I suggest clicking the link to read each part separately. I've collated them all together so I have them handy.
ON January 23, 2020, the pharmaceutical giant Moderna and the Coalition for Epidemic Preparedness (CEPI) signed a $1million funding agreement to begin manufacturing a Covid-19 vaccine.
In an associated press release, Dr Richard Hatchett, CEPI’s Chief Executive Officer stated: ‘CEPI has moved with great urgency and in coordination with WHO [World Health Organisation], who is leading the development of a coordinated international response, to promote the development of new vaccines against the emerging threat of nCoV-2019.’
Hatchett, who was Director for Biosecurity Policy on the US Homeland Security Council in the George W Bush administration and former Chief Medical Officer of the Biomedical Advanced Research Development Authority (BARDA), and had served as CEPI’s CEO since 2017, also stated: ‘The novel coronavirus represents the first new epidemic disease of note to emerge since CEPI’s founding at Davos in 2017, with the express intent that it should be ready to respond to epidemics rapidly and effectively, wherever they emerge.’
CEPI had indeed moved fast. So quickly as to raise eyebrows if not questions.
The story that follows of how the Moderna vaccine was developed casts new light on a December 19, 2019 tweet from Bill Gates, whose foundation was already funding Moderna’s development of an mRNA HIV vaccine. He wrote: ‘I’m particularly excited about what the next year could mean for one of the best buys in global health: vaccines.’
Interestingly or coincidentally, a China CDC Weekly article of January 21, 2020, dated the start of the Wuhan illness outbreak to December 21, just two days after the Gates tweet: ‘A cluster of pneumonia cases with an unknown cause occurred in Wuhan starting on December 21, 2019.‘ The same article stated that the first complete genome of the novel β genus coronaviruses (2019-nCoVs) had been identified from a patient from Wuhan by scientists of the National Institute of Viral Disease Control and Prevention on January 3, 2020.
A CEPI press conference to announce the Moderna agreement, held at the World Economic Forum meeting in Davos on January 23, 2020, was fronted by Richard Hatchett, Jeremy Farrar (Director of Wellcome, recipient of the Order of Ho Chi Minh, who has since stepped down from the board of CEPI) and Stephan Bancel, the French billionaire CEO of Moderna (recently honoured in France for his ‘Covid efforts’), Bancel said:
Bancel said: ‘The design of the vaccine has been done over the last few weeks at the National Institutes of Health (NIH) in the US, because they have access to the sequence of the virus . . . The US government is helping us with doing the design because there is great expertise there. What we are doing is we are going to make the product, quality clinical-grade material thanks to the support of CEPI.’
Bancel and Hatchett had thrashed out an agreement during the WEF annual meeting.
You can watch the press conference here.
This grand CEPI announcement was made on the very same day that Chinese authorities sent their dramatic message to the world that they had put Wuhan, the sprawling mid-China city, under lockdown.
However a disclosure by Moderna to the Securities Exchange Commission on January 21 2020 revealed that news of its vaccine nearly broke the day before the lockdown was imposed:
The statement that Moderna Inc provided a news outlet regarding its participation in the potential creation of a vaccine to respond to the current public health threat of the coronavirus labeled (sic) 2019-nCoV. read:
‘Moderna’s mRNA vaccine technology could serve as a rapid and flexible platform that may be useful in responding to newly emerging viral threats, such as the novel coronavirus. While we have not previously tested this rapid response capability, Moderna confirms that we are working with NIH/NIAID/VRC on a potential vaccine response to the current public health emergency. Moderna is committed to addressing infectious diseases and improving global public health.’
Contrary to Moderna’s statement, no public health emergency existed on January 21 when it spoke to the news outlet. In fact, that day, a regional delegation from the WHO was completing a two-day field visit to Wuhan. When they arrived on Monday January 20 the Chinese said they had 200 patients. The delegation reported they had discussed China’s plan to expand the 2019-nCOV case definition. Three days later the Chinese reported 537 patients to the WHO.
