at hopeful generalists that can dream big” per one skeptical investor, made it clear why the company’s last funding round had appealed to “unconventional” biotech investors rather than veteran investors focused on the industry.

A veteran biotech investor, who spoke anonymously due to the slide deck’s confidentiality, stated that “it’s a deck designed to tell the ‘we’re going to be huge’ story to a group of rather unsophisticated investors — and it does that beautifully … Just enough science and platform stuff to convey the ‘We know what we’re doing’ sentiment, but not enough to engender technical questions.”

Per those who sat through Moderna’s pitch, the company was “very generous on the market-size assumptions for their programs,” with one former Moderna collaborator placing the real-world value of a treatment the company had claimed was worth billions annually at closer to “$100 million to 250 million.”

Of course, that revenue estimate comes with the caveat that the treatment, tested thus far only in mice, would someday prove to work in humans. A former Moderna employee in its rare diseases division stated at the time that Moderna “continue[s] to rush forward and over-promise the potential for broad use of mRNA prior to any evidence beyond vaccines or very early experiments in mice.”

Despite Moderna’s ability to convince “unsophisticated” and/or “unconventional” investors to back its early 2018 funding round, it appears that one of its most important promises used to attract investors — that it had solved the nanolipid particle toxicity issue — was not true.

In a filing with the Securities and Exchange Commission dated November 2018, months after Moderna had claimed to have fixed the issues with its lipid nanoparticle delivery system, the company made several claims that appear to contradict its purported development of a new, safer nanoparticle technology. For example, the filing states on page 33:

Most of our investigational medicines are formulated and administered in an LNP [lipid nanoparticle] which may lead to systemic side effects related to the components of the LNP which may not have ever been tested in humans. While we have continued to optimize our LNPs, there can be no assurance that our LNPs will not have undesired effects.

Our LNPs could contribute, in whole or in part, to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation [sic] reactions, antibody reactions including IgA, IgM, IgE or IgG or some combination thereof, or reactions to the PEG from some lipids or PEG otherwise associated with the LNP.

Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events in one or more of our clinical trials. Many of these types of side effects have been seen for legacy LNPs.

There may be resulting uncertainty as to the underlying cause of any such adverse event, which would make it difficult to accurately predict side effects in future clinical trials and would result in significant delays in our programs. (emphasis added)

Based on these statements, Moderna appeared to be uncertain as to whether its current lipid nanoparticle delivery system was any safer than that which led to the indefinite delay of its Crigler-Najjar therapy. In addition, the reference to “adverse reactions within liver pathways,” one of the main issues that triggered the specific delay of the Crigler-Najjar therapy, suggests a continued reliance on technology sublicensed from Acuitas.

As will be noted in Part II, the Moderna COVID-19 vaccine also appears to use the controversial Acuitas technology that had prompted significant safety, legal, and financial concerns for Moderna for years.

The November 2018 SEC filing makes other statements regarding its supposedly fixed lipid nanoparticle delivery system that are worth noting:

If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting trial participants to any of our clinical trials, trial participants may withdraw from trials, or we may be required to abandon the trials or our development efforts of one or more development candidates or investigational medicines altogether …

Even if the side effects do not preclude the drug from obtaining or maintaining marketing approval, unfavorable benefit risk ratio may inhibit market acceptance of the approved product due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition, and prospects.

These statements are significant in that they openly suggest at least one reason for Moderna’s long-standing tendency toward secrecy in publishing data about its treatments, as public knowledge of its technology’s persistent challenges would threaten its ability to attract trial participants, investors, and, later, consumers.

About a month after these troubling admissions were made in fine print, Moderna succeeded in pulling off a record-setting initial public offering (IPO) in December 2018. For that IPO, Moderna had retained the services of eleven investment banks, which is reportedly around “twice the number normally seen in biotech offerings.”

However, its stock value tumbled just hours afterward, “a sign the company and its underwriters might have over-estimated demand for the richly valued company.”

A month after the IPO, Moderna’s stock continued its downward slide, “doing exactly the opposite of what private investors look for in an IPO.” Those who had predicted this post-IPO outcome before Moderna went public had also warned that this downward trend would likely continue through early 2020 if not longer.

Skeptics such as STAT’s Damian Garde had warned right before Moderna’s IPO that that the company’s sliding stock value would likely continue throughout 2019 due to “a seeming lack of impending news,” given that “momentum in biotech, positive or negative, is driven by catalysts” and “Moderna is in for a fairly quiet 2019.”

Meanwhile, media reports warned, as they had for years, that Moderna “is still in the early days of proving [their] technology’s potential,” despite being a nine-year-old company. Such reports also noted that Moderna’s inability to prove its technology’s worth after nearly a decade in business was hampered by its “struggl[e] in its initial efforts to turn mRNA into drugs that can be repeatedly dosed, leading it to pivot to vaccines, which can be administered just once or twice.”

Investors at the 2019 JP Morgan health-care conference spoke of concerns that “Moderna [has] yet to rule out the lingering risks tied to mRNA, and, even at its depressed valuation, the company is simply too expensive.” Others confided in reporters that they would be “sitting on the sidelines until Moderna either changes the narrative with promising human data or gets substantially cheaper.”

A few weeks later, Moderna’s Bancel attended the World Economic Forum’s 2019 annual meeting alongside Johnson & Johnson executive Paul Stoffels and other pharmaceutical and biotech leaders in order to “rub elbows with world leaders and one-percenters — and talk about the future of healthcare.”

Other health-care figures in attendance included head of the World Health Organization, Tedros Adhanom Ghebreyesus, and “global health philanthropist” Bill Gates, whose foundation entered into “a global health project framework” with Moderna in 2016 to “advance mRNA-based development projects for various infectious diseases.”

The Bill & Melinda Gates Foundation is the only foundation listed as a “strategic collaborator” on the Moderna website. Other “strategic collaborators” include the US government’s Biomedical Advanced Research and Development Authority (BARDA), the US military’s DARPA, and pharmaceutical giants AstraZeneca and Merck.

Moderna first teamed up with the WEF just a few years after its founding back in 2013, when it was named to the Forum’s community of Global Growth Companies (GGC). That year, Moderna was one of just three North American health companies to receive the honor and was additionally recognized by the Forum as “an industry leader in innovative mRNA therapeutics.”

“We are honored to be recognized for our efforts to advance our platform and ensure its potential is realized on a global scale, and we look forward to being a member of the World Economic Forum community,” Bancel said at the time.

stephane bancel at the world economic forum annual meeting
Stéphane Bancel at the World Economic Forum Annual Meeting, January 2020. Source: WEF

As a WEF Global Growth Company, Moderna has closely and regularly engaged with the Forum since 2013 at both the Chinese-hosted Annual Meeting of the New Champions and the WEF’s regional meetings, while also having access to the WEF’s exclusive networking platform that provides the company privileged access to the world’s most powerful business and government leaders.

Additionally, such carefully selected companies are given opportunities by the Forum “to shape global, regional and industry agendas and engage in meaningful exchanges about ways to continue on a sustainable and responsible path of growth.”

Essentially, the roster of such companies constitutes a consortium of corporations that are promoted and guided by the Forum because of their commitment to “improving the state of the world,” that is, their commitment to supporting the Forum’s long-term agendas for the global economy and for global governance.

