Vaccines have become a moribund area of research and development in the historically heavily marketized and corporate dominated pharmaceutical sector. Corporations have avoided investment in developing vaccines for many of the emerging and re-emerging pathogens that threaten pandemics for two reasons. The first is associated with the fact that a range of highly infectious viruses are mainly associated with low income populations, regions and markets, this producing a lack of effective economic demand that would pull in substantial R&D investments necessary to develop a new vaccine (Williams, 2012) Thus, why bother investing in this there are more profits to be made out of diseases that command the disease burden tables of developed countries. Where public investments have been committed, they have been on the basis of narrow national biosecurity and medical countermeasures efforts as opposed to infectious disease burdens and multilateral priority setting by the WHO and others (Mackey et al, 2014). Such investments have suffered from peaks and troughs of political attention following epidemic outbreaks of the past, and government financing towards vaccines for particular viral infections has fallen off after outbreaks have disappeared, as was the case following SARS in 2002-4.
Pharmaceutical companies have gradually withdrawn from vaccine development, leaving just four large corporations that focus on producing novel vaccines, with another dozen firms capable of manufacturing vaccines at volume and other small labs and firms in engaged in R&D. The reluctance to invest in R&D is completely commercially and market driven – and firms have been very open various reasons for not investing including substantial candidate attrition, long-lead times for recouping revenues, the high-volume low-value structure of many vaccine markets, the uncertainties of cost recovery, and the inability of the patent system to incentivise investment public and welfare good technologies like vaccines (Shen and Cooke, 2019, Santos-Rutschman, 2017). Wider progress in biotechnology, virology and understanding of the immune system has not led to a corresponding translational development of industry investments in new vaccine platform technologies for new vaccine production (at speed). Plant capacity, or lack of it, is an huge issue (as is rapid scalability of certain types of vaccines), this also being a product of the disincentives regarding investing in the huge sunk costs of new vaccine production. For neglected viruses and vaccines in general the picture from the 1990s is of under-investment, the use antiquated techniques, or glaring gaps in needed vaccines, diagnostic tools, or vector control technologies to treat or prevent outbreaks of old and new pandemic threats (Gostin et al, 2016)
As recently as 2016, the WHO responded to concerns about longstanding market failure and the lack of ‘R&D preparedness for neglected viral diseases’ with a plan to build new capacities to respond to future pandemics. The R&D Blueprint listed 10 priority neglected emerging and re-emerging diseases, including Coronaviruses such as MERS and SARS. The year after (2017) saw the foundation of the Norway-based Coalition for Epidemic Preparedness Innovations (funded by 12 states and two foundations) which would coordinate and provide an R&D ecosystem of universities, firms and government labs, crucially involving push financing for innovation in order to circumvent market failure for R&D towards vaccines for neglected diseases such as Coronaviruses. The problem of market failure is acute in pandemic response preparedness and efforts have been made to take R&D out of the market, albeit with often blurry statements on IPR and equitable access plaguing CEPI since its foundation.
Since COVID emerged and the first genome sequence of the virus was released by Chinese labs in January, we have witnessed a staggering race to develop a vaccine which seems to be the only exit from a disease which is clearly endemic globally. The response by life sciences, university and government virology laboratories, and firms have all been extraordinary by any standards, compressing vaccine development timelines from the standard six years to a decade to an anticipated single year. By July 2020 we had 165 vaccine candidates and 6 are in Phase 3 trials (NYT). Even with high anticipated rates of attrition of these candidates, it appears that a vaccine of unknown efficacy and duration of immune response will be available, at least by 2021. However, despite progress and optimism we may be plagued by the failures of the past.
To be clear, these failures are not purely market failures in the strict sense of being produced by price signalling or lack of effective economic demand for the COVID vaccine (although both are already present), but will also be products of the historical relationship and governance arrangements that define relations between high-income countries and innovator pharmaceutical firms. The firms developing COVID vaccines are housed in HICs (with present exception being China), have received large amounts of up-front research funding for COVID R&D, and have been historically co-dependent on government funding via national institutes and university basic and applied research to form the basis of innovations they commercialise and bring to market. These core neoliberal states have also historically structured both medical technology markets by instituting a global intellectual property rights regime, conferring patents on innovations and measures to protect data accruing from clinical and other trials. As others have noted, this type of hybridity in state-firm partnership for technology-driven growth and capitalism is quintessentially a neoliberal model, with firms dependent on governments interventions and public finance as the basis of commercialisation and accumulation.