Dr Tedros Adhanom Ghebreyesus, director general of the WHO, convened an Emergency Committee (EC) meeting on January 22; he was unable to declare a Public Health Emergency of International Concern (PHEIC) without its recommendation. (This is a procedural nicety the current US proposed revisions to the WHO treaty, now rejected, would have dispensed with.) The Committee members were briefed on their roles and responsibilities by the WHO’s legal department and its compliance, risk management and ethics department, and warned of their duty of confidentiality. After considering the evidence, the EC decided the situation in China did not amount to a PHEIC. The Chinese lockdown appears to have been a response to its non-imposition.
A WHO statement issued by Dr Tedros the day after the lockdown read: ‘After the announcement of new containment measures in Wuhan on 22 January, the Director-General asked the Emergency Committee to reconvene on 23 January to study the information provided by Chinese authorities about the most recent epidemiological evolution and the risk-management measures taken.’ Again the Committee declined to offer a recommendation.
CEPI however pressed ahead with its vaccine plans. Announcing the $1million award to Moderna to begin manufacturing an mRNA vaccine for SARS CoV2, Dr Hatchett said, ‘Given the rapid global spread of the nCoV-2019 virus the world needs to act quickly and in unity to tackle this disease. Our intention with this work is to leverage our work on the MERS coronavirus and rapid response platforms to speed up vaccine development. There are no guarantees of success, but we hope this work could provide a significant and important step forward in developing a vaccine for this disease. Our aspiration with these technologies is to bring a new pathogen from gene sequence to clinical testing in 16 weeks – which is significantly shorter than where we are now.’
According to the company, Moderna and the US National Institutes of Health (NIH) developed its vaccine, based on an entirely new biotechnology, within two days of Chinese researchers releasing the genetic sequence to them on January 11.
Moderna said: ‘At that time, the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, disclosed their intent to run a Phase 1 study using the mRNA-1273 vaccine in response to the coronavirus threat and Moderna beganmobilizing towards clinical manufacture.’
Yet Moderna had not previously tested its rapid response capability, anddespite close to two decades of effort, no vaccine had been successfully developed for the closely related SARs virus. In fact after one unsuccessful attempt at developing a conventional SARS vaccine in 2012, Chieng-te (Kent) Seng, a researcher at the University of Texas, Galveston said, ‘Caution in proceeding to application of a SARS-CoV vaccine in humans is indicated.’
Furthermore, when the animals in this 2012 research study encountered the virus post-vaccination they died from ‘cytokine storms’: excessive inflammatory and immune responses which occur especially in the lungs that lead to acute respiratory distress (ARDS), fluid on the lungs and multiple organ failure. Cytokine storms are one of the mechanisms by which Covid-19 itself kills.
Documents obtained in June 2020 by AXIOS via a freedom of information disclosure reveal that Moderna and the NIH did not formally begin collaborating on a MERS vaccine until June 2019 when they signed an agreement to develop vaccines for MERS and Nipah, a tropical virus. Interestingly, of the 858 deaths from MERS recorded between 2012 and 2019, 812 occurred in Saudi Arabia. It had an estimated case fatality rate of 37.2 per cent. Two-thirds of the victims suffered from diabetes.
Appendix A of the 2019 collaboration agreement, signed by Moderna on 16 December 2019, outlining the scope of the MERS & Nipah research project, was revised and signed by the NIH on January 13 2020, the day that Moderna reported the SARS CoV2 vaccine design was agreed. The agreements are heavily redacted. They advanced a MERS vaccine candidate to the animal research phase that must precede human clinical trials in December 2019. This animal research study was contracted out to Dr Ralph Baric at the University of North Carolina Chapel Hill. Baric, a leading expert in coronaviruses, had previously worked collaboratively with Dr Shi Zhengli, the Wuhan Institute of Virology bat researcher. The animal study required the execution of another agreement called a material transfer agreement (MTA). All previous agreements refer specifically to MERS vaccines.
