Charity or empowerment? The role of COVAX for low and middle‐income countries

Abstract What has the past reaction to the COVID‐19 pandemic taught us? We have seen that many low and middle‐income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID‐19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts of “donations” and “charity” with “vaccine equity” and the “empowerment” of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously.


| INTRODUCTION
Even though vaccine scarcity in low and lower middle-income countries has been a concern right from the beginning of the COVID-19 pandemic, it seems little progress has been made in the last year. 1 Almost 10 billion vaccine doses have been administered globally, over eight months after the first vaccine deliveries worldwide, and around 61% of the world's population has received at least one dose of a vaccine at this point. Breaking down the numbers, however, shows that only 10% of people living in low-income countries (LICs) have received one dose of a vaccine, 2 which means that health workers and vulnerable people in many poorer countries still lack immunization. The vast majority of the doses have so far gone to people in high and upper middleincome countries. 3 The current global vaccine allocation has created large health benefits in richer countries, while poorer countries had to bear the adverse consequences owing to low vaccine quantities. Most notably, there is a strong assumption among scientists that precisely the lack of sufficient vaccination coverage in many countries leads to new SARS-CoV-2 variants and increased and continuous outbreaks, which affects both rich and poor nations. 4 In the following, we discuss whether the current strategies, most notably donations by the international community and the COVAX facility, offer meaningful solutions to solve the global vaccine production and access problem in low-and middle-income countries (LMICs). At the centre of our analysis, we juxtapose the imperatives of "donation", "charity" and "beneficence" on the one hand and "allocation", "empowerment" and "equity" on the other. Eventually, we suggest that structural reforms, and most importantly capacity building, are required to positively impact the achievement of a fair global vaccine production and distribution that truly takes into consideration the interests of the global poor. In this context, we also provide a short analysis of the potential benefits related to patent waivers and their role as a catalyst to promote the empowerment of LMICs.

| LESSONS LEARNED: BILATERAL DONATIONS AND THE COVAX FACILITY
Since many LMICs currently face a significant lack of vaccine access, G20 health ministers called in 2021 for more justice regarding the global vaccine rollout on their behalf. 7 The G7 had previously agreed to donate 1 billion COVID-19 doses to poorer countries in June 2021 and big pharma, including Pfizer and BioNTech, announced to Russia gave vaccines to countries that were willing to purchase the Sputnik V vaccine. 10 Vaccines have thus become, according to the author Vilasanjuan, a weapon in a geopolitical struggle. 11 This has furthermore brought many poorer countries to a situation of dependency and disempowerment when it comes to accessing and manufacturing vaccines.
Donations have also been provided through the global cooperative scheme COVAX. The core idea of COVAX has been to set up a cooperative facility to accelerate the global vaccine development, production, and eventually the equitable access to COVID-19 vaccines, tests, and treatments. Here, wealthier countries co-finance F I G U R E 1 Percentage of people who received at least one COVID-19 vaccine dose per country, in relation to their income (GNI nominal per capita). In green, the 10 HICs with the highest per capita income; in orange, the 10 MICs with the most average per capita income within thin category; in red, the 10 LICs with the lowest per capita income. those countries that only have limited access to vaccines and insufficient resources to enter into bilateral agreements with the manufacturers. As the first initiative ever to fight a pandemic by establishing a global vaccine allocation mechanism, it overcame the unfavourable history of vaccine development and allocation during last pandemics. 12 In this sense, COVAX can be certainly considered a laudable enterprise. 13 What distinguishes COVAX from the bilateral donations is most notably its aim, that is, the establishment of a fairness criterion; even if the current framework of a proportional fairness criterion is controversial. 14 COVAX's distribution policy has been rightly criticized: a principle of equity has not been adequately taken into account (for example considering differential needs). 15 Instead, COVAX' distribution criterion merely adhered to proportionality. It relies on a mechanism that ensures equal distribution proportionate to each country's population. It assumes that fair allocation requires treating differently situated countries identically, rather than equitably responding to each country's distinctive needs. 16 COVAX as a mechanism has been an intermediate strategy for cooperation, where countries are still able to buy vaccines outside the facility and where international agreements to limit bilateral deals do not exist. Despite a strong December 2021, in which 300 million doses were shipped, the facility did not meet its own objectives to deliver 2 billion doses to low and middle-income countries by the end of 2021. 17 The current status quo shows that 1 billion COVID-19 vaccines have been shipped to 144 participating countries. 18 Despite its aim, serious difficulties hound COVAX. One problem is that the facility is chronically underfunded. To deliver on its full promise, the Access to COVID-19 Tools (ACT) Accelerator, 19 including COVAX, would need 16.8 billion USD. 20 According to the latest release of the World Health Organization in March 2022, the ACT Accelerator has a funding gap of 15.7 billion USD regarding the 2021-22 budget. 21 Moreover, COVAX has been criticised for its insufficient coordination when it set up the facility, which led commentators to think that it failed to keep its promise to vaccinate the world. 22 Cooperation also fails in the sense that many HICs with financial resources are still unproportionally prioritising their own populations and therefore hoarding vaccines that could be given to the COVAX facility and then administered to LMICs to effectively reduce the global burden caused by the pandemic. 23  vaccines to 144 participants. Data retrieved January 20, 2022, from https://www.gavi.org/ covax-vaccine-roll-out. 19 The ACT Accelerator is a global collaboration to accelerate the development, distribution and equitable access to COVID-19 tests, treatments, and vaccines. The COVAX facility is part of the ACT Accelerator. | 3 the domestic population from a country's perspective is to a certain extent understandable. In this regard, we tend to accept moderate vaccine nationalism as well as moderate cosmopolitanism. 28 Our position recognizes special duties borne by governments towards its citizens and residents, and furthermore acknowledges general obligations to other persons in need. 29 This, however, means to leave vaccine hoarding behind.
We can certainly learn from the COVID-19 pandemic that the current vaccine production, procurement, and donation mechanisms alone achieve suboptimal outcomes at the global level. The pandemic has, for instance, revealed that countries in which manufacturers with patents are located, tend to hoard vaccines for their own populations, and poorer countries depend on their benevolence. Bilateral donations furthermore seem to be linked to geopolitical interests.
This impairs the empowerment of especially those (mostly middleincome) countries that could develop capacities to produce and adequately allocate vaccines themselves. If COVAX had followed its stated goals as it should have done, it could