The oligarchy running the Trans Atlantic System certainly loves the centralized control found in the Chinese system, and they adore the behaviorist social credit stuff, but that is where the admiration ends, Matt Ehret writes.
Ever since the earliest days of the Coronavirus pandemic, evidence began to emerge that the virus was not a naturally occurring evolutionary phenomenon as asserted by the WHO, Nature, and editors at the Lancet, but had other origins.
Among the earliest of those who found themselves supporting this theory were the Chinese Foreign Ministry Spokesman Lijian Zhou who made international waves by sharing two articles by Larry Romanov on the possibility of “gene targeting” of the virus which was having a disproportionately bad effect on Iranians, Italians and various Asian genotypes. Zhou was soon joined by bioweapons experts like Francis Boyle, prominent virologists Luc Montagnier and Judy Mikovits, followed by a growing array of scholars, scientists and academics from around the world who all assessed that the virus’ apparent gene sequencing implied human handiwork. While all agreed that COVID appeared to have originated from a lab, it was still unclear whether that lab was Chinese or controlled by the USA.
Another obvious question arose with this lab theory: Was it an accidental leak or was it consciously deployed?
Since pandemic war game operations had become a normalized part of western geopolitical life from the early days of Dark Winter in 2000 to the Rockefeller Foundation’s 2011 Lock Step to the World Economic Forum’s Event 201 (and dozens more in between), the likelihood of conscious deployment was a very serious possibility.
Who had the motive, means and modus operandi to carry out such a global operation?
The Wuhan Theory Begins
By February 2020, the Wuhan lab leak hypothesis began to make headlines fed by evidence that Dr. Anthony Fauci had exported certain gain of function coronavirus experiments from U.S. bioweapons laboratories to Wuhan’s Institute of Virology – one of two BSL-4 labs in China equipped to conduct this sort of research in China.
When Sir Richard Dearlove (former head of MI6) became a loud proponent of the Wuhan lab leak hypothesis in June 2020, something seemed amiss. Dearlove certainly knew a thing or two about bioweapons. He knew very well of the Pentagon’s vast array of internationally extended bioweapons labs peppered across the world, and he certainly understood the art of misdirection being a byzantine shadow creature who operated at the highest echelons of British intelligence. Dearlove was after all in charge of the “yellowcake” dodgy dossier that launched an Iraq war, he knew of the fallacious reports of nerve gases used by the governments of Libya and Syria sponsored by MI6, had even overseen major components of Russiagate that drove a color revolutionary process in the USA. Dearlove also knew a thing or two about the Porton Down labs that manufactured Novichok used in the Skripal Affair.
While Dearlove’s cheerleading of the Wuhan lab theory raised alarm bells, as time passed, no smoking gun evidence surfaced that one could fully “take to court”. In this respect, Dearlove’s operation had the upper hand since receipts from Fauci’s NIH to the Wuhan Lab did make headlines. How convenient.
Before going into the next phase of the story, it is important to recall that the absence of empirical evidence is not by itself a proof of one party’s innocence, just as the existence of a piece of empirical evidence is not a proof of another party’s guilt. This was a sad discovery made far too late by Shakespeare’s Othello after Iago’s planted “evidence” of a handkerchief resulted in the foolish warrior to murder his loving wife.
Wuhan Lab Origins Go Viral Again
In recent weeks, the Wuhan lab leak hypothesis has once again become all the rage.
Rand Paul’s May 10 showdown with Fauci over this the latter’s funding of the Wuhan Institute of Virology added fuel to the fire. Sky News’ May 7 reporting of public Chinese policy papers discussing covid-based bioweapons have gone viral. On March 26, former Center of Disease Control head Robert Redfield asserted support for the Wuhan lab leak theory. While the scanned receipts of the funds transfer from the NIH to Wuhan via Eco Health Alliance ($600 thousand went to Wuhan) for coronavirus research, had been available since last February, one must wonder why it is now over a year later that this fact is being spread across the perception landscape on all levels.
Both mainstream and alternative media across the western world representing both the left and right have jumped on board the bandwagon blaming China for leaking the virus whether by accident or intent (though obviously, intent is the conclusion which anyone is being expected to draw. But again, I must ask: In a world of misdirection, psychological warfare and perception management, do the clues that we are being given force us to conclude that the Chinese government is behind the global shutdown?
Chinese Leaders Blame the CIA
Zeng Guang, a chief epidemiologist at China’s Center of Disease Control recently joined the conspiracy club on February 9, 2021 in an interview with Chinese media. While denying that the Chinese Wuhan lab is the source of the virus as so many in the west have claimed, Guang asserted that SarsCov2’s origins in a laboratory should not be discounted. Pointing to the 200 globally extended U.S. bioweapons labs littering the earth (and citing the USA’s proven track record of deploying bioweapons as part of its asymmetrical war arsenal since WWII), Guang asked:
“Why are there so many laboratories in the United States when biology labs are all over the world? What is the purpose? On many things, the United States requires others to be open and transparent, only to find that it is the United States itself that is often the most opaque. Whether or not the United States has any special fame on the issue of the new crown virus this time, it should have the courage to be open and transparent. The United States should take responsibility for proving itself to the world, rather than being caught up in hegemonic thinking, hiding itself from the virus and dumping others.”
“I’d like to stress that if the United States truly respects facts, it should open the biological lab at Fort Detrick, give more transparency to issues like its 200-plus overseas bio-labs, invite WHO experts to conduct origin-tracing in the United States, and respond to the concerns from the international community with real actions.”
Those who tend to avoid looking at the history and scope of Pentagon controlled bioweapon warfare tend to ignore the content of such remarks cited by those Chinese officials above for a multitude of reasons. For one: it is easy to believe that Fauci and Gates are corrupt, and this theory not only implicates both men but also ties them to a Chinese government which most westerners have come to fear and hate as a bastion of global debt-trappery, genocide, technocracy and imperialism.
After conducting a short review of some of the fundamental facts of recent world history alongside certain geopolitical realities of our present world order referenced by the head of the Chinese CDC, I believe that China’s Wuhan Lab is being set up. Here’s why…
Fact #1) Depopulation Then and Now
While many people may wish to avoid looking at this fact, depopulation is a driving factor behind international unipolar policy today as it had been during the days of WW2 when Rockefeller Foundation, Macy Foundation, City of London and Wall Street interests gave their backing to both the rise of fascism as an economic miracle solution for the economic woes of the great depression and eugenics (the science of population control) as the governing religion of a new scientific priesthood.
Today, this agenda masquerades behind a new transhumanist movement, shaped by a words like “Fourth Industrial Revolution”, “decarbonized economies”, and “Great Resets”. The primary targets of this agenda remain: 1) the Institution of the sovereign nation state itself as it was the target a century ago when the Bank of England arranged the formation of the 1919 League of Nations, and 2) the “overpopulated zones” of the world with a focus on China, India, South America and Africa.
For anyone who would find themselves instinctively inclined to brush aside such claims as “conspiracy theorizing”, I would encourage a brief review of Sir Henry Kissinger’s infamous NSSM-200 report: Implications of Worldwide Population Growth for U.S. Security and Overseas Interests published in 1974. This declassified report went far to transform U.S. foreign policy from a pro-development philosophy to a new paradigm of population control. Kissinger warned that “if future numbers are to be kept within reasonable bounds, it is urgent that measures to reduce fertility be started and made effective in the 1970s and 1980s…. (Financial) assistance will be given to other countries, considering such factors as population growth… Food and agricultural assistance is vital for any population sensitive development strategy… Allocation of scarce resources should take account of what steps a country is taking in population control… There is an alternative view that mandatory programs may be needed….”
In Kissinger’s twisted logic, U.S. Foreign Policy doctrine had too often foolishly sought to end hunger by providing the means of industrial and scientific development to poor nations.
A true Malthusian through and through, Kissinger believed that aiding the poor to stand on their own feet would result in global disequilibrium as the new middle classes would consume more, and use the strategic resources found under their own soil, which would set the world system into greater disequilibrium and accelerated entropy.
This was deemed unacceptable to the mind of Kissinger and any misanthropic follower of Malthus who shared his views of humanity and government.
Kissinger’s Master-Slave Global Society
At the time of Kissinger’s ascent to power as Secretary of State under Nixon, a new grand strategy was unleashed designed to create a new “master-slave” dependency between the developed and undeveloped sectors of the world… with a special emphasis on the 13 nations targeted by NSSM 200 plus China.
China itself was only permitted to acquire western tech needed to start climbing out of abject poverty on the condition that they obeyed the Rockefeller-World Bank demands that one child policy programs were imposed to curb population growth.