In April 2019, Moderna published some information on modifications to its lipid nanoparticles (discussed in more detail in Part II). A month later, in May 2019, Moderna published positive results in the journal Vaccine for phase 1 data on mRNA vaccine candidates for “two potential pandemic influenza strains” administered as two doses three weeks apart.

The company’s press release on the study stated that “future development of Moderna’s pandemic influenza program is contingent on government or other grant funding,” suggesting that it would use the trial results to lobby the government for funds for a continuation of this particular program.

Notably, at the same time as these results were published, the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, then filled by Robert Kadlec, was in the midst of conducting Crimson Contagion, a multimonth simulation of a global pandemic involving an influenza strain that originates in China and spreads globally through air travel.

The strain at the center of the simulation, called H7N9, is one of the very strains used in the Moderna study.

Moderna published those results on May 10, just four days before the Crimson Contagion simulation hosted its federal interagency seminar. BARDA, which the ASPR office oversees, is a major strategic ally of Moderna and was co-developing these “potential pandemic influenza” vaccines that are mentioned in this timely press release, that is, for H10N8 and H7N9 influenza infections.

Crimson Contagion is notable for several reasons, most significantly for Kadlec’s own history with the Dark Winter simulations that preceded and eerily predicted the 2001 anthrax attacks. As has been discussed in detail in a previous TLAV – Unlimited Hangout investigation, the 2001 anthrax attacks conveniently rescued anthrax vaccine manufacturer BioPort, now Emergent Biosolutions, from certain ruin, much like the way the COVID crisis did for Moderna.

A month later, in June 2019, Moderna again managed to generate positive headlines on making its debut at the American Society of Clinical Oncology annual meeting, where it sought to promote its ability to produce the personalized cancer treatments that had been key to wooing investors both before and after its record-setting IPO.

It was the first time the company had publicly presented data on a cancer treatment, and this particular treatment was being co-developed with Merck. The data showed positive results in preventing relapses in cancer patients whose solid tumors had been removed via surgery, but the trial failed to show any definitive effect in cancer patients whose tumors had not been removed.

Thus, the early data seemed to indicate that Moderna’s treatment would only help cancer patients stay in remission after other medical interventions had been performed. Though the news allowed Moderna to bask in some much-needed positive press and to promote its oncology products in development, some reports rightly noted that it was “still too early for any definitive judgment” on the cancer treatment’s clinical benefit.

Despite this apparent advance, by September 2019, Moderna’s stock price continued to decline, leading to a loss of about $2 billion in market value from the company’s $7.5 billion valuation at the time of its record-setting IPO.

The main factors for this were the same persistent problems the company had been facing for years — lack of progress, including lack of products on the market; persistent safety problems with its mRNA technology; and the lack of data showing that advances were being made to make that technology commercially feasible.

In mid-September 2019, Moderna gathered investors together to showcase scientific evidence it claimed would finally prove that its mRNA technology could “turn the body’s own cells into medicine-making factories” and hopefully “turn skeptical investors into believers.” This data, which was derived from a very preliminary study that involved only four healthy participants, had complications.

Three of the four participants had side effects that prompted Moderna to state at the meeting that they would need to reformulate the mRNA treatment to include steroids, while one of the participants suffered heart-related side effects, including a rapid heart rate and an irregular heartbeat.

Moderna, which asserted that none of the heart-related side effects was serious, could not “definitively pinpoint the cause of the heart symptoms.” Yet, as previously mentioned, it was likely related to the safety issues that had been plaguing its experimental products for years.

The company’s preliminary data, which was promoted in yet another bid to keep investors from leaving, also included the caveat that Moderna had decided to pause trials for this particular product, which was a single-injection mRNA treatment for the chikungunya virus. That treatment was being developed in partnership with the Pentagon’s DARPA.

Other more positive data from a preliminary trial were also released at this meeting. That trial, however, was for an mRNA treatment for cytomegalovirus, “a common virus that is usually kept in check by the body’s immune system and rarely causes problems in healthy people,” meaning its mRNA vaccine for that condition was unlikely to ever be lucrative.

Not long after this lackluster investors meeting, on September 26, 2019, the once highly secretive Moderna announced it would collaborate with researchers at Harvard University “in hopes that the research will spur new drugs,” as its product pipeline appeared to have stalled.

Moderna president Stephen Hoge described the collaboration as select Harvard researchers receiving “a package of stuff that we put our blood, sweat, and tears in, and then someone’s going to do something with it. We’ll find out afterward how that went.” For a company long known for its extreme secrecy in an already secretive industry, Moderna’s arrangement with Harvard, which it admitted was “unusual,” came across as somewhat desperate.

A month later, at the 2019 Milken Institute Future of Health Summit, there was a panel discussion on universal flu vaccines and how a “disruptive” event would be needed to upset the long-existing bureaucratic vaccine-approval process to facilitate wider adoption of “nontraditional” vaccines, such as those produced by Moderna.

Panel speakers including former FDA commissioner Margaret Hamburg, a veteran of the 2001 Dark Winter exercise and scientific advisor to the Gates foundation, as well as Anthony Fauci of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and Rick Bright of BARDA, who previously worked for the Gates-funded PATH.

The panel discussion notably took place shortly after the controversial coronavirus pandemic simulation called Event 201, whose moderators and sponsors had been intimately involved in 2001’s Dark Winter.

2019 milken institute universal flu vaccine panel
Screengrab from the 2019 Milken Institute Universal Flu Vaccine panel. Full video available here.

During the panel, the moderator — Michael Specter of the New Yorker — asked the question: “Why don’t we blow the system up? Obviously, we just can’t turn off the spigot on the system we have and then say ‘Hey! everyone in the world should get this new vaccine we haven’t given to anyone yet,’ but there must be some way.”

Specter then mentioned how vaccine production is antiquated and asked how sufficient “disruption” could occur to prompt the modernization of the existing vaccination development and approval process. Hamburg responded first, saying that as a society we are behind where we need to be when it comes to moving toward a new, more technological approach and that it is now “time to act” to make that a reality.

Several minutes later, Anthony Fauci stated that the superior method of vaccine production involves “not growing the virus at all, but getting sequences, getting the appropriate protein and it sticking in on self-assembling nanoparticles,” essentially referring to mRNA vaccines.

Fauci then stated: “The critical challenge … is that in order to make the transition from getting out of the tried and true egg-growing [method] … to something that has to be much better, you have to prove that this works and then you have got to go through all of the critical trials — phase 1, phase 2, phase 3 — and show that this particular product is going to be good over a period of years. That alone, if it works perfectly, is going to take a decade.”

Fauci later stated that there is a need to alter the public’s perception that the flu is not a serious disease in order to increase urgency and that it would be “difficult” to alter that perception along with the existing vaccine development and approval process unless the existing system takes the posture that “I don’t care what your perception is, we’re going to address the problem in a disruptive way and an iterative way.”

During the panel, Bright stated that “we need to move as quickly as possible and urgently as possible to get these technologies that address speed and effectiveness of the vaccine” before discussing how the White House Council of Economic Advisers had just issued a report emphasizing that prioritizing “fast” vaccines was paramount.

Bright then added that a “mediocre and fast” vaccine was better than a “mediocre and slow” vaccine. He then said that we can make “better vaccines and make them faster” and that urgency and disruption were necessary to produce the targeted and accelerated development of one such vaccine.

