This is the fourth part of a series in which Paula Jardine examines how the Covid vaccine programme was conceived by US defence planners nearly 20 years ago as a 21st century ‘Manhattan Project’ for biodefence. You can read Part 1 here, Part 2 here and Part 3 here.

BILL Frist was the 2003-2007 US Senate majority leader who championed the USA’s biodefence projects and promoted the concept of a ‘Manhattan Project’ against a pandemic, described in Parts 1, 2 and 3 of this series. He was also the politician who sponsored the Public Readiness and Emergency Preparedness Act (PREP) Act of December 2005 as soon as the World Health Organisation’s International Health Regulations had been amended to include a provision enabling WHO to declare Public Health Emergencies of International Concern (PHEIC). Critically it was this Act that established indemnity for the manufacturers of therapeutics, vaccines or diagnostics released during the course of a public health emergency against any and all harm caused.

Also working to influence US national biosecurity policy was Dr Robert Kadlec, described in Part 3. Working with him, and principally under the auspices of the Johns Hopkins Centre for Health Security (founded by Dr Tara O’Toole in 1998) were other participants in Operation Dark Winter, the code name for a senior-level situational simulation conducted on June 22-23, 2001, designed to wargame a covert and widespread smallpox bio-terrorist attack on the United States. These biosecurity hawks included O’Toole and Tom Inglesby of the Johns Hopkins Center for Civilian Biodefense Strategies (CCBS).

When O’Toole was nominated some years later to serve in the Department of Homeland Security in 2009, critics warned of her paranoia. Microbiologist Dr Richard Ebright, one of the scientists who, in May 2021, called for a full and unrestricted international forensic investigation into the origins of Covid-19, said it was a disastrous nomination: ‘O’Toole supported every flawed decision and counterproductive policy on biodefense, biosafety, and biosecurity during the Bush Administration. [She] is as out of touch with reality, and as paranoiac, as former Vice President Cheney . . . It would be hard to think of a person less well suited for the position . . . She was the single most extreme person, either in or out of government, advocating for a massive biodefense expansion and relaxation of provisions for safety and security’. Dr Ebright concluded: ‘She makes Dr Strangelove look sane.’

It was Kadlec who formed the Bipartisan Commission on Biodefense in 2014 and began the planning his Manhattan Project in earnest. Those involved with him in this commission included Tom Ridge, the first Homeland Security Secretary, Donna Shalala, a former Health and Human Services (HHS) Secretary, Dr Margaret Hamburg, a former Food and Drug Administration (FDA) commissioner, Scooter Libby,  formerly of Project for a New American Century (PNAC), William Karesh, the vice president of EcoHealth Alliance and an adviser to the WHO on reforms to the International Health Regulations (IHR), and Kenneth Wainstein, now the Under Secretary of Homeland Security for Intelligence and Analysis.

The Commission’s National Blueprint for Biodefense published in2015 called for major ‘reform’. Consider it the blueprint for Kadlec’s Manhattan Project, for the CEPI (Coalition for Epidemic Preparedness Innovations) strategy and for the subsequent changes to the WHO IHR required to make the plan work.

The list of the BioDefense Commissions ‘we must’ demands follows:

·         revolutionise the development of Medical Countermeasures (MCM, which are vaccines and therapeutics) for emerging infectious diseases; 

·         fully fund and incentivise the MCM enterprise; 

·         remove bureaucratic hurdles to MCM innovation; 

·         develop a system for environmental detection that leverages the ingenuity of industry and meets the growing threat; 

·         overhaul the Select Agent Program (which oversees the possession, use and transfer of risky biological agents and toxins) to enable a secure system that simultaneously encourages participation by the scientific community; 

·         help lead the international community toward the establishment of a fully functional and agile global public health response apparatus.

Three years later in May 2018 when Johns Hopkins ran Clade X, a table top simulation around a novel parainfluenza virus, O’Toole was involved once again. Johns Hopkins CHS also co-hosted with the Bill and Melinda Gates Foundation the better-known coronavirus simulation Event 201 in October 2019.

It was during a Clade X discussion on manufacturing capacity sufficient to end the fictitious pandemic through vaccination that O’Toole said: ‘Industry are more than willing to help but vaccines are very specific creatures that are difficult to turn to new purposes. We’re going to have to go to innovative manufacturing methods that will require a lot of leniency from the FDA and the understanding of the American people that we’re doing things on an emergency basis so every box in terms of safety and risk assessment may not be checked. But the vaccine is the only way forward.’ [My emphasis]

This was clear advocacy for vaccines as the exit strategy for the Clade X novel parainfluenza virus pandemic, and later once the Covid pandemic was underway, was to be the only exit offered to lockdown.

