Totilas, the “miracle stallion” is dead! — World Animals Voice

Totilas was considered a “miracle stallion” and record breaker in dressage riding and was the most expensive dressage horse in the world. His life in equestrian sport was marked by agony and suffering. Now Totilas died on the evening of December 14, 2020, at the age of just 20 years. A painful death ends his […]

Totilas, the “miracle stallion” is dead! — World Animals Voice

CHD Article on Big-Picture Look at Current Pandemic Beneficiaries Accepted

CHD Article on Big-Picture Look at Current Pandemic Beneficiaries Accepted by Peer-Reviewed Journal

An article by Children’s Health Defense on how the pandemic facilitated a financial, tech, biopharmaceutical and military-intelligence push for centralized, technocratic control has been accepted by the International Journal of Vaccine Theory, Practice and Research.

By Children’s Health Defense Team0

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“Planned Surveillance and Control by Global Technocrats: A Big-Picture Look at the Current Pandemic Beneficiaries,” a peer-reviewed article by Children’s Health Defense, has been accepted for publication in the journal, International Journal of Vaccine Theory, Practice and Research. The journal was launched in 2020 by John W. Oller, Jr., Ph.D. (editor-in-chief) and Christopher A. Shaw, Ph.D. (senior editor) “to make independent research, free from constraints of monetary, political, or any other undisclosed influence, about vaccine theory and practice freely accessible.”

The Children’s Health Defense article, which will appear in the journal by year’s end, assesses how the pandemic has facilitated a financial, tech, biopharmaceutical and military-intelligence push for centralized, technocratic control.

Here’s the article:

Abstract

Global financial patterns and pronouncements point to a seismic overhaul of governance and financial systems that is playing out beneath the surface of the Covid-19 pandemic, reaching far beyond the health domain. Increased centralized control has the potential to create an unbridgeable chasm between a tiny handful of winners and a majority of losers. To foster an integrated analysis of the technocratic and financial forces and agendas at play, this rapid review identifies some of the pandemic’s principal beneficiaries across the interwoven financial, tech, biopharmaceutical, and military-intelligence sectors, assessing developments in the context of the accelerating global push for technocratic consolidation and control. The evidence suggests that Trojan horse coronavirus vaccines may challenge bodily integrity and informed consent in entirely new ways, transporting invasive technologies into people’s brains and bodies. Technologies such as brain-machine interfaces, digital identity tracking devices, and cryptocurrency-compatible chips would contribute to the central banking goal of replacing currencies with digital transaction and identification systems and creating a global control grid that connects the world population to the military-pharma-intelligence cloud of the global technocrats. Moreover, using vaccines as a delivery vehicle for surveillance technologies cancels any legal liability.

Keywords: Biopharmaceuticals; central banks; Covid-19 pandemic; digital identity; Operation Warp Speed; technocracy; vaccines

Introduction

On March 11, 2020, the World Health Organization (WHO) upgraded a reportedly novel coronavirus from a global health emergency (as of January 30) to a global pandemic, having given the name “Covid-19” to the newly minted disease associated with the virus (Forster, 2020; World Health Organization, 2020a). If one examines actions taken both before and since the WHO’s March decree, it seems evident that many highly placed individuals and sectors were able to strategically position themselves to benefit from the declared crisis (Children’s Health Defense, 2020b). At the same time, with a “new form of economic shock” being imposed worldwide under cover of Covid-19 (Lagarde, 2020), it has become apparent that old-fashioned corporate profiteering is far from the whole story.

In fact, global financial patterns and pronouncements point to a seismic overhaul of governance and financial systems that is playing out beneath the surface of the pandemic, reaching far beyond the health domain. These developments highlight a disturbing push for global technocracy — a form of centralized, expert-led control over resource production and consumption that the Wall Street Journal has characterized as “anti-democratic rule by elites who think they know better” (Wood, 2018, 2020; Fitts, 2020a; Schinder, 2020; Schumacher, 2020; White, 2020). In the U.S., many of the actions unfolding behind the scenes are also benefiting from a climate of institutionalized secrecy enabled by the October 2018 adoption of a game-changing policy statement (FASAB Statement 56), which turned financial disclosure rules upside-down to allow the U.S. government and its contractors to maintain secret books (Federal Accounting Standards Advisory Board, 2018; Ferri & Lurie, 2018).

As 2020’s rapid-fire events suggest, substantially increased centralized control and secrecy have the potential to create an unbridgeable chasm between a tiny handful of elite winners and a majority of upper and lower middle class losers. In early June, CNBC’s Wall Street analyst Jim Cramer heatedly pointed out the fact that the pandemic had already produced “one of the greatest wealth transfers in history” (Clifford, 2020). Others have echoed these observations, describing the “monumental transfer of wealth from the bottom of the economic ladder to the top” (Barnett, 2020; Kampf-Lassin, 2020). In comparison to the benefits flowing to large corporations and billionaires, Cramer bluntly observed that pandemic-related restrictions have had a “horrible effect” on America’s small-business economy, with a similar pattern on display outside the U.S. (Clifford, 2020). Even the World Economic Forum — which has promoted many of the structural changes now underway at its annual Davos meetings — acknowledges the “asymmetric nature” of Covid-19-related hardships and the “greater ferocity and velocity” of the pandemic’s impact on populations already under stress before 2020 (World Economic Forum, 2020).

By early fall, fifty million Americans (many with already high burdens of debt) had lost jobs; financial forecasters were issuing warnings about further layoffs; and millions of the still-employed were earning less than pre-pandemic (Andriotis, 2020). In addition, the bulk of the trillions in federal stimulus (which by early May exceeded the gross domestic product of all but six nations worldwide) had made its way to large corporations; Forbes reported that roughly 70 percent of the initial $350 billion intended for struggling small businesses went to large companies (Simon, 2020). Observers suggest that by channeling taxpayer bailouts to the companies that already had the greatest ability to withstand the shutdowns, the largest players have been able to gain even more of a “stranglehold” over the economy (Kampf-Lassin, 2020).

As U.S. billionaires’ wealth increased by almost a trillion dollars (a weekly average of $42 billion), weekly jobless claims, requests for food bank assistance, and reports of addiction, overdoses, depression, and suicide began “shatter[ing] all historical records” (Feeding America, n.d.; Alcorn, 2020; Americans for Tax Fairness, 2020; Baldor & Burns, 2020; Community FoodBank of New Jersey, 2020; Dubey et al., 2020; Ettman et al., 2020; Hollyfield, 2020; Lerma, 2020; Prestigiacomo, 2020; Schwarz, 2020; Sergent et al., 2020; Thorbecke, 2020; Wan & Long, 2020). Outside the U.S., the situation is similar (Bueno-Notivol et al., 2020). As a marker of the global surge in hunger, the Nobel Committee awarded its 2020 Peace Prize to the World Food Programme, prompting the agency’s head to warn that the world is “on the brink of a hunger pandemic” that could result in “famines of biblical proportions” in the coming year (Lederer, 2020).

In November, the Centers for Disease Control and Prevention (CDC) released data identifying over 100,000 excess U.S. deaths “indirectly” associated with the pandemic (Rossen et al., 2020), including a “stunning 26.5% jump” in excess deaths in young adults in their mid-twenties through mid-forties (Prestigiacomo, 2020). Commenting on these mortality data — which reflect “a death count well beyond what [researchers] would normally expect” (Preidt, 2020) — the former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb voiced his suspicion that “a good portion of the deaths in that younger cohort were deaths due to despair,” including drug overdoses (Squawk Box, 2020). University researchers writing about mortality in JAMA concurred that “Excess deaths attributed to causes other than COVID-19 could reflect deaths . . . resulting from disruptions produced by the pandemic” (Woolf et al., 2020), including “spillover effects . . . such as delayed medical care, economic hardship or emotional distress” (Preidt, 2020). Multilateral entities like the Organisation for Economic Co-operation and Development (OECD) emphasize that it will be essential to assess the long-term impact of “confinement and deteriorating financial conditions” on mortality and warn that the social and economic fallout is likely to be “significant” (Morgan et al., 2020).

As an ideology, technocracy is recognized for exalting knowledge and expertise as the principal sources of legitimate power and authority and for asserting that there is “one best way” that only “the experts” (e.g., engineers, scientists, and doctors) can determine (Burris, 1989). However, critics of technocracy have long pointed out that, particularly in crisis situations, the know-how, “discretionary interventions” and seemingly “elastic” power claimed by technocrats can end up blurring the line between useful expertise and “arbitrary rule” (White, 2020). Moreover, technocrats typically resist attempts to make explicit “the non-rational attributes of technocratic decision-making” (Burris, 1989).

With the noticeable absence of any cost-benefit analysis and the increasingly “non-rational” justifications being put forth for Covid-19 restrictions (Handley, 2020; Kristen, 2020; Kulldorff et al., 2020; The Reaction Team, 2020) — as well as the economic, political, social, and cultural changes rolling out at dizzying speed — it is important to try to understand the technocratic and financial agendas at play. Three increasingly interwoven sectors (Big Finance, Big Tech, and Big Pharma) are reaping rewards from Covid-19, benefiting from close relationships with the military-intelligence apparatus (Glaser, 2020; Usdin, 2020). This rapid review seeks to (1) identify some of the pandemic’s principal beneficiaries (financial and otherwise) across these sectors, and (2) assess these parties’ actions in the context of the accelerating global push for technocratic consolidation and control through invasive surveillance.

Methods

Rapid reviews are used to synthesize evidence in a streamlined manner, abbreviating the timeline and requirements of more involved systematic reviews (Ganann et al., 2010). A rapid review is particularly well suited to emerging current event sequences, and the dynamic Covid-19-related situation certainly qualifies. Though not exhaustive, rapid reviews make it possible to quickly summarize available evidence across multiple disciplines, whether for the purpose of informing policy-making and decision-making or to identify patterns and take stock of the bigger picture.