Later in the panel, Bright said the best way to “disrupt” the vaccine field in favor of “faster” vaccines would be the emergence of “an entity of excitement out there that’s completely disruptive, that’s not beholden to bureaucratic strings and processes.” He later very directly said that by “faster” vaccines he meant mRNA vaccines.

The Bright-led BARDA and the Fauci-led NIAID in just a few months’ time became the biggest backers of the Moderna COVID-19 vaccine, investing billions and co-developing the vaccine with the company, respectively.

As will be explained in Part II of this series, the partnership between Moderna and the NIH to co-develop what would soon become Moderna’s COVID-19 vaccine was being forged as early as January 7, 2020, long before the official declaration of the COVID-19 crisis as a pandemic and before a vaccine was proclaimed as necessary by officials and other individuals.

Not only did the COVID-19 vaccine quickly become the answer to nearly all Moderna’s woes but it also provided the disruptive scenario necessary to alter the public’s perceptions of what a vaccine is and eliminate existing safeguards and bureaucracy in vaccine approval. (Watch the 2019 Universal Flu Vaccine event here.)

As Part II of this series will show, it was an alleged mix of “serendipity and foresight” from Moderna’s Stéphane Bancel and the NIH’s Barney Graham that propelled Moderna to the front of the “Warp Speed” race for a COVID-19 vaccine.

That partnership, along with the disruptive effect of the COVID-19 crisis, created the very “Hail Mary” for which Moderna had been desperately waiting since at least 2017 while also turning most of Moderna’s executive team into billionaires and multi-millionaires in a matter of months.

However, Moderna’s “Hail Mary” won’t last – that is, unless the mass administration of its COVID-19 vaccine becomes an annual affair for millions of people worldwide. Even though real-world data since its administration began challenges the need for as well as the safety and efficacy of its vaccine, Moderna – and its stakeholders – cannot afford to let this opportunity slip through fingers. To do so would mean the end of Moderna’s carefully constructed house of cards.

A ‘Leap’ Toward Humanity’s Destruction

Wellcome leap

This article originally appeared on Unlimited Hangout.

The world’s richest medical research foundation, the Wellcome Trust, has teamed up with a pair of former DARPA directors who built Silicon Valley’s skunkworks to usher in an age of nightmarish surveillance, including for babies as young as three months old. Their agenda can only advance if we allow it.

A UK nonprofit with ties to global corruption throughout the COVID-19 crisis as well as historical and current ties to the UK eugenics movement launched a global health-focused DARPA equivalent last year. The move went largely unnoticed by both mainstream and independent media.

The Wellcome Trust, which has arguably been second only to Bill Gates in its ability to influence events during the COVID-19 crisis and vaccination campaign, launched its own global equivalent of the Pentagon’s secretive research agency last year, officially to combat the “most pressing health challenges of our time.”

Though first conceived of in 2018, this particular Wellcome Trust initiative was spun off from the Trust last May with $300 million in initial funding. It quickly attracted two former DARPA executives, who had previously served in the upper echelons of Silicon Valley, to manage and plan its portfolio of projects.

This global health DARPA, known as Wellcome Leap, seeks to achieve “breakthrough scientific and technological solutions” by or before 2030, with a focus on “complex global health challenges.” The Wellcome Trust is open about how Wellcome Leap will apply the approaches of Silicon Valley and venture capital firms to the health and life science sector.

Unsurprisingly, their three current programs are poised to develop incredibly invasive tech-focused, and in some cases overtly transhumanist, medical technologies, including a program exclusively focused on using artificial intelligence (AI), mobile sensors, and wearable brain-mapping tech for children three years old and younger.

This Unlimited Hangout investigation explores not only the four current programs of Wellcome Leap but also the people behind it. The resulting picture is of an incredibly sinister project that poses not only a great threat to current society but to the future of humanity itself. An upcoming Unlimited Hangout investigation will examine the history of the Wellcome Trust along with its role in recent and current events.

Leap’s Leadership: Merging Man and Machine for the Military and Silicon Valley


The ambitions of the Wellcome Leap are made clear by the woman chosen to lead it, former director of the Pentagon’s DARPA, Regina Dugan. Dugan began her career at DARPA in 1996; she led a counterterrorism task force in 1999 before leaving DARPA about a year later.

After departing DARPA, she cofounded her own venture capital firm, Dugan Ventures, and then became special adviser to the US Army’s vice chief of staff from 2001 to 2003, which coincided with the invasions of Afghanistan and Iraq. In 2005, she created a defense-focused tech firm called RedXDefense, which contracts with the military and specifically for DARPA.

In 2009, under the Obama administration, Dugan was appointed director of DARPA by Defense Secretary Robert Gates. Much was made over her being the first female director of the agency, but she is best remembered at the agency for her so-called “Special Forces” approach to innovation. During her tenure, she created DARPA’s now defunct Transformational Convergence Technology Office, which focused on social networks, synthetic biology, and machine intelligence.

Many of the themes previously managed by that office are now overseen by DARPA’s Biological Technologies Office, which was created in 2014 and focuses on everything “from programmable microbes to human-machine symbiosis.” The Biological Technologies Office, like Wellcome Leap, pursues a mix of “health-focused” biotechnology programs and transhumanist endeavors.

Right before leaving the top role at DARPA, Dugan greenlighted the agency’s initial investments in mRNA vaccine technology, which led to DARPA’s investments in Pfizer and Moderna shortly thereafter. The DARPA scientist who lobbied Dugan to back the program, Dan Wattendorf, now works as the director of Innovative Technology Solutions at the Bill & Melinda Gates Foundation.

While Dugan’s efforts at DARPA are remembered fondly by those in the national-security state, and also by those in Silicon Valley, Dugan was investigated for conflicts of interest during her time as DARPA’s director, as her firm RedXDefense acquired millions in Department of Defense contracts during her tenure.

Though she had recused herself from any formal role at the company while leading DARPA, she continued to hold a significant financial stake in the company, and a military investigation later found she had violated ethics rules to a significant degree.

Instead of being held accountable in any way, Dugan went on to become a top executive at Google, where she was brought on to manage Google’s Advanced Technology and Products Group (ATAP), which it had spun out of Motorola Mobility after Google’s acquisition of that company in 2012. Google’s ATAP was modeled after DARPA and employed other ex-DARPA officials besides Dugan.

At Google, Dugan oversaw several projects, including what is now the basis of Google’s “augmented reality” business, then known as Project Tango, as well as “smart” clothing in which multitouch sensors were woven into textiles. Another project that Dugan led involved the use of a “digital tattoo” to unlock smartphones. Perhaps most controversially, Dugan was also behind the creation of a “digital authentication pill.”

According to Dugan, when the pill is swallowed, “your entire body becomes your authentication token.” Dugan framed the pill and many of her other efforts at Google as working to fix “the mechanical mismatch between humans and electronics” by producing technology that merges the human body with machines to varying degrees.

While serving in this capacity at Google, Dugan chaired a panel at the 2013 Clinton Global Initiative called “Game-Changers in Technology” and attended the 2015 Bilderberg meeting where AI was a main topic of discussion.

In 2016, Dugan left Google for Facebook where she was chosen to be the first head of Facebook’s own DARPA-equivalent research agency, then known as Building 8. DARPA’s ties to the origins of Facebook were discussed in a recent Unlimited Hangout report.