Today, O’Toole is an executive vice-president of the CIA spin-off venture capital firm In-Q-Tel in charge of a strategic initiative called BiologyNext. In April 2020 in a presentation to the Centre for Strategic and International Studies (CSIS) she said: ‘The bio-revolution is really founded on several core technologies that I’m going to simplify greatly. But it is all about being able to read, write, and edit the code of life. One of the most important recognitions of the past century in science, at least, is that life is written in code. And as Jason Kelly of Ginkgo Bioworks has put it: Biology is essentially programmable . . .

‘Ron Weiss, who is a synthetic biologist, predicted in 2014 that an RNA-based delivery method that allowed you to use RNA as a kind of platform to deliver new bits and pieces inside the cell would be a game-changing inflection point in synthetic biology. And the Covid-19 pandemic is giving us a chance to test that out. You may know that one of the vaccines that is coming on very quickly is made by Moderna. And it is a messenger RNA-based vaccine. So if that works, Ron Weiss’s prediction may come true.’ [My emphasis]

In August 2019 Kadlec’s department ran yet another table-top simulation, the Crimson Contagion. It simulated the impact of and response to the arrival in the US of an avian flu from China. It was a scoping exercise to identify legal authorities, US federal government funding resources and manufacturing capabilities for vaccines. It concluded that $10billion would be required to respond to a novel pandemic influenza strain.

A month later on September 19, 2019, President Trump signed the Executive Order on Modernizing Influenza Vaccines which launched the Manhattan Project by directing various US government departments and the US Department of Defense to propose a plan and a budget within 120 days – by January 17, 2020, to be precise. 

Anthony Fauci’s diary, released following a freedom of information request, notes a teleconference concerning the ‘Global pandemic’ taking place on January 15, 2020, a date at which a global pandemic existed only in some people’s imaginations.

On January 23, 2020, after the Moderna vaccine announcement in Davos, Fauci had a conference call with Dr Richard Hatchett, CEPI’s CEO, and the following day, a Saturday, he had a senior leadership update with Dr Kadlec in advance of a meeting with Stephane Bancel of Moderna on Monday January 27. Perhaps Kadlec, Hatchett and Bancel were amongst the unnamed people on Fauci’s January 15conference call.

On January 30, 2020, when the WHO declared a SARS CoV2 Public Health Emergency of International Concern, just 7,818 patients were said to be sick with Covid, of whom only 82 were outside China. As far as Kadlec was concerned, this was now a shooting war.

Following CEPI’s announcement in Davos on January 23, US-based manufacturers Innovio Pharmaceuticals were miraculously ready to begin developing a Covid vaccine, and Moderna already had its funding to begin manufacturing the first batch of the vaccine co-owned and co-developed with Anthony Fauci’s National Institute of Allergy and Infectious Diseases (NIAID) for use in a human clinical trial. 

The legislation that he and Frist had shepherded through Congress between 2003 and 2005 had concentrated power in the hands of the US Health and Human Services Secretary (and the US Administration for Strategic Preparedness and Response) during public health emergencies. 

The basic goals of the architects had been achieved. These, the American investigative paralegal Katherine Watt has argued, were to set up legal conditions in which all governing power in the United States would be automatically transferred from the citizens and the three constitutional branches into the hands of one person, the Health and Human Services Secretary, ‘effective at the moment the HHS Secretary himself declared a public health emergency, legally transforming free citizens into enslaved subjects’.

The HHS Secretary Alex Azar, to whom ASPR’s Kadlec reported, was the senior legal counsel at HHS when the PREP Act was passed in 2005. Azar co-operatively declared a public health emergency on January 30, 2020, backdating it to January 27.

He then made a PREP Act declaration on February 4, enhancing liability protection for any person or firm involved in developing countermeasures, including Innovio and Moderna.

The announcement said: ‘The world is facing an unprecedented pandemic. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.’

HHS Secretary determinations are unreviewable by the US courts.

Further research by Katherine Watt into another PREP Act declaration for medical countermeasures by Azar in March 2020 shows it effectively sidestepped the Nuremberg Code by stipulating that the ‘use’ of any counter measures ‘shall not be considered to constitute a clinical investigation’ while also removing the right to informed consent. As there is, by decree, no clinical trial, there are no stopping conditions for the use of said countermeasures.