The UNCCH MTA signed by Moderna on December 17, 2019, two days before the Gates tweet, refers to ‘mRNA Coronavirus Vaccine Candidates developed and jointly owned by NIAID and Moderna’. It could concern only the MERS vaccine as Nipah is not a coronavirus.
The evidence points to a plan activated in December, directed by CEPI, in which Moderna was an active participant, to get these new ‘vaccines’ rolled out, possibly with new ‘bio-surveillance’ measures on the back of them, before the first pneumonia case was even reported in China.
How Moderna happened to have a vaccine ready to be repurposed on short notice is the focus of Part 2. She reveals a story of preparations that began before December 21, 2019 when the Chinese Centre for Disease, Control and Prevention said the first pneumonia patient became sick. It simply does not add up.
ON January 22, 2020, the Coalition for Epidemic Preparedness Innovations (CEPI), which exists to ‘accelerate the development of vaccines’, to ‘outsmart’ epidemics and ‘create a world in which epidemics and pandemics are no longer a threat to humanity’ found itself with a solution looking for a problem.
On January 11, just as the first Covid-19 death occurred in Wuhan, Professor Edward Holmes of Sydney University, who is a visiting professor at Fudan University in Shanghai, tweeted a link to ‘an initial genome sequence of the coronavirus associated with the Wuhan outbreak’ to the world.
One team of researchers immediately set to work over the weekend. By Monday January 13, the US National Institutes of Health (NIH) and the much-hyped but unprofitable biotechnology firm Moderna had designed a vaccine for the ‘novel’ pathogen. Once in Davos, Moderna’s CEO Stephane Bancel and CEPI’s CEO Dr Richard Hatchett set about agreeing the terms of a funding agreement to begin manufacturing the first batch for use in human trials.
As Bancel told a press conference in Davos on January 23, ‘What we are trying to do with the US Government, with the NIH and with CEPI is to use our technology to help.’
The day before, the announcement had for a while looked stillborn. The Emergency Committee of the World Health Organisation (WHO) after considering their team’s Wuhan field visit report into the pneumonia cases, decided it did not amount to a Public Health Emergency of International Concern (PHEIC).
In the absence of a PHEIC, who needed an experimental vaccine, especially a hastily developed one based on an unproven and hitherto unauthorised biotechnology? There was a second problem. As reported in Part 1, at least one news outlet already knew about the vaccine. A crisis would certainly help things along, and if it happened before the end of the week when the World Economic Forum concluded, all the better.
Fortunately CEPI had an influential associate in China, one Dr George Gao, a coronavirus expert who is Director of the China Centre for Disease Control and Prevention, a past member of CEPI’s interim Scientific Advisory Committee who had participated in Event 201, the coronavirus ‘high level pandemic exercise’ that took place in New York on October 18, 2019.
In locking down the city of Wuhan and putting the world on notice that the threat from the virus was serious despite WHO’s decision not to call it a pandemic, China threw CEPI and Moderna a lifeline. Perhaps it was a coincidence – or perhaps someone put in a call for help.
This was not the only piece of luck that Moderna profited from. It just happened that on December 17, 2019, bosses signed a material transfer agreement (MTA) to send ‘mRNA coronavirus vaccine candidates developed and jointly owned by NIAID [the NIH offshoot headed by Dr Antony Fauci] and Moderna’ to Dr Ralph Baric of the University of North Carolina Chapel Hill for animal testing.
Baric is a leading expert in coronaviruses. He developed many of the reverse-genetics techniques used to alter the function of viruses that are now used by other virologists including those at the Wuhan Institute of Virology. Baric has a collegial relationship with Dr Shi Zhengli, the Wuhan Institute of Virology bat researcher.