For the purposes of this broad overview of current events, we relied primarily on the so-called grey literature as well as media accounts (from both the legacy media and independent journalists) and various online sources. We also consulted relevant peer-reviewed literature. Notably, while the peer-review process is ordinarily slow-moving, Covid-19-related studies have been making their way through the pipeline at breakneck speed (Packer, 2020).

Examples of sources consulted for this review include conventional and alternative financial commentary; webpages and communications from public health agencies, international organizations, and universities; individual blogs and commentary; and peer-reviewed studies cataloguing the impact of Covid-19 restrictions.

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Big Finance

Assisted by the media, commentators have had an easy time framing the events of 2020 principally as a health crisis. With each passing month, however, those claims wear thinner (Barnett, 2020). In a comprehensive analysis titled The State of Our Currencies, former U.S. Assistant Secretary of Housing Catherine Austin Fitts (2020a) offers a broader and more instructive interpretation. Informed by close attention to financial patterns, Fitts asserts that the “shock doctrine” measures being imposed under cover of Covid-19 are helping lay the train tracks for a new global central banking machine and a technocratic “regulatory and economic model that permits far greater central control”.

Fitts calls attention to G7 central bankers’ August 2019 approval in Jackson Hole, Wyoming of a plan called “Going Direct” (Bartsch et al., 2019) that makes the case for a novel “blurring [of] the lines between government fiscal policy and central bank monetary policy” (Martens & Martens, 2020). Drafted months before Covid-19, the plan — co-branded by the World Economic Forum (n.d.) as “the Great Reset” — evokes the prospect of a serious economic downturn and “unusual circumstances” that could be used to justify “unprecedented” global measures (Bartsch et al., 2019).

Fitts (2020a) postulates that central bankers have both a short-term aim (to extend the existing dollar-based reserve currency system) and an ambitious longer-term goal: to implement a “new global governance and financial transaction system, and gather the power necessary to herd all parties into the new system”. Characterizing these aspirations as nothing short of ending currency as we know it, Fitts suggests that the top-down digital-currency-based model being promoted as a replacement could end up sidelining traditional intermediaries and instead directly furnish populations with something akin to a “credit at the company store”. Spelling out the implications of such a model, Fitts notes that with the help of digital surveillance and a social credit system, the central-bank-controlled “credit” could easily be “adjusted or turned off on an individual basis”. General Manager Agustín Carstens of the Bank for International Settlements (BIS) — the central bank of central banks — recently acknowledged as much, stating that in stark contrast to cash, a Central Bank Digital Currency (CBDC) would give central banks “absolute control” over CBDC use “and the technology to enforce” CBDC rules and regulations (International Monetary Fund, 2020). With a vaccine-injected digital surveillance program in individuals, the CBDC would have dictatorial power at the level of individual buying and selling.

Fitts’ analysis suggests that central bankers began laying the groundwork for the desired global transition well in advance of the coronavirus mayhem. In 2019 alone, G7 finance ministers endorsed a cryptocurrency action plan in July; in August, the G7 central bankers approved “Going Direct”; in September, the U.S. Federal Reserve (“the Fed”) started making hundreds of billions of dollars in loans “direct” to Wall Street trading houses; and in October, the BIS issued a major report on global cryptocurrencies (Bank for International Settlements, 2019; Helms, 2019; Fitts, 2020a; Martens & Martens, 2020). In the middle of the frenzy of central bank activity in October, the Bill & Melinda Gates Foundation (along with the World Economic Forum and Johns Hopkins Center for Health Security) held the well-publicized “pandemic tabletop exercise” called Event 201, which played out a global coronavirus outbreak scenario strikingly similar to 2020’s actual events (Center for Health Security, n.d.).

In January 2020, U.S. corporations witnessed a record number of CEO departures (Ausick, 2020; Marinova, 2020) — a mass exodus that strategically allowed over 200 departing executives to sell their stock at or near the market high (see Table 1). Other wealthy and influential insiders also engaged in surprisingly well-timed stock market transactions. For example, following a late-January, behind-closed-doors briefing about the virus (which had yet to affect a single American), certain U.S. senators sold hundreds of thousands of dollars of stock, “unloading shares that plummeted in value a month later” (Lane, 2020). The world’s wealthiest person, Amazon CEO Jeff Bezos, sold nearly $4.1 billion over an 11-day period in early February after having also sold $2.8 billion in shares in August 2019 (Palmer, 2020).

Table 1. U.S. CEO Departures in January 2020

Sources: Ausick, 2020; ChallengerGray, 2020

As the U.S. government turned on the stimulus spigot in March, the Fed sustained its irregular intervention in the U.S. economy. By the summer of 2020, the Fed had expanded its balance sheet by $2.9 trillion — much of it unaccounted for, according to Fed-watcher John Titus (2020) — and financial observers were warning that “the market is no longer the biggest factor in selecting [economic] winners and losers” (Whalen, 2020). Titus (2020) concurs with this assessment, baldly characterizing 2020’s events as a Fed-led “coup d’état”. Titus (2014) has been chronicling major financial forces and legal changes since the 2008 financial crisis, describing how central banks are not only able to “loot” the American people “in broad daylight” but can do so without fear of prosecution — probably because, as Titus and Fitts (2020a) both point out, the Department of Justice depends on Fed member banks for its financial operations.

The coronavirus stimulus has provided abundant financial opportunities advantageous to Fed member banks. Over a two-week period in April, for example, large banks earned $10 billion in fees (ranging from 1 to 5 percent) simply for processing the government’s loans to businesses (Sullivan et al., 2020). Class-action lawsuits subsequently alleged that the banks prioritized larger loans (and larger companies) in order to garner the largest fees, while shutting out “tens of thousands” of eligible but smaller businesses (Sullivan et al., 2020). Serving as lender to the parent company of a national restaurant chain, Fed member bank JPMorgan Chase (the largest and most profitable bank in the U.S.) earned a $100,000 fee for a single “one-time transaction for which it assumed no risk and could pass through with fewer requirements than for a regular loan” (Sullivan et al., 2020).

In September, Senator Marco Rubio (Chairman of the Senate Committee on Small Business and Entrepreneurship) wrote to the JPMorgan Chase CEO expressing “alarm” about allegations that JPMorgan employees “may have been involved in potentially illegal conduct” in the distribution of Paycheck Protection Program and Economic Injury Disaster Loan funds (Rubio, 2020). Bloomberg later confirmed the possibility of Covid-19-related banking abuse on a wide scale (David, 2020). Importantly, this is not a new pattern of behavior for the U.S. banking behemoth. Since 2002 (and primarily since the 2008 financial crisis), JPMorgan Chase has paid out at least $42 billion in settlements for questionable, unethical, or illegal behavior (Fitts, 2019); its public-facing Wikipedia page lists involvement in 22 different “controversies,” including the economically shattering Enron and Madoff scandals (“JPMorgan Chase”, n.d.). Nevertheless, JPMorgan continues to earn glowing accolades from the financial community. In June 2020, Forbes urged investors to “bank on the best” in the uncertain Covid-19 environment (Trainer, 2020), citing JPMorgan’s post-2009 “industry-leading profitability” and asserting that the bank is exceptionally well positioned to expand its market share both during and post-pandemic. In October, JPMorgan rolled out a new smartphone credit card reader designed to compete with Square and PayPal (Son, 2020).

Big Tech

By July 2020, global billionaires’ wealth had surged to an all-time high of $10.2 trillion — an increase of 27.5 percent since April, and a 41.3 percent increase for tech billionaires (Phillipps, 2020). U.S. billionaires accrued a significant share of this pandemic wealth bonus, increasing their worth by $845 billion from mid-March to mid-September and prompting the observation that “for American billionaires specifically, things have never looked better” (Lerma, 2020). As a whole, U.S. billionaires’ wealth reached the equivalent of almost one-fifth of the U.S. gross domestic product, with four tech billionaires (Jeff Bezos, Bill Gates, Elon Musk, and Mark Zuckerberg) plus Warren Buffett seeing their total wealth climb by 59 percent (da Costa, 2020). Calling attention to Bezos, in particular, the Institute for Policy Studies described his surge in wealth as “unprecedented in modern financial history”, requiring “a real-time hour-by-hour tracker” to keep up (Collins et al., 2020).

The companies with which top-tier billionaires are affiliated include Amazon and Amazon Web Services (Bezos), Apple (Tim Cook), Facebook (Zuckerberg), Google/Alphabet (Larry Page and Sergey Brin), Microsoft (Steve Ballmer and Gates), Oracle (Larry Ellison), Zoom (Eric Yuan), and the variety of companies (including Neuralink, SpaceX, and Tesla) spearheaded by Musk (Alcorn, 2020; Collins et al., 2020; Toh, 2020). In July, as Bloomberg described these companies’ “outsized influence on U.S. markets”, it noted that they are as well-situated to profit from the U.S. shutdown as they are to take advantage of a recovering Europe and Asia — a “one-two punch” that has already increased FAANG companies’ market (Facebook, Amazon, Apple, Netflix, and Google, plus Microsoft) by 62 percent (Ritholtz, 2020). Suggesting that Silicon Valley will go down in history as “the standout sector” (Divine, 2020a), a U.S. News analyst unabashedly recommended Facebook as a 2020 “best buy” because “it’s gobbling up the world, and reasonable people could argue that if privacy is dying, individual investors may as well profit alongside Silicon Valley” (Divine, 2020b).