Kissinger began organizing for this new set of relations in society around “Have”, post-industrial consumers and a massive “Have-Not” class of poor laborers with access to industry, but remaining stagnant, cheap and without the means of purchasing the goods they produced. The other darker skinned parts of the world would be even more worse off, having neither the means of production, nor consumption while remaining in constant states of famine, war and backwardness. These dark age zones would be largely made up of Sub Saharan Africa and would find their resource-rich lands exploited by the corporate middle men and financiers trying to run the world order above the “obsolete order” of nation states.
Kissinger’s model of a world order was absolutely static with no room for population growth or technological progress which would have any connection to increasing the powers of production. Mao and the Gang of Four which ran the cultural revolution appeared to be highly compatible with Kissinger’s agenda. But when Mao died and the Gang of Four were rightfully imprisoned, a new long-term strategy known as the Four Modernizations shaped by Zhou Enlai and carried out by Deng Xiaoping was launched. This program was far more foresighted than Kissinger realized.
Fact #2) China is currently a leading force of pro-population growth.
While the west has been accelerating into a decaying path on every measurable level, China is quickly moving in an opposing trajectory via extending long term investments and advanced tech development into its own society as well as to its neighbors through such comprehensive projects as the Belt and Road Initiative.
While its own population has not healed from the disastrous 1979 one child policy and is far from achieving the 2.1 children per couple needed for replacement fertility, it did lift the one child limit to two in 2015 and leading Bank of China economists have called for a total elimination of all limits immediately. Meanwhile, the top-down national orientation of China towards increasing the free energy needed to support and grow the economy is unlike anything we have seen in the closed-system western world for many decades.
A vital fact often forgotten is that together China and India were instrumental in sabotaging the December 2009 COP-14 program in Copenhagen which had promised to establish legally binding emission target cuts to guide the de-carbonization (and de-industrialization) of much of society.
The London Guardian had reported that “Copenhagen was a disaster. That much is agreed. But the truth about what actually happened is in danger of being lost amid the spin and inevitable mutual recriminations. The truth is this: China wrecked the talks, intentionally humiliated Barack Obama, and insisted on an awful “deal” so western leaders would walk away carrying the blame.”
Apparently China and India, along with African governments like Sudan (which had not yet been carved up on the careful watch of Rhodes’ Susan Rice) did not wish to sacrifice their industry and national sovereignty on the altar of climate change models and technocrats that had only weeks earlier been publicly exposed as frauds by East Anglia University researchers during the embarrassing Climategate scandal.
While China and India should be celebrated for having sabotaged this effort 11 years ago, very few people have been able to hold this drama in their memory, and fewer still realize how this fight over sovereignty was in any way connected to China’s 2013 creation of the Belt and Road Initiative as the vital force behind the Multipolar Alliance.
Fact #3) Soros at Davos 2020: The two greatest threats to Open Society: 1) Donald Trump’s USA and 2) Xi Jinping’s China.
During his January 2020 Davos speech, Soros took aim at both Trump and Xi Jinping as the two greatest threats to his Open Society who had to be stopped at all costs. In September 2019 (just as Event 201 was happening) Soros wrote in the Wall Street Journal :
“As founder of the Open Society Foundations, my interest in defeating Xi Jinping’s China goes beyond U.S. national interests. As I explained in a speech in Davos earlier this year, I believe that the social-credit system Beijing is building, if allowed to expand, could sound the death knell of open societies not only in China but also around the globe.”
Before becoming mired into the “China virus” narrative, Donald Trump had worked exceptionally hard to emphasize good relations with China and even managed one of the most important trade deals that had successfully moved into phase one the week Soros spoke at Davos. This first phase involved China creating a market to purchase U.S. finished goods as part of the program to rebuild America’s lost manufacturing sector that had been hollowed out over 5 decades of “post industrialism”. Where Kissinger called NAFTA “the most creative step toward a new world order taken by any group of countries since the end of the Cold War” Trump went far to renegotiate the anti-nation state treaty giving nation states a role to play in shaping economic policy for the first time in over 25 years.
While talking tough on China until 2020, Trump also resisted the war hawks pushing a total military encirclement of China begun under Obama’s Asia Pivot which is threatening nuclear war (same thing is happening on Russia’s perimeter). He took the fuel out of the THAAD missile encirclement of China which has justified its expansion based on the “North Korean threat” for over a decade – always denying the truth that the real target were both Russia and China. Trump’s push to build friendly relations with Kim Jong Un had much greater ramifications at changing U.S. Pacific military policy than many realized, although that fact was certainly not missed by the Chinese intelligentsia.
While the Soros/CIA-driven color revolutionary operations have so far failed to divide up China in Hong Kong, Tibet and Xinjiang, they have been successful in the USA.
Fact #4) The Pentagon’s Global Bioweapons Complex Is a Fact
While China is the proud owner of a total of TWO bioweapons labs (both within its borders), a vast array of dozens of Pentagon-run bioweapons labs litter the international landscape. Exactly how many is hard to estimate as Alexei Mukhin (Director General of Russia’s Center for Political Information) stated in a May 2020 interview:
“According to the Russian Ministry of Defense, in the post-Soviet space, 65 American secret bio-laboratories operate: 15 – in Ukraine, 12 – in Armenia, 15 – in Georgia, 4 – in Kazakhstan. In the United States, such activity is prohibited. Accordingly, the Pentagon, in its own laws, is engaged in illegal activities (in spirit, not in letter). The goal is the creation of biological weapons directed against the peoples who inhabited the territory of the USSR. Fortunately, biological material is “at hand.”
In 2018, investigative journalist Dilya Gaytandzhieva documented the Pentagon’s multibillion dollar budget that sustains bioweapons labs in 25 nations (and 11 within the USA itself) which grew exponentially since the December 2001 bioweaponized anthrax attack killed five Americans and justified a hyperbolic increase of bioweapon warfare to rise from $5 billion when Cheney’s Bioshield Act was passed in 2004 to over $50 billion today.
Additionally, an October 2000 policy document co-authored by William Kristol, John Bolton, Richard Perle, Dick Cheney, Paul Wolfowitz, Elliot Abrams, and Donald Rumsfeld titled Rebuilding America’s Defenses (RAD) explicitly stated that in the new American Century, “combat will likely take place in new dimensions: In space, cyber-space and perhaps the world of microbes… advanced forms of biological warfare that can “target” specific genotypes may transform biological warfare from the realm of terror to a politically useful tool”.
Fact #5) International Pandemic War Game Scenarios Laid the groundwork for the international response to Covid. Not China
The driving force behind such bioweapon war game exercises such as the June 2000 Operation Dark Winter, the May 2010 Rockefeller Foundation report Operation Lock step, and the World Economic Forum/Gates Foundation/CIA Event 201 pandemic exercises indicate to me that China is not the causal nexus.
All in all, I think these facts have persuaded me that China is being set up and is in fact a primary target for destruction.
How China would find itself the beneficiary of such an irresponsible unleashing of a novel virus that hammered its own economy, accelerated the blow out of the world financial bubble economy and led to a shut down of international stability is absurd to the extreme… especially considering the fact that everything China has done for the past decades has indicated a consistent desire to create stability, long term development and win-win cooperation with the international community. Nothing similar has been seen among members of the Five Eyes or their Trans Atlantic network of over bloated imperialists.
The oligarchy running the Trans Atlantic System certainly loves the centralized control found in the Chinese system, and they adore the behaviorist social credit stuff, but that is where the admiration ends. The Kissinger, Gates, Carney or Schwab- types hate and fear everything China has actually done for development, population growth, national banking, long term credit generation, building full spectrum industrial economies and defending sovereignty along with Russia whom they are tightly bonded with in the Eurasian Multipolar alliance.
It is sad to see what used to be a serious, scientific body prostitute itself to global warming scaremongering:
New maps launched by the British Geological Survey (BGS) reveal how climate change is likely to drive an increase in subsidence-related issues for British homes and properties over the next 50 years.
Experts at the BGS, the UK’s geoscientific advisor which helps to advance our knowledge about changes in the environment, warns that the number of properties in Great Britain facing subsidence issues and damage to property from shrink-swell is on the rise, with figures of just 3 per cent in 1990 likely to reach 10 per cent by 2070. … Full article
Note that there is no evidence offered that any of this has actually gotten any worse in recent years. Instead, the report is all based around UKCP18, the Met Office’s modelled projections for what might happen if global temperatures rise significantly. We are of course familiar with previous Met Office projections, which have proved wide of the mark.