Under Dugan, Building 8 invested heavily in brain-machine interface technology, which has since produced the company’s “neural wearable” wristbands that claim to be able to anticipate movements of the hand and fingers from brain signals alone. Facebook showcased prototypes of the project earlier this year.

Dugan left Facebook just eighteen months after joining Building 8, announcing her plans “to focus on building and leading a new endeavor,” which was apparently a reference to Wellcome Leap. Dugan later said it was as if she had been training for her role at Wellcome Leap ever since entering the workforce, framing it as the pinnacle of her career.

When asked in an interview earlier this year who the clients of Wellcome Leap are, Dugan gave a long-winded answer but essentially responded that the project serves the biotech and pharmaceutical industries, international organizations such as the UN, and public-private partnerships.

In addition to her role at Wellcome, Dugan is also a member of the Council on Foreign Relations-sponsored taskforce on US Technology and Innovation policy, which was formed in 2019. Other members include LinkedIn’s Reid Hoffman, McKinsey Institute Global Chairman James Manyika, former head of Google Eric Schmidt and President Biden’s controversial top science adviser Eric Lander.

The other executive at Wellcome Leap, chief operating officer Ken Gabriel, has a background closely tied to Dugan’s. Gabriel, like Dugan, is a former program manager at DARPA, where he led the agency’s microelectromechanical systems (MEMS) research from 1992 to 1996.

He served as deputy director of DARPA from 1995 to 1996 and became director of the Electronics Technology Office from 1996 to 1997, where he was reportedly responsible for about half of all federal electronics-technology investments. At DARPA, Gabriel worked closely with the FBI and the CIA.

Ken Gabriel
Ken Gabriel – COO of Wellcome Leap. Source: Wellcome Leap

Gabriel left DARPA for Carnegie Mellon University, where he was in charge of the Office for Security Technologies in the aftermath of September 11, 2001. That office was created after 9/11 specifically to help meet the national-security needs of the federal government, according to Carnegie Mellon’s announcement of the program.

Around that same time, Gabriel became regarded as “the architect of the MEMS industry” due to his past work at DARPA and his founding of the MEMS-focused semiconductor company Akustica in 2002. He served as Akustica’s chairman and chief technology officer until 2009, at which time he returned to work at DARPA where he served as the agency’s deputy director, working directly under Regina Dugan.

In 2012, Gabriel followed Dugan to Google’s Advanced Technology and Products Group, which he was actually responsible for creating. According to Gabriel, Google cofounders Larry Page and Sergey Brin tasked Gabriel with creating “a private sector ground-up model of DARPA” out of Motorola Mobility. Regina Dugan was placed in charge, and Gabriel again served as her deputy.

In 2013, Dugan and Gabriel co-wrote a piece for the Harvard Business Review about how DARPA’s “Special Forces” innovation approach could revolutionize both the public and private sectors if more widely applied.

Gabriel left Google in 2014, well before Dugan, to serve as the president and CEO of Charles Stark Draper Laboratories, better known as Draper Labs, which develops “innovative technology solutions” for the national-security community, with a focus on biomedical systems, energy, and space technology. Gabriel held that position until he abruptly resigned in 2020 to co-lead Wellcome Leap with Dugan.

In addition to his role at Wellcome, Gabriel is also a World Economic Forum “technology pioneer” and on the board of directors of Galvani Bioelectronics, a joint venture of GlaxoSmithKline, which is intimately linked to the Wellcome Trust, and the Google subsidiary Verily.

Galvani focuses on the development of “bioelectronic medicines” that involve “implant-based modulation of neural signals” in an overt push by the pharmaceutical industry and Silicon Valley to normalize transhumanist “medicines.”

The longtime chairman of the board of Galvani, on which Gabriel serves, was Moncef Slaoui, who led the US COVID-19 vaccine development and distribution program Operation Warp Speed. Slaoui was relieved of his position at Galvani this past March over well-substantiated claims of sexual harassment.

Jeremy Farrar, Pandemic Narrative Manager

While Dugan and Gabriel ostensibly lead the outfit, Wellcome Leap is the brainchild of Jeremy Farrar and Mike Ferguson, who serve as its directors. Farrar is the director of the Wellcome Trust itself, and Ferguson is deputy chair of the Trust’s board of governors.

Farrar has been director of the Wellcome Trust since 2013 and has been actively involved in critical decision making at the highest level globally since the beginning of the COVID crisis. He is also an agenda contributor to the World Economic Forum and cochaired the WEF’s Africa meeting in 2019.

Farrar’s Wellcome Trust is also a WEF strategic partner and cofounded the COVID Action Platform with the WEF. Farrar was more recently behind the creation of Wellcome’s COVID-Zero initiative, which is also tied to the WEF.

Farrar has framed that initiative as “an opportunity for companies to advance the science which will eventually reduce business disruption.” Thus far it has convinced titans of finance, including Mastercard and Citadel, to invest millions in research and development at organizations favored by the Wellcome Trust.

Wellcome Trust Director Jeremy Farrar with NTI Co-Chairman Sam Nunn
Wellcome Trust Director Jeremy Farrar with NTI Co-Chairman Sam Nunn, who led the 2001 Dark Winter exercise.
Source: NTI.com

Some of Wellcome’s controversial medical-research projects in Africa, as well as its ties to the UK eugenics movement, were explored in a December article published at Unlimited Hangout.

That report also explores the intimate connections of Wellcome to the Oxford-AstraZeneca COVID-19 vaccine, the use of which has now been restricted or banned in several countries. As mentioned in the introduction, the Wellcome Trust itself is the subject of an upcoming Unlimited Hangout investigation (Part 2).

Jeremy Farrar, who was born in Singapore in 1961, had previously been director of the Oxford University Clinical Research Unit in Ho Chi Minh City, beginning in 1998. During that time, he authored numerous epidemiological research papers. He claimed in a 2014 Financial Times article that his decision to move to Vietnam was due to his disdain for conference halls full of white men.

Southeast Asia was obviously a much less regulated environment for someone in the medical-research industry wishing to indulge in groundbreaking research. Although based in Vietnam, Farrar was sent by Oxford to various locations around the globe to study epidemics happening in real time.

In 2009, when swine flu was wreaking havoc in Mexico, Farrar jumped on a plane to dive right into the action, something he also did for subsequent global outbreaks of Ebola, MERS, and avian flu.

Over the past year, many questions have arisen regarding exactly how much power Farrar wields over global public health policy. Recently, the US president’s chief medical adviser, Anthony Fauci, was forced to release his emails and correspondence from March and April 2020 at the request of the Washington Post.

The released emails reveal what appears to be a high-level conspiracy by some of the top medical authorities in the US to falsely claim that COVID-19 could only have been of zoonotic origin, despite indications to the contrary. The emails were heavily redacted as such emails usually are, supposedly to protect the information of the people involved, but the “(b)(6)” redactions also protect much of Jeremy Farrar’s input into these discussions.

Chris Martenson, economic researcher and post-doctorate student of neurotoxicology and founder of Peak Prosperity, has had some insightful comments on the matter, including asking why such protection has been offered to Farrar given that he is the director of a “charitable trust.” Martenson went on to question why the Wellcome Trust was involved at all in these high-level discussions.

One Fauci email, dated February 25, 2020, and sent by Amelie Rioux of the WHO, stated that Jeremy Farrar’s official role at that time was “to act as the board’s focal point on the COVID-19 outbreak, to represent and advise the board on the science of the outbreak and the financing of the response.”

