The wisdom of distributing global vaccine manufacturing capacity across the world is difficult to contest: the tremendous success in the development of highly effective COVID-19 vaccines has been radically attenuated by highly uneven access. The epidemiological threat of novel mutants and vaccine-evading super-variants emerging from unchecked transmission compounds the ‘catastrophic moral failure’ of denying immunisation to the world’s poorer populations. A more distributed model of vaccine production would ensure a more resilient global outbreak response, providing a bulwark against both the daunting logistical challenges of wide-scale delivery and the crippling effects of protectionist geopolitics.
But what precisely should this project entail? Transferring industrial capabilities for highly-complex biologic products such as vaccines is a challenging proposition. Unlike small molecule drugs, which can be adequately reverse-engineered and reproduced under variable manufacturing conditions, biologics demand a far more stringent adherence to production processes, as even the slightest deviations in how products are cultured and mixed can have considerable impacts on immunogenicity and safety. Tech-transfer is much more than providing access to a recipe: it is a labour and time-intensive process demanding extensive onsite-expert oversight, specialist equipment, a secure and steady supply of raw materials, and hefty upfront investment in facilities, not to speak of clinical and second-order infrastructures, such as electrical supply and safe waste-disposal. All these elements must be supported by prerequisite regulatory capacity to ensure quality and, finally, considerable adjustments in international trade law to enable tech-transfer for vaccines still under patent protection. While the pragmatic challenge of distributing vaccines manufacturing capacity looms large, the attention that manufacturing processes are currently receiving presents a unique opportunity for global health. Shedding light on the linkages between vaccines, infrastructures, expertise and publics, it allows us to raise fundamental questions about our current models of global health innovation – what kinds of vaccines should be produced, by whom and under what conditions. As we attempt to translate the lessons of the COVID-19 pandemic into durable systems for preparedness, tech-transfer creates a platform to ‘upstream’ mechanisms for greater equity. ‘A New Public Health Order’ need not be a case of old wine in new bottles – it might be a spur to rethink entirely how global health goods are imagined.
Paradigm shifts
While improving vaccine access has become a key focus in global health policy, discussions over Africa’s health security have gathered momentum in the last five years. The 2014–16 West African Ebola Virus Disease epidemic marked a watershed in vaccine development, with the deployment of unlicensed, experimental vaccine candidates to bring the outbreaks to a halt. CEPI is one of Ebola’s key legacies. Launched in 2017 at Davos, the Coalition describes its goals as, first, to ‘establish investigational vaccine stockpiles before epidemics begin (just in case)’ and, second, ‘to accelerate the development and manufacture of vaccines against previously unknown pathogens (just in time)’. To achieve these objectives, CEPI’s has focused its attention on correcting the lack of product innovation by creating demands where markets are uncertain or do not yet exist. Building off key initiatives such as the Global Vaccine Alliance (GAVI) – led by the World Bank, the WHO, the Gates Foundation and UNICEF – and latterly the WHO’s R&D Blueprint, CEPI has emphasized earlystage vaccine development, de-risking the development of innovative technologies that promise to radically compress R&D timelines. This process of acceleration is driven by intersectional innovations in vaccinology and bio-engineering that have yielded novel nucleic acid and viral vector vaccine platforms that, through a ‘plug-and-play’ approach, promise to reduce the costs, complexities and inefficiencies of traditional vaccine development.
COVID-19 presents a transformative moment in CEPI’s efforts. The successes of accelerated vaccine development notwithstanding, multilateral initiatives to ensure wide-spread vaccine access such as Advance Market Commitments (AMC), pool procurement schemes and ‘fair’ vaccine allocation frameworks, have been bedevilled by the logistical and political constraints on production and distribution. CEPI’s current investment case emphasises ignition capital for late-stage scaled-up and, critically, scaled-out manufacturing – an end-to-end acceleration, which they believe can slash vaccine development manufacturing timelines to 100 days and ensure fairer distribution. ‘Equitable access,’ CEPI’s CEO Richard Hatchet argued at the ‘Africa’s Vaccine Manufacturing’ conference, ‘can be best addressed by building capacities in countries at risk.’ The UK is set to become a load-baring pillar for this 100-day ambition. It has committed hundreds of millions of pounds to fund WHO’s pooled vaccine procurement scheme, and has agreed to the host a 2022 global submit on speeding vaccine development in partnership with CEPI. But as global health equity comes into sharper relief, we risk introducing familiar blind-spots, not least about what equity actually entails.
Accelerated access
Global health equity is typically framed as a problem of distribution and access – whether to healthcare services or life-saving products. In relation to the latter, addressing the problem of ‘market failure’ has served as the focus of previous efforts, leading to programmes to incentivise companies to invest in innovation through scalable-models, pooled procurement, or donor-subsided advanced purchasing agreements. And yet, the paradigm-shift from distribution to production has brought ‘vaccine know-how’ front and centre in the geopolitical debate. In the form of the TRIPS waiver this has elicited a radical challenge to WTO’s intellectual property regime, but enduring structural inequities bedevil any hope for a rapid decentralisation of vaccine production – and by extension threaten collective global health security in general.
As global leaders demur on the merits of waiving or enforcing intellectual property rights, manufacturing innovations are underway to facilitate high-volume production in resource-constrained environments. Methods such as densification (which reduce the volume and cost of key equipment such as bioreactors), or chaining (enabling autonomised semi-continuous processing) can reduce the footprint of facilities and the number of steps needed for production. Because some of these approaches allow prefabrication, they also reduce the potential for contamination and the burden of quality control. As promising as these disruptive models may be for ensuring global vaccine supply, they may not generate local level support everywhere. Whereas African leaders have hailed the potential of innovative technologies in bolstering R&D capacities on the continent, the resistance they elicit elsewhere echoes in many respects those raised against IP flexibilities. In making the case against US President Biden’s recent decision to support the proposed WTO IP waver, Stephen Ubl (Head of U.S, industry trade group PhRMA) commented: ‘It flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery.’ For countries across Africa and the Global South looking to develop their own vaccine production capacities, this is part of a broader argument for industrial investment that integrates health into larger development efforts. The potential public health benefits of local capacity in vaccine manufacture are considerable in themselves, as it will enable governments to respond to future needs more rapidly, without having to wait until the populations of wealthy countries have been vaccinated. But investments in vaccine infrastructures also hold transformative potential for national economies – positive externalities that re-contextualise the question of ‘access’ within more far-reaching strategies of national development. In this light, the development of capacity in vaccine manufacture is part of a necessary shift from investments in mineral and fossil fuel extraction to investment in industries that address local needs.
Just-in-time meets Just-in-case
An effective end-to-end preparedness and response ecosystem requires geographical reach. Novel viruses will continue to emerge, and without distributed local manufacturing capacity to respond quickly we will find ourselves facing a perennial pandemic precarity. Understanding this project solely in terms of access to products or remedial action towards ‘market failures’ forecloses a more far-reaching discussion over what equitable R&D and manufacturing might entail. To truly ‘build back better’ we need to be asking questions about the nature of tech-transfer, linked to a nuanced understanding of how it fits into the broader knowledge economies and public health needs of specific countries. The promotion of accelerated vaccine development is essential, but it needs to exist in conjunction with efforts to decentralise research, development and manufacturing. There could not be a more powerful and persuasive moment for globally responsible innovation, a new paradigm that could articulate the vision of global solidary upon which such advances depend.