Covid-19 has provided Big Tech (and Big Telecom) with an opportunity to bring a range of controversial technologies further out into the open, despite many unresolved concerns about safety and ethics (Boteler, 2017; Gohd, 2017; Ross, 2018; Boyle, 2019; Feiner, 2019; Markman, 2019; Plautz, 2019; Zhang et al., 2019; Bajpai, 2020; Goodwin, 2020; Gyarmathy, 2020; McGovern, 2020; Novet, 2020; Reuters, 2020; Tucker, 2020; U.S. Department of Defense, 2020). Singly and in combination, the technologies (some of which are listed in Table 2) have the potential to usher in unprecedented societal changes, strengthening technocrats’ ability to control many facets of daily life. Artificial intelligence (AI), 5G, “smart” utility meters, and the Internet of Things (IoT), for example, are rapidly and fundamentally changing the nature of cities, businesses, and homes — what Fitts (2020a) calls the “final mile” — forming an essential part of the strategy to convert the economic model to a technocratic model that uses AI and software to achieve centrally controlled resource allocation.

Table 2. Covid-19 and the Rollout of Control Technologies

In October 2020, the World Economic Forum — the Great Reset’s front-row marketer — released a report on the future of jobs, describing the significant displacement of workers resulting from the pandemic and the related global restructuring that the organization has been taking the opportunity to promote (Petzinger, 2020). With automation and Covid-19 causing a “double-disruption” that is not only accelerating job destruction in the short term but “shrinking opportunities” in the longer term, the report solemnly pronounced a “new division of labour between humans, machines and algorithms” (World Economic Forum, 2020). Well before the pandemic, Amazon had established a robot-centric system at its fulfillment centers, with a process focused on “limit[ing] movement of people [and] let[ting] robots move everything” (Masud, 2019). This downsizing of humans has apparently served Amazon well; by May 2020, Amazon’s e-commerce business had shot up by 93 percent compared to the previous May (Klebnikov, 2020).

A September 2020 survey showed that many other companies plan to substantially boost their spending on AI and machine learning, citing Covid-19 as their rationale for prioritizing “the adoption of new technologies that enhance and enable automation” (Shein, 2020). Observers also predict, however, that the AI gold rush will lead to even more market consolidation and control by Amazon and three other big Covid-19 winners — Alphabet, Facebook, and Microsoft. These four companies, according to Forbes, have the “scale to push the envelope”, the “talent and the technology to perfect [AI]”, and the computing power to dominate the field (Markman, 2019). Amazon already controls nearly 46 percent of the worldwide public cloud-computing infrastructure that is a key backstop for AI functions such as parallel processing and the digestion of Big Data (Atlantic.Net, 2018; Nix, 2019).

Before Covid-19, consumer rejection of 5G wireless technology had been growing (Castor, 2020). However, the imposition of social distancing measures, remote learning, and online work requirements has provided the telecommunications industry with a ready-made pretext to fast-forward 5G’s deployment while attempting to burnish the industry’s unfavorable public image. Taking advantage of virus fears, Big Tech and Big Telecom are claiming that 5G can help enable “a future in which business, health care and human interaction must be at more than an arm’s length” (Wasserman, 2020). Forbes has praised communication service providers for responding to the coronavirus lockdowns “with a sense of urgency, purpose and empathy” (Wilson, 2020). Describing areas requiring more “advanced connectivity”, a technology expert at Deloitte Consulting cited the example of “cameralytics” (video surveillance) “to help worker safety and social distancing” (Howell, 2020). Whatever the rationale, the reality on the ground has been a massive increase in U.S. telecom companies’ capital spending on 5G and a “full steam ahead” rollout of spectrum and infrastructure that has placed the U.S. “ahead of schedule” (Knight, 2020; Ludlum, 2020). The European Commission is now attempting to follow the U.S.’s lead by pushing for the removal of “regulatory hurdles” and making the case that 5G will aid the region’s post-coronavirus economic recovery (McCaskill, 2020).

Covid-19 has also brought another of Big Tech’s interests into sharper focus: food. Billionaires such as Bill Gates and Peter Thiel have, for some time, been investing in biotech start-ups that aim to produce, in a lab, stem-cell-based “meat”, “fish”, “dairy”, and “breastmilk” (Kerr, 2016; Kosoff, 2017; Beres, 2020; Wuench, 2020). These start-ups and their investors have been only too happy to position the burgeoning industry as a partial solution to pandemic-related food insecurity and supply chain interruptions (Galanakis, 2020; Pereira & Oliveira, 2020; Yeung, 2020), welcoming Covid-19 as an “accelerator” as well as an opportunity to overcome consumer skepticism (Siegner, 2019; Morrison, 2020). In addition, as the coronavirus breathes new life into the term “sustainability” — long used by technocrats as a cover term for more centralized control (Wood, 2018) — global partners like the United Nations and the World Economic Forum are making the improbable claim that the complex, high-dollar, lab-created food substitutes (which require genetically stable cell lines, bioreactors, “edible scaffolds”, and cell culture media) are a “sustainable” option (Whiting, 2020). The biopharma giant Merck is also getting in on the “cultured meat” action, offering to make its “extensive knowledge of the relevant science and biotechnology” available to companies seeking to overcome “critical technological challenges” (Whiting, 2020). Merck frequently collaborates with the Gates Foundation, including in the development of Covid-19 vaccines (Lardieri, 2020).

Big Pharma

In September 2019, an annual Gallup poll reported that the restaurant industry was America’s top-ranked and most-liked among the 25 industries regularly assessed by the polling group (McCarthy, 2019). Sadly, less than a year later the Independent Restaurant Coalition predicted the permanent demise of up to 85 percent of independent restaurants (Jiang, 2020). In contrast, the pharmaceutical industry came in “dead last” in the 2019 poll, despite $9.6 billion spent annually on direct-to-consumer advertising and another $20 billion on marketing to health professionals (McCarthy, 2019; Schwartz & Woloshin, 2019). The U.S. is one of only two countries in the world that allows drug companies to market directly to consumers and, in non-election years, roughly 70 percent of news outlets’ advertising revenues come from pharma (Solis, 2019).

The pharmaceutical industry’s history of “fraud, bribery, lawsuits and scandals” is well known (Compton, n.d.), and no less a figure than Bill Gates has suggested that the public perceives Big Pharma as “kind of selfish and uncooperative”; however, Mr. Gates and Fortune magazine propose that Covid-19 may offer the industry an opportunity for “redemption” (Leaf, 2020). The stage may have been set for Big Pharma’s year of opportunity in January, when JPMorgan Chase held its 38th annual invitation-only health care conference. The business press describes the yearly conference as “one of the biggest biotech dealmaking events, often setting the tone for funding rounds, partnerships and mergers and acquisitions” (Leuty, 2020). Thus, just when the coronavirus ball was getting rolling, the conference brought an estimated 20,000 venture capitalists, investment bankers, and drug development executives and entrepreneurs to San Francisco to hear keynote addresses by JPMorgan’s and GlaxoSmithKline’s CEOs and to stoke expectations of a strong year for the biotech-plus-pharma chimera known as “biopharma” (JPMorgan, n.d.; Leuty, 2020; Lipschultz, 2020). In 2014, McKinsey & Company described the investment opportunities in biopharmaceuticals as “big and growing too rapidly to ignore”, with an annual growth rate more than double that of conventional pharma and a 20 percent share of global pharmaceutical revenues (Otto et al., 2014).

A few weeks after the JPMorgan conference — and well before any Covid-19 deaths in the U.S. — the Department of Health and Human Services (HHS) helped ensure that significant pandemic benefits would flow into the biopharma and medical space. HHS did so by issuing a declaration (on February 4) making vaccines and all Covid-19-related medical countermeasures immune from legal liability (HHS, 2020a). On March 6, roughly a week after the first reported coronavirus death, President Trump sweetened the pot by signing into law the first in a series of emergency stimulus packages, earmarking 40 percent of the $8.3-billion bill for vaccines and drugs under terms the pharmaceutical industry openly dictated (Karlin-Smith, 2020).

Following the February 4 HHS declaration eliminating legal liability, Bill and Melinda Gates instantly pledged $100 million in funding for coronavirus vaccine research and treatments, followed by another $150 million in mid-April (Bill & Melinda Gates Foundation, 2020; Voytko, 2020). When Operation Warp Speed followed, making untold billions available for research and development of therapeutics and vaccines at taxpayer expense (see Table 3), dozens of biopharma companies jumped into the fray (HHS, n.d.). Catherine Austin Fitts notes that a system that exempts from liability anything labeled as a “vaccine” amounts to “an open invitation to make billions . . . particularly where government regulations and laws can be used to create a guaranteed market through mandates” (Fitts, 2020b). Moreover, each time the CDC’s Advisory Committee on Immunization Practices (ACIP) adds a given vaccine to the CDC schedule, it is not only the equivalent of a “golden ticket” for the vaccine manufacturer but also directly benefits the CDC, which owns dozens of vaccine-related patents and routinely shares licensing agreements with manufacturers (Taylor, 2017; Children’s Health Defense, 2019).

Currently, there is one injury for every 39 vaccinations administered (2.6%), often resulting in a “disastrous outcome of life-altering iatrogenic illnesses” (Harvard Pilgrim Health Care, n.d.; Kennedy Jr., 2019; Kristen, 2019). A CDC study published in JAMA in 2016 reported that one in five young children (19.5%) under age five who were admitted to emergency rooms for drug reactions were suffering from vaccine injuries (Shehab et al., 2016). Early clinical trial results and Covid-19 vaccines’ use of an array of experimental, never-before-approved technologies suggest that comparable (or worse) levels of injury could follow the rollout of coronavirus vaccines (Children’s Health Defense, 2020a, 2020c, 2020d, 2020e). The Moderna and Pfizer vaccines, for example, feature mRNA molecules that are known to be “intrinsically unstable and prone to degradation”, with an inflammatory component that risks dangerous immune reactions (Feuerstein, Garde, & Joseph, 2020; Jackson et al., 2020; Wadhwa et al., 2020). Assuming the same vaccine injury rate of 2.6 percent, Operation Warp Speed’s projected vaccination of roughly 25 million Americans per month (Owermohle, 2020b) could conceivably result in 3.9 million injuries over just the first six months. (Given that the leading vaccines will require two initial doses and probable boosters thereafter, this figure could even be an underestimate.) If Bill Gates and other technocrats succeed in their declared aspiration to manufacture billions of doses of coronavirus vaccine and “get them out to every part of the world” (Gates, 2020), the scale of injury would not only be unprecedented but could open a lucrative, long-term gateway to the wider drug market to manage the injuries (Kristen, 2019).