London has always been a hot spot for subsidence, as London Clay is one of the most shrinkable of soil types of all. However there is no evidence that the London region is getting wetter or drier. In particular, summers were frequently drier in the past than recently, which totally undermines the BGS’ conclusions.
Opinion polls show that very few people are seriously concerned about climate change, which is no doubt the reason why the BGS has decided to publish this farcical study.
“There is now the capacity to make tyranny total in America.”― James Bamford
It never fails.
Just as we get a glimmer of hope that maybe, just maybe, there might be a chance of crawling out of this totalitarian cesspool in which we’ve been mired, we get kicked down again.
Talk about taking one step forward and two steps back.
Precrime, straight out of the realm of dystopian science fiction movies such as Minority Report, aims to prevent crimes before they happen by combining widespread surveillance, behavior prediction technologies, data mining, precognitive technology, and neighborhood and family snitch programs to enable police to capture would-be criminals before they can do any damage.
This particular precrime division will fall under the Department of Homeland Security, the agency notorious for militarizing the police and SWAT teams; spying on activists, dissidents and veterans; stockpiling ammunition; distributing license plate readers; contracting to build detention camps; tracking cell-phones with Stingray devices; carrying out military drills and lockdowns in American cities; using the TSA as an advance guard; conducting virtual strip searches with full-body scanners; carrying out soft target checkpoints; directing government workers to spy on Americans; conducting widespread spying networks using fusion centers; carrying out Constitution-free border control searches; funding city-wide surveillance cameras; and utilizing drones and other spybots.
The intent, of course, is for the government to be all-seeing, all-knowing and all-powerful in its preemptive efforts to combat domestic extremism.
Where we run into trouble is when the government gets overzealous and over-ambitious and overreaches.
This is how you turn a nation of citizens into snitches and suspects.
In the blink of an eye, ordinary Americans will find themselves labeled domestic extremists for engaging in lawful behavior that triggers the government’s precrime sensors.
Of course, it’s an elaborate setup: we’ll all be targets.
In such a suspect society, the burden of proof is reversed so that guilt is assumed and innocence must be proven.
It’s the American police state’s take on the dystopian terrors foreshadowed by George Orwell, Aldous Huxley and Phillip K. Dick all rolled up into one oppressive pre-crime and pre-thought crime package.
What’s more, the technocrats who run the surveillance state don’t even have to break a sweat while monitoring what you say, what you read, what you write, where you go, how much you spend, whom you support, and with whom you communicate.
Computers now do the tedious work of trolling social media, the internet, text messages and phone calls for potentially anti-government remarks, all of which is carefully recorded, documented, and stored to be used against you someday at a time and place of the government’s choosing.
In this way, with the help of automated eyes and ears, a growing arsenal of high-tech software, hardware and techniques, government propaganda urging Americans to turn into spies and snitches, as well as social media and behavior sensing software, government agents are spinning a sticky spider-web of threat assessments, behavioral sensing warnings, flagged “words,” and “suspicious” activity reports aimed at snaring potential enemies of the state.
It works the same in any regime.
As Professor Robert Gellately notes in his book Backing Hitler about the police state tactics used in Nazi Germany: “There were relatively few secret police, and most were just processing the information coming in. I had found a shocking fact. It wasn’t the secret police who were doing this wide-scale surveillance and hiding on every street corner. It was the ordinary German people who were informing on their neighbors.”
Here’s the thing as the Germans themselves quickly discovered: you won’t have to do anything illegal or challenge the government’s authority in order to be flagged as a suspicious character, labeled an enemy of the state and locked up like a dangerous criminal.
In fact, all you will need to do is use certain trigger words, surf the internet, communicate using a cell phone, drive a car, stay at a hotel, purchase materials at a hardware store, take flying or boating lessons, appear suspicious to a neighbor, question government authority, or generally live in the United States.
The following activities are guaranteed to get you censored, surveilled, eventually placed on a government watch list, possibly detained and potentially killed.
Use harmless trigger words like cloud, pork and pirates. Use a cell phone. Drive a car. Attend a political rally. Express yourself on social media. Serve in the military. Disagree with a law enforcement official. Call in sick to work. Limp or stutter. Appear confused or nervous, fidget, whistle or smell bad. Allow yourself to be seen in public waving a toy gun or anything remotely resembling a gun, such as a water nozzle or a remote control or a walking cane, for instance. Stare at a police officer. Appear to be pro-gun, pro-freedom or anti-government. Attend a public school. Speak truth to power.
Long before Chelsea Manning and Edward Snowden were being castigated for blowing the whistle on the government’s war crimes and the National Security Agency’s abuse of its surveillance powers, it was activists such as Martin Luther King Jr. and John Lennon who were being singled out for daring to speak truth to power. These men and others like them had their phone calls monitored and data files collected on their activities and associations. For a little while, at least, they became enemy number one in the eyes of the U.S. government.
The new US administration is reportedly planning to reverse course on a previous policy not to spy on members of its own military by monitoring political opinions they express on social media.
In the past, this type of surveillance was not used out of fear that it might infringe on service members’ First Amendment rights, but now that the Biden administration is making combating “domestic extremism” one of its main narratives, that is changing.
According to The Intercept, which said it had access to relevant internal Defense Department documents and spoke to a source with direct knowledge, a pilot program is in the works to continuously screen behavior on social media of the members of the military, looking for any concerning signs, in the context of opinions espousing domestic extremism.
According to the same source, the Pentagon plans to outsource this job to a private surveillance company – most likely Babel Street – and thus bypass the First (and Fourth) Amendment.
Babel Street is already selling controversial products to US law enforcement, who use its services as a method of circumventing government requirements, like warrants. Babel Street buys and sells massive amounts of phone location data, and some of the previous clients have been the Secret Service and US Special Operations Command.
The latest pilot program seems to be developed far from the eyes and the ears of Congress. Don Bacon, a member of the House Armed Services Committee, said that so far they had heard nothing from the Department of Defense (DoD) “that would confirm this story.”
However, an email from the House Armed Services Committee sent later said it was their understanding that the DoD intends to use social media screening as an additional vetting tool, rather than one for ongoing surveillance.
“That said, Secretary Austin has been clear about his intentions to understand to what extent extremism exists in the force and its effect on good order and discipline. We look forward to hearing the results of the stand down and the Department’s plan to move forward,” the email said.
Meanwhile, neither Babel Street, nor Bishop Garrison, who is behind the project, have commented about it. Garrison is a senior adviser to the defense secretary and head of an extremism steering committee, who has drawn attention for what has been described as a purge of Trump supporters from the military. In 2008, he is said to have authored an opinion piece that referred to free speech as “digital black plague.”
Facebook is seen as trying to promote the self-regulating model known as its Oversight Board as a success story that could become a standard for other similar platforms.
There were indications of an ambition to turn the Oversight Board into a bigger, more widely-encompassing regulatory body in a letter CEO Mark Zuckerberg penned in 2019, announcing the Board and saying that while it would initially deal with a small number of contentious cases, Facebook hoped it would in time expand to include “more companies across the industry as well.”
More recently, discussing Facebook’s decision to ban President Trump, VP of Global Affairs Nick Clegg did not disagree with his boss’s initial sentiments around the Oversight Board.
“Who knows, maybe in the future it could either be the germ of an idea that is then taken up in statutory regulation or it could be something that could operate for more companies than just for Facebook,” Clegg said.
One of the members of the board, Rachel Wolbers, said the body hopes to do such good work that “other companies might want our help.”
Officially, the Board has commented to say that while the model of “online governance” they are testing here might prove useful to others, their focus is currently on Facebook and Instagram.
And while the signs are there that Facebook would like to at least set the tone and become a leader in the censorship and moderation “standard” for social media – or just toot its own horn as doing this highly controversial work well – those other companies, its competitors, have so far remained silent, and that includes YouTube, Twitter, and Reddit.
One reason some observers give for this is that they “like their autonomy and have different rules” – but there is also the issue of how such an idea might be brought to life technically, given the different platforms and appeals systems currently in place.
There are examples of entire industries self-regulating to introduce agreed upon rules, like the gaming industry. But those who see the idea of the Oversight Board as a far fetched role model for others say that its own existence is “still controversial.”
Emergent BioSolutions will be in the spotlight today during a House Select Subcommittee Meeting on the Corona Virus Crisis, today at 10:30 am. It can be watched here.