Farrar had previously chaired the WHO’s Scientific Advisory Council. The emails also show the preparation, within a ten-day period, of the SARS-CoV-2 “‘origins” paper, which was entitled “The Proximal Origin of SARS-CoV-2” and was accepted for publication by Nature Medicine on March 17, 2020.

The paper claimed that the SARS-CoV-2 virus could only have come from natural origins as opposed to gain-of-function research, a claim once held as gospel in the mainstream but which has come under considerable scrutiny in recent weeks.

Shaping the presentation of an origin story for a virus of global significance is something Farrar has been involved with before. In 2004–5, it was reported that Farrar and his Vietnamese colleague Tran Tinh Hien, the vice director at the Hospital for Tropical Diseases, were the first to identify the re-emergence of the avian flu (H5N1) in humans.

Farrar has recounted the origin story on many occasions, stating: “It was a little girl. She caught it from a pet duck that had died and she’d dug up and reburied. She survived.” According to Farrar, this experience prompted him to found a global network in conjunction with the World Health Organization to “improve local responses to disease outbreaks.”

An article published by Rockefeller University Press’s Journal of Experimental Medicine in 2009 is dramatically titled, “Jeremy Farrar: When Disaster Strikes.” Farrar, when referring to the H5N1 origin story stated: “The WHO people—and this is not a criticism—decided it was unlikely that the child had SARS or avian influenza.

They left, but Professor Hien stayed behind to talk with the child and her mum. The girl admitted that she had been quite sad in the previous days with the death of her pet duck. The girl and her brother had fought over burying the duck and, because of this argument, she had gone back, dug up the duck, and reburied it—probably so her brother wouldn’t know where it was buried.

With that history, Professor Hien phoned me at home and said he was worried about the child. He took some swabs from the child’s nose and throat and brought them back to the hospital. That night the laboratory ran tests on the samples, and they were positive for Influenza A.”

With Farrar now having been revealed as an instrumental part of the team that crafted the official story regarding the origins of SARS-CoV-2, his previous assertions about the origin of past epidemics should be scrutinized.

As the director of a “charitable trust,” Jeremy Farrar is almost completely unaccountable for his involvement in crafting controversial narratives related to the COVID crisis. He continues to be at the forefront of the global response to COVID, in part by launching the Wellcome Leap Fund for “unconventional projects, funded at scale” as an overt attempt to create a global and “charitable” version of DARPA.

Indeed, Farrar, in conceiving Wellcome Leap, has positioned himself to be just as, if not more, instrumental in building the foundation for the post-COVID era as he was in building the foundation for the COVID crisis itself.

This is significant as Wellcome Leap CEO Regina Dugan has labeled COVID-19 this generation’s “Sputnik moment” that will launch a new age of “health innovation,” much like the launching of Sputnik started a global technological “space age.” Wellcome Leap fully intends to lead the pack.

“Rulers” of the Gene-Sequencing Industry

In contrast to the overt DARPA, Silicon Valley, and Wellcome connections of the others, the chairman of the board of directors of Wellcome Leap, Jay Flatley, has a different background. Flatley is the long-time head of Illumina, a California-based gene-sequencing hardware and software giant that is believed to currently dominate the field of genomics.

Though he stepped down from the board of Illumina in 2016, he has continued to serve as the executive chairman of its board of directors. Flatley was the first to be chosen for a leadership position at Wellcome Leap, and he was responsible for suggesting Regina Dugan for the organization’s chief executive officer, according to a recent interview given by Dugan.

Illumina Campus
Illumina Campus. Source: Glassdoor

As a profile on Illumina in the business magazine Fast Company notes, Illumina “operates behind the scenes, selling hardware and services to companies and research institutions,” among them 23andMe. 23andMe’s CEO, Anne Wojcicki, the sister of YouTube CEO Susan Wojcicki and the wife of Google cofounder Sergey Brin, told Fast Company, “It’s crazy. Illumina is like the ruler of this whole universe and no one knows that.”

The report notes that 23andMe, like most companies that offer DNA sequencing and analysis to consumers, uses machines produced by Illumina.

In 2016, Illumina launched an “aggressive” five-year plan to “bring genomics out of research labs and into doctors’ offices.” Given the current state of things, particularly the global push toward gene-focused vaccines and therapies, that plan, which concludes this year, could not have been any better timed.

Illumina’s current CEO, Francis DeSouza, previously held key posts at Microsoft and Symantec. Also in 2016, Illumina’s executive teams forecast a future in which humans are gene tested from birth to grave for both health and commercial purposes.

Whereas most companies have struggled financially during the coronavirus pandemic, some have seen a massive increase in profits. Illumina has witnessed its share price double since the start of the COVID crisis.

The company’s $1 billion plus in profits during the last tax year was obviously helped by the quick approval of the NovaSEQ 6000 machines, which can test a large number of COVID samples more quickly than other devices. An individual machine has a hefty price tag of almost $1 million, and thus they are mostly found at elite facilities, private labs, and top-tier universities.

Jay Flatley
Jay Flatley, Executive Chairman, Illumina, speaking at World Economic Forum in Davos 2018. Source: WEF

In addition to his long-standing leadership role at Illumina, Jay Flatley is also a “digital member” of the World Economic Forum as well as the lead independent director of Zymergen, a WEF “tech pioneer” company that is “rethinking biology and reimagining the world.”

Flatley, who has also attended several Davos meetings, has addressed the WEF on the “promise of precision [i.e., gene-specific] medicine.”

At another WEF panel meeting, Flatley, alongside UK Health Secretary Matt Hancock, promoted the idea of making genomic sequencing of babies at birth the norm, claiming it had “the potential to shift the healthcare system from reactive to preventative.”

Some at the panel called for the genomic sequencing of infants to eventually become mandatory.

Aside from Flatley as an individual, Illumina as a company is a WEF partner and plays a key role in its platform regarding the future of health care. A top Illumina executive also serves on the WEF’s Global Future Council on Biotechnology.

A New HOPE

Wellcome Leap currently has four programs: Multi-Stage Psych, Delta Tissue, 1KD, and HOPE. HOPE was the first program to be announced by Wellcome Leap and stands for Human Organs, Physiology and Engineering. According to the full program description, HOPE aims “to leverage the power of bioengineering to advance stem cells, organoids, and whole organ systems and connections that recapitulate human physiology in vitro and restore vital functions in vivo.”

human organs physiology and engineering
Source: Wellcome Leap, https://wellcomeleap.org/hope/

HOPE consists of two main program goals. First, it seeks to “bioengineer a multiorgan platform that recreates human immunological responses with sufficient fidelity to double the predictive value of a preclinical trial with respect to efficacy, toxicity and immunogenicity for therapeutic interventions.”

In other words, this bioengineered platform mimicking human organs would be used to test the effects of pharmaceutical products, including vaccines, which could create a situation in which animal trials are replaced with trials on gene-edited and farmed organs.

Though such an advance would certainly be helpful in the sense of reducing often unethical animal experimentation, trusting such a novel system to allow medical treatments to go straight to the human-testing phase would also require trusting the institutions developing that system and its funders.

As it stands now, the Wellcome Trust has too many ties to corrupt actors in the pharmaceutical industry, having originally begun as the “philanthropic” arm of UK drug giant GlaxoSmithKline, for anyone to trust what they are producing without actual independent confirmation, given the histories of some of their partners in fudging both animal and human clinical trial data for vaccines and other products.