An NIH spokesperson later told the news service AFP that the Baric MTA which was publicly disclosed as part of a freedom of information release to the news outlet AXIOS concerned a MERS vaccine. The spokesperson said the NIH and Moderna had been working collaboratively on vaccines since 2017. Amongst the other documents released to AXIOS was the MERS and Nipah research collaboration agreement (RCA) between Moderna and the NIH. It has an effective date of June 19, 2019, when Dr Barney Graham, the deputy director of the NIH Vaccine Research Centre, put the final signature to it. Despite all the signatories inking this contract in May and June 2019, the NIAID internal reference number assigned to it has a 2017 date, apparently linking it to an earlier confidentiality agreement concerning the tropical Nipah virus, which is not a coronavirus.
No contract exists for formal collaboration on a MERS vaccine prior to the RCA being signed in June 2019. Moderna signed an amendment to Appendix A of the RCA outlining the scope of the research project on December 16 2019 which was countersigned by Barney Graham of the NIH on January 13 2020, the day Moderna says the design of the SARS CoV-2 vaccine was finalised.
According to CEPI’s press release of January 23, ‘Our intention with this work is to leverage our work on the MERS coronavirus and rapid response platforms to speed up vaccine development.’ Moderna’s CEO Bancel spoke at the Davos press conference about all the work Moderna was doing on vaccines for infectious diseases, listing pandemic influenza, RSV, parainfluenza, zika, and cytomegalovirus, while neglecting to mention a MERS vaccine. Nor is there any mention of a MERS vaccine in filings made with the US Securities and Exchange Commission (SEC) in November 2019 and on January 8 2020.
A March 11, 2020 story in Pharma trade publication STAT News headlined ‘Researchers rush to test coronavirus vaccine in people without knowing how well it works in animals’ suggests that the company did not do pre-clinical animal studies of its own. They report Dr Tal Zaks, Moderna’s Chief Medical Officer (CMO), as saying that scientists at the National Institutes of Health are ‘working on nonclinical research in parallel’.
‘I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,’ Zaks told them.
The documents released to AXIOS have been heavily redacted. One redaction in the Baric MTA, concealing the specific animal model to be used for testing the jointly owned coronavirus vaccines, raises another question. Moderna’s Annual Report for 2019 provides an update on the SARS CoV-2 vaccine in which it states:
‘We have begun evaluating our SARS-CoV-2 vaccine construct in animal models, with further testing of the clinical batch expected shortly. In an existing collaboration with the VRC to develop a vaccine against MERS, we designed an mRNA-based vaccine targeting the prefusion-stabilized Spike protein. In preclinical studies to assess the immunogenicity of the potential vaccine against MERS, rabbits were dosed with either one or two doses of vaccine (one dose plus a booster at day 21) and then challenged with MERS virus at day 42.’
As Baric outlines in a 2005 paper, genetically altered ‘humanised’ mice were developed to facilitate coronavirus research. Dr Kizzmekia Corbett, the NIH in-house expert on coronaviruses whose doctoral work was supervised by Baric, published a paper in August 2020, explaining how her research on MERS was used to develop the SARS CoV-2 vaccine. As evidenced in this paper, Corbett used mice in the studies she conducted.
Rabbits, which Moderna said were used to test their MERs vaccine on, are not one of the animal species the international panel assembled by the WHO in February 2020 identified as suitable for Covid-19 research. According to research published in 2015, rabbits do not get sick from MERS, which might render post-vaccination viral challenge tests redundant.
Has the animal model been redacted from the MTA because an unsuitable animal was used to test the MERS vaccine? The question then is why would an expert researcher use an unsuitable animal model and whose decision was it?
On December 9 2019, three days before Baric and Barney Graham signed the MTA, Peter Barton Hutt, a director who sat on Moderna’s Product Development Committee, resigned from Moderna’s Board. The timing of his departure, six months after his re-election for a further three-year period, is curious. The statement on his resignation filed with the SEC says, ‘Mr Hutt’s decision to resign was not the result of any disagreement with the Company on any matters relating to the Company’s operations, policies or practices.’
Hutt, a senior counsel at the Washington DC law firm Covington & Burling LLP and a former chief counsel to the US Food and Drug Administration (FDA), has extensive knowledge of regulatory and legal issues related to drug development.