Table 3. U.S. Taxpayer Monies Awarded to Pharmaceutical and Other Companies via Operation Warp Speed* (March–October, 2020), in Millions (M) or Billions (B)

*HHS note on Operation Warp Speed funding: “Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act. Congress has also appropriated other flexible funding. The almost $10 billion specifically directed includes more than $6.5 billion designated for countermeasure development through BARDA and $3 billion for NIH research.”

By mid-October, 44 candidate vaccines were in clinical evaluation worldwide, with another two hundred or so in the pipeline (Agrawal et al., 2020; World Health Organization, 2020b). Furnishing predictably uncritical coverage ensured by the pharmaceutical industry’s strategic entanglements with the media, scientists, and medical journals, the press has been telling the public that the vaccines will play “an important role in most response scenarios”, including “‘sav[ing] the world’ in worse scenarios” and serving as an “insurance policy against continued health and economic shocks” (Agrawal et al., 2020). Only a handful of journalists have called attention to Big Pharma’s pandemic profiteering, pointing out that “insiders at companies developing experimental vaccines and treatments . . . aren’t waiting until they finish the job to collect their reward” (Wallack, 2020).

An October piece in the Boston Globe cited the example of Moderna (Wallack, 2020). It took Moderna a mere three weeks after Bill Gates’ initial funding installment to send its first batch of experimental vaccine to research and patent partner, the National Institute of Allergy and Infectious Diseases (NIAID), leading to an immediate surge in share price of 28 percent (Lee, 2020; Loftus, 2020). By early April, Moderna’s CEO had become an overnight billionaire; by October, he had sold nearly $58 million in stock, followed by another $2 million in mid-November, just ahead of the company’s intended filing for vaccine Emergency Use Authorization (Nagarajan, 2020; Tognini, 2020; Wallack, 2020). Meanwhile, Moderna’s chief medical officer has been “systematically liquidating all of his company stock” — about $70 million — “in a series of pre-planned trades that have made him roughly $1 million richer each week” (Wallack, 2020). Thus far this year, company insiders have sold $309 million in stock versus under $2 million in 2019, fueling suspicion that they may be “downplaying possible obstacles to goose stock prices — and increase their personal profits” (Wallack, 2020). Also among those selling Moderna stock options is Moncef Slaoui, the former Moderna board member and former GlaxoSmithKline executive who now heads up Operation Warp Speed (Rozsa & Spencer, 2020).

From Moderna’s perspective, the Covid-19 vaccine represents a lifeline, rescuing the company from a shaky bottom line due to its prior inability to bring any products to market (Garde, 2017; Nathan-Kazis, 2020). Other biopharma companies formerly on the skids are likewise poised to make record profits from the coronavirus (Webb & Diego, 2020). Characterizing the business model for Covid-19 (and other) vaccines as a “great scheme” — particularly given the HHS-guaranteed, risk-free environment — a watchdog group spokesman told the Boston Globe, “Taxpayers cover the upfront investment costs and shoulder any downside, while their [biopharma’s] executives and shareholders can capture the upside if their drugs pan out and are shoveling obscene amounts of money into their pockets throughout the process” (Wallack, 2020). In the words of a business school professor, “You announce a sliver of positive hope about a product and your stock price goes up,” even though “the chances of that product panning out might be relatively low” (Wallack, 2020). In 2020, the company Vaxart saw its per-share stock price rise from 27 cents to a high of $17.49 (Wallack, 2020).

Rolling Stone journalist Matt Taibbi (2020) describes Covid-19 as “the ultimate cash cow”, a “subsidy-laden scam”, and a legal opportunity for “giant-scale gouging”, quoting a legislator who admits that while the public is paying for the research and manufacturing, “the profits will be privatized”. Writing in August about how the government-subsidized business model played out for Gilead’s drug remdesivir, Taibbi (2020) recounted: “Gilead, a company with a market capitalization of more than $90 billion, making it bigger than Goldman Sachs, develops an antiviral drug with the help of $99 million in American government grant money. Though the drug may cost as little as $10 per dose to make, and is being produced generically in Bangladesh at about a fifth of the list price, and costs about a third less in Europe than it does in the U.S., Gilead ended up selling hundreds of thousands of doses at the maximum conceivable level, i.e., the American private-insurance price — which, incidentally, might be about 10 times what it’s worth, given its actual medical impact”.

Always a major lobbying presence on Capitol Hill, the pharmaceutical industry has been more lavish than usual with its political spending in 2020, donating over $11 million to individual candidates involved with health care policy and related political action committees (Facher, 2020a). Although the overall amounts represent a pittance for companies earning tens of billions a year, pharma and its lobbying groups recognize that “small chunks of corporate change”, when strategically allocated, “can have a significant impact” (Facher, 2020b). Coronavirus vaccine frontrunner Pfizer, the second-largest drug and biotech company in the world and the fourth-highest earner of vaccine revenues (Statista, n.d.; Hansen, 2020), has been the top political spender, likely laying the groundwork for its November 20 filing for Emergency Use Authorization for its coronavirus vaccine (Chander, 2020; Children’s Health Defense, 2020d). Pfizer has also benefited from repeated endorsements from the financial community and self-proclaimed spokesmen like Bill Gates (Speights, 2020a, 2020b).

The Military-Intelligence Complex

Traditional vaccines have their fair share of safety problems, but coronavirus and other 21st-century vaccines promise to challenge bodily integrity and informed consent in entirely new ways, particularly given their strong reliance on various forms of nanotechnology (Health and Environment Alliance, 2008; Li et al., 2009; Chauhan et al., 2020; Children’s Health Defense, 2020a). Many of the technologies being rolled into Covid-19 vaccines and their delivery systems originated in the military sphere or benefited from Defense Advanced Research Projects Agency (DARPA) funding. DARPA has had a Biological Technologies Office since 2014 and, since the emergence of Covid-19, has specifically directed many of its pandemic-related efforts toward coronavirus therapeutics and vaccines (Gallo, 2020). Far from being suspect, the military’s role has been celebrated. A BioCentury report optimistically suggested in March that as an agency “that specializes in turning science fantasies into realities”, DARPA might offer the “best hopes” for Covid-19 biotech solutions due to its willingness to pursue “high-risk, high-reward technologies”, set goals “that defy conventional wisdom”, and go after its goals with a “laser” focus (Usdin, 2020).

One of the principal DARPA-incubated vaccine technologies to gain prominence in the Covid-19 era are the nucleic acid (mRNA and DNA) vaccines that turn the human body into its own “bioreactor” (Ghose, 2015; Usdin, 2020). Vaccines using mRNA (such as Moderna’s and Pfizer’s) — which developers compare to “software” (Garde, 2017) and praise for their “programmability” (Al-Wassiti, 2019) — target the cell’s cytoplasm and rely on delivery technologies such as lipid nanoparticles to “ensure stabilization of mRNA under physiological conditions” (Wadhwa et al., 2020). DNA vaccines (such as Inovio’s) are intended to penetrate all the way into a cell’s nucleus and come with the risk of “integration of exogenous DNA into the host genome, which may cause severe mutagenesis and induced new diseases” (Zhang, Maruggi, Shan, & Li, 2019). Describing the scientific community’s early doubts about nucleic acid vaccines — arising from the potential for “many things” to go wrong — a DARPA program manager recently noted, “It was something that was much too risky for groups like the NIH to fund” (Usdin, 2020).

Risks aside, DARPA and vaccine manufacturers are attracted to one chief benefit of nucleic acid vaccines: They can be developed much more quickly and cheaply. Other military-initiated technologies are also coming into view with Covid-19 vaccines. These include electroporation, which applies a high-voltage electrical pulse to make cell membranes permeable to a vaccine’s foreign DNA (Inovio Pharmaceuticals, 2020); syringe-injected biosensors that enable continuous wireless monitoring of vital signs and body chemistry (Peer, n.d.; Profusa, n.d.; Diego, 2020b; Tucker, 2020); and the quantum-dot-based infrared detectors that are under discussion as a tool for tracking vaccination status (Johnson, 2011; Trafton, 2019). DARPA has also played a leading role in developing and funding technologies that “blur the lines between computers and biology”, including brain-machine interfaces and neuromonitoring and mind-reading devices (CB Insights, 2019; Gent, 2019; Tullis, 2019).

Some of Moderna’s earliest funding came from DARPA, which awarded the company $25 million in 2013 to develop the mRNA platform that has become a key feature of its coronavirus vaccine (Usdin, 2020). Other DARPA beneficiaries now involved in efforts to develop Covid-19 vaccines or therapeutics include AbCellera Biologics, CureVac, Inovio Pharmaceuticals, Regeneron Pharmaceuticals, and Vir Biotechnology; some of AbCellera’s partners include major players like Pfizer and Gilead (Usdin, 2020).

The Pentagon’s involvement in coronavirus-related efforts goes well beyond DARPA-funded research. Four-star General Gustave Perna is serving as chief operating officer of Operation Warp Speed alongside chief advisor Moncef Slaoui. General Perna, in charge of U.S. Army Materiel Command, oversees the global supply chain for over 190,000 U.S. Army employees (HHS, 2020b). For the first time ever, the distribution of the eventual coronavirus vaccines is being planned as a “joint venture” between the CDC and the Pentagon, with the latter overseeing “all the logistics of getting the vaccines to the right place, at the right time, in the right condition” (Owermohle, 2020a). In a CBS “60 Minutes” appearance in early November, General Perna indicated that Operation Warp Speed already had doses of (currently unapproved) vaccine and syringes stockpiled and protected by armed guards, and intends to get them out the door “within 24 hours” of vaccine approval and delivered “to every zip code in this country” (Martin, 2020).