Added to this cosy dynamic of co-dependence and blurring of roles and commercial interests, pandemics of the recent past have seen the assertion of national security and national biosecurity agendas into pandemic responses. For example, vaccines developed for H5N1 in 2009 were stockpiled by the US government and European Union member states, and with SARS patents and hoarding threatened true global availability before that potential pandemic petered out. Governments have therefore routinely intervened in vaccine markets, but not in a good way in terms of globally equitable access to pandemic emergencies real or threatened, and never in manner that challenges commercial monopoly rights.
All these tensions are playing out in the COVID vaccine race, and while the outcome is unsettled there are reasons for pessimism. While the WHO, CEPI and GAVI have sensed hat measures are needed to introduce some semblance of equity into distribution, with launching in May the COVID-19 Vaccine Global Access (COVAX) initiative. This would deliver 2 billion doses of the vaccine, with 950 million doses to high-and-middle-income countries and the same to low income countries, with 100 million doses reserved for humanitarian cases. Signatory countries spread the risk of attrition in candidates by committing to pooling access to over a dozen potential vaccines, with manufacturers in turn guaranteed advance market commitments for volume purchase. CEPI has meanwhile lined up a range of 200 producers to manufacture vaccines at volume.
Against these clearly innovative moves to introduce a semblance of equity into vaccine distribution (and even the COVAX plan has deep flaws in its planned distributions), the pandemic has seen countervailing pressures. The first is apparent in the consistent signalling that a successful vaccine will be subject to patent rights for the successful innovator firm, at least if they originate and are produced in the USA or Europe. For example here, the Moderna and NIH candidates are seeing both the firm and the government institution are considering IP issues, ownership and relative stakes. Moderna, Jansen, Novovax, and AstraZeneca, for example, are all using multiple patent routes to ensure proprietary rights to their COVID candidates, including follow on patents, and patents on methods of treatment, methods of manufacturing the vaccine, or for manufacturing large-scale batches of the vaccine, and so on. The question is whether these rights will mean price gouging or reluctance to freely share the technology or license production to other producers. It is significant that economically powerful states, such as Germany, France and Canada, have joined Ecuador, Israel and Chile in announcing that patents on COVID vaccines will be met by compulsory licensing to ensure production and supply for national needs. This could spell a real crisis in the global IPR system that has provided a regulatory bedrock of advanced capitalist technology production under neoliberalism.
Second, the first half of 2020 saw what now has widely described as vaccine nationalism. A growing number of so-called pre-production agreements being signed between manufacturers and governments to secure guaranteed access to doses even before efficacy is proven or approvals received. The US government has signed deals worth $6 billion with several companies in terms of up-front money for vaccine research and is using this to leverage priority access. It has secured 600 million doses from Pfizer, 300 million from the Oxford Group, and 100 million from Novovax. The UK has also a series of largely secret deals with several companies, including AstrasZeneca, and 30 million from Pfizer. Germany, Italy, France and the Netherlands have formed a negotiating partnership – Inclusive Vaccine Alliance – with the European Commission and many of those country leaders still signalling the need for a COVID vaccine to be treated as a global public good.
Whatever, the fallout of the state and market failures as the pandemic progresses, we are again in faced with the need to take vaccines out of a market and regulatory system that routinely fails it. Investments by governments in firm-led research has been huge in the pandemic, yet this is not exceptional as a modality of funding, and mirrors the history of financial support for life sciences sectors by state funding in the OECD. What is ostensibly grounded on a desire for national comparative advantages thinly veils a wider pharmaceutical sector that has commodified the fruits of publicly generated knowledge and investments. States continue to be complicit in this system, and COVID has seen the neoliberal heartland states willing to pay exorbitant prices to secure access to vaccines that will play to national audiences and security logics. It all has serious implications for a viable global pandemic response, that should at least be prioritising vaccination of those most at risk and immediately in need of prophylaxis, such as the health workforce and elderly, as production ramps up to provide greater coverage. This is precisely why the public goods dimensions of any vaccine, but especially those responding to a global pandemic, should override national and commercial imperatives. We cannot afford to let monopoly prices exclude countries or people from access or there will be no real elimination, nor should vaccine nationalism, or hoarding, lead to skewed distribution away from countries and regions that might in the short-term be facing potentially much more calamitous epidemics than those jumping the queue.