The second goal of HOPE is to open up the use of machine-human hybrid organs for transplantation into human beings. That goal focuses on restoring “organ functions using cultivated organs or biological/synthetic hybrid systems” with the later goal of bioengineering a fully transplantable human organ after several years.

Later on in the program description, however, the interest in merging the synthetic and biological becomes clearer when it states: “The time is right to foster synergies between organoids, bioengineering and immunoengineering technologies, and advance the state-of-the-art of in vitro human biology … by building controllable, accessible and scalable systems.”

The program description document also notes the interest of Wellcome in genetic-engineering approaches for the “enhancement of desired properties and insertion of traceable markers” and Wellcome’s ambition to reproduce the building blocks of the human immune system and human organ systems through technological means.

Transhumanist Toddlers?

The second program to be pursued by Wellcome Leap is called “The First 1000 Days: Promoting Healthy Brain Networks,” which is abbreviated as 1KD by the organization. It is arguably the most unsettling program because it seeks to use young children, specifically infants from three months to three-year-old toddlers, as its test subjects.

The program is being overseen by Holly Baines, who previously served as strategy development lead for the Wellcome Trust before joining Wellcome Leap as the 1KD program leader.

the first 1000 days
Source: Wellcome Leap, https://wellcomeleap.org/1kd/

1KD is focused on developing “objective, scalable ways to assess a child’s cognitive health” by monitoring the brain development and function of infants and toddlers, allowing practitioners to “risk-stratify children” and “predict responses to interventions” in developing brains.

The program description document notes that, up to this point in history, “our primary window into the developing brain has been neuroimaging techniques and animal models, which can help identify quantitative biomarkers of [neural] network health and characterise network differences underlying behaviours.” It then states that advances in technology “are opening additional possibilities in young infants.”

The program description goes on to say that artificial neural networks, a form of AI, “have demonstrated the viability of modelling network pruning process and the acquisition of complex behaviours in much the same way as a developing brain,” while improvements in machine learning, another subset of AI, can now be used to extract “meaningful signals” from the brains of infants and young children.

These algorithms can then be used to develop “interventions” for young children deemed by other algorithms to be in danger of having underdeveloped brain function.

The document goes on to note the promise of “low-cost mobile sensors, wearables and home-based systems” in “providing a new opportunity to assess the influence and dependency of brain development on natural physical and social interactions.”

In other words, this program seeks to use “continuous visual and audio recordings in the home” as well as wearable devices on children to collect millions upon millions of data points. Wellcome Leap describes these wearables as “relatively unobtrusive, scalable electronic badges that collect visual, auditory and motion data as well as interactive features (such as turn-taking, pacing and reaction times).”

Elsewhere in the document there is a call to develop “wearable sensors that assess physiological measures predictive of brain health (e.g., electrodermal activity, respiratory rate, and heart rate) and wireless wearable EEG or eye-tracking technology” for use in infants and children three and under.

Like other Wellcome Leap programs, this technology is being developed with the intention of making it mainstream in medical science within the next five to ten years, meaning that this system—although framed as a way to monitor children’s brain functioning to improve cognitive outcomes—is a recipe for total surveillance of babies and very young children as well as a means for altering their brain functioning as algorithms and Leap’s programmers see fit.

1DK has two main program goals. The first is to “develop a fully integrated model and quantitive measurement tools of network development in the first 1000 days [of life], sufficient to predict EF [executive function] formation before a child’s first birthday.”

Such a model, the description reads, “should predict contributions of nutrition, the microbiome and the genome” on brain formation as well as the effects of “sensimotor and social interactions [or lack thereof] on network pruning processes” and EF outcomes. The second goal makes it clear that widespread adoption of such neurological-monitoring technologies in young children and infants is the endgame for 1DK.

It states that the program plans to “create scalable methods for optimising promotion, prevention, screening and therapeutic interventions to improve EF by at least 20% in 80% of children before age 3.”

True to the eugenicist ties of the Wellcome Trust (to be explored more in-depth in Part 2), Wellcome Leap’s 1DK notes that “of interest are improvements from underdeveloped EF to normative or from normative to well-developed EF across the population to deliver the broadest impact.”

One of the goals of 1DK is thus not treating disease or addressing a “global health public challenge” but instead experimenting on the cognitive augmentation of children using means developed by AI algorithms and invasive surveillance-based technology.

Another unsettling aspect of the program is its plan to “develop an in vitro 3D brain assembloid that replicates the time formation” of a developing brain that is akin to the models developed by monitoring the brain development of infants and children.

Later on, the program description calls this an “in-silico” model of a child’s brain, something of obvious interest to transhumanists who see such a development as a harbinger of the so-called singularity.

Beyond that, it appears that this in-silico and thus synthetic model of the brain is planned to be used as the “model” to which infant and children brains are shaped by the “therapeutic interventions” mentioned elsewhere in the program description.

It should be clear how sinister it is that an organization that brings together the worst “mad scientist” impulses of both the NGO and military-research worlds is openly planning to conduct such experiments on the brains of babies and toddlers, viewing them as datasets and their brains as something to be “pruned” by machine “intelligence.”

Allowing such a program to advance unimpeded without pushback from the public would mean permitting a dangerous agenda targeting society’s youngest and most vulnerable members to potentially advance to a point where it is difficult to stop.

A “Tissue Time Machine”

The third and second-most recent program to join the Wellcome Leap lineup is called Delta Tissue, abbreviated by the organization as ?T. Delta Tissue aims to create a platform that monitors changes in human-tissue function and interactions in real time, ostensibly to “explain the status of a disease in each person and better predict how that disease would progress.”

Referring to this platform as a “tissue time machine,” Wellcome Leap sees Delta Tissue as being able to predict the onset of disease before it occurs while also allowing for medical interventions that “are targeted to the individual.”

delta tissue
Source: Wellcome Leap, https://wellcomeleap.org/delta-tissue/

Well before the COVID era, precision medicine or medicine “targeted or tailored to the individual” has been a code phrase for treatments based on patients’ genetic data and/or for treatments that alter nucleic acid (e.g., DNA and RNA) function itself. For instance, the US government defines “precision medicine” as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.”

Similarly, a 2018 paper published in Technology notes that, in oncology, “precision and personalized medicine … fosters the development of specialized treatments for each specific subtype of cancer, based on the measurement and manipulation of key patient genetic and omic data (transcriptomics, metabolomics, proteomics, etc.).”

Prior to COVID-19 and the vaccine roll outs, the mRNA vaccine technology used by the DARPA-funded companies Moderna and Pfizer were marketed as being precision medicine treatments and were largely referred to as “gene therapies” in media reports.

They were also promoted heavily as a revolutionary method of treating cancer, making it unsurprising that the Delta Tissue program at Wellcome Leap would use a similar justification to develop a program that aims to offer tailored gene therapies to people before the onset of a disease.

This Delta Tissue platform works to combine “the latest cell and tissue profiling technologies with recent advances in machine learning,” that is, AI.

Given Wellcome Leap’s connections to the US military, it is worth noting that the Pentagon and Google, both former employers of Wellcome Leap CEO Regina Dugan and COO Ken Gabriel, have been working together since last September on using AI to predict disease in humans, first focusing on cancer before expanding to COVID-19 and every disease in between.