The Pentagon has indicated that private-sector involvement could be a key feature of the distribution strategy, and the private sector is positioning itself to participate. Merck, for example, is testing drone delivery of vaccines in partnership with Volansi, Inc., a company that provides “on-demand” drone services for the military (Landi, 2020; Simmie, 2020). In July, Merck’s CEO set the stage for its logistics involvement by describing vaccine distribution as “even a harder problem” than the “scientific conundrum of coming forward with a vaccine that works” (Murray & Griffin, 2020).

Outside the pharmaceutical arena, technological transformations that are speeding the world toward more centralized control also reveal the influence of the military-intelligence sector. For example, Amazon Web Services has held cloud-computing contracts with the CIA since 2013, with the original $600 million contract extending to all 17 intelligence agencies (Konkel, 2014). In October of 2019, the Department of Defense awarded the $10 billion JEDI cloud computing contract to Microsoft, a decision that Amazon has unsuccessfully disputed in court (Sandler, 2020). In early 2020, the U.S. Navy awarded a cloud computing contract to Leidos (Leidos, 2020).

5G, too, relies in part on the high-range millimeter-wave spectrum previously used almost entirely by the military for “non-lethal” crowd dispersal weapons (Joint Intermediate Force Capabilities Office, n.d.). In October, the Department of Defense announced it would spend $600 million to test “dual-use” applications of 5G to enhance the U.S. military’s “leap-ahead capabilities”, including applications such as 5G-enabled augmented/virtual reality, 5G-enabled “smart” warehouses, and 5G technologies “to aid in Air, Space, and Cyberspace lethality” (U.S. Department of Defense, 2020).

Both 5G and cloud computing are critical components of the Big Data and IoT build-out that is enabling the conversion of individual data into the “new oil” (Fitts, 2020a), and both have exploded in 2020 (Howell, 2020; Klebnikov, 2020). The technologies are essential to the “centrally controlled digital financial transaction systems” envisioned by central bankers, who plan to rely on seamless data flows to and from “every smartphone, community, and home without exception” (Fitts, 2020a).

Discussion

As more individuals and organizations connect the technocratic dots and look beneath the coronavirus pandemic’s seductively simple surface, it should become increasingly apparent that the pandemic profiteers do not have people’s best interests at heart. In The State of Our Currencies and other pandemic-related writings, Catherine Austin Fitts (2020a, 2020b) strongly emphasizes the importance of accepting that what is transpiring in the financial, tech, biopharmaceutical, and military-intelligence sectors is interconnected. Part of this involves recognizing that the coronavirus vaccines currently dominating the headlines represent something likely to go far beyond the simple health intervention being held out by scientists and officials as a panacea. Instead, the evidence suggests that Covid-19 vaccines are intended to serve as a Trojan horse to transport invasive technologies into people’s brains and bodies. These technologies could include brain-machine interface nanotechnology, digital identity tracking devices, technology that can be turned on and off remotely, and cryptocurrency-compatible chips (Fitts, 2020b).

In Fitts’ (2020a, 2020b) view, this type of intimate access — achieved “without notice, disclosure, or compensation” — represents the “final inch” of interest to technocrats. Together with external technologies to control behavior (Max, 2020), such access could permit the achievement of several goals: (1) replacing currencies with a digital transaction system, digital identification, and tracking (an “embedded credit card system”); (2) creating a global control grid that connects the population to the military-intelligence clouds; and (3) obtaining continuous access to valuable individual data on a 24/7 basis (Fitts, 2020b). Countries in West Africa are already piloting a venture by the Gates Foundation, the Gates-funded GAVI vaccine alliance, and Mastercard that “marks a novel approach towards linking a biometric digital identity system, vaccination records, and a payment system into a single cohesive platform” (Diego, 2020a). As Fitts (2020b) summarizes, “Just as Gates installed an operating system in our computers, now the vision is to install an operating system in our bodies and use ‘viruses’ to mandate an initial installation followed by regular updates”. The “neat trick”, as Fitts sees it, is that the use of vaccines as the delivery vehicle cancels out legal liability.

It is noteworthy that Bill Gates announced that he was stepping down from the Microsoft board of directors on March 13 — the same day that President Trump declared the pandemic a national emergency (Haselton & Novet, 2020). That same month, the Pentagon reaffirmed its intention for the JEDI cloud-computing contract to go to Microsoft (Rash, 2020; Sun, 2020). By distancing himself from the appearance of conflicts of interest with Microsoft’s Defense Department commitments and the Pentagon’s subsequent role in Operation Warp Speed, Mr. Gates had more freedom to make the rounds and begin promoting worldwide vaccination and digital certificates (Haggith, 2020). Gates has been less successful in distracting attention from other potential conflicts of interest. An exposé by The Nation (ironically also published in March) showed that the Gates Foundation gives billions to corporations in which the foundation holds stocks and bonds — including all of the major pharmaceutical companies — creating a “welter of conflicts of interest” (Schwab, 2020). A dozen years ago, around the time of the 2007-2008 financial crisis, the Los Angeles Times outlined the Gates Foundation’s numerous holdings in a number of notoriously “destructive or unethical” companies (Piller et al., 2007).

Mr. Gates is not the only party strenuously promoting digital IDs and “no-escape” financial tracking (marketed under the benevolent guise of “financial inclusion”). In October, Kristalina Georgieva, the International Monetary Fund’s (IMF’s) Managing Director, evoked “a world in which digital is the way in which financial transactions take place” and made it clear that she views universal digital IDs as a non-negotiable requirement for moving in the “right direction” (International Monetary Fund, 2020). Georgieva has, not unhappily, described Covid-19 as a “once in a lifetime pandemic” (Bello, 2020).

Georgieva’s remarks should be examined in the context of a proposal by the U.S. House of Representatives to bestow the IMF with $3 trillion “no-strings-attached” U.S. dollars as “coronavirus relief aid” (Huessy, 2020; Roberts, 2020). A U.S. taxpayer-funded gift of this magnitude would be unprecedented and would increase the IMF’s lending resources (called Special Drawing Rights or SDRs) by as much as 10-fold (Roberts, 2020). 2020’s events (including global debt entrapment and actual or potential food shortages) and the IMF’s bullying track record (Bello, 2020) suggest that the IMF could then wield the $3 trillion as a weapon, strong-arming countries into accepting an array of unwanted measures such as digital identities, forced vaccination, and eventually (as the World Economic Forum predicts), the relinquishment of private property (World Economic Forum, 2016). As a step in this general direction, the IMF has strongly praised India’s leadership in biometric identification systems. It celebrates the “delivery of social benefits through direct electronic payments to eligible bank account holders”, but glosses over the systems’ vulnerability to “unauthorized access” and the data breaches that are already rampant (Jha, 2018).

While current prospects for ordinary citizens certainly appear challenging, nothing is a foregone conclusion. Large-scale protests against the curtailment of civil rights have occurred and continue to occur in many countries, most notably in Germany (Depuydt, 2020). The Great Barrington Declaration — a statement crafted by public health scientists from Harvard, Stanford, and Oxford — has garnered signatures from over 12,000 scientists, over 35,000 medical practitioners, and nearly 639,000 citizens from around the world, all concerned about “the damaging physical and mental health impacts of the prevailing COVID-19 policies” (Kulldorff et al., 2020). Similarly, an Appeal authored in May by Archbishop Carlo Maria Viganò, former Apostolic Nuncio to the United States, gathered 40,000 signatures within a few days, with the signatories (religious leaders, doctors, journalists, lawyers, and other professionals) all seeking to draw attention to the threats to sovereignty and freedom that pandemic-related mandates have unleashed (Tosatti, 2020). Archbishop Viganò has also penned severe critiques of the Great Reset, describing its architects as “a global elite that wants to subdue all of humanity, imposing coercive measures [and a health dictatorship] with which to drastically limit individual freedoms and those of entire populations” (Viganò, 2020).

One of the signatories of Archbishop Viganò’s Appeal is attorney Robert F. Kennedy, Jr., founder and chief legal counsel of Children’s Health Defense, an organization dedicated to ending childhood epidemics by working to eliminate harmful exposures, holding those responsible accountable, and establishing stronger safeguards. In late October, Kennedy recorded a 19-minute video message to people around the world, describing the “coup d’état by big data, by big telecom, by big tech, by the big oil and chemical companies and by the global public health cartel” (Kennedy Jr., 2020). In his closing remarks, Kennedy also indicated that citizens who wish to maintain their freedoms cannot afford to remain complacent: “You are on the front lines of the most important battle in history, and it is the battle to save democracy, and freedom, and human liberty, and human dignity from this totalitarian cartel that is trying to rob us simultaneously, in every nation in the world, of the rights that every human being is born with.”

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Biohazard Nightmare at Merck Vaccine Plant

Whistleblower: FDA Failed to Address ‘Biohazard Nightmare’ at Merck Vaccine Plant

A former FDA employee-turned-whistleblower says the agency downgraded his report on safety violations at a Merck vaccine plant. The allegation raises questions about how the FDA will monitor safety of COVID vaccine manufacturers.

By Children’s Health Defense Team8

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A former employee of the U.S. Food and Drug Administration (FDA) whose job it was to inspect vaccine manufacturing plants told Vanity Fair last week that when the FDA ignored his allegations of gross safety violations at a Merck vaccine plant, he blew the whistle — only to be ignored.

Coming amid growing concerns over the safety of COVID vaccines, which are being rushed to market at unprecedented speed, the newly revealed allegations raise questions about how the FDA will oversee safety at COVID vaccine manufacturing operations.

According to Vanity Fair, “the unprecedented effort to actually make the more than 300 million doses that a successful national vaccination effort will require has gotten less attention” than issues related to the safety and efficacy of the actual vaccines themselves.

