This week, as part of the World Bank’s 2020 Annual Meetings, the World Bank announced approval of $12 billion for the purchase and distribution of COVID-19 vaccines, tests, and treatments. The funding would go a long way to meeting needs—the Access to COVID-19 Tools (ACT) Accelerator estimates a requirement of $35 billion for all COVID products, with $1.19 billion raised so far. The announcement mentions that, “In implementing the program, the World Bank will support multilateral efforts currently led by WHO and COVAX.” This is encouraging given that each country on its own would lack access to a large pool of potential vaccine candidates and may face higher prices or more limited volumes than would be optimal for population health impact.
To maximise the impact of this badly needed investment to combat COVID and, most importantly, to avoid any perverse and potentially catastrophic implications of World Bank financing undermining current global efforts led by Gavi and CEPI, we propose that the World Bank commit to the four principles below. We also suggest it works with external partners and independent experts to operationalise these principles as part of the implementation of the funding.
1. Access to a diversified portfolio/product selection
To assure this access, the World Bank should link formally to the COVAX portfolio, by far the most diversified set of potential vaccines for purchase outside of the US Operation Warp Speed initiative (see CGD analysis). (COVAX is the vaccines pillar of the Access to COVID-19 Tools [ACT] Accelerator and is led by the Coalition for Epidemic Preparedness Innovations [CEPI]; Gavi, the Vaccine Alliance; and the World Health Organization [WHO].) Although the COVAX portfolio is reasonably diversified, the World Bank should push its portfolio towards further diversification by going from the current 9 to at least 12 vaccine candidates, thereby raising the chances of getting to a successful product from under 70 percent to over 80 percent. Operating outside of COVAX may not only deprive individual countries from access to a diversified portfolio but may well also reduce the chances of COVAX succeeding by encouraging additional bilateral deals between middle-income country governments and industry, and in so doing weakening the COVAX pool’s purchasing power.
Formally joining COVAX and accessing its portfolio would empower the World Bank to seek stronger governance, transparency of process in selecting vaccine candidates, and broader diversification on behalf of country purchasers, and a discussion of country options should the COVAX portfolio fail to deliver. World Bank technical leadership and funding can also strengthen COVAX by shifting the emphasis from advocacy to analysis, enhancing transparency including sharing of contract offer design and terms, and an exposition of the legal framework for enforcing these, going beyond information currently available.
2. Regulatory standards and licensing
The World Bank must commit to WHO pre-qualification (PQ) as a regulatory and licensing standard for vaccine developer and manufacturing/fill and finish sites. Not including WHO PQ as an acceptable regulatory standard for the World Bank financing package risks insufficient manufacturing capacity or inadequate portfolio diversification, which could have knock-on effects for access. For example, part of the current manufacturing capacity (both fill and finish—when vials and syringes are filled and packed for transport—and bulk antigen production), particularly in middle-income countries, is WHO-pre-qualified, but not approved by a stringent regulatory authority. Further, relying only on high-income country stringent regulatory authorities only (e.g., the US Food and Drug Administration, the European Medicines Agency, Australia’s Therapeutic Drugs’ Administration, or Japan’s Pharmaceuticals and Medical Devices Agency) risks creating backlash from countries that would not recognize approval from these agencies for domestic political and legal reasons. While backing WHO PQ, the World Bank can also allocate resources and technical assistance for vaccine regulatory capacity strengthening (e.g. building on the projects such as its African Medicines Regulatory Harmonisation project) as part of this large financing package given that vaccine regulation in low- and middle-income countries (LMICs) is extremely weak. At the same time, there is a need for regulatory checks and balances in relation to products licensed without the completion of Phase 3 trials and/or without sufficient safety and efficacy data, which could be achieved through a coordinated WHO PQ effort.