The Delta Tissue program appears to have related ambitions, as its program description makes clear that the program ultimately aims to use its platform for a host of cancers and infectious diseases.

The ultimate goal of this Wellcome Leap program is “to eradicate the stubbornly challenging diseases that cause so much suffering around the world.” It plans to do this through AI algorithms, however, which are never 100 percent accurate in their predictive ability, and with gene-editing treatments, nearly all of which are novel and have not been well tested.

That latter point is important given that one of the main methods for gene-editing in humans, CRISPR, has been found in numerous studies to cause considerable damage to the DNA, damage that is largely irreparable (see here, here and here).

It seems plausible that a person placed on such a hi-tech medical treatment path will continue to need a never-ending series of gene-editing treatments and perhaps other invasive hi-tech treatments to mitigate and manage the effects of clumsy gene splicing.

Total Surveillance to Treat “Depression”

Wellcome Leap’s most recent program, launched just this week, is called “Multi-Channel Psych: Revealing Mechanisms of Anhedonia” and is officially focused on creating “complex, biological” treatments for depression.

multi channel psych
Source: Wellcome Leap, https://wellcomeleap.org/mcpsych/

Those behind Wellcome Leap frame the problem they aim to tackle with this program as follows:

“We understand that synaptic connections serve as the currency of neural communication, and that strengthening or weakening these connections can facilitate learning new behavioral strategies and ways of looking at the world.

Through studies in both animal models and humans, we have discovered that emotional states are encoded in complex neural network activity patterns, and that directly changing these patterns via brain stimulation can shift mood. We also know that disruption of these delicately balanced networks can lead to neuropsychiatric illness.” (emphasis added)

They add that “biologically based treatments” for depression “are not being matched to the biology of the human beings they’re being used in,” and, thus, treatments for depression need to be tailored “to the specific biology” of individual patients. They clearly state that what needs to be addressed in order to make such personal modifications to treatment is to gain “easy access to the biological substrate of depression—i.e. the brain.”

Wellcome Leap’s program description notes that this effort will focus specifically on anhedonia, which it defines as “an impairment in the effort-based reward system” and as a “key symptom of depression and other neuropsychiatric illnesses.” Notably, in the fine print of the document, Wellcome Leap states:

“While there are many definitions of anhedonia, we are less interested in the investigation of reduced consummatory pleasure, the general experience of pleasure, or the inability to experience pleasure. Rather, as per the description above, we will prioritize investigations of anhedonia as it relates to impairments in the effort-based reward system—e.g. reduced motivation to complete tasks and decreased capacity to apply effort to achieve a goal.”

In other words, Wellcome Leap is only interested in treating aspects of depression that interfere with an individual’s ability to work, not in improving an individual’s quality or enjoyment of life.

Leap notes, in discussing its goals, that it seeks to develop models for how patients respond to treatments that include “novel or existing behavior modification, psychotherapy, medication, and neurostimulation options” while also capturing an individual’s “genome, phenome [the sum of an individual’s phenotypic traits], [neural] network connectivity, metabolome [the sum of an individual’s metabolic traits], microbiome, reward processing plasticity levels,” among others.

It ultimately aims to predict the relationship between an individual’s genome to how “reward processing” functions in the brain. It implies that the data used to create this model should involve the use of wearables, stating that researchers “should seek to leverage high frequency patient-worn or in-home measurements in addition to those obtained in the clinic, hospital or laboratory.”

One of the main research areas included in the program looks to “develop new scalable measurement tools for reliable and high-density quantification of mood (both subjectively reported and objectively quantified via biometrics such as voice, facial expression, etc.), sleep, movement, reward system functioning, effort/motivation/energy levels, social interaction, caloric intake, and HPA axis output in real-world situations.”

The HPA (hypothalamic-pituitary-adrenal) axis is mentioned throughout the document, and this is significant as it is both a negative and positive feedback system regulating the mechanisms of stress reactions, immunity, and also fertility in the human body.

The latter is especially important given the Wellcome Trust’s ties to the UK eugenics movement. It is also worth noting that some commercially available wearables, such as Amazon’s Halo, already quantify mood, sleep, and movement.

The program’s authors go even further than the above in terms of what they wish to monitor in real time, stating, “We specifically encourage the development of non-invasive technology to directly interrogate human brain state.” Examples include “a non-invasive spinal tap equivalent,” “behavioral or biomarker probes of neural plasticity,” and “single-session neural monitoring capabilities that define a treatment-predictive brain state.”

In other words, this Wellcome Leap program and its authors seek to develop “non-invasive” and, likely, wearable technology capable of monitoring an individual’s mood, facial expressions, social interactions, effort and motivation, and potentially even thoughts in order to “directly interrogate human brain state.”

To think that such a device would stay only in the realm of research is naive, especially given that WEF luminaries have openly spoken at Davos meetings about how governments plan to use such technology widely on their populations as a means of pre-emptively targeting would-be dissent and ushering in an era of “digital dictatorships.”

The focus on treating only the aspects of depression that interfere with a person’s work further suggests that such technology, once developed, would be used to ensure “perfect worker” behavior in industries where human workers are rapidly being replaced with AI and machines, meaning the rulers can be more selective about which people continue to be employed and which do not.

Like other Wellcome Leap programs, if completed, the fruits of the Multi-Channel Psych program will likely be used to ensure a population of docile automatons whose movements and thoughts are heavily surveilled and monitored.

The Last Leap for an Old Agenda

Wellcome Leap is no small endeavor, and its directors have the funding, influence, and connections to make their dreams reality. The organization’s leadership includes the key force behind Silicon Valley’s push to commercialize transhumanist tech (Regina Dugan), the “architect” of the MEMS industry (Ken Gabriel), and the “ruler” of the burgeoning genetic-sequencing industry (Jay Flatley).

It also benefits from the funding of the world’s largest medical-research foundation, the Wellcome Trust, which is also one of the leading forces in shaping genetics and biotechnology research as well as health policy globally.

A 1994 Sunday Times investigation into the Trust noted that “through [Wellcome Trust] grants and sponsorships, government agencies, universities, hospitals and scientists are influenced all over the world. The trust distributes more money to institutions than even the British government’s Medical Research Council.” It then notes:

“In offices on the building’s first floor, decisions are reached that affect lives and health on scales comparable with minor wars. In the conference room, high above the street, and in the meeting hall, in the basement, rulings in biotechnology and genetics are handed down that will help shape the human race.”

Little has changed regarding the Trust’s influence since that article was published. If anything, its influence on research paths and decisions that will “shape the human race” has only grown. Its ex-DARPA officials, who have spent their careers advancing transhumanist technology in both the public and private sectors, have overlapping goals with those off Wellcome Leap.

Dugan’s and Gabriel’s commercial projects in Silicon Valley reveal that Leap is led by those who have long sought to advance the same technology for profit and for surveillance. This drastically weakens Wellcome Leap’s claim to now be pursuing such technologies to only improve “global health.”

type from your brain
Regina Dugan’s Keynote at Facebook F8 2017. Source: YouTube

Indeed, as this report has shown, most of these technologies would usher in a deeply disturbing era of mass surveillance over both the external and internal activities of human beings, including young children and infants, while also creating a new era of medicine based largely on gene-editing therapies, the risks of which are considerable and also consistently downplayed by its promoters.