“Vital questions about the FDA’s inspections of vaccine plants have slipped under the radar,” the magazine reported.

Vanity Fair, the first to report on the whistleblower complaint, focused on concerns related exclusively to the manufacturing process. The article dismissed concerns about the actual safety of the vaccine.

In an interview after her article was published, reporter Katherine Eba told PBS NewsHour the “last thing she wanted to do” was contribute to “vaccine hesitancy.”

“You know, the issues we raised in this story have nothing to do with the anti-vaxxer position. They have to do with whether the FDA is doing the job it is supposed to do, which is ensuring that all these manufacturing plants follow good manufacturing practices.”

But many people, including doctors and scientists, have raised a multitude of concerns about the safety of the leading COVID vaccine candidates. In fact, polls consistently show that more people than not, including healthcare workers, won’t sign up, at least not right away, for the vaccines.

Compounding concerns about the safety of the vaccines themselves, are concerns about the FDA’s process for emergency authorization — will the agency prioritize public safety over pharmaceutical industry profits?

According to Arie Menachem, the whistleblower who told his story to Vanity Fair, that’s not been his experience with the FDA, at least not when it comes to the safety of vaccine manufacturing.

Menachem — who according to Vanity Fair holds a master’s degree in biochemistry and worked for 13 years in quality assurance and compliance at several pharmaceutical companies before joining the FDA in 2014 — was a member of the FDA’s Team Biologics.

The “elite” team’s 14 members were responsible for inspecting 280 manufacturing plants that make vaccines and blood products for U.S. patients.

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In November 2018, Menachem filed a whistleblower complaint with the U.S. Office of Special Counsel after his initial report detailing a host of disturbing safety violations at a Merck vaccine plant was downgraded by FDA officials.

Menachem’s report — based in part on information provided to him by whistleblowers within the company — included this, according to Vanity Fair:

“The allegations described a biohazard nightmare. Workers appeared to be defecating and urinating in their uniforms, and feces had been found smeared on the floor of the plant’s production area, the letter alleged. In a sterile manufacturing plant, bathroom breaks can be difficult to take because they require additional time, which could serve as one possible explanation for the events inside the Merck plant. Ungowning can take 15 minutes, regowning can take 15 minutes, and on a night shift, there may be no one else to cover an essential worker during that time, Menachem said.”

Vanity Fair said the magazine confirmed Menachem’s account, as well as his description of conflict inside Team Biologics, “through interviews with four current or former FDA employees, including Menachem, a detailed review of documents, and an analysis of Team Biologics inspection data.”

Merck isn’t the only drugmaker whose manufacturing operations have been called into question. As Children’s Health Defense previously reportedEli Lilly, which has been working on a COVID therapeutic drug, recently had a run-in with the FDA over problems with one of its manufacturing plants. Reuters reported that the FDA had cited “serious quality control problems” at an Eli Lilly plant working on an antibody therapy.

A former associate counsel at the FDA told Reuters the violations were “serious enough and have a significant enough impact on the public health that something needs to be fixed.”

When it comes to COVID vaccines, Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, told Vanity Fair, “There is not a lot of room for error on a COVID vaccine.”

But as Vanity Fair and Bloomberg pointed out, if the FDA, as it’s expected to, grants emergency use authorization for a COVID-19 vaccine, “it is not even clear whether the FDA will require full inspections of manufacturing plants” because transparency has been “notably absent in Operation Warp Speed,” the public-private partnership launched by the Trump administration to rapidly develop and distribute a COVID-19 vaccine.

More Vaccine Truths

12/10/20•

BIG PHARMA › VIEWS

Sausage Making at FDA: How Human Cancer Cells Got Into Vaccines

In a 2012 meeting, the FDA voted to allow the use of human fetal cells and adult human tumor cells in vaccines, despite acknowledging the many risks, including that vaccine recipients might later develop cancer.

By Robert F. Kennedy, Jr.12

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“If the American people knew some of the things that went on at the FDA, they’d never take anything but Bayer aspirin.” — Len Lutwalk, FDA scientist

“The FDA, by spinelessly knuckling under to every whim of the drug companies, has thrown away its high reputation, and in doing so, forfeited our trust.” — Drummond Rennie, deputy editor of JAMA

“[The] honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER (Center for Drug Evaluation and Research of the FDA) have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs … If we asked questions that could delay or prevent a drug’s approval — which of course was our job as drug reviewers — management would reprimand us, reassign us, hold secret meetings about us or worse … When you are able to dig in, if you found issues that would make you turn down a drug, you could be pressured to reverse your decision, or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document … I believe I also have documentation of falsification of documents, fraud, perjury and widespread racketeering, including witnesses tampering and witness retaliation.” — Ronald Kavanagh, Ph.D., pharmacist who reviewed medications for the FDA from 1998 to 2008

Vaccines and related biological products advisory committee today

Today — Thursday, Dec. 10 — the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which is the U.S. Food and Drug Administration’s (FDA) internal panel that licenses new vaccines as “safe and effective,” will meet to consider Pfizer’s COVID vaccine. VRBAC will meet in one week, Dec. 17, to consider approval of the Moderna vaccine.

The damning safety studies in Pfizer’s late release clinical trial data dump, and the severe (life-threatening) allergic reactions that bedeviled the vaccine’s UK rollout, have raised red flags and public anxiety about the safety of the companies’ mRNA vaccines. Anthony Fauci has addressed growing skepticism about COVID vaccines and the Operation Warp Speed program, by reassuring the public that “VRBPAC” is an “independent panel of leading experts” whom the public can absolutely trust to assure vaccine safety.

In order to help you make your own conclusion about how reliably VRBPAC will protect your health, I excerpt below the transcripts from the cavalier, ignorant and astonishingly unethical deliberations during the 2012 VRBPAC meeting where panelists voted unanimously to allow use of human tumor cells in vaccines. I urge you to read and make up your own mind whether you want to place your health — and perhaps your life — in the hands of these reckless charlatans and irresponsible clowns.

How FDA originally approved use of fetal cells in vaccines

FDA allows both human fetal cells and adult human tumor cells in vaccines. Both types have cancer risks. While both Pfizer and Moderna tested their mRNA vaccine using fetal cells, there are no fetal cells, cell debris or DNA in their final products.

However, according to company documents, Johnson and Johnson (Janssen) and Altimmune’s COVID vaccines are manufactured in the human fetal cell line PER-C6, and thus the final vaccine products will contain cellular debris and DNA fragments from these cells. Researchers harvested these cell lines from the eyeball of an 18-week-old human fetus aborted in 1985, and then rendered them immortal by making them cancerous.

The AstraZeneca, Cansino, Gamayela, Vaxart, LongComm and Upitt vaccines are manufactured in the human fetal cell line HEK293, and thus the final vaccine products will contain cellular debris and DNA fragments from the fetal HEK-293 cell line. Scientists harvested this cell line from the kidney of a female Dutch fetus legally aborted in 1973 and then immortalized the cells by rendering them cancerous.

Normal primary cells, which are unable to replicate indefinitely, ultimately die. Immortalized cell lines are derived from known malignant cancer cells such as those obtained from Henrietta Lacks (HeLa) or created in the laboratory by introducing viral oncogenes or chemical exposures capable of mutating normal primary cells into immortal tumor cells.

According to FDA’s “The Pink Sheet” dated Nov. 29, 1999, for two decades the agency has been acutely aware of the inherent risks of using immortalized cell lines for vaccine development. The FDA CBER Director Dr. Peter Patriarca, M.D. explained that continuous cell lines are used for their ability to self-propagate, making them an ideal substrate on which to grow viruses, “the worst thing we are concerned about is …  malignancy, because some of these continuous cells have the potential for growing tumors in laboratory animals.”

Patriarca further conceded that “the technology to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work.” This dire “black box” conundrum that Patriarca described in 1999 is even more acute today with the urgent pressure to develop COVID vaccines before manufacturers have tested them in animals or subjected them to long-term safety studies.

We call vaccines “biologics” because vaccinologists have traditionally grown their antigens on biological substrates — usually animal tissue. Competing companies culture COVID vaccines on a variety of animal strata. The Merck and IAVA COVID vaccines are manufactured in vero monkey cells, and thus contain cellular debris and DNA fragments from vero monkeys in the final product. The Sanofi, GSK, and Novavax COVID jabs are manufactured in insect cells and thus contain insect cellular debris and DNA fragments in the final products.

Public health advocates criticize the use of animal tissues in vaccines due to risks that they carry endogenous viruses, microbes, parasites and lack safety testing. (Plague of Corruption, Mikovits 2020).The first use of human fetal cells in vaccines occurred around 60 years ago, but the practice is increasingly popular. It was always controversial. Immunologists long considered using cells from aborted human fetuses in vaccines to be a high-risk gambit; human DNA debris is much more likely to infiltrate cells in vaccinated individuals than insect or monkey DNA.

Researchers and regulatory agencies have worried for more than 50 years about the potential for injected DNA to cause cancer. According to Dr. Theresa Deisher, a research scientist, primitive (unmethylated) DNA chains from human fetuses have the ability to 1) activate immune receptors that could lead to autoimmune attacks in susceptible individuals who have genetic predispositions that cause their own DNA to be under-methylated, or 2) insert into cells where they could combine with host DNA and cause mutations.

Regulators have in the past predicted that the odds of that happening were less than 1 in a trillion. However, in early gene therapy trials this event did indeed occur in 4 of 9 boys, 1 of whom died from the leukemia the insertions caused.

“Researchers have long observed that when introduced DNA enters a cell, it chooses a region of the cell that gives it a survival advantage. These could be the regions that are most likely to produce long-living cancer cells,” Dr. Deisher told me. FDA has never made any effort to test the safety of this practice or to determine whether the epidemic of soft-tissue cancers is “vaccine-generation” children is related to the use of cancerous fetal cells in vaccines. Even worse, in 2002, FDA green-lighted vaccine companies to use cancerous tumor cells from adults in vaccines.