3. Assure value for money in vaccine selection, procurement, and pricing negotiations
The World Bank should commit to launch Health Technology Assessment (HTA) in parallel to WHO PQ to assure that vaccine candidates that are ultimately purchased are as cost-effective as possible. As noted in some of our previous work, the likely efficacy and relative cost-effectiveness of the set of vaccine candidates is still mostly unknown and must be rigorously assessed using HTA to determine best value use of funds. HTA is a process already carried out by middle-income countries such as Thailand and the Philippines in relation to COVID-19 commodities and endorsed by WHO. The World Bank can commission analyses from WHO Strategic Advisory Group of Experts (SAGE), especially as comparative clinical and cost effectiveness are part of the SAGE scope and from international centres of excellence to inform product selection and tiered pricing as well as vaccine roll out. Outside COVAX, and on a country-by-country basis, product selection will likely be based on subjective criteria, which may or may not consider vaccine effectiveness or value for money and may allow for inappropriate practices, as we have seen so far in relation to COVID commodity procurement at much lower amounts of money. Encouraging (or indeed requiring) bilateral or bank-facilitated procurement could result in an uncoordinated, opaque, inefficient process, and generate competition for COVAX/CEPI in the process, undermining access for LMICs. Such an approach could also encourage what we are already seeing: MICs including large African nations directly negotiating with Chinese and Russian manufacturers.
In addition to product selection, price negotiation will be hard to manage outside a multi-country platform such as COVAX (World Bank joining may also bring an end to current COVAX discussions on what we see as suboptimal ideas of cofinancing by LMICs and vaccine exchanges for wealthier countries). WB can introduce a transparent and well governed process for product selection and tiered pricing based on comparative product effectiveness and cost-effectiveness assessments ensuring some cash flow visibility and better accountability. Linking with the COVAX pool is consistent with the financing flowing directly from the country or the Bank Facilitated Procurement on behalf of the country, whilst the contract abides by COVAX rules. In the longer term, this level of investment in vaccine as well as treatment and test R&D and manufacturing can derisk the market and crowd in private investment to tackle this and the next outbreak.
4. Manufacturing capacity
The World Bank financing package should coordinate with the IFC facility to include a clear framework for managing manufacturing capacity globally, including know-how transfer and investing in high-quality developing country vaccine manufacturers (DCVM). Ensuring sufficient manufacturing capacity to meet global demand requires working with and expanding a globally distributed footprint of high-quality vaccine manufacturers. The challenge is not as much about intellectual property as about having the right manufacturing assets and technical know-how, especially for the novel platforms, e.g., nucleic acid vaccines, viral vectors. IFC’s COVID financing facility could be used to provide fixed and working for proven high-quality DCVM network vaccine manufacturers, but it needs to be connected much more closely with Bank financing for COVID-19 vaccines. Tech transfer is much more challenging here than it is for oral solids such as antiretroviral treatments. Existing voluntary licensing facilitation or pooling mechanisms may not have the required technical capacity to carry out such a role. Also, the new companies with COVID-19 vaccine candidates (e.g., Novavax, Moderna, Innovio, Curevac) have no experience of such tech transfer and don’t have in-house teams with the experience to think through voluntary or compulsory licensing, tiered pricing, tech transfer, and so on.
A Word Bank and COVAX partnership
It is not clear from the public release what safeguards have been put in place to shape implementation of the $12 billion package ex post and whether any of the above four points are included. The stakes are high and the risks significant, from undermining the COVAX efforts through allowing direct bilateral (country/industry) procurement and aggravating emerging markets by requiring approvals by high-income-country regulators to severely restricting manufacturing capacity for LMICs and allowing resources to be wasted through inefficient, bilateral, and at times corrupt national procurement practices.
On the other hand, the World Bank money can inject data and contract and process transparency into the COVAX effort, require more active country engagement, and allow more flexibility and choice—all concerns voiced in relation with COVAX. Experiences of countries such as Mexico and Colombia, which considered going at it alone but ultimately joined COVAX, show that pooling expertise and resources makes sense for middle-income as well as low-income countries.
The very real risks of nationalism, politics, and individual self-interest undermining the global race to get to a vaccine and which are already manifesting themselves in the vaccines arms race driven by high-income countries, are best confronted and addressed through the only existing multinational platform aimed at serving developing nations. The World Bank can be a force for good, forcing governance reforms whilst also boosting COVAX’s vaccine portfolio and enhancing its chances of success. And in making available to countries a wealth of technical expertise in procurement and manufacturing, a wide range of vaccine choices, as well as financial resources, a World Bank/COVAX partnership can appeal to middle-income countries already in bilateral discussions with China and Russia whilst also offering industry a badly needed single point of contact for negotiations. Will the World Bank rise to the challenge?