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Thursday, February 22, 2024
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HomeCOVID-19How Fauci pulled the Moderna vaccine rabbit out of the hat

How Fauci pulled the Moderna vaccine rabbit out of the hat

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IN THE new era of biosecurity totalitarianism when authorities actively seek to silence even the most qualified dissenting voices, perhaps nothing could be more corrosive to public confidence than finding that a leading research institute participated in a deliberate fraud. The scientific misconduct in question is the intentional selection of an inappropriate animal model for a pre-clinical study and its subsequent concealment. Intentional scientific misconduct for financial gain is fraud.The organisation in question is the US National Institutes of Health (NIH), the largest public funder of biomedical and behavioural research in the world, which describes itself as ‘the driving force behind decades of advances that improve health, revolutionize science, and serve society more broadly’. In this case, the interests served were the NIH’s own finances and those of a private company, Moderna.

The NIH was implicated by Stephane Bancel, CEO of Moderna, in an April 1, 2020 webcast hosted by MIT Sloan Business School Finance Professor Andrew Lo and co-hosted by the Laboratory for Financial Engineering. Bancel’s presentation, ‘Accelerating mRNA medicines to patients’, was about the company’s Covid-19 vaccine candidate mRNA-1273 developed jointly over the course of a pre-Davos January 2020 weekend with the NIH’s National Institute for Allergy and Infectious Disease (NIAID), led by Dr Anthony Fauci. Investor interest in the company and its vaccine was high. Moderna was leading the race for a Covid-19 vaccine with the NIH not long having announced that it had dosed the first human volunteer with mRNA-1273 in a Phase 1 clinical trial expected to run for six weeks. 

An excited Bancel said, ‘What I want to share with you is just one set of data, but I think it is important. It is data that we published in our S-3 in February. This is the pre-clinical data on a related coronavirus MERS, the Middle East Respiratory Syndrome, that many of you will recall happened in the Middle East, in Saudi, a few years ago and a few years later again in South Korea. So what you see here is a rabbit model.’ 

Bancel showed his audience graphs of data from a pre-clinical study conducted on rabbits and concluded: ‘We are very excited to see this data that was realised with the NIH, with the team of Dr Tony Fauci.’  

One of the graphs showed antibody levels over time in a placebo group injected with saline and in single and double dose vaccine groups. But the antibody levels induced by the vaccine doses should have been compared with the levels of antibodies produced by exposure to the MERS virus itself, as a vaccine response must be shown to be superior to antibody levels induced by natural infection to be beneficial. Alongside was a second graph showing viral loads in the nose, throat and lungs following a challenge test in which the animals were exposed to ‘much higher doses of virus’ than during a natural infection. A caption on the slide claimed ‘We observed an induction of neutralising antibodies (my italics) that reduced viral load in the nose, throat and lungs of vaccinated animals’. 

The rabbit study was not intended to fool drug regulators, who require an explanation of the relevance of the chosen animal model to the human disease the vaccine is meant to be protecting against. Customarily, before drug regulators permit clinical trials to begin with human volunteers, the efficacy of the candidate vaccine in preventing symptomatic clinical disease and/or pathologies associated with the disease must be demonstrated in a suitable animal model. The induction of antibodies is evidence of immunogenicity but in and of itself is not evidence of efficacy. Antibodies can be either neutralising or non-neutralising, the latter meaning that they fail to prevent reinfection following exposureto the targeted virus.

The choice of animal model for pre-clinical trials is an important one and consequently animal models must be validated. The scientific evidence that rabbits are an unsuitable model for testing the efficacy of a MERS vaccine had been in the public domain for years. In July 2019, the Coalition for Epidemic Preparedness Innovations (CEPI) hosted a workshop and subsequently commissioned IAVI (International Aids Vaccine Initiative) to prepare a report, ‘MERS-CoV standards, assays and animal models vaccine development landscape analysis’, which was funded by the NIAID, NIH, and the US Department of Health and Human Services (HHS). So far as rabbits are concerned it concluded: ‘Despite the fact that rabbits shed MERS-CoV from their URT [upper respiratory tract], it appears that the New Zealand white rabbit model is neither suitable to study MERS-CoV transmission, nor is the model appropriate for studying clinical disease progression, given that rabbits remained asymptomatic after MERS-CoV inoculation.’ 