FDA as an arm of Big Pharma

Before reviewing the shocking transcript of the FDA meeting that approved this dubious practice, we need to understand the conflicts and corruption that pervade this rogue agency. If we are to ever develop safe, effective COVID vaccines, we need first to stop thinking of the FDA as a regulatory agency; it is an arm of the notoriously corrupt pharmaceutical industry.

According to a 2017 Emory University study entitled “Thick as Thieves? Big Pharma Wields Its Power with the Help of Government Regulation,” FDA bureaucrats act as “enablers, or perhaps worse still, [they are] complicit in questionable or ethically unsound activity as a result of being driven by self-serving motives ….” A 1992 law that allows drugmakers to buy fast-track approvals for new products from FDA has poured concrete on a regulatory dynamic already corrupted by all the ubiquitous mechanisms of “agency capture.”

Between 2000 and 2010, pharmaceutical companies paid the FDA $3.4 billion to gain rapid drug approvals. Today, Pharma companies underwrite three-quarters of FDA’s budget for scientific reviews (ProPublica) and fund nearly 50% of the FDA’s total annual budget through PDUFA fees. In exchange, the agency increasingly fast-tracks expensive drugs and vaccines with significant side effects and unproven health benefits.

No one at FDA wins kudos for slowing down those money flows. To the contrary, according to FDA’s own employees, drug company payments bias regulators, with “an inclination toward approval.”

According to Dr. Michael Carome, a former Health and Human Services (HHS) official and a director of the advocacy group Public Citizen, “Instead of a regulator and a regulated industry, we now have a partnership … That relationship has tilted [the FDA] away from a public health perspective to an industry friendly perspective.”

Corrupt vaccine approval panels

But as corrupt as FDA is, the internal panels — VRBAC — that approve new vaccines make the rest of the agency look like a Sunday church picnic.

When Dr. Fauci, Paul Offit, Peter Hotez and Bill Gates tell you that you needn’t worry because FDA is the “gold standard” for vaccine safety and that the ultimate licensing decision will be made by an “independent panel of experts,” they are talking about VRBPAC. But VRBPAC is far from “independent.” It is not even comprised exclusively of public officials. Instead, it is populated by outside “experts” who are almost all pharmaceutical industry insiders.https://www.youtube.com/embed/XZzT2Riq69c?enablejsapi=1&autoplay=0&cc_load_policy=0&iv_load_policy=1&loop=0&modestbranding=0&fs=1&playsinline=0&controls=1&color=red&cc_lang_pref=&rel=1&autohide=2&theme=dark&

In 2003, following a 3-year investigation, the United States Congress’s House Oversight Committee found VRBAC was completely dominated by the vaccine industry.

According to findings of the congressional investigation, VRBAC’s “independent” vaccine panel members often share vaccine patents with the pharmaceutical companies whose products they are evaluating. They “own stock in those vaccine companies, receive payment from those companies for research and paid speeches. They occupy consulting lofty and powerful sinecures and accept payments to monitor vaccine trials and funding for their academic departments.”

The 2000-2003 U.S. House Government Reform Committee’s investigation of VRBPAC found that: (1) “The overwhelming majority of members, both voting members and consultants, have substantial ties to the pharmaceutical industry.” (2) “Conflict of interest rules employed by the FDA … have been weak, enforcement has been lax and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings … In many cases, significant conflicts of interest are not deemed to be conflicts at all.”

Congressional investigators offered a typical example of the sort of financial entanglements that put VRBPAC under Pharma’s slavish control. That example was the December 12, 1997, VRBPAC meeting that approved Wyeth’s (now Pfizer’s) rotavirus vaccine, Rotashield.

The Congressional investigators detailed the committee’s cozy nepotism with vaccine makers.

“Examples of Conflicts of Interest:

  1. “For instance, 3 out of 5 FDA advisory committee (VRBPAC) members who voted to approve the rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.
  2. “One out of five voting members’ employer had a $9,586,000 contract for a rotavirus vaccine.
  3. “One out of five voting members was the principal investigator for a Merck grant to develop a rotavirus vaccine.
  4. “One out of five voting members received approximately $1 million from vaccine manufacturers toward vaccine development.”

Congressional investigators concluded that, “Altogether, four out of the five committee members had conflicts of interest that required waivers, and their recommendation for approval of the vaccine was unanimous.”

Here’s what happened at the 2012 FDA meeting on fetal cells

HHS acknowledges that the FDA and Centers for Disease Control committees that contract and review new vaccines have historically not used “evidence-based medicine.” To illustrate what this means, one only need read (below) the astonishing transcript of the 2012 panel that first approved the use of adult cancer tumor cells in vaccines.

This transcript shows what the public is never supposed to see: the behind-the-scenes sausage-making of federal vaccine approvals. Here, you will read for yourself how the “independent,” “gold standard” panelists entrusted with protecting your children made monumentally consequential decisions, not on evidence-based science, but by rolling the dice and taking what they knew was a horrendously risky bet on public health

In any other realm, this transcript would be proof of negligent homicide. The sickening side-view of VRBAC’s deliberations reveals FDA’s “trusted experts” for what they are; sadistic boys in lab coats giddily discussing the removal of wings from flies. We are all lab rats in their high-risk population-wide experiment. At FDA’s vaccine division, that sort of reckless decision-making is routine.

In 2012, most live virus vaccines were from animal tissue and the idea of putting potentially cancerous tumor cells from adult “donors” in vaccines was still a daring and audacious gamble. That September, the FDA VRBPAC committee met to discuss this risky innovation. The transcript of that meeting — showing captive FDA officials considering a proposal by the pharma cabal to allow the use of human cancer cells (HeLa) to replace animal tissue in the manufacture of vaccines — is proof of reckless criminal conduct.

The HeLa cells are well known to cause cancer in animals, but Big Pharma wanted to lower production costs of vaccines and this method is cheaper and faster than using animal tissue for the cultivated media. The obvious question of whether such vaccines might induce cancer in recipients was on the top of the VRBPAC agenda. Health authorities and vaccine manufacturers blatantly acknowledged their uncertainty regarding the safety of vaccines made from HeLa cancer tumors as they voted to make a dangerous high-stakes gamble that would lower costs for vaccine makers

Unbelievably, FDA voted to allow pharmaceutical companies to produce vaccines using human cells without reviewing a single scientific study to determine if the outcome would be safe.

Before, I quoted some of the criminally reckless statements from the meeting directly. A more detailed account appears in this article.

This was a full meeting of FDA’s VRBPAC in 2012 to decide on the use of human tumor cell lines for the production of vaccines. I list these speakers and their titles at that time:

  • Dr. Philip Krause, Acting Deputy Director of OVRR (Office of Vaccine Research and Review) and FDA’s CBER (Center for Biologics Evaluation and Research). Also, Principal Investigator for Vaccine Safety: Virus Detection and Latency.
  • Dr. Doug Lowy, Director of the National Cancer Institute of the NIH.
  • Dr. Robert Daum, Chair of the VRBPAC.
  • Donald W. Jehn M.S., Designated Federal Officer for VRBPAC.
  • Keith Peden, PhD, Chief of LDNAV, DVP/OVRR/CBER.
  • Dr. Marion Gruber, Director of the FDA’s Office of Vaccines.
  • Dr. Nathanial Brady, a self-described clinician.
  • Dr. Pamela McInnes, a vaccine development expert and the Director of the Division of Extramural Research at the NIH’s National Institute of Dental and Craniofacial Research, and previously a Deputy Director under Anthony Fauci at the National Institute of Allergy and Infectious Diseases.

Pharma knew that their tumorigenic vaccines might cause tumors in recipients.

Dr. Philip Krause acknowledged the risks when he said: “We have really identified three major factors that could potentially convey risk from tumor-derived cells. And these include the cells themselves … and if they were tumor-derived cells then maybe they themselves could form tumors in a vaccine recipient.”

Government regulators acknowledged that tumor cell lines can cause tumors.

Dr. Doug Lowy acknowledged this when he said: “What I think is qualitatively different about the tumor cell lines is the fact that they can cause tumors.”

FDA officials knew that tumors might occur decades after vaccination.

Dr. James Cook acknowledged this when he commented: “But certainly, if you are going to address this question about tumor risk from vaccines made in tumor cell lines, it’s going to have to be a decade’s question.”

FDA openly acknowledged that its primary objective was not to assure public safety but to help vaccine manufacturers.

Dr. Robert Daum, the leader of the meeting, commented: “ …but we are here to consider the issues that we would like to advise the agency to consider in helping the company continue the manufacturing process, what should they be concerned about, what should they be watching for.”

FDA officials knew that they could not prove vaccine safety using test animals to assess oncogenicity.

Dr. Keith Peden acknowledged this fact when he said: “I’m not optimistic that we’re going to find animal models to assess oncogenicity of DNA. That’s why I’m feeling that maybe it’s the clearance aspect that we have to deal with, with respect to DNA.”

FDA officials deliberately terminated animal safety tests too early in order to conceal consequences.

Dr. Robert Daum acknowledged this fact when he said: “Are they watching these animals long enough? Should it be longer?”

Dr. Keith Peden acknowledged this fact when he said: “Is it relevant to safety that a cell forms a tumor after a year, a year-and-a-half?”

FDA decided to keep the tumor cell lines secret, because doctors and the public may be alarmed and say “Oh, my God!” if they knew the truth.

Dr. Nathanael Brady acknowledged this when he said: “How is this group (of vaccines) going to be able to be accepted by the consumers … As soon as you hear “a tumor-derived cell line,” how do you explain that, put the public at ease?”

Dr. Robert Daum further acknowledged these facts: “ …the practicing medical community and also the lay public. They are going to hear that we are recommending, or that the manufacturers are making, vaccines with tumorigenic cell lines and say, ‘Oh, my God,’ even if there’s no scientific basis to say, ‘Oh, my God.’”

