This is the final part of Paula Jardine’s investigation into the US Biowarfare Manhattan Project that led to the Covid debacle and more than 5billion people injected with highly risky gene therapies. Part 7 told how Moderna’s mRNA-MERS vaccine went underground in response to the US moratorium on gain-of-function research. Part 8 reveals how America’s biodefence researchers also found ways to continue their programmes. Click on the numbers to read the previous instalments: 1, 2, 3, 4, 5, 6, 7.
AROUND the time of the 2014 gain-of-function moratorium MERS (Middle East respiratory syndrome) coronavirus, though designated a cause of severe acute respiratory disease, had been confirmed in only 1,728 cases, resulting in just 624 deaths in a global population of 7.5billion. Sixty-six per cent of these patients were male with the most severe cases tending to be in older males. The highest number of fatalities were amongst those with co-morbidities such as diabetes, obesity or existing kidney disease which presumably aren’t common in soldiers, the relevance of which will become clear.
First reported in Saudi Arabia in 2012, this outbreak of MERS (in common with a subsequent one in 2015 in South Korea) occurred principally in hospitals. Yet the detection of an isolated MERS case in the USA in 2013 led Kathryn Sebelius, the Health and Human Services (HHS) secretary, to make a declaration of a potential public health emergency concerning MERS. This enabled the US Food and Drug Administration (FDA) to issue an emergency use authorisation for a diagnostic test – PCR, of course! Sebelius’s Assistant Secretary of Preparedness and Response (ASPR) at the time happened to be Dr Nicole Lurie who oversaw the Biomedical Advanced Research and Development Authority (BARDA) where Dr Richard Hatchett was Deputy Director and the Chief Scientific Officer in charge of the countermeasure development pipeline. Lurie now works for the Coalition for Epidemic Preparedness Innovations (CEPI).
The US military quickly designated MERS-CoV a priority pathogen for research purposes. The US has 30,000 soldiers deployed to the oil-rich and strategically important Middle East, so US military planners placed a high importance on MERS countermeasure research in case an outbreak of an infectious disease (dangerous to elderly men with co-morbidities) might impair the operational effectiveness of the young, fit and healthy troops posted there.
Two distinct types of biologically engineered countermeasures were in development: prototype vaccines using novel rapid response platforms and synthetically produced antibodies called monoclonal antibodies. Prior to the moratorium the latter hadlooked more promising in early trials although they too could cause severe adverse reactions.
The US National Institutes of Health (NIH) filed a patent application for a MERS-CoV monoclonal antibody just one day before the US government moratorium was imposed in October 2014. In June 2015, to get round it, they engaged the University of Queensland in Australia to co-develop it. The university is a collaborating institution member of the Medical Countermeasures Consortium formed in 2006 by the US, UK, Canadian and Australian departments of defence, and had previously collaborated with NIH.
Efforts began to internationalise the vaccine programmes. The World Health Organization (WHO) was also co-opted into drawing up a Research & Development blueprint for emergency preparedness and selecting MERS-CoV as a priority pathogen. The key stakeholders involved in the exercise were BARDA, the US National Institute of Allergy and Infectious Diseases (NIAID), the International Vaccine Institute (IVI), Wellcome Trust, European Commission Directorate-General Research & Innovation, the GLOPID-R network of funders coordinated via the European Commission, and the Bill and Melinda Gates Foundation (BMGF).
In December 2015, the WHO hosted a two-day consultation on the MERS R&D Roadmap. Dr Barney Graham of the NIAID Vaccine Research Centre and Kayvon Modjarrad of the US Walter Reed Army Institute of Research participated, as did Dr Christian Drosten of coronavirus PCR test fame. Amongst the observers were Erik Stemmy, an officer from the DMID/NIAID Human Coronavirus Research Program, and three senior officials from BARDA including Dr Rick Bright, Director of the influenza division.
Dr Modjarrad, the primary author of the resulting 2016 WHO Roadmap for MERS vaccine development, gave the game away. The final strategic goal for the enabling environment, he said, was to ‘establish line of sight for manufacturers from pre-clinical proof-of-concept to procurement of MERS products once licensed, by establishing public health-oriented financing model for MERS products, and other products for emerging pathogens prioritized by WHO blueprint process.’ This mirrors BARDA’s stated purpose.
The ultimate outsourcing tool was the creation of CEPI, an international clone of BARDA. The idea for this self-appointed transnational body is said to have been hatched during the January 2016 World Economic Forum conference in Davos. A January 2017 WEF press release announcing CEPI’s launch revealed its key objective was ‘to prepare vaccines to speed up global response to epidemics’.
CEPI now raises money from governments around the world https://www.conservativewoman.co.uk/the-real-story-behind-lockdown-part-1/ to fund the research and development of vaccines for infectious diseases with no natural commercial markets. Think of it like an insurance policy for the American biodefence agencies ensuring the continuity of their development pipelines in the event of a US government funding cut or another moratorium.
