In Part 1 of this series I showed how the Wuhan lockdown saved CEPIs Moderna vaccine announcement in January 2020. Here I examine how the partnership discussions that preceded the grand reveal matured.
ON April 27, 2020, following partnership discussions between the Coalition for Epidemic Preparedness Innovations (CEPI) and the Chinese government which began prior to the Wuhan lockdown, CEPI announced it was opening a ‘representative office’ in Shanghai. In a statement made in conjunction with one Mr Quan Zhang, the Director of Science and Technology Commission of Shanghai Municipality, CEPI said its purpose was to ‘seek co-operation with China in the prevention and control of pandemic diseases including the funding of public health research projects, research and development of vaccines, and international scientific, technology and development co-operation and exchanges’.
Explaining that CEPI already had offices in Oslo, London and Washington DC, chief executive officer Dr Richard Hatchett said: ‘CEPI is a global organisation, working on global solutions to global issues.’ Adding the CEPI Shanghai Representative Office to that list would ‘facilitate our collaboration with China’ and they looked forward ‘to working closely with Chinese partners in the fight against COVID-19’.
CEPI’s 2016 preliminary business plan sets out its intention ‘to build a growing community of product developers with pipelines for new vaccines, diagnostics and drugs for many high-burden diseases that primarily affect citizens living in the poorest countries.’ It was, it said, continuing the work of governments and philanthropies in pursuing the 2000 Millennium Development Goals.
The challenge CEPI set for itself was ‘to ensure robust and effective private sector participation in future outbreaks’. According to the World Economic Forum’s then Head of Global Health and Healthcare, Arnaud Bernaert, ‘The current model to develop and test vaccines is unsustainable.’
The plan outlined a new vaccine finance model, saying that ‘industry will require a reliable risk/reward sharing system, a prioritisation system for emerging infectious diseases (EIDs), and a clear development pathway for emergency-use vaccines’. It was based on three operating principles.
The first principle of this ‘CEPInomics’ is to ensure what they describe as ‘equitable access’ by making the vaccines ‘affordable and available to low and middle income countries’. The second and third principles follow the maxim ‘Manus manum lavat’, the one hand washes the other, the second being that vaccine developers’ direct and indirect costs must be fully reimbursed and the third that any economic benefits that might accrue on products it sponsored must be shared with CEPI. The plan didn’t envision CEPI-sponsored vaccines becoming profitable, as the intended recipients of CEPI’s beneficence are the poor of the tropics, but in the event that they did, ‘agreements between CEPI and the developer will ensure either that CEPI’s investment is reimbursed or that profits are shared through royalties or other mechanisms’.
On the same day CEPI trumpeted the plan for its Shanghai office, it made a second announcement awarding $3.5million in funding to Clover Biopharmaceuticals Australia, a wholly owned subsidiary of Sichuan Clover Biopharmaceuticals Inc (China) to commence phase 1 testing of a Covid vaccine. Clover, with no products yet on the market, is a loss-making company founded by Dr Peng Liang, a former biochemistry professor at Richard Hatchett’s alma mater Vanderbilt University, in Nashville Tennessee.
It so happens that the Clover vaccine is another novel gene-fusion therapy. It uses Trimer-Tag™, a gene therapy technology platform developed by Dr Liang that was patented in 2007 by his first company GenHunter and licensed to Clover. Like Moderna and BioNTech’s mRNA gene therapies, it was not originally intended for use as a vaccine, having been conceived as an advanced therapy against autoimmune diseases, cancer, Aids, osteoporosis and heart disease.
By November 2021, CEPI’s cumulative investment in Clover amounted to $397.4million, representing one of its largest investments in a single company. This included funding for the scaling-up of manufacturing capacity, although Clover, like Moderna and BioNTech before it, lacks a licensed product. It is currently seeking regulatory approval of its vaccine in China and Europe and from the WHO.
Meanwhile CEPI is separately funding two other clinical trials to evaluate mix-and-match booster vaccination strategies to combat the ever-evolving virus. In the now crowded Covid vaccine market, it envisions the Clover gene-fusion vaccine will be used under yet another emergency use authorisation as a universal ‘booster’. One potential competitive advantage the Clover vaccine has over the mRNA vaccines is that it requires only standard refrigeration storage and transport, making it useful in the largely untapped market in the low and middle income countries CEPI was intended to provide for where Covid vaccination rates hover at a meagre 16 per cent.
‘While multiple safe and effective Covid-19 vaccines are now available we know that Covid-19 is here to stay, so further R&D [research and development] is needed to inform vaccination strategies that will help control the virus in the long-term,’ said Dr Hatchett. ‘I’m pleased to further expand CEPI’s R&D partnership with Clover which will maximise the potential impact of this vaccine as we seek to protect those most at risk from Covid-19, wherever they are in the world.’
Clover’s vaccine is itself boosted, using a ‘broad adjuvant platform’ patented by a financially troubled American company called Dynavax Technology. Adjuvants are substances added to vaccines to increase the immune response to weak antigens. Clover and Dynavax announced their collaboration agreement on March 24, 2020. It was one of five partnerships Dynavax entered into as CEPI’s Covid vaccine project ignited.
On August 13, 2020, the Bill and Melinda Gates Foundation (BMGF) awarded Dynavax a $3.4million grant. A month later Dynavax appointed a member of CEPI’s Scientific Advisory Committee, Dr Peter Paradiso, to its board of directors.
In early 2021, Dynavax obtained a $99million ‘forgivable’ loan from CEPI, repayable on vaccine sales. Three months later it secured another $77million, bringing CEPI’s total investment in Dynavax to $176million.
CEPI’s combined commitment to the Clover/Dynavax vaccine is $573.4million, which is more than a third of the $1.5billion it eventually succeeded in raising for its Covid vaccine project.
The huge investment in the Clover/Dynavax vaccine and these companies doesn’t end with CEPI. On June 30, 2021, Gavi, the Bill Gates-linked Vaccine Alliance, signed an advance purchase agreement with Clover for 414million doses of its Covid vaccine. (Such agreements, which transfer risk from the supplier to the purchaser, have become routine for the purchase of pandemic vaccines. They are justified in emergency management circles on the premise that it is better to be over- than under-prepared; the practice is referred to as ‘no regrets’ buying.)
Dr Hatchett said: ‘Today’s announcement of an advanced purchase agreement between Gavi and Clover will secure hundreds of millions of doses – pending an Emergency Use Listing from WHO – for globally fair allocation and will further support low-income and middle-income countries so that they can protect the most vulnerable members of their societies against this deadly virus.’
Covid-19, the ‘deadly’ disease Dr Hatchett speaks of, is known to have a mortality rate of less than 1 per cent, comparable with influenza, and an average age of mortality of 82.
To date, Clover has received $224million from Gavi. In December 2021, Unicef also signed a procurement agreement with Clover, conditional upon its vaccine achieving Emergency Use Listing from the WHO.
Clover Biopharmaceuticals Ltd (Cayman Islands), which is estimated to have a market valuation of $2billion, made its international public offer on the Hong Kong stock exchange in October 2021. This is not tied directly to profit on the CEPI-sponsored vaccine, making it unlikely to fall within the scope of a sharing agreement with CEPI.
In January 2022, Clover began building a new research and development centre in Shanghai. Dr Nicholas Jackson, the managing director of CEPI’s Shanghai office and its head of Vaccine R&D, joined Clover as its President of Global Research on February 1, 2022.
In the next instalment I will examine the involvement of the US Defense Advanced Research Projects Agency (DARPA) in CEPI’s pandemic vaccine programme.