The CEPI report states: ‘Since concerns over SARS-related pathology led to a US Food and Drug Administration (FDA) clinical hold on vaccine studies, investigation of MERS-CoV vaccine candidates to induce virus-enhancing antibodies and harmful immune response in animal models could be informative before human clinical trials are initiated.’  

The FDA ‘hold’followed the October 2014 gain of function research moratorium on SARs, MERS and influenza ordered by the US government. However some research on MERS continued. As some people were believed to have asymptomatic MERS infections and rabbits were known to be asymptomatic when infected with it, researchers from the NIAID studied the phenomenon in rabbits. The NIH declared the experiments ‘were determined by the NIH to be urgently necessary to protect the public health or national security and as such, were exempted from the US Government Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS viruses.’ 

The results of this asymptomatic study were published in 2017.  The findings were not positive: ‘The rabbits developed antibodies against viral proteins that lacked neutralizing activity and the animals were not protected from reinfection (my emphasis).’ Further, the studyfound that even without an increase in viral RNA titers, reinfection resulted in increased inflammation of the lungs. The researchers warned: ‘Our data from the rabbit model suggests that people exposed to MERS-CoV who fail to develop a neutralizing antibody response, or persons whose neutralizing antibody titers have waned, may be at risk for severe lung disease on re-exposure to MERS-CoV.’

Bancel told the webinar audience thatmRNA mimics natural infection without introducing the actual virus. But if exposure to the virus itself does not produce antibodies that protect against reinfection, there is no mechanism by which artificially stimulated antibodies can, thus rendering the company’s specific claim that the MERS vaccine induced ‘neutralizing antibodies’ untrue. The company repeated the claim in the S-3 referred to by Bancel, which was a $500million supplementary stock offer made in February 2020, where investors were told: ‘We have demonstrated the ability to induce neutralizing antibodies that confer protection against viral challenge with a related coronavirus, MERS.’

Bancel said that Fauci’s team at NIAID helped Moderna realise the data, raising the question of why NIAID would accept the use of a model their own researchers who conducted the 2017 study knew to be unsuitable? 

The week before the Phase 1 human clinical trial started in March 2020, STAT News reported on Moderna’s pre-clinical animal studies. None of the interviewees mentioned the MERS rabbit study that Moderna presented to investors and the US Patent Office the previous month. STAT News reported that they had been told by NIAID by email that ‘Virologists at NIAID tried the new vaccine [mRNA-1273] on run-of-the-mill lab mice, on the same day that the [phase 1] trial began enrolling participants’. They quoted Dr Barney Graham, the now retired Director of the NIAID Vaccine Research Centre, as saying that those mice showed the same sort of immune response generated by a similar mRNA vaccine against MERS, another coronavirus. ‘That level of immune response was sufficient to protect mice from MERS CoV infection,’ he wrote. Graham also said that mice susceptible to SARS-CoV2 ‘are being bred so that the colony can be enlarged’ adding that they ‘will be available for experiments within the next few weeks’. 

Humanised mice are a validated study model for MERS, whereas rabbits are not, so if data from a mouse study of the mRNA-MERS vaccine was available, as Graham claimed, why wasn’t it used in Moderna’s February prospectus and the patent application? 

Under the Research Collaboration Agreement between Moderna and NIAID, which has an effective date of July 19, 2019, NIAID was to conduct immunogenicity studies on Moderna’s mRNA-MERS vaccine in animals. During 2020, Dr Kizzmekia Corbett, the NIAID researcher assigned to run these studies for Moderna’s Covid-19 vaccine mRNA-1273, wrote two papers: a June 11, 2020 preprint article entitled ‘SARS-CoV2 mRNA vaccine development enabled by prototype pathogen approach’ and a second peer reviewed paper published in the journal Nature on August 5, 2020 entitled ‘SARS-CoV-2 mRNA Vaccine Development Enabled by Prototype Pathogen Preparedness’. In addition to mice studies on mRNA-1273, both papers cite the mRNA-MERS mouse study that Graham told STAT News about. Neither mentions an mRNA-MERS rabbit study. Oddly, neither is the mRNA-MERS vaccine’s alpha-numeric identifier given.