The first 2 million doses of anthrax vaccine came from a stockpile that had been made for the US army by Michigan’s state vaccine lab (Michigan Biologics Products Institute). What became known in November 1997, after the FDA performed an inspection, was that most of the army’s 11 million dose stockpile of anthrax vaccine, stored at the Michigan lab, was multiply expired, had been redated, and was contaminated, with visible bacterial and fungal growth in some of the lots. FDA immediately shut down the anthrax vaccine factory, and quarantined 9 million of the 11 million existing doses. Unfortunately, FDA allowed the Defense Department to use 2 million doses, which it did over the next two years.
The Conclusions from FDA’s 1998 and 1999 inspection reports of the facility can be read here.
The Michigan state lab was a massive affair with many buildings on a campus in downtown Lansing. It produced a large variety of vaccines and blood products for the state of Michigan. However, over the years the state had not made the required repairs and updates. After the 1997 FDA inspection, Michigan had to repair the place or close it. Michigan decided to sell, and looked for a buyer.
The former head of the Joint Chiefs of Staff, Admiral William Crowe, heard about the sale. He had come to know the el Hibri family when he was Ambassador to the UK. The el Hibri’s had purchased anthrax vaccine from the UK government laboratory at Porton Down just before the Gulf War, and resold it to the Saudi government at a 100x markup.
The new company, formed in the first half of 1998, was named Bioport. It chose to focus on its sales of anthrax vaccine to the Army. However, the new company was deeply concerned about potential liability for the lab’s products. The purchase was delayed until the Secretary of the Army signed an indemnification for injuries that might result from use of anthrax vaccine in soldiers, and it also indemnified the company against claims if the vaccine failed to provide the expected protection against anthrax. The state of Michigan had also been indemnified by the Army to produce the vaccine. But from its 1970 licensure until 1998, almost all the anthrax vaccine had only been used in animal experiments.
After FDA had shuttered the anthrax vaccine plant for manufacturing defects, the Army paid to bulldoze and then rebuild the factory in 1999. But even after it was rebuilt, FDA withheld its approval, and the plant lay idle.
Meantime, the 2 million doses that FDA had failed to quarantine were injected into 500,000 military service-members between 1998 and 2001. Many thousands became ill. An official report on the program, quoting unnamed government officials, claimed that 1-2% of recipients had developed permanent disabilities. The military vaccinations were mandatory, and refusers were punished with a court martial or loss of a month’s pay and performance of extra duties. Nonetheless, seeing the injuries sustained by their colleagues, many refused.
Five Congressional hearings were held throughout 1999 on different aspects of the anthrax vaccine program by the House Committee on Government Reform and National Security (now known as the House Committee on Oversight and Reform). Additional hearings held by other Congressional committees also touched on the vaccine program. The Government Reform and National Security Committee wrote up its findings in a report titled Unproven Force Protection. Its June 30, 1999 hearing dealt specifically with Bioport and its sole source contracts.
Despite this, Bioport has been very successful. Although the Pentagon was considering an end to the anthrax vaccine program in the summer of 2001, the sudden appearance of the anthrax letters after the September 11, 2001 attacks breathed new life into the vaccine program and turned Bioport’s fortunes around. DHHS Secretary Tommy Thompson announced in November 2001 that the anthrax vaccine plant would finally receive an FDA approval and begin production. At the end of January 2002 that is what happened.
But that was not the end of Bioport’s problems. Soldiers challenged the legality of the vaccine’s license in federal court. It was learned that while there had been efficacy testing of an earlier version of the vaccine, the current vaccine formulation had never undergone either efficacy or safety testing in a clinical trial. Aware of this major omission, FDA had withheld the issuing of a “final rule and order” for the anthrax vaccine for over thirty years.
The soldiers prevailed on the legal issues, and First District Court Judge Emmett Sullivan rescinded the vaccine license in 2004, based on the company’s failure to prove efficacy or meet basic FDA standards for licensure.
Unwilling to bow to judicial authority, the Defense Department rolled out a backup plan. A new regulatory authority had just been created, the Emergency Use Authorization (EUA). An EUA was slapped on the unlicensed anthrax vaccine, and DOD quickly restarted its mandatory vaccinations. (There was no emergency: the issuing of an EUA required only the potential for an emergency.)
The attorneys for the soldiers took the case back to court, and Judge Sullivan ruled that even if an experimental medical product received an EUA, it was still investigational and could not be mandated. The law required that EUA products be offered with informed consent. To receive an EUA (unlicensed) product, the recipient must be apprised of the risks and benefits of the product, be informed of alternatives to the product, and no coercion in any form could be applied. Ergo, no mandate.
FDA waited about 18 months, and then issued a full license for Bioport’s anthrax vaccine, although there were still no efficacy data. FDA instead claimed that a 1950’s era trial of a very different anthrax vaccine was sufficient for licensure, even though that trial failed to show benefit against inhalation anthrax.
When the soldiers and their attorneys challenged the licensing decision in court, the next judge ruled in favor of FDA on the basis of “deference”—meaning that FDA could ignore its own regulations when making a determination on safety and efficacy, with or without acceptable data. In 2006 mandatory vaccination restarted.
Bioport then shed its old skin in an attempt to leave its baggage behind. It renamed itself Emergent BioSolutions. Its vaccine had been renamed BioThrax.
Emergent BioSolutions (EBS) then branched out, buying other companies, primarily those making other sole source biodefense products. The military continued to mandate anthrax and (in 2003) smallpox vaccines for service-members. Eventually EBS purchased the smallpox company as well, and the cholera and typhoid vaccines used in the US.
A 2010 report on Emergent BioSolutions, written by Scott Lilly for the Center for American Progress, was titled, “Getting Rich off Uncle Sucker.” It revealed 300% profit margins, unique for a government contractor.
In 2012 EBS got one of three DHHS contracts to house a so-called Center for Innovation in Advanced Development and Manufacturing (CIADM) that could be used to produce pandemic or biodefense products in the event of emergencies. With this grant EBS purchased and expanded what became its Bayview factory in Baltimore. The CIADM contract essentially guaranteed Emergent a big role in any future pandemic response.
Emergent acquired the maker of Narcan nasal spray, the opioid overdose antidote. Soon FDA began recommending to prescribers that they write a Narcan script whenever they wrote a narcotic script, just in case. States started buying large quantities for free distribution. Sales rose 600% after EBS bought the company.
Under the Trump administration, retired Air Force Colonel, physician and biodefense consultant Robert Kadlec was appointed to the position of Assistant Secretary of DHHS for Preparedness and Emergency Response (aka ASPR). Kadlec had also been a consultant and business partner of EBS’ founder and chairman Fuad el-Hibri. Kadlec had omitted this information from the required disclosures for Senate confirmation. Once confirmed as Assistant Secretary, Kadlec was able to transfer responsibility for the National Strategic Stockpile (containing the US stockpiles of pandemic remedies, masks and equipment) from the CDC to his own agency. Kadlec then gave multiple sweetheart deals to EBS, until the value of EBS’ contracts with ASPR exceeded those of every other contractor.
Covid-19 presented a huge opportunity for Emergent BioSolutions. EBS received $628 million from DHHS to retool its CIADM factory. It inked additional contracts with the Astra-Zeneca, Johnson and Johnson, Novavax, Providence Therapeutics and VaxArt companies to provide bulk manufacturing of their vaccines in its Baltimore facilities. Altogether its pandemic contracts were worth about $1.5 Billion. It was slated to manufacture 9 separate medical products to address Covid-19, all designed by other companies.
But there were serious potential problems.
While it had a storied Board of former federal officials, Emergent BioSolutions had never brought a single product to market. Its expertise was in contracting and acquisitions, not production. It had a history of production failures, and had demanded that the federal government bail the company out, or else the sole source products the company provided would become unavailable. Some of this was detailed in the Congressional report Unproven Force Protection. Entering the pandemic, EBS was still making the same mistakes it had been guilty of twenty years earlier:
EBS sold and continues to sell nerve gas auto-injectors to federal agencies which have been defective and are not licensed. According to the law, these products can neither be produced in the US nor sold here. Instead, Emergent manufactures them in Germany and restricts its sales to US embassies overseas.
EBS did not have an active workforce in Baltimore. On September 30, EBS held an online job fair which it titled “Warp Speed Careers Event.” The event sought to recruit 300 employees. Yet EBS had begun inking vaccine contracts 5 months earlier, and could have hired and trained a workforce that was ready to go when FDA gave it the go-ahead. Instead, doing things on the cheap, EBS hired late, failed to provide adequate training to its employees, and experienced a spectacular series of production failures. Many millions of doses of its Johnson and Johnson and its Astra-Zeneca Covid vaccines had to be dumped. J and J missed its 20 million dose quota for the end of March, and FDA, despite repeated inspections, would not give the plant an authorization so its products could be used.