It is startling how Dr Kadlec and his few associates have, over a period of more than 20 years, managed to orchestrate an undemocratic and unethical bio-security coup with global reach. 

The Manhattan Project was renamed Operation WarpSpeed when it was launched in May 2020. The involvement of the US Federal Government which through the NIAID owns the patent for the spike protein used in the vaccines, and its Department of Defense that ran and financed Operation WarpSpeed, arguably elevates this War on Microbes Manhattan Project to an unprecedented bioweapon attack on humanity using an under-tested novel injectable pharmaceutical.

This is the third part of a series in which Paula Jardine examines how the Covid vaccine programme was conceived by US defence planners nearly 20 years ago as a 21st century ‘Manhattan Project’ for biodefence. You can read Part 1 here and Part 2 here. 

WHEN it comes to the business of vaccines and biosecurity, the land of free enterprise is all up for large-scale state intervention to create and prop up markets.  Some of the generals behind the biosecurity ‘Manhattan Project’ believe the War on Microbes is too important to leave to politicians or Adam Smith’s invisible hand.

In June 2020, former Senator Bill Frist appeared before the Senate Health, Education, Labor and Pensions (HELP) Committee, reminding them he’d argued the need for this project fifteen years earlier. 

‘I called for and had outlined “a greater than Manhattan Project for the 21st century” with no less than “the creation, with war-like concentration, of the ability to detect, identify and model any emerging or newly emerging infection, natural or otherwise; for the ability to engineer the immunization and cure, and to manufacture, distribute and administer whatever may be required to get it done and to get it done in time”,’ Frist told the Senate in his testimony.

‘We have a dangerously inadequate vaccine manufacturing base in the United States. This must be rectified. Bottom line: there’s so little profit and so much uncertainty in vaccine manufacturing today. We must establish longstanding public-private partnerships with industry that are sustained and are not at risk of disappearing with each [Congressional] appropriations cycle.  We cannot expect the private sector to independently invest billions of dollars developing antivirals and vaccines for novel viruses that we hope we’ll never need to use. That’s not a sustainable business model.’ 

For some years to come, Frist asserted, this should be the chief work of the nation, ‘for the good reason that failing to make it so would be to risk the life of the nation’.

Whether this idea originated from Senator Frist is another matter. Dr Robert Kadlec, the ‘General Ripper’ behind this new Manhattan Project, was at that time the leading biosecurity official in President George W Bush’s administration. He was at the April 2005 National Academy of Sciences Pandemic Influenza Symposium where an unidentified participant called for funding for a Manhattan-like Project to protect against a pandemic, calling it an insurance policy. 

But the groundwork for this Manhattan Project was being laid even earlier. In June 2001, two months before the 9/11 atrocity, the Johns Hopkins Center for Health Security (CHS) held a table-top exercise it called Dark Winter, simulating a smallpox bioterrorism attack on the US orchestrated by Osama bin Laden’s Al Qaeda. Dr Tara O’Toole, who founded the CHS in 1998, was the principal designer of the exercise, butKadlec is credited with giving it its name. AColonel Randall Larsen, who’d hired Kadlec to work at the Air War College in the mid-1990s, was another designer of the exercise along with Tom Inglesby, the CHS’s current director. 

Kadlec became the Homeland Security Director of Biosecurity Policy in January 2002 and soonafter attempted to restart the smallpox vaccination programme. In 2004, he launched Project Bioshield, a $5.6billion ten-year programme which created BARDA, the Biomedical Advanced Research and Development Authority. This was intended to motivate US pharmaceutical companies to start developing biodefence products (medical countermeasures which are principally vaccines) ‘by providing a substantial guaranteed market, expediting governmental contracting practices and clarifying FDA regulatory requirements for products used in a public health emergency’. 

Project Bioshield funding enabled the US government to stockpile smallpox and anthrax vaccines manufactured by the companies Bavarian Nordic and Emergent BioSolutions. Both companies and the industry lobby group Biotechnology Innovation Organization were amongst the funders of Kadlec’s Bipartisan Commission on Biodefense he founded ten years later, in 2014, when he was working as a paid consultant to Emergent BioSolutions.The company, founded by Fuad El-Hibri and originally known as BioPort Inc, purchased a vaccine factory and the rights to manufacture anthrax vaccine for the US military in 1998.