When one understands the intimate bond that has long existed between eugenics and transhumanism, Wellcome Leap and its ambitions make perfect sense. In a recent article written by John Klyczek for Unlimited Hangout, it was noted that the first director general of UNESCO and former president of the UK Eugenics Society was Julian Huxley, who coined the term “transhumanism” in his 1957 book New Bottles for New Wine.

As Klyczek wrote, Huxley argued that “the eugenic goals of biologically engineering human evolution should be refined through transhumanist technologies, which combine the eugenic methods of genetic engineering with neurotech that merges humans and machines into a new organism.”

Earlier, in 1946, Huxley noted in his vision for UNESCO that it was essential that “the eugenic problem is examined with the greatest care and that the public mind is informed of the issues at stake so that much that is now unthinkable may at least become thinkable,” an astounding statement to make so soon after the end of World War II.

Thanks in large part to the Wellcome Trust and its influence on both policy and medical research over the course of several decades, Huxley’s dream of rehabilitating eugenics-infused science in the post–World War II era could soon become reality. Unsurprisingly, the Wellcome Trust hosts the archive of the formerly Huxley-led Eugenics Society and still boasts close ties to its successor organization, the Galton Institute.

The over-riding question is: Will we allow ourselves to continue to be manipulated into allowing transhumanism and eugenics to be openly pursued and normalized, including through initiatives like those of Wellcome Leap that seek to use babies and toddlers as test subjects to advance their nightmarish vision for humanity?

If well-crafted advertising slogans and media campaigns painting visions of utopia such as “a world without disease” are all that is needed to convince us to give up our future and our children’s future to military operatives, corporate executives, and eugenicists, then there is little left of our humanity to surrender.

Is This the Road to Totalitarianism?

People can tell themselves that they didn’t see where things have been heading for the last 17 months, but they did. They saw all the signs along the way. The signs were all written in big, bold letters, some of them in scary-looking Germanic script. They read … “THIS IS THE ROAD TO TOTALITARIANISM.”

I’m not going to show you all those signs out again. People like me have been pointing them out, and reading them out loud, for 17 months now. Anyone who knows anything about the history of totalitarianism, how it incrementally transforms society into a monstrous mirror image of itself, has known since the beginning what the “New Normal” is, and we have been shouting from the rooftops about it.

We have watched as the New Normal transformed our societies into paranoid, pathologized, authoritarian dystopias where people now have to show their “papers” to see a movie or get a cup of coffee and publicly display their ideological conformity to enter a supermarket and buy their groceries.

We have watched as the New Normal transformed the majority of the masses into hate-drunk, hysterical mobs that are openly persecuting “the Unvaccinated,” the official “Untermenschen” of the New Normal ideology.

We have watched as the New Normal has done precisely what every totalitarian movement in history has done before it, right by the numbers. We pointed all this out, each step of the way. I’m not going to reiterate all that again.

I am, however, going to document where we are at the moment, and how we got here … for the record, so that the people who will tell you later that they “had no clue where the trains were going” will understand why we no longer trust them, and why we regard them as cowards and collaborators, or worse.

Yes, that’s harsh, but this is not a game. It isn’t a difference of opinion. The global-capitalist ruling establishment is implementing a new, more openly totalitarian structure of society and method of rule. They are revoking our constitutional and human rights, transferring power out of sovereign governments and democratic institutions into unaccountable global entities that have no allegiance to any nation or its people.

That is what is happening … right now. It isn’t a TV show. It’s actually happening. The time for people to “wake up” is over. At this point, you either join the fight to preserve what is left of those rights, and that sovereignty, or you surrender to the “New Normal,” to global-capitalist totalitarianism.

I couldn’t care less what you believe about the virus, or its mutant variants, or the experimental “vaccines.” This isn’t an abstract argument over “the science.” It is a fight … a political, ideological fight. On one side is democracy, on the other is totalitarianism. Pick a fucking side, and live with it. Anyway, here’s where we are at the moment, and how we got here, just the broad strokes.

It’s August 2021, and Germany has officially banned demonstrations against the “New Normal” official ideology. Other public assemblies, like the Christopher Street Day demo (pictured below), one week ago, are still allowed. The outlawing of political opposition is a classic hallmark of totalitarian systems. It’s also a classic move by the German authorities, which will give them the pretext they need to unleash the New Normal goon squads on the demonstrators tomorrow.

christopher street day

In Australia, the military has been deployed to enforce total compliance with government decrees … lockdowns, mandatory public obedience rituals, etc. In other words, it is de facto martial law. This is another classic hallmark of totalitarian systems.

In France, restaurant and other business owners who serve “the Unvaccinated” will now be imprisoned, as will, of course, “the Unvaccinated.” The scapegoating, demonizing, and segregating of “the Unvaccinated” is happening in countries all over the world. France is just an extreme example. The scapegoating, dehumanizing, and segregating of minorities — particularly the regime’s political opponents — is another classic hallmark of totalitarian systems.

In the UK, Italy, Greece, and numerous other countries throughout the world, this pseudo-medical social-segregation system is also being introduced, in order to divide societies into “good people” (i.e., compliant) and “bad” (i.e., non-compliant).

The “good people” are being given license and encouraged by the authorities and the corporate media to unleash their rage on the “the Unvaccinated,” to demand our segregation in internment camps, to openly threaten to viciously murder us. This is also a hallmark of totalitarian systems.

And that, my friends, is where we are. We didn’t get here overnight. Here are just a few of the unmistakable signs along the road to totalitarianism that I have pointed out over the last 17 months.

June 2020 … The New (Pathologized) Totalitarianism

August 2020 … The Invasion of the New Normals

October 2020 … The Covidian Cult

November 2020 … The Germans Are Back!

March 2021 … The New Normal (Phase 2)

March 2021 … The “Unvaccinated” Question

May 2021 … The Criminalization of Dissent

June 2021 … Manufacturing New Normal “Reality“

And now, here we are, where we have been heading all along, clearly, unmistakably heading … directly into The Approaching Storm, or possibly global civil war. This isn’t the end of the road to totalitarianism, but I’m pretty sure we are in the home stretch. It feels like things are about to get ugly. Very ugly. Extremely ugly.

Those of us who are fighting to preserve our rights, and some basic semblance of democracy, are outnumbered, but we haven’t had our final say yet … and there are millions of us, and we are wide awake.

So pick a side, if you haven’t already. But, before you do, maybe look back at the history of totalitarian systems, which, for some reason, never seem to work out for the totalitarians, at least not in the long run. I’m not a professional philosopher or anything, but I suspect that might have something to do with some people’s inextinguishable desire for freedom, and our willingness to fight for it, sometimes to the death.

This kind of feels like one of those times. Sorry for going all “Braveheart” on you, but I’m psyching myself up to go get the snot beat out of me by the New Normal goon squads tomorrow, so I’m a little … you know, overly emotional. Seriously, though, pick a side … now … or a side will be picked for you.

About the Author

C.J. Hopkins is an award-winning American playwright, novelist and political satirist based in Berlin. His plays are published by Bloomsbury Publishing and Broadway Play Publishing, Inc. His dystopian novel, Zone 23, is published by Snoggsworthy, Swaine & Cormorant.

Volumes I and II of his Consent Factory Essays are published by Consent Factory Publishing, a wholly-owned subsidiary of Amalgamated Content, Inc. He can be reached at cjhopkins.com or consentfactory.org.