His replacement, Francois Nader, was appointed the following day, suggesting that Hutt’s decision to step down was not sudden. Hutt began, modestly in comparison with other directors such as Bancel, exercising his share options – buying and selling on a total of $5.8million of Moderna shares in September and November 2019. Ordinarily, unexercised stock options expire when a director steps down but Moderna disclosed to the SEC that Hutt would remain as a consultant to Moderna with stock options continuing to vest. As a lawyer outwith the Board, his advice to the company would be protected by client privilege and he no longer had any fiduciary duties to the company as a director.
By Bancel’s own admission in Davos, trying to go so fast for a vaccine had never been done before. In Part 3 we will examine whether Moderna’s Chief Medical Officer had full confidence in the Covid-19 vaccine plan.
THE Coalition for Epidemic Preparedness and Innovation’s (CEPI) stated objective on January 23, 2020, was to get a Covid vaccine into human clinical trials within 16 weeks. As of January 6, Moderna had previously tested three other mRNA vaccines for infectious diseases on only 365 people, half of whom received placebos. CEPI, eager to fulfil its self-appointed mission to save the world from epidemics, was unconcerned about Moderna’s technology being new and unproven. It wasted little time in agreeing to finance the manufacture of ‘clinical grade material’ for the first human trials.
The US National Institute of Allergy and Infectious Diseases (NIAID), co-owner of the Moderna prototype coronavirus vaccine, and whose long term Director is Anthony Fauci, began recruiting volunteers for the Phase 1 trial it ran on behalf of Moderna, on March 16, 2020. The recruitment announcement placed by its parent body, the US National Institutes of Health (NIH) said that VRC (Vaccine Research Centre) and Moderna scientists were already working on an investigational MERS vaccine targeting the spike protein, ‘which provided a head start for developing a vaccine candidate to protect against COVID-19’.
Much of the preliminary research was done by a former doctoral student of Dr Ralph Baric, Dr Kizzmekia Corbett.
(Dr Baric, as detailed in Part 2 of this investigation, conducted animal testing on the prototype coronavirus vaccines. He is a Professor in the Department of Epidemiology and also in the Department of Microbiology and Immunology at the University of North Carolina Chapel Hill, the University now renowned for viral ‘gain of function’ research which was placed under a moratorium in the US in October 2014. Baric developed many of the reverse-genetics techniques used to alter the function of viruses that are now used by other virologists including those at the Wuhan Institute of Virology and maintains a collegial relationship with Dr Shi Zhengli, the Wuhan Institute of Virology bat researcher.)
Once the genetic information of SARS-CoV-2 became available, courtesy of Professor Edward Holmes on January 11, 2020, the NIH said, ‘the scientists quickly selected a sequence to express the stabilized spike protein of the virus in the existing mRNA platform’.
Amendment 1 to the June 2019 Moderna/NIH Research Collaboration Agreement was signed by the NIH on January 13 2020, nearly a month after Moderna had signed it, giving the appearance that the NIH were indeed waiting for something.
Research collaboration agreements and royalty agreements customarily stipulate which NIH patents are being used by industry partners and how and when royalties are to be paid to the US Federal Government agency if a product is successfully commercialised. The unredacted parts of the AXIOS FOI documents contain no mention of any intellectual property relating to a spike protein. Under the 1986 Federal Technology Transfer Act the NIH researchers named on the patents may also receive royalty payments of up to $150,000 per year from each licensee. By November 2020, the NIH-designed SARS CoV2 prefusion stabilised spike protein had been licensed to 21 biotechnology and pharmaceutical companies, most of whom were planning to utilise it in vaccines.
Despite the December 2019 material transfer agreement for the prototype vaccine between Professor Baric, the NIH and Moderna, stating that the coronavirus vaccine was jointly owned by Moderna and the NIAID, Moderna did not name three NIH employees, Dr Corbett, Dr Barney Graham and Dr John Mascola, as the co-inventors on their patent application for the COVID vaccine. This subsequently led to a dispute between the two collaboration partners. Moderna argued its researchers had independently developed the mRNA sequence for the vaccine. NIH researchers, however, said that they developed the sequence and shared it with the company.