Heavily redacted copies of Moderna’s contracts with NIAID were released following a freedom of information application by AXIOS News. On December 17, 2019, Moderna signed a material transfer agreement (MTA) transferring ‘mRNA coronavirus vaccine candidates developed and jointly owned by NIAID and Moderna’ to Dr Ralph Baric at the University of North Carolina Chapel Hill (UNC-CH), directing him to perform animal challenge studies. The research programme is redacted. More suspiciously, so is the animal model stipulated in paragraph 3. Dr Baric did not respond when he was asked by me if he was commissioned to run the mRNA-MERS rabbit study.

Dr Baric is widely regarded as the world’s leading coronavirus researcher. He was a member of the World Health Organization working group on animal models to accelerate the development of Covid-19 vaccines and therapeutics. So too was Dr Graham who signed the MTA on behalf of NIAID. Given their expertise, the selection of a suitable animal model should have been a straightforward matter rather than a contentious one requiring concealment. One possible explanation for why experts would choose an inappropriate model is that they were in a hurry and suitable mice were not available. As per a 2015 paper in Virology, the first transgenic mice for MERS research were breed by Dr Agarwal at the University of Texas. Laboratory mice specially bred such as those developed by Dr Baric for his research into the original SARS are not susceptible to MERS. Baric certainly has the expertise to breed his own, given sufficient time. In 2020, he filed an invention report with UNC-CH (UNC ref 18752) for a mouse adapted model to test SARS-CoV-2 countermeasures. 

On December 16, 2019, the day before Moderna signed the Baric MTA for the jointly owned Moderna/NIAID mRNA coronavirus vaccines, the company signed an amendment to the July 2019 NIAID research collaboration agreement. This amendment was countersigned by Vincent Feliccia, the branch chief of NIAID Technology Transfer and Intellectual Property Office, on January 13, 2020, the day the design of Moderna’s SARS-CoV-2 vaccine was finalised. 

Intentional scientific misconduct for financial gain is fraud. In addition to publishing the mRNA-MERS rabbit data in its supplementary stock offer, Moderna used it to apply for a patent for an mRNA-betacoronavirus vaccine on February 28, 2020. The same patent covers Spikevax, its Covid-19 vaccine. The US Patent Office is notoriously poor at detecting scientific fraud in patent applications even when it is in the public domain. In 2014 it astonishingly issued a patent to Dr Hwang Woo-suk for a technique to clone human embryos although the associated journal paper had been retracted in 2005 due to the data having been faked. Unlike drug regulators, the Patent Office apparently does not require the use of validated animal models, or a justification for the selection of a given model. 

As was widely reported in 2021, Moderna and NIAID became embroiled in a dispute over the NIAID’s ownership interest in mRNA-1273. The company omitted to include Dr Kizzmekia Corbett, Dr Barney Graham and his boss, Dr John Mascola, when it filed for its patent. An NIH spokesperson told CBS news: ‘Omitting NIH inventors from the principal patent application deprives NIH of a co-ownership interest in that application and the patent that will eventually issue from it.’

As of the end of February 2023, Moderna is reported to have earned $36billion from Spikevax. Despite the ongoing patent dispute with NIAID, following negotiations in December 2022 the company gave NIH a $400million ‘catch-up royalty payment’.

Under the provisions of the Bayh-Dole Act, US government researchers are also entitled to receive up to $150,000 in royalties annually if their inventions are commercialised. Meanwhile, despite Bancel’s initial enthusiasm for sharing the mRNA-MERS rabbit data, it soon disappeared. Perhaps that’s because it’s hard to see how their indemnity shield under the US Public Readiness and Emergency Preparedness (PREP) Act stretches that far. 

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Paula Jardine
Paula Jardine
Paula Jardine is a writer/researcher who has just completed the graduate diploma in law at ULaw. She has a history degree from the University of Toronto and a journalism degree from the University of King’s College in Halifax, Nova Scotia.

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