Despite this, somehow millions of doses produced in the unauthorized plant were shipped to Canada, the European Union, South Africa and Mexico. The EU, at least, used the product. How did that occur? We don’t know. Did any get distributed in the US? We can’t be sure none did.
On April 4, 2021, EBS announced it would receive an additional $23 million from DHHS for new equipment to use in the manufacture of Johnson and Johnson’s Covid-19 vaccine.
As of last week, EBS was facing another lawsuit from its shareholders, and its stock price had fallen to $60 from the peak on February 12 of $125 per share. However, Emergent CEO Robert Kramer exercised his stock options in January and February, near the stock’s peak, earning himself over $7 million dollars in profit.
In summary, EBS, despite considerable manufacturing shortcomings, has been extremely successful at obtaining government contracts and earning huge profits. But its products have repeatedly been unreliable. The company has managed to turn failures into success, especially when its products, like civilian stockpiles of anthrax and smallpox vaccine, and nerve gas auto-injectors, are stockpiled but not used.
The public has only gradually been learning that the vaccines it thought were being produced by huge Pharma companies Astra-Zeneca and Johnson and Johnson were in fact being manufactured by the anthrax vaccine company, Emergent BioSolutions. How did it come to pass that the federal government, and these established pharmaceutical companies, bet the farm on EBS’ production of Covid-19 vaccines?
THERE was a time in the not-too-distant past when our freedoms were predicated on the vulnerable being vaccinated. This was the limiter which justified the continuation of draconian measures into winter after Christmas was stolen. Christmas was stolen to save January. November was stolen to save Christmas. They told us in October that if we didn’t lock down then we would face 4,000 deaths a day. A number they knew at the time to be a gross overestimate. They used it anyway.
We now know unequivocally that we are victims of this government’s unethical psychological campaign of coercion. We know many loved ones believe their relatives’ deaths were falsely certified as Covid deaths on presumption and not evidence. And that a quarter of recently attributed deaths were not caused by the virus. I am still incredulous at the statement ‘deaths of any cause within 28 days of a positive Covid test’ as the caveat to daily reported figures.
We have simply lost our minds.
Of course no one wants to get Covid. Like any seasonal flu it has the potential to be nasty. But it remains a relatively insignificant virus for the vast majority of the population. Despite an average death age for the disease (82) higher than population life expectancy (81), we have been forced to endure an endless campaign of mendacious claims and impositions justified with empty promises.
Now the end of the long and ‘irreversible’ roadmap (which has for several months been at odds with the once solid claim of ‘data not dates’) is being re-framed before our eyes with Sage claiming the possibility of 10,000 hospital admissions per day in July and restrictions continuing beyond June 21.
The justification for this new round of official caution, the ‘Indian variant’, has been promulgated with several weeks of distressing media imagery. Just a few weeks before a similar stream of distress was being transmitted from Brazil.
For those who want to balance the BBC’s scenes of mass graves in Brazil and funeral pyres across India, it may be worth researching these countries’ Covid deaths per million to gain some proportion.
For many of us the past six months has been psychological torture. Endless days of winter isolation leading to a half-life in spring. A persistent sense of atrophy has remained with the dull ache of forced containment. Small businesses placed into induced comas. The nation’s cultural treasures kept under lock and key. Human connection severed. Life’s potential suppressed.
If you are buying into the official narrative you are rewarded with a sense of moral vindication. Your sacrifice is for a greater national good. It’s bad manners to question the motives and morality of what has taken place. Or to entertain the idea that taking an unlicensed medical treatment may not be okay.
If, like me, you are uncertain about the jab for perfectly sensible and personal reasons, you may be preparing for the extraordinary reality that access to your ‘normal’ life, including the things you love, be it cultural, social or leisure, may soon be off limits. You may be wondering if your job is going to be at risk. And whether you will again be allowed to travel abroad.
The Covzealots are now rounding on those of us they label with ‘vaccine hesitancy’. We are determined to be a risk, so it seems fair game to consider people like me to be selfish, idiotic, anti-vaxxer-conspiracy-nuts. The ramping up against us has the signs of becoming a persecutory campaign.
For what it’s worth, I’ve spent eight years of my life in various volunteering roles. Supporting the elderly, the mentally ill and young people. I’m as fallible as the next man. But I’m not going to take lectures on morality because I won’t be bullied or coerced into compliance by the state.
If you are observing the official narrative, you have seen the pattern. You were well prepared for the approaching about-turn on restriction easing. You were prepared for the forthcoming drive to vaccinate children (I was shocked when they announced the recommendation for pregnant women) with a medical device which remains in its trial phase.
The propaganda bomb, created with sophisticated psychological techniques, deployed throughout the media and driven forwards by state activists in the press, has been designed to rattle even the hardiest among us. For many, the commonplace week or two of coughs, aches and sneezes has become the existential terror of ‘is this really it?’
Whilst I understand the power of fear, I cannot grasp how so many fellow citizens have become so blinded. There seem to be two branches of the same pro-Covid narrative playing out within the mainstream: willingness to excuse ‘Boris’ and therefore lend sympathy for his government’s vaccine nationalism, or anger at his incompetence, that enough wasn’t done at the outset, so the endless spiral of restrictions is necessary (according to the ‘experts’). Either way they work together to support compliance.
Before the Iraq war, I was shouted down for questioning an agenda where so many things did not add up. The dodgy dossier latterly proved doubters like me to be correct. The same people are shouting at me again. Many supposedly astute individuals seem to want to lend good faith to another state operation being supported by Tony Blair.
I wonder if those amongst us going along with a monumental attack on truth, freedom and individual liberty would see through the shoddy claims of the government Covid salesmen were they lent the autonomy to be the ‘rational actors’ Sage planners had originally determined the population should be treated as? We will never know.
IN THE previous instalments I explored the extraordinary hold Bill Gates has over global health policy and the spread of its influence right into the heart of British public health policy via the funding by the Bill and Melinda Gates Foundation (GF) of science businesses, foundations and public bodies through a complex web of interconnection and crossover of personnel.
This, however, is not the sum total of the GF’s reach into the world of British science and public health. It has been funding British university science departments, projects, and individuals for more than two decades. The topics involved include research into and manufacturing of vaccines.
No government-appointed science committee has influenced public health policy as much as Sage. Many of its members, who cross over with Independent Sage and Nervtag and are already somewhat compromised by connections to the GF-funded GlaxoSmithKline and Wellcome Foundation, are also employees of universities and colleges which have received massive GF grants and, in some cases, work in partnership with them. Three of Sage’s members, Professors Graham Medley, Andrew Rambaut and Matt Keeling, are individual recipients of grants from the GF.
Readers may remember the three modelling papers produced by Imperial College London (ICL), Warwick University and the London School of Tropical Hygiene and Medicine (LSHTM) which received considerable press attention at the end of March, and their dramatic simultaneous warnings of a ‘third’ Covid-19 wave and new lethal variants; cautioning (yet again) how this will put the NHS under stress. All recommended stricter lockdowns, Test and Trace and, tellingly, booster vaccines.
SPI-M-O had assigned each university a specific task: ICL’s was ‘Evaluating England’s Roadmap out of Lockdown’, Warwick’s to produce ‘Road Map Scenarios and Sensitivity’ and LSHTM’s to make an ‘Interim roadmap assessment: prior to Step 2’.
Promoting the ICL paper was none other than the multi-tasking Sage member Professor Neil Ferguson, co-founder and Principal Investigator of the Centre for Global Infectious Disease Analysis (MRC GIDA) at Imperial College, a centre that works closely with the GF, the Global Fund and Gavi, Vice Dean of the Faculty of Medicine, School of Public Health at ICL, a Director and Adviser at the World Health Organisation (WHO) and a recipient of cloud computing time from Microsoft and Amazon for Covid-19 modelling.
Warwick’s paper emphasised the ‘danger’ of new variants to an even greater degree than the ICL paper. It warned that ‘stringent methods’ would be needed to counteract them and that the current vaccination programme might not adequately contain them.
The paper produced by the LSHTM group was the most pessimistic of all. It warned that a ‘third wave’ and new variants would bring a high death toll. It also stressed the need for Test and Trace which, together with that other Sage recommendation, vaccine passports, is the new formula for digital slavery and a surveillance state.
How Ferguson, whose modelling methodologies and predictions had been so comprehensively discredited, was getting away with this repeat performance seemed baffling, but for the fact that as a key member of the SPI-M-O subgroup he had been able to commission the new modelling research as well as that of supportive colleagues at Warwick University and the LSHTM.