A US Securities and Exchange Commission (SEC) disclosure filed two weeks after the NIH began recruiting volunteers for the Phase 1 human trial reveals that Dr Tal Zaks, Moderna’s Chief Medical Officer (CMO) who was responsible for overseeing clinical trials, accepted an inducement to stay with the firm. On March 29, 2020, Zaks signed an executive retention agreement with the company awarding him a $1million bonus providing he didn’t leave the company before 30 September 2021.
Zaks started selling his Moderna shares in February 2020 at a regular rate reported by STAT NEWS to be making him $1million a week. It said corporate governance experts described this sell-off as ‘uniquely alarming’ given his importance in overseeing the clinical trials. High-volume sales of company stock by insiders undermine market confidence in the company.
By September Forbes magazine were questioning why Moderna insiders were selling so much stock and asking if they had concerns with the vaccine that weren’t being shared with investors. Zaks alone had sold $50 million worth by October 2020.
On April 25 2020, five weeks after the NIH commenced Phase I human testing of the Moderna vaccine, Jeremy Farrar (Director of the Wellcome Trust and a co-founder of CEPI), Dr Richard Hatchett, (CEPI’s CEO) Dr Antony Fauci, the Director of NIAID and Dr George Gao, head of China’s Centre for Disease Control and Prevention, all took part in a webinar organized by Dr Victor Dzau, the President of the US National Academy of Medicine.
Although the case fatality rate is now known to be comparable to flu, Gao reported that Chinese data in April 2020 put the crude case fatality rate at 5.6 per cent. He said China had confirmed 1,575 symptomatic cases and 44 suspected asymptomatic cases. Gao added that with no treatment and no vaccines, the Chinese had introduced what he termed ‘classical non-pharmaceutical interventions’ of social distancing, masking, handwashing, travel restrictions and lockdowns.
Both Jeremy Farrar and Richard Hatchett insisted ‘the exit strategy’ from the pandemic, not to mention the lockdowns which were being used to manage it that had also now spread beyond China, was a vaccine. Hatchett, an oncologist who became a US Homeland Security official after experiencing the trauma of the 9/11 attacks first hand in New York, is the primary author of the 2006 US Pandemic Influenza plan and is credited with having developed social distancing as a ‘classical non-pharmaceutical intervention’. Lockdowns are mentioned in his 2006 plan but perhaps to avoid any association with the prison management software of the same name during a time of heightened post-9/11 sensitivities over the curtailment of civil liberties, he calls them ‘snow days’.
(A footnote in the annex of the 2005 WHO global influenza preparedness plan reveals that a recommendation to consider population wide measures to reduce the number of cases and death by reducing mixing of adults was made ‘given a pandemic strain with significant morbidity and mortality in all age groups occurring and the absence of a vaccine’. The suggested measures included closing work places, discouraging mass gatherings and furloughing non-essential workers. The use of the word furlough, a term used for the temporary layoff of US government employees during government shutdowns due to Congressional budgetary impasses such as those in 1995 and 1996, indicates this contribution to the consultation in December 2004 came from the US.)
During the webinar, Hatchett said: ‘I think Covid represents an absolute watershed. The effect on global society, on the economy, literally everybody on the planet, is absolutely going to change the approach to preparing for these kinds of events in the future and it will be a very very, different world.’
Aside from their links to CEPI, Gao and Farrar are old friends from Oxford University in the mid-1990s. It turns out that Professor Edward Holmes, the virologist who tweeted the Covid virus genome sequence and some of whose research has been funded by Farrar’s Wellcome Trust, was a fellow at Oxford during the same time.
You are bound to wonder about the ways in which they helped Hatchett to execute CEPI’s ‘just in case, just in time’ vaccine plan.
Moderna Vaccine Timeline