Bill Gates, co-chair of the BMGF, explained CEPI’s purpose: ‘Unfortunately even though there is substantial risk for epidemics, there is not a natural market for vaccines. You have to get governments to create the right incentive structure.’ He added: ‘If you can predict what the pathogens are going to be and can get vaccines stockpiled, then that would be a very good response.’ https://www.weforum.org/press/2017/01/cepi-initiative-aims-to-prepare-vaccines-to-speed-up-global-response-to-epidemics/
Dr Richard Hatchett, who had been BARDA’s acting director, was appointed chief executive of CEPI weeks after its launch.If CEPI was to be the B-52 bomber in the Strangelovian War on Microbes, Hatchett was the Major Kong flying it.
CEPI’s first targets for its ‘just in case, just in time’ vaccines were MERS-CoV, Lassa and Nipah. By the time the US moratorium was lifted in December 2017, it was sponsoring vaccine development using its own funding stream independent of the US government and free from the constraints of the moratorium while at the same timeadvancing the BARDA/DARPA bio-defence agenda. In the first two years it awarded funding, CEPI committed $156.1million to MERS vaccine development.
On January 23, 2020, CEPI announced that it was funding the manufacture of Moderna’s Covid-19 vaccine. It also announced that it was pivoting two of the MERS vaccine projects already in its portfolio to SARS-CoV-2 vaccines.
CEPI also announced a third SARS-CoV-2 vaccine project at the University of Queensland. The university had been awarded $10.9million in funding from CEPI in January 2019 to develop a rapid response vaccine platform using ‘molecular clamp’ technology to create new influenza, MERS and RSV vaccines. The Queensland SARS-CoV-2 vaccine was discontinued in December 2020 after what were described as false positive HIV tests amongst the participants in the Phase 1 clinical trial.
CEPI also sponsored MERS viral vector vaccine projects which would adapt already licensed vaccines by genetically modifying the viruses to target different infectious diseases. The first award for a frankenvirus vaccine was to an Austrian company called Themis Bioscience which was developing a MERS vaccine by inserting coronavirus spike protein genes into measles virus. The company was acquired by Merck in June 2020. The Themis measles vector SARS CoV-2 vaccine proved ineffective due to ‘original antigenic sin’: the immune systems of people previously inoculated with measles didn’t recognise the modified virus properly and recipients were mounting a sub-optimal immune response. Development on this too was discontinued after the Phase 1 trial.
Another recipient of CEPI funding was Professor Sarah Gilbert (now Dame Sarah) of the Oxford Jenner Institute who, in partnership with Janssen, was awarded funding of $19million in 2018 to develop a chimpanzee adenovirus vector MERS vaccine. This was the prototype for the Oxford-AstraZeneca Covid-19 vaccine. Although the Oxford-AstraZeneca vaccine was never authorised for use in the US (the FDA authorised a rival manufactured by Johnson & Johnson) thisdidn’t stop Dr Robert Kadlec’s backers at Emergent Biosolutions from benefiting. They manufactured millions of doses shipped to Canada and Mexico, discovered later to be contaminated due to poor manufacturing. The Oxford-AstraZeneca Covid vaccine is no longer on offer in the UK or the European Union due to the high numbers of adverse events and deaths associated with it.
CEPI’sfinal viral vector vaccine award is perhaps the most interesting. A German contract development and manufacturing company called IDT Biologika received $36million to develop a MERS vaccine using the ‘recombinant vaccinia Ankara virus’ vector. This is a genetically engineered version of Bavarian Nordic’s third generation smallpox vaccine. Bavarian Nordic was the other principal beneficiary of Kadlec’s Project Bioshield in 2003 as its vaccine was stockpiled by the US government after attempts to reintroduce it as a routine vaccine failed. Like Emergent Biosolutions, Bavarian Nordic sponsored Kadlec’s Bipartisan Biodefense Commission. In 2022, following the WHO Public Health Emergency of International Concern (PHEIC) announcement on June 23, this same BN vaccine was deployed against monkeypox.
As the Covid-19 response shows, CEPI enthusiastically and recklessly promotes the liability-free emergency use of vaccines with no long-term safety data against poorly understood viruses. It wasted no time in pushing for an even more reckless endeavour, Kadlec’s 2021 Apollo project. While still bathed in the exhilaration of their success at having bypassed all the norms of ‘regulatory science’ to launch mRNA therapeutics into the arms of the trusting public, Dr Nicole Lurie and Dr Richard Hatchett wrote in the journal Foreign Affairs: ‘Experts at CEPI now believe that a vaccine against an entirely new pathogen – not just a new variant of the virus that causes Covid-19 – also needs to be produced in 100 days to adequately respond to a future epidemic with pandemic potential.’
CEPI’s success with its mission, despite its record of research failure, was underlined by the G7’s 2021 backing of the 100-Day mission. The Biodefense Commission’s Athena Agenda to advance the Apollo project states that ‘the Commission remains convinced that Covid-19 is not a once-in-a-century pandemic. Another biological event will occur much earlier than that’. They seem determined that it will.
The Biodefense Commission report inadvertently points to where the real danger lies and brings us back to the reason why the US government imposed the 2014 gain-of-function moratorium. Although both the threat and effectiveness of bioweapons is hugely exaggerated, gain-of-function is bioweapons research by another name. All the examples the Commission cites to support its rationale for the Apollo project are risky and dangerous biodefence laboratory associated events.