Curiously, several SPI-M-O members turn out to be affiliated to one or another of these three universities too and are the very same academics who wrote these modelling papers. Given that they have commissioned themselves and sit on the subgroup, no independent assessment or scrutiny of their work has taken place. This is the epitome of jobs for the boys and girls.
Here are the SPI-M-O members connected to ICL:
Professors Neil Ferguson (Sage), Stephen Brett, Nicholas Grassly, Steven Riley, Wendy Barclay (Sage) and Drs Marc Baguelin, Samir Bhatt and Tim Lucas. Ferguson and Baguelin contributed to the ICL paper.
Here are the SPI-M-O members who work at Warwick University:
Professor Matt Keeling and Drs Louise Dyson, Edward Hill, Michael Tildesley and Joe Hilton. Keeling, Dyson, Tildesley and Hill are four out of five authors of the Warwick paper.
The following SPI-M-O members are connected to the LSHTM:
Professors John Edmunds (Sage), Mark Jit, Graham Medley (Sage), Drs Nick Davies, Rosalind Eggo, Sebastian Funk, Thibaut Jombart, Petra Klepac, Adam Kurcharski, Rohini Mathur, Sam Clifford, Elizabeth Fearon, Gwen Knight and Bill Quilty. Edmunds, Jit and Davies are three out of four of the authors of the LSHTM paper.
The Deputy Chief Medical Officer, Professor Jonathan Van-Tam, is a member of both Sage and SPI-M-O.
It will surprise few readers to learn that ICL, Warwick University and the LSHTM, are historically heavily funded by the GF.
The GF made its first grant to ICL of $31.9million in 2000. ICL received a further $46.7million from the GF in 2006 to research tropical diseases. The GF granted ICL a total of $446,205 in 2019 for research into enteric and diarrhoeal diseases, technology solutions, malaria, and ‘Discovery and Translational Sciences’. In 2020 it gave ICL a total of $91.5million for studies into polio, tuberculosis, global health, technology solutions, malaria, HIV, Discovery and Translational Sciences and family planning.
Last January, Sage member Professor Sir Mark Walport was appointed chair of the Imperial College Academic Health Science Centre (AHSC) Strategic Partnership. His ICL colleagues Professor Robin Grimes and Dr David Halpern sit on Sage too. Professor Ferguson and two ICL colleagues, Professors Wendy Barclay and Peter Openshaw, are members of Nervtag as well.
Warwick University’s GF funding goes back to 2015. An initial grant of $20,000 from the GF rapidly increased to a current total of $8.3million. In 2017, the GF awarded Warwick University $3million to research disease modelling, and in 2020 $2.2million to study neglected tropical diseases.
Sage member Professor Yvonne Doyle works at the LSHTM as does Nervtag member Professor John Edmunds and Independent Sage member Professor Martin McKee. Professor Edmunds was recently a recipient of a grant worth £5million from UKRI, which collaborates with the GF, to study disease modelling in Africa.
The late Professor Val Curtis, a member of Independent Sage, also worked at the LSHTM.
Predictably, none of the recent modelling by this closed shop takes into account the economic damage, social disintegration or consequences of lockdown, or the neglect of non-Covid-19 diseases as a result of lockdown and social distancing policies. Yet all this is now extensively catalogued. The conflicts of interest and cross over with these government advisers and highly directed research in universities heavily funded by GF, which has one narrow vision global vaccination agenda, is alarming.
Even more alarming is that it is on this basis that an unaccountable and unelected body has effectively dictated Government policy and our lives this past year. Its controversially modelled predictions of worst-case scenarios, none of which to date have been borne out, have been useful for two things: terrifying the populace into submission and priming the government, and us, into further lockdowns next autumn and winter – and establish them as the ‘new normal’.
Whether the men and women named here are useful idiots for Gates, or self-servers without moral compass, such scientific narrow vision reflects very poorly on them and their institutions.
The tentacles of the GF are everywhere. In the final part of this series I will be looking at its funding of the Oxford Recovery trials, Cambridge Science Park, its interconnections with the AstraZeneca project, its funding of several other universities, and finally at its investment in Serco, one of the outsourcing companies behind the Test and Trace programme.
After rollout under emergency authorisation, manufacturers of covid-19 vaccines now have their sights on regulatory approval. But what’s the rush, asks Peter Doshi, and is just six months of data from now unblinded trials acceptable?
In April 2021, Pfizer and Moderna announced efficacy results at the six month mark from the phase III trials of their respective covid-19 vaccines.1 2
Pfizer CEO Albert Bourla said the company’s data “confirm the favourable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the US FDA [Food and Drug Administration].”1 And on 7 May it formally initiated that application which, if successful, will earn the Pfizer-BioNTech product, BNT162b2, the distinction of becoming the first covid-19 vaccine approved by the FDA.
Because lest we forget, all covid-19 vaccines currently in use in the US are available under emergency access only.
(The situation is similar in Europe, where four covid-19 vaccines have been granted “conditional marketing authorisations,” a fast track mechanism that can be used in emergencies. These can be converted into standard “marketing authorisations” pending positive data after authorisation, but this has not yet happened for any covid-19 vaccine being administered.)
As hundreds of millions of people around the world get vaccinated, it may seem like wordsmithing to highlight the fact that none of the covid-19 vaccines in use are actually “approved.” Through an emergency access mechanism known as Emergency Use Authorisation (EUA), the products being rolled out still technically remain “investigational.”3 Factsheets distributed to vaccinees are clear: “There is no FDA approved vaccine to prevent covid-19.”4
The approval-authorisation distinction is often misunderstood by the media,5 even in the scientific press. But it was the focus of much discussion back in September 2020. With large phase III trials by Pfizer and Moderna well under way, and the November US presidential election looming, many worried about political pressure resulting in the rollout of an unsafe or ineffective vaccine.6
The FDA had already come under fire, accused of bending to the White House in granting EUAs for two covid-19 treatments, hydroxychloroquine and convalescent plasma. But those fears largely dissipated when the FDA published a guidance document in early October outlining its expectations for the EUA. According to the document, at least half of a trial’s participants would need to be followed for at least two months.7 This alone made it all but certain no vaccine could cross the line before the election.
The FDA also said it would want a vaccine at least 50% effective (with a confidence interval reaching no lower than 30%) against a primary endpoint of preventing SARS-CoV-2 infection or covid-19 disease of any severity8—parameters it had previously defined as necessary for approval. Even for non-clinical parameters, like manufacturing quality, the FDA characterised its expectations for the EUA as “very similar” to those for approval.3
Six months: enough?
One key difference between EUA and approval (also called “licensure,” and which for vaccines is known as a BLA (Biologics License Application)) was the expected length of follow-up of trial participants. Unlike its clear articulation of two months for an EUA, the FDA has not committed to a clear minimum for approval.
Cody Meissner, a professor of paediatrics at Tufts University and member of the FDA’s advisory committee, was curious. “Is it possible to predict or estimate when conditions of safety and efficacy might be satisfied for BLA?” Meissner asked at the agency’s 10 December meeting which had been convened to consider the FDA’s first emergency authorisation for the Pfizer vaccine.
The FDA’s Doran Fink responded: “I couldn’t predict, but I will say that we typically ask for at least six months of follow-up in a substantial number of clinical trial participants to constitute a safety database that would support licensure.”
An approval based on six months of data would represent one of the fastest for a novel vaccine in FDA history. Among the six “first in disease” vaccines approved by the FDA since 2006, pre-licensure pivotal trials were a median of 23 months in duration, according to a recent analysis.9
Six months also seems substantially shorter than previously conceptualised expectations. A World Health Organization expert group on covid-19 vaccines (which included FDA regulators) in August 2020 called for follow-up “until at least month 12, or until an effective vaccine is deployed locally.”10 Another group, composed of industry and academic authors, similarly wrote in October 2020: “we recommend longer term follow-up of all participants … for at least a year after randomisation.”11
On paper, the phase III studies by Pfizer, Moderna, and Janssen are all of two years’ duration. But the FDA’s official position on minimum follow-up before licensure is unclear at best.
In its formal guidance last June, the agency said that for licensure applications, it wanted participants followed for covid-19 outcomes for “as long as feasible, ideally at least one to two years”12 after the first injection. But the same document states that safety assessments for “serious and other medically attended adverse events” should be studied “for at least six months after completion of all study vaccinations. Longer safety monitoring may be warranted for certain vaccine platforms.”
Asked to clarify whether its guidance is asking for follow-up of at least six months or one year, a spokesperson told The BMJ: “We do not have any further information beyond what is in the guidance document.”
Unblinded and without a control group—what about safety?
Duration of protection is not the only question that longer, placebo controlled trials can address. They also address vaccine safety.
“Very often, it’s the fact that we have that placebo controlled follow-up over time, that gives us the ability to say that the vaccine didn’t cause something at a longer period of time after vaccination,” the FDA’s Philip Krause explained last December.13
Yet there is a gap—currently of unknown size but growing—between any expectation of blinded placebo controlled data, and the reality that within weeks of the vaccines receiving an EUA the unblinding of trials commenced as placebo recipients were offered the chance to get vaccinated.
Steven Goodman, associate dean of clinical and translational research at Stanford University, told the FDA in an invited presentation last December, “Once a vaccine is made widely available and encouraged, maintaining a double blinded control group for more than a nominal period is no longer in the investigator’s (or regulator’s) control and undue pressure to do so may undermine the entire vaccine testing enterprise.”14
Goodman’s recommendation was to rapidly convert the trials into crossover studies, enabling those on placebo to get vaccinated (and vice versa), while maintaining the blind. The companies challenged the feasibility, calling it “onerous,” and a crossover never occurred.15
The BMJ asked Moderna, Pfizer, and Janssen (Johnson and Johnson) what proportion of trial participants were now formally unblinded, and how many originally allocated to placebo have now received a vaccine. Pfizer declined to say, but Moderna announced that “as of April 13, all placebo participants have been offered the Moderna covid-19 vaccine and 98% of those have received the vaccine.”2 In other words, the trial is unblinded, and the placebo group no longer exists.
Janssen told The BMJ: “We do not have specific figures on how many of our study participants have received a vaccine at this time.” But the company confirmed it was implementing an amended protocol across all countries to unblind all participants in its two phase III trials, the earlier of which passed the median of two month follow-up mark in January.
How the FDA will weigh the loss of blinding and placebo controlled follow-up is unclear, but just months ago the agency said these trial properties were vital.
“Continuation of placebo controlled follow-up after EUA will be important and may actually be critical to ensure that additional safety and effectiveness data are accrued to support submission of a licensure application as soon as possible following an EUA. … Once a decision is made to unblind an ongoing placebo controlled trial, that decision cannot be walked back. And that controlled follow-up is lost forever,” the FDA said last October.3
At its next advisory committee in December 2020, the FDA reiterated the importance of the placebo group: “Placebo controlled follow-up can be very important in showing that whatever happened in the vaccine group also happened in the placebo group. Because that’s our best way of knowing.”13
What’s the rush?
The US’s “Operation Warp Speed” delivered on its promise to get a novel vaccine into arms in record time (box). Millions of doses of vaccines are being administered daily across the US, making clear that lack of FDA approval is no barrier to access. So just what benefit is there in seeking, and granting, a BLA?
The BMJ asked the manufacturers why they were seeking a BLA. Moderna did not respond and Janssen only confirmed it intended to apply for a BLA “later in 2021.” Pfizer likewise did not answer but instead quoted an FDA webpage on medical devices, which stated: “Sponsors of EUA products are encouraged to follow up the EUA with a pre-market submission so that it can remain on the market once the EUA is no longer in effect.”16 But EUAs have no built-in expiry date—in fact, 14 EUAs for Zika diagnostic tests remain active despite the public health emergency expiring in 2017.17
Cody Meissner told The BMJ he saw some distinct advantages of a BLA over EUA. An approved vaccine, for one, would provide “an element of assurance,” increasing public trust in the vaccines, particularly for those currently sitting on the fence. It would also pave the way for claims of vaccine injury to be routed through a more established compensation programme, and for adding the vaccine to government funded schemes to reach children in financial need.18 Finally, it may affect the potential for vaccine mandates: “It is unlikely these vaccines will be mandated while an EUA is in place. Remember that currently these vaccines are still considered experimental.”
While still under EUA, an increasing number of educational and other institutions have already mandated vaccines, but debates over the legality of these actions has hinged on the distinction between authorisation and approval.19
But approving a vaccine in order to legally support mandates or convince people of its safety arguably puts the cart before the horse. Meissner responded that a BLA would not be issued until the FDA is convinced of the short and long term safety of these vaccines.
No new biodistribution studies for covid-19 vaccines
Officials have consistently emphasised that despite shaving years off traditional timelines for producing vaccines, no compromises in the process were taken.20 However one type of study, tracking the distribution of a vaccine once injected in the body, was not conducted using any of the three vaccines currently authorised in the US.
Such biodistribution studies are a standard element of drug safety testing but “are usually not required for vaccines,” according to European Medicines Agency policy,21 which adds, “However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients.”
In the case of covid-19 vaccines, regulators accepted biodistribution data from past studies performed with related, mostly unapproved compounds that use the same platform technology.22232425
Janssen told The BMJ its covid-19 vaccine leverages the same technology as its Ebola vaccine, which received licensure last June. “Our confidence in our adenovirus vector Ad26 is based on our experience with this vector.”
Pfizer and Moderna did not respond to The BMJ’s questions regarding why no biodistribution studies were conducted on their novel mRNA products, and none of the companies, nor the FDA, would say whether new biodistribution studies will be required prior to licensure.
Footnotes
Competing interests PD gave a public statement at the October and December FDA advisory committee meetings mentioned in this article (transcripts here: https://faculty.rx.umaryland.edu/pdoshi/#publications), and may continue to engage in public input towards regulatory decision making around covid-19 vaccines. PD is also employed by a university that has mandated covid-19 vaccines for all faculty, staff, and students. The views and opinions expressed here are those of the author and do not necessarily reflect official policy or position of the University of Maryland.
US Food and Drug Administration. 161st Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. 2020. https://www.fda.gov/media/143982/download
US Food and Drug Administration. Development, authorization and licensure of vaccines to prevent COVID-19. October 6, 2020. https://www.fda.gov/media/142723/download
. An overview of vaccine development, approval, and regulation, with implications for covid-19. Health Aff (Millwood)2021;40:25–32.doi:10.1377/hlthaff.2020.01620pmid:33211535
US Food and Drug Administration. 162nd Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. 2020. https://www.fda.gov/media/144859/download
Goodman S. Considerations for placebo-controlled trial design if an unlicensed vaccine becomes available. Vaccines and related biological products advisory committee. 2020. https://www.fda.gov/media/144354/download
. Emergency use authorizations (EUAs) versus FDA approval: implications for covid-19 and public health. Am J Public Health2021;111:1065–9.doi:10.2105/AJPH.2021.306273pmid:33950730
“The pandemic represents a rare but narrow window of opportunity to reflect, reimagine, and reset our world to create a healthier, more equitable, and more prosperous future” — Klaus Schwab, WEF
Say it’s 2014 and you’ve had this idea for a technocratic Great Reset of the world economy for some time now, but it only works if the entire planet is rocked by a pandemic. How do you go about selling your idea?
If you are World Economic Forum (WEF) Founder Klaus Schwab, you attempt to sell your vision of a global Utopia via a Great Reset of the world order in three simple steps:
Announce your intention to revamp every aspect of society with global governance, and keep repeating that message
When your message isn’t getting through, simulate fake pandemic scenarios that show why the world needs a great reset
If the fake pandemic scenarios aren’t persuasive enough, wait a couple months for a real global crisis to occur, and repeat step one
It took Schwab and the Davos elite about six years to watch their great reset ideology grow from a tiny Swiss seed in 2014 to a European super-flower pollinating the entire globe in 2020.
The so-called “Great Reset” promises to build “a more secure, more equal, and more stable world” if everyone on the planet agrees to “act jointly and swiftly to revamp all aspects of our societies and economies, from education to social contracts and working conditions.”
But it wouldn’t have been possible to contemplate materializing such an all-encompassing plan for a new world order without a global crisis, be it manufactured or of unfortunate happenstance, that shocked society to its core.
“In the end, the outcome was tragic: the most catastrophic pandemic in history with hundreds of millions of deaths, economic collapse and societal upheaval” — Clade X pandemic simulation (May, 2018)
So, in May, 2018, the WEF partnered with Johns Hopkins to simulate a fictitious pandemic — dubbed “Clade X” — to see how prepared the world be if ever faced with such a crisis.
A little over a year later, the WEF once again teamed-up with Johns Hopkins, along with the Bill and Melinda Gates Foundation, to stage another pandemic exercise called Event 201 in October, 2019.
