The first part of Paula Jardine’s investigation into Moderna’s mRNA Covid-19 vaccine points to the Wuhan lockdown having been a device to keep an announcement timed to coincide with the World Economic Forum on track.
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.