FDA decided to use deceptive language to convince doctors and the public that the vaccines were safe even when they, themselves, were unconvinced of safety.

Dr. Philip Krause acknowledged this when he said: “… because it’s a discussion of how one communicates these issues and how the public will perceive them. But I’m not completely sure that we have a complete answer on the fundamental scientific question. So how can you communicate a scientific consensus that the product is safe unless we’re sure that you, the experts we are asking to advise us, are convinced that it’s safe?”

FDA decided to hide information about their use of tumor cells and omit it from package inserts.

Dr. Marion Gruber proposed this deception when he said: “The minute you describe something in the package insert in terms of potential clinical safety concerns, I think that really precludes using these cell substrates.”

Dr. James Cook agreed to the deception when he said: “When it gets right down to what’s in the vial and what the patient is going to ask me about, whether it’s safe, I’m not going to say, well, you know, HeLa cells kill nude mice.”

Dr. Robert Daum acknowledged the deception when he said: “I don’t know that our charge is to micromanage the package insert today. I think that’s a new discussion, with lots of issues that we haven’t really aired completely.”

Health authorities were skeptical about safety of the tumor lines, but they decided to subject the public to the risk, so that they could perform a global population-wide live human experiment.

Dr. Robert Daum agreed to conduct the mass human experiment with the following statement: “So I’m not sure that we can give a certainty there’s no risk — don’t worry about this … It’s sort of a brave new world. We’re all doing it together. But I think that you are doing a beautiful job.”

FDA officials opted to toss the dice, perform the population-wide human experiment, and learn about the risks as time goes by.

FDA officials even cast this experiment as a noble venture in the quest for scientific knowledge. Dr. Pamela McInnes made this stunning appeal to her colleagues: “… even though there are challenges [risks to humans] to using the new technologies, they have to be embraced and we have to continue to try to learn from them and struggle through that learning curve.”

In the end, FDA decided to take the risks. The leader of the committee says, “I’m a vaccine guy,” then urged his cronies to approve.

Dr. Robert Daum said: “I’m a vaccine guy. They are wonderful to prevent infectious diseases … I hope that I’m speaking for everybody when I say that’s the answer to your question. If not, please chime in now.”

The committee formally approves the method of making vaccines from human cancer tumors.

Dr. Robert Daum said: “To come back to the agency’s question of whether this committee believes it’s correct scientifically to go forward with the development of these vaccines, our answer is yes.”

Prior to voting to go forward, the committee made the following conclusions:

  • Making vaccines with cells that are directly derived from human cancer tumors is faster and cheaper than breeding animals for the culture media.
  • Millions of potentially cancer-causing vaccines will be produced.
  • The vaccines may possibly cause genetic mutations.
  • Millions of dollars will be made by vaccine promoters.
  • The health of millions of consumers may be jeopardized.
  • Information about how vaccines are made will be hidden from doctors and consumers.

This 2012 VRBPAC meeting perfectly illustrates the reckless, malevolent and murderous zeitgeist underlying the Pharma/HHS partnership. VRBPAC’s “devil-may-care” decision-making allowed pharmaceutical companies to use potentially cancerous fetal cells to make millions of vaccines.

Since that meeting, vaccines containing cancerous cells and DNA strands from aborted fetuses have become pervasive among the 72 doses of vaccines that FDA has approved, and CDC “recommends” for American children. Today, the vaccines for chickenpox, MMR, hepatitis A and shingles contain fetal DNA.

There is little chance of consequence to vaccine makers from making this reckless choice, and much potential benefit. The 1986 National Vaccine Injury Act makes pharmaceutical companies immune from negligence claims and from product defect lawsuits by injured plaintiffs. Since cancer takes years to develop, causation is virtually impossible for injured petitioners to prove in the Federal Vaccine Court where HHS is the defendant.

Furthermore, by the time a tumor develops, the three-year statute of limitations for the vaccine injury has long expired. Pharma is therefore recklessly and pathologically bold about putting carcinogens in vaccines.

Finally, it’s worth considering that cancer treatment drugs like Keytruda are among pharmaceutical companies’ largest profit makers. Precipitating a cancer epidemic in human populations only benefits vaccine makers’ bottom line.

Remember, these are the same companies and the same FDA regulators that brought us the opioid epidemic.

RFK, Jr. Warned FDA Three Months Ago About Ingredient in Pfizer COVID Vaccine That Likely Caused Life-Threatening Reaction in Two UK Healthcare Workers

An investigation this week identified polyethylene glycol (PEG) as the likely reason two people in the UK suffered anaphylaxis after receiving Pfizer’s COVID vaccine. In September, CHD Chairman RFK, Jr. warned the FDA that PEG in COVID vaccines could lead to severe allergic reactions.

By Lyn Redwood, RN, MSN2

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On Dec. 2, Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) became the first in the world to approve a COVID-19 vaccine developed by Germany’s BioNTech and Pfizer.

A mass vaccination campaign that targeted frontline workers to receive the vaccine began on Dec. 8. Within 24 hours of launching the campaign, MHRA acknowledged two reports of anaphylaxis and one report of a possible allergic reaction.

Reuters reported late yesterday afternoon that an investigation into the anaphylactic reactions by MHRA has identified polyethylene glycol, or PEG, as the likely culprit.

Imperial College London’s Paul Turner, an expert in allergy and immunology who has been advising the MHRA on its revised guidance, told Reuters: “The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk.”

It was also reported that PEG, which helps to stabilize the shot, is not in other types of vaccines.

The statements by Turner that “PEG is not in other types of vaccines” and that people with allergies to “just one medicine should not be at risk” are a failed attempt to provide false assurances and are patently untrue.

Moderna, Pfizer/BioNTech and Arcturus Therapeutics COVID vaccines all utilize a never-before-approved messenger RNA (mRNA) technology, an experimental approach designed to turn the body’s cells into viral protein-making factories. This technology involves the use of lipid nanoparticles (LNPs) that encapsulate the mRNA to protect them from degradation and promote cellular uptake.

The LNP formulations in the three COVID-19 mRNA vaccines are “PEGylated,” meaning that the vaccine nanoparticles are coated with a synthetic, non-degradable and increasingly controversial PEG.

COVID mRNA vaccines are not the only vehicle for PEG involvement in COVID-19 vaccine production. Researchers at Germany’s Max Planck Institute report developing a process for COVID-19 vaccine production to purify virus particles at “high yield.” The process involves adding PEG to a virus-containing liquid and passing the liquid through membranes.

On Sept. 25, Robert F. Kennedy, Jr., chairman and chief legal counsel for Children’s Health Defense (CHD), notified the Steven Hahn, director of the U.S. Food and Drug Administration (FDA), Dr. Peter Marks director of FDA’s Center for Biologics Evaluation and Research and Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, of the serious and possibly life-threatening anaphylactic potential of PEG.

CHD received the following response from the FDA, on Dec. 2, but has not yet received a response from Fauci.

In earlier communications with Moderna scientists regarding the controversial use of PEG in the company’s COVID-19 vaccine due to the potential for life-threatening anaphylaxis and need for pre-screening for PEG antibodies prior to vaccine administration, they insisted that the existence of PEG antibodies was purely hypothetical and underserving of concern:

“Pre-screening populations based on hypothesized biomarkers, such as anti-PEG antibodies, is not a strategy currently employed in our clinical trials.”

Given the recent evidence of PEG anaphylaxis in Pfizer mRNA vaccine recipients, I wonder if FDA and vaccine manufacturers will now reconsider their position.

An extensive review of PEG therapeutics, published in 2013, documented adverse effects of PEGylation and questioned the wisdom behind the continued use of PEG in drug development. The authors concluded that “the accumulating evidence documenting the detrimental effects of PEG on drug delivery make it imperative that scientists in this field break their dependence on PEGylation.”

The statement by Turner that “people with a known allergy to just one medicine should not be at risk,” is also not true.

2018 study, “Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized” reports there are more than 1,000 products, including prescription drugs, that contain PEG. (See chart below for detailed descriptions of PEG containing drugs.)

The decision to allow people with other medication allergies to receive vaccines that utilize PEG in the manufacturing or delivery of the vaccine is a very risky proposition — especially given that Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials.

We have no idea what the incidence of allergy or anaphylactic reactions will be once Pfizer begins global distribution of the vaccine, without such exclusions.

2016 study reported detectable and sometimes high levels of anti-PEG antibodies in approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s. The population’s increased exposure to PEG-containing products since the 1990’s makes it natural to assume that anti-PEG antibodies will continue to be widespread.

As approval of PEGylated mRNA vaccines for COVID-19 occurs, the uptick in exposure to injected PEG products will be unprecedented and potentially disastrous.

While four out of five doctors regularly prescribe PEGylated drugs, only one out of five are aware of the potential for anti-PEG antibody responses. And only a third even know that PEG is in the drugs that they are prescribing.

A Vanderbilt University researcher agrees that there is a widespread lack of recognition that PEG hypersensitivity is possible, much less that it manifests on a regular basis. While it has been recommended to screen patients for anti-PEG antibody levels “prior to administration of therapeutics containing PEG” such testing is currently only available in research settings.

In a declaration effective Feb. 4, the Secretary of Health and Human Services invoked the Public Readiness and Emergency Preparedness Act (PREP Act) and declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency warranting liability protections for covered countermeasures, including vaccines.

The fact that the FDA has abdicated its responsibility for assuring the safety of COVID vaccines to vaccine  manufacturers means we are on our own to study the science, and weigh the benefits and risks of all drugs and vaccines.

CHD will continue to monitor this important safety issue in an effort to keep you well informed on the science and public policies surrounding COVID-19 vaccine development.

Descriptions of PEG containing drugs:

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.SUGGEST A CORRECTION