Both simulations concluded that the world wasn’t prepared for a global pandemic.
And a few short months following the conclusion of Event 201, which specifically simulated a coronavirus outbreak, the World Health Organization (WHO) officially declared that the coronavirus had reached pandemic status on March 11, 2020.
“The next severe pandemic will not only cause great illness and loss of life but could also trigger major cascading economic and societal consequences that could contribute greatly to global impact and suffering” — Event 201 pandemic simulation (October, 2019)
Since then, just about every scenario covered in the Clade X and Event 201 simulations has come into play, including:
Governments implementing lockdowns worldwide
The collapse of many industries
Growing mistrust between governments and citizens
A greater adoption of biometric surveillance technologies
Social media censorship in the name of combating misinformation
The desire to flood communication channels with “authoritative” sources
A global lack of personal protective equipment
The breakdown of international supply chains
Mass unemployment
Rioting in the streets
And a whole lot more!
After the nightmare scenarios had fully materialized by mid-2020, the WEF founder declared “now is the time for a “Great Reset”.
Was it excellent forecasting, planning, and modeling on the part of the WEF and partners that Clade X and Event 201 turned out to be so prophetic, or was there something more to it?
Timeline
Below is a condensed timeline of events that tracks the Great Reset agenda that went from just a “hope” in 2014 to a globalist ideology touted by royalty, the media, and heads of state the world-over in 2020.
2014-2017: Klaus Schwab calls for Great Reset and WEF repeats message
Ahead of the 2014 WEF meeting in Davos, Switzerland, Schwab announced that he hoped the WEF would push the reset button on the global economy.
The WEF would go on to repeat that message for years.
Between 2014 and 2017, the WEF called to reshape, restart, reboot, and reset the global order every single year, each aimed at solving various “crises.”
2014: WEF publishes meeting agenda entitled “The Reshaping of the World: Consequences for Society, Politics and Business.”
2016: WEF holds panel called “How to reboot the global economy.”
2017: WEF publishes article saying “Our world needs a reset in how we operate.”
Then in 2018, the Davos elites turned their heads towards simulating fake pandemic scenarios to see how prepared the world would be in the face of a different crisis.
2018-2019: WEF, Johns Hopkins & Gates Foundation simulate fake pandemics
On May 15, 2018, Johns Hopkins Center for Health Security hosted the “Clade X” pandemic exercise in partnership with the WEF.
The Clade X exercise included mock video footage of actors giving scripted news reports about a fake pandemic scenario (video below).
The Clade X event also included discussion panels with real policymakers who assessed that governments and industry were not adequately prepared for the fictitious global pandemic.
“In the end, the outcome was tragic: the most catastrophic pandemic in history with hundreds of millions of deaths, economic collapse and societal upheaval,” according to a WEF report on Clade X.
“There are major unmet global vulnerabilities and international system challenges posed by pandemics that will require new robust forms of public-private cooperation to address” — Event 201 pandemic simulation (October, 2019)
Then on October 18, 2019, in partnership with Johns Hopkins and the Bill and Melinda Gates Foundation, the WEF ran Event 201.
During the scenario, the entire global economy was shaken, there were riots on the streets, and high-tech surveillance measures were needed to “stop the spread.”
Two fake pandemics were simulated in the two years leading up to the real coronavirus crisis.
“Governments will need to partner with traditional and social media companies to research and develop nimble approaches to countering misinformation” — Event 201 pandemic simulation (October, 2019)
The Johns Hopkins Center for Health Security issued a public statement on January 24, 2020, explicitly addressing that Event 201 wasn’t meant to predict the future.
“To be clear, the Center for Health Security and partners did not make a prediction during our tabletop exercise. For the scenario, we modeled a fictional coronavirus pandemic, but we explicitly stated that it was not a prediction. Instead, the exercise served to highlight preparedness and response challenges that would likely arise in a very severe pandemic.”
Intentional or not, Event 201 “highlighted” the “fictional” challenges of a pandemic, along with recommendations that go hand-in-hand with the great reset agenda that has set up camp in the nefarious “new normal.”
“The next severe pandemic will not only cause great illness and loss of life but could also trigger major cascading economic and societal consequences that could contribute greatly to global impact and suffering” — Event 201 pandemic simulation (October, 2019)
Together, the Johns Hopkins Center for Health Security, the World Economic Forum, and the Bill and Melinda Gates Foundation submitted seven recommendations for governments, international organizations, and global business to follow in the event of a pandemic.
The Event 201 recommendations call for greater collaboration between the public and private sectors while emphasizing the importance of establishing partnerships with un-elected, global institutions such as the WHO, the World Bank, the International Monetary Fund, and the International Air Transport Organization, to carry out a centralized response.
One of the recommendations calls for governments to partner with social media companies and news organization to censor content and control the flow of information.
“Media companies should commit to ensuring that authoritative messages are prioritized and that false messages are suppressed including though [sic] the use of technology” — Event 201 pandemic simulation (October, 2019)
According to the report, “Governments will need to partner with traditional and social media companies to research and develop nimble approaches to countering misinformation.
“National public health agencies should work in close collaboration with WHO to create the capability to rapidly develop and release consistent health messages.
“For their part, media companies should commit to ensuring that authoritative messages are prioritized and that false messages are suppressed including though [sic] the use of technology.”
Sound familiar?
Throughout 2020, Twitter, Facebook, and YouTube have been censoring, suppressing, and flagging any coronavirus-related information that goes against WHO recommendations as a matter of policy, just as Event 201 had recommended.
2020: WEF declares ‘Now is the time for a Great Reset’
After calling for a great reset in 2014, the Davos crowd repeated the same ideology for a few more years before pivoting towards simulating faux pandemic scenarios.
A few months after the WEF established that nobody was prepared to deal with a coronavirus pandemic, the WHO declared there was a coronavirus pandemic.
All of a sudden! the great reset narrative that the WEF had been nurturing for six years, found a place to pitch its tent in the “new normal” camp.
“The pandemic represents a rare but narrow window of opportunity to reflect, reimagine, and reset our world to create a healthier, more equitable, and more prosperous future,” Schwab declared on June 3, 2020.
And that’s where we’re at today.
The Davos elites said they wanted a global reset of the economy many years ago
They role-played what would happen if a pandemic were to occur
And now they’re saying that the great reset ideology is the solution to the pandemic, and it must be enacted quickly
The great reset is a means to an end.
Next on the agenda is a complete makeover of society under a technocratic regime of un-elected bureaucrats who want to dictate how the world is run from the top down, leveraging invasive technologies to track and trace your every move while censoring and silencing anyone who dares not comply.
Here is Politifact quoting me from the film Plandemic, which Politifact then disputed by citing a March 17, 2020 Nature Medicinearticle, which I had mentioned in the film as being bogus:
“I feel quite convinced that this was a laboratory designed organism.” — Dr. Meryl Nass, internal medicine specialist
POLITIFACT August 18, 2020: Research shows that the virus could not have been created in a lab. An article published March 17 says the genetic makeup of the coronavirus, documented by researchers from several public health organizations, does not indicate it was altered.
Now, it seems, many have awakened, after being spoon-fed an analysis of the facts by Nicholas Wade, and realized the Nature Medicinepaper makes absolutely no sense.
Some scientists have argued that the lab-leak hypothesis deserves to be taken much more seriously than it was earlier in the pandemic, and that dismissals of it as conspiracy theory were premature. Claims of complete certainty on either side remain unfounded.
No mention, of course, of Politifact’s previous smear of me and the movie. All the fact-checkers piled on me last August, as I described in a blog post, for saying the origin of Covid was a lab. Where are the rest of them now? Do the rest of the fact-checkers correct their facts?
Do the social media platforms that banned the movie resurrect it?
Former Irish Prime Minister Charles Haughey was warned by loyalist paramilitaries that they were once tasked with murdering him in an assassination plot purportedly dreamt up by the British secret service.
The sensational disclosure was sent in a letter to the Irish government, newly released under the Public Records Act, which requires documents of historical value to be published by the National Archives within 30 years.
Written on Ulster Volunteer Force (UVF) signature paper, the warning claims the terrorist organization was asked by an MI5 operative about the prospect of carrying out an attack on Republic of Ireland leader Haughey in 1985.
At the time, Haughey would have been in opposition as head of political party Fianna Fáil, but details of the solicitation did not become known to Irish authorities until 1987.
“In 1985 we were approached by a M15 officer attached to the Northern Ireland Office and based in Lisburn, Alex Jones was his supposed name,” the letter reads, according to the Irish Times. “He asked us to execute you.”… continue
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