On his appointment as Assistant Secretary for Preparedness and Response (ASPR) in 2017, Kadlec failed to declare a conflict of interests on his ethics forms, that in 2012 he and El-Hibri had co-founded an international biodefence company called East West Solutions LLC or that he had been employed by Emergent BioSolutions as a consultant. https://www.help.senate.gov/imo/media/doc/05062020%20Kadlec%20Ethics%20Letter%20Updated%20signed%20pdf.pdf  In September 2019, when Kadlec was ASPR and in control of the US national stockpile, Emergent BioSolutions was awarded a ten-year $2billion contract to replenish the US national stockpile of smallpox vaccine.

Emergent BioSolutions was later subcontracted to manufacture Covid vaccines for AstraZeneca and Johnson & Johnson in the US. However the company’s poor manufacturing standards led to a Congressional investigation being launched in 2021. 

Since Covid, the ‘war on microbes’ has not let up: attention simply moved on to the next opportunity to promote a vaccine. Each outbreak seems to follow the oft-repeated pattern of having been preceded by a Strangelove-like situational simulation based on a fictional scenario. Outbreaks of disease, requiring the WHO to declare a public health emergency of international concern (PHEIC) and public health authorities to announce a vaccination campaign, have a strange knack of occurring soon after the simulation exercises, ensuring the public health community is well prepared in advance.

In December 2020, the Nuclear Threat Initiative (NTI), whose interim vice president is the former US Department of Health and Human Services Secretary Margaret Hamburg, conducted a consultation with experts for a table top exercise on ‘reducing high-consequence biological threats’ in preparation for the exercise to run at the Munich Security Conference in March 2021. The scenario involved a fictitious monkeypox outbreak. Hamburg was herself a player in the June 2001 Dark Winter smallpox table top exercise and is a member of the Biodefense Commission. At the 2021 Munich monkeypox simulation she was joined by a familiar roster of biosecurity figures including the ubiquitous Sir Jeremy Farrar, his old friend George Gao, the then head of the China CDC, Dr Chris Elias of the Bill & Melinda Gates Foundation, US Senator Sam Nunn who played the President in Dark Winter, Luc Debruyne, Vice President of CEPI, Dr Michael Ryan, Director of the WHO Emergencies Programme, with whom Anthony Fauci was in weekly contact in early 2020 during the time that Covid was escalated to a pandemic, and Arnaud Bernaert the WEF’s Head of Shaping the Future of Health and Health Care.

Bernaert, Gao and Elias were involved in Event 201, the coronavirus table top exercise co-sponsored by the Johns Hopkins Centre for Health Security, the Gates Foundation and the WEF in October 2019. In the WEF press release for Event 201 Bernaert said, ‘We are in a new era of epidemic risk, where essential public-private cooperation remains challenged, despite being necessary to mitigate risk and impact. Now is the time to scale up cooperation between national governments, key international institutions and critical industries, to enhance global capacity for preparedness and response.’

In May 2022, the WHO declared a monkeypox outbreak which was escalated to a full-scale Public Health Emergency of International Concern in July 2022. Bavarian Nordic, the Danish headquartered vaccine manufacturer belonging to a Washington-based consortium called the Alliance for Biosecurity, signed a contract with an unnamed European country to supply smallpox vaccines for use as a monkeypox vaccine. The company is a sponsor of Kadlec’s Biodefense Commission, and its largest shareholder is ATP, Denmark’s national pension fund. Other notable entities amongst its top five shareholders include Vanguard Asset Management and Norway’s sovereign wealth fund Norge Bank.

In Part 4 I will examine how Kadlec began preparations for his Manhattan Project two years before the 2016 US Presidential election.

This is the second part of a series in which Paula Jardine examines how the Covid vaccine programme was conceived by US defence planners nearly 20 years ago as a 21st century ‘Manhattan Project’ for biodefence. You can read Part 1 here. 

THE name Robert Kadlec may mean nothing to you, but anyone who has watched Stanley Kubrick’s Cold War era satirical masterpiece Dr Strangelove will quickly get the idea of who this man is. 

Colonel Kadlec is the General Ripper of the War on Microbes. It is no small irony that the Biodefense Commission that Kadlec set up in 2014 is funded by the Hudson Institute, which was co-founded by Herman Kahn, the Rand Corporation war gamer. Kahn’s theory that nuclear war could be deterred if the Soviet Union believed the United States had second strike capability was the inspiration for Kubrick’s Dr Strangelove character and the film.

Kadlecbegan his career as an Air Force physician before he diverted into the world of biological weapons during the first Gulf War of 1990-91. He became an intelligence analyst for the US Joint Special Operations Command (JSOC) on chemical and biological weapons. He subsequently became a member of the UN Weapons Inspection team in Iraq led by Dr David Kelly, who was found dead in 2003.

Kadlec was later (2014) to tell the House of Representatives Committee on Homeland Security that ‘while the United States was victorious in 1991, the scale and scope of Iraq’s biological weapons programme remained elusive despite the most intrusive inspection and monitoring regime ever conceived and implemented by the United Nations Special Commission (UNSCOM).’ 

No conclusive proof was ever found that Iraq had biological weapons, but testimony in 1995 from a defector, Saddam Hussein’s son-in-law Colonel General Hussein Kamel Hassan al-Majid, intelligence which was later assessed as being of limited content and value, maintained the belief of Kadlec and others that they did exist, providing the pretext for the 2003 Iraq War which removed Hussein from power. This belief was no doubt bolstered in part because in the 1980s the Iraqi Technical and Scientific Import Division had (quitelegally) bought samples of an anthrax strain developed by US germ warfare researchers at Fort Detrick, from the American Type Culture Collection, a non-profit organisation in Manassas, Virginia, that provides samples of bacteria and viruses for scientific study. (Arguably the absence of concrete evidence reinforced rather than diminished this belief in the graveness of the threat.)

Between 1993-96 Kadlec served on the US Delegation to the Biological Weapons Convention. His thinking on biowarfare is set out in his contribution to a 1995 Air War College book called Battlefield of the Future. 

In it he argued that biological weapons are the poor nations’ nuclear bombs: they could be made cheaply and easily in facilities with other legitimate purposes, are invisible and, if aerosolised, could be spread over wide areas using an agricultural crop duster. His contention was that they uniquely offered the possibility of ‘plausible deniability’ to the perpetrators because pathogenic agents could be mistaken for naturally occurring epidemics. His particular concern was that vaccines, which are highly specific in what they protect against, take ten to 15 years to develop. 

Wired magazine reported on the US military’s desire for genetic vaccines to make soldiers ‘immune to all known pathogens’ in 1996. As if that wasn’t enough of an aspirational Pandora’s Box, it also reported the military’s desire for the capability of targeting enemy leaders using genetically engineered super pathogens ‘so selective in their behaviour they’re capable of targeting specific individuals, verifying their identities by means of their DNA sequences’. 

It was immediately after 9/11 in 2001 thatKadlec became a special adviser to Defense Secretary Donald Rumsfeld and subsequently appointed Director of Biosecurity Policy in the Homeland Security Department of President George W Bush, where he drafted a document calledNational Biodefense Policy for the 21st Century. This, in April 2004, became the Homeland Security Presidential Policy Directive 10. Kadlec wrote that theUnited States ‘will continue to use all means necessary to prevent, protect against, and mitigate biological weapons attacks perpetrated against our homeland and our global interests’. 

Speaking about the need for a Homeland Biosecurity Policy,President G W Bush said: ‘Armed with a single vial of a biological agent, small groups of fanatics, or failing states, could gain the power to threaten great nations, threaten world peace. America, and the entire civilized world, will face this threat for decades to come. We must confront the danger with open eyes, and unbending purpose.’

Notably Kadlec’s 2018 update of this policy went much further. It declared the extraordinary intent to apply the US approach to countering weapons of mass destruction to all infectious disease outbreaks, naturally occurring or otherwise.

Returning to 2005, this was the year that saw Kadlec attending a National Academy of Sciences Symposium on Pandemic Influenza. This centred on the belief of American public health authorities thatthe recurrence of an influenza pandemic with high mortality was both inevitable and posed a grave threat to humanity. Becauseinfluenza rapidly mutates and is not usually particularly lethal it provideda good research model for biosecurity purposes, not to mention a useful tool for advancing policy objectives. The ubiquitous Imperial College London modeller Neil Ferguson told the symposium that disease containment required ‘a concerted international response – probably with teams on the ground chasing cases’, effectively laying the groundwork for ‘all means necessary’ not to stop at the US border.

Though the 1918 influenza pandemic was originally said to have been caused by H1N1 swine flu, today the US Centers for Disease Control (CDC) says it was caused by ‘H1N1 with genes of avian origin’. This is based onUS Army researchers who claimed in 1999 to have fully sequenced ‘Spanish Influenza’ (using PCR) from autopsy samples taken in 1918 and a sample retrieved from a victim buried in permafrost since 1918. They said the illness was more closely related to avian flu than any mammalian species.

Ferguson’s modelling on avian flu was published in August 2005, claiming that ‘if targeted action is taken within a critical three-week window, then an outbreak could be limited to fewer than 100 individuals within two months’, but if unchecked up to 200million could die. This was just one of his wildly improbable and spectacularly wrong forecasts.

It was claimed that if bird flu mutated to more readily infect humans, the mortality rate would be more than 50 per cent. Bird flu, which first appeared in Thailand’s huge commercial poultry flocks, serendipitously appeared just as an eight-year marathon effort to have the World Health Assembly of the WHO agree key amendments to the International Health Regulations was coming to a close. The significance of these amendments, finally adopted in 2005, is that they included a new provision toenable the Director General to declare Public Health Emergencies of International Concern (PHEIC) on the recommendation of the WHO Emergency Committee. This mirrored the Public Health Emergency provision added to American public health law in 1983. Covid was declared a PHIEC by the WHO on January 30, 2020. 

From 2003 to 2007, only 216 people died from bird flu. The threat and the headline fatality rate appear to have been overstated. Dr Nguyen Tuong Van of Hanoi’s Institute for Clinical Research, who treated some bird flu victims during the 2004 outbreak said, ‘Most people who die of bird flu are poor and not in the best physical condition in the first place.’  

Jeremy Farrar’s 2004 paper on the Vietnamese outbreaks says rapid antigen testing was ‘less sensitive than PCR for diagnosis of influenza H5N1.’ Patients were given anti-viral drugs, mainly Tamiflu, which was developed by Gilead Sciences, a company chaired by Donald Rumsfeld, and almost all were mechanically ventilated, which itself elevates the mortality rate. Tamiflu may have been part of the problem. As a recent review of Tamiflu concludes: ‘A cocktail of pandemic panic, publicity propaganda, and scientific misconduct turned a new medicine with only modest efficacy into a blockbuster. It appears that the multiple regulatory checks and balances gave way as science lost its primacy and pharmaceutical enterprise lost no time in making the most of it.’ 

The 2005 WHO report Avian Influenza: Assessing the pandemic threat  itself makes curious, and occasionally implausible, reading. According to this account, the ‘highly pathogenic’ bird flu, as it was usually described, was being spread asymptomatically by wild waterfowl (airborne bioterrorists to Kadlec’s way of thinking) to the small domestic free-range flocks kept by rural families in Asia, and that these birds were transmitting it to people. The real problem according to the business end of the report was that H5N1 bird flu was so ‘highly pathogenic’ that it was killing the chicken embryos used for flu vaccine manufacture. This made finding new methods of manufacturing them all the more desirable. Even better if these new methods could produce more vaccines, faster. 

Another conundrum, Dr Jesse Goodman of the FDA told the NAS symposium, was the markets.   ‘Markets – that is demand and sales – are the main drivers of manufacturing. No one is going to build factories just for a possible pandemic,’ he said. 

The WHO had convened a meeting in November 2004 with all the major vaccine manufacturers to explore ways in which industry, regulatory authorities, governments, and WHO could collectively speed up the development of pandemic vaccines that could be made rapidly and in as large a quantity as possible. It was argued that wider use of seasonal vaccines would make the vaccines more commercially viable and the resulting increased production capacity would enable manufacturers to pivot production to pandemic strains whenever they should be needed. 

Senator Bill Frist, the Republican Senate Majority leader at the time Kadlec was the leading bioterrorism expert in the Bush Jr Administration, full-throatedly echoed Kadlec’s thinking at the 2005 WEF at Davos, saying: ‘The greatest existential threat we have in the world today is biological. Why? Because unlike any other threat it has the power of panic and paralysis to be global.’  He also asserted: ‘We need to do something that even dwarfs the Manhattan Project,’ the codename for the US effort to devise an atomic weapon during the Second World War. 

Next: Kadlec’s simulation exercises and his conflicts of interest.

In this series, Paula Jardine examines how the Covid vaccine programme was conceived by US defence planners nearly 20 years ago as a 21st century ‘Manhattan Project’ for biodefence.

WHEN Dominic Cummings testified before Parliament in June 2021 and he was asked about the UK Covid Vaccine taskforce, he said: ‘What Bill Gates and people like that said to me and others at No 10 was, “You need to think of this much more like some of the classic programmes of the past – the Manhattan Project in World War Two or the Apollo programme – and build it all in parallel. In normal Government accounting terms, that is completely crazy, because if nothing works out you have spent literally billions building all these things up, and the end result is nothing – you get zero for it, it’s all waste.’

Gates is the promoter, facilitator and profiteer-in-chief of the great vaccine Manhattan Project but he certainly isn’t the originator of it. The call for a biosecurity Manhattan Project dates back to the George W Bush administration.

On July 11, 2019, a think tank called the Biodefence Commission held a panel discussion entitled A Manhattan Project for Biodefence: Taking Biological Threats off the Table. The objective was to ‘create a national, public-private research and development undertaking to defend the United States against biological threats’.

Dr Robert Kadlec, the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services (HSS) was a panellist. During the discussion Kadlec said, ‘It’s time to say “Go big, or go home” on this issue.’ Covid-19 gave him just the opportunity to implement this Manhattan Project as appears to have been intended. 

Kadlec founded the Biodefense Commission in 2014 when he was a consultant to one of its donors, the vaccine manufacturer Emergent Biosolutions. The Hudson Institute, a think tank co-founded by Herman Kahn of the Rand Corporation, the pioneer of war gaming who was satirised as Dr Strangelove in Stanley Kubrick’s film of the same name, is the Commission’s fiscal sponsor. 

On Wednesday December 4, 2019, the House Committee on Energy and Commerce held its annual hearing on US public health preparedness and response for seasonal and pandemic influenza. Testifying before it were Dr Anthony Fauci of the National Institute of Allergy and Infectious Diseases, Dr Nancy Messonnier from the Centers for Disease Control (CDC), Dr Peter Marks from the Food and Drug Administration (FDA) and Kadlec. 

Seventy-six days earlier,on September 19, 2019, an Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health had been signed by President Trump, directing the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), the CDC and the FDA to ‘accelerate the adoption of improved influenza vaccine technologies’. The Departments of Health and Human Services and the Department of Defense were to propose a plan and a budget for this effort within 120 days,  in other words, before January 17, 2020. 

The White House said: ‘Unfortunately, many of the vaccines we use today are produced overseas, using time-consuming, egg-based technology, which limits their effectiveness and makes production too slow to effectively combat a potential deadly influenza pandemic.’ 

Fauci may be the best known of the four witnesses but Kadlec is by far the most consequential. Kadlec, a retired US Air Force Colonel, and former Director of Biosecurity Policy in the George W Bush Administration, is the principal architect of 21st century US biosecurity policy. He said in his testimony: ‘ASPR’s mission is to save lives and protect Americans from 21st century health security threats.’ 

As a member of Bush’s Homeland Security Council he drafted the 2004 National Biodefense Policy for the 21st Century. He was the instigator behind the 2004 Project Bioshield Act that created a strategic national stockpile of anthrax and smallpox vaccines (manufactured by his Biodefense Commission’s funders). In 2005, as staff director to Senator Richard Burr’s Subcommittee on Bioterrorism, hedrafted the 2006 Pandemics and All-Hazards Preparedness Act (PAHPA, pronounced ‘Papa’). This act created the Biomedical Advanced Research and Development Authority (BARDA) and the Assistant Secretary of Preparedness and Response (ASPR) position. The ASPR controls the national stockpile of smallpox and anthrax vaccines and otherpublic health emergency medical equipment such as ventilators. During emergencies this Assistant Secretary has expansive powers enabling him or her to act as the single point of control co-ordinating national response. Kadlec was confirmed as ASPRin August 2017 after being recommended to President Trump by Senator Burr. 

At the December 4, 2019 meeting of the House Committee on Energy and Commerce, Kadlec was asked what his department was doing to enhance American manufacturing capacity. He said: ‘On the issue of vaccines alone, I think the key thing is, I can’t go into the particulars but we’re going to have an announcement here shortly that will indicate some investments domestically to expand some of our newer technologies for vaccine manufacturing and I think the key thing there is, we are actively pursuing this in accordance with the executive order.’ 

Fauci testified that pursuant to Trump’s executive order his agency, the National Institute for Allergy and Infectious Disease (NIAID), was conducting and supporting research into new platform technologies including mRNA. Fauci said: ‘State-of-the-art technologies could be used to develop universal influenza vaccines as well as improve the speed and agility of influenza vaccine manufacturing.’ 

When Kadlec wasasked what the benefits were to the American people of investing in platform technologies such as mRNA he said: ‘The availability of such platform-based approaches would transform national preparedness against currently known threats as well as newly emerging threats in the future.’ Citing theASPR/BARDA funded development of a Zika vaccine made using mRNA technology he went on: ‘This technology has promise as a rapid platform for a number of infectious diseases, including influenza and novel diseases that may emerge in the future. 

The Zika vaccine he referred to was being developed by Moderna, the US-based mRNA gene-therapy biotech. It didn’t have an influenza vaccine in development but it was actively working with Fauci’s NIAID to develop a ‘jointly owned coronavirus vaccine’. A prototype of this vaccine was sent to Dr Ralph Baric, the leading coronavirus expert who has worked collaboratively with Dr Shi Zhenghli of the Wuhan Institute of Virology, for animal testing on December 17, 2019. 

Moderna’s European rival BioNTechannounced in August 2018 that it was in collaboration with Pfizer todevelop an mRNA flu vaccine. It was aiming to move this from the preclinical stage to phase 1 trials by the end of 2020. Professor Dr Ugur Sahin, co-founder and CEO of BioNTech said: ‘A significant presence in infectious disease supports our goal of building a global immunotherapy company that provides more effective and precise immune-mediated approaches for the prevention and treatment of serious illnesses, such as the prevention of flu and the treatment of cancer.’ 

BioNTech diversified from developing cancer therapies – none of which was successfully licensed – into vaccines after a provision in a 2009EU directive intended to enable genetic engineered viruses to be used in vaccines was identified in 2016 and interpreted by them and others as a regulatory loophole enabling gene therapies directed at infectious diseases to circumvent the more stringent and onerous Advance Medicines Clinical Trials protocols. In 2020, this flu vaccine research was pivoted to Covid vaccine research.

Using this regulatory back door, both the UK Medicines and Healthcare Regulatory Agency (MHRA) and the European Medicines Agency (EMA) evaluated BioNTech’s mRNA Covid gene therapies as run-of-the-mill vaccines. The mRNA gene therapies contain no viruses; instead they genetically modify the recipient, reprogramming their cells to produce a protein from the virus that will stimulate their immune system to create a response against the virus, meaning the EU directive should not have been applicable.

During the launch of Coalition for Epidemic Preparedness Innovations (CEPI) at Davos in January 2017, Gates enthusiastically promoted mRNA vaccines. ‘Now there’s a new class of vaccine, DNA / RNA vaccine that we hope we can just change a small part of it, and so the manufacturing facility would already be there, the trials you would go through would be very quick. You would understand what end point, what correlate you want and so in an emergency, the regulators would understand what sort of protocol we’re going to use,’ said Gates.  

‘With Ebola we had a scientific challenge that these platforms weren’t ready, we didn’t understand which country, what type of indemnity, and so there was a lot of fumbling around. It’s only by fixing those regulatory uncertainties and using these new platforms that we have a chance of getting that time to be less than a year.’ 

Gates’s foundation took an equity stake in BioNTech ahead of its October 2019 US stock market launch. When he was asked in 2017 about the danger of these platform vaccines making people less well, he said: ‘You are right that the safety threshold is really, really extremely high because we have to maintain the reputations of all the vaccines, convince parents in all these countries that these shots are really there to help your child out. Anything that you do to healthy people is going to have a tougher standard than, say, a new cancer drug, where if you don’t have the new drug, the outcome is going to be quite negative.’

This tougher standard was soon forgotten. The Pfizer/BioNTech product was pushed into use by the UK Medicines and Healthcare Regulatory Authority (MHRA) on December 2, 2020 using a ‘compassionate use’ mechanism called a Temporary Use Authorisation to bypass the European regulator during the last month that the UK was under European Union law. MHRA reviewed only a few hundred pages of summary data, not the full dossier.

The FDA has a pathway for accelerated approval of ‘vaccines licensed in other countries with competent regulatory authorities.’  p21 Emergency Use Authorisation of the Pfizer/BioNTech vaccine as provided for under the 2004 Project Bioshield Act quickly followed in the US on December 11, 2020 and the European Medicines Authority (EMA) fell into line on December 21.  Kadlec’s long-desired Manhattan Project was now detonating. 

Part 2 of this series will focus on Dr Robert Kadlec, the principal planner of the US’s War on Microbes and of this biosecurity ‘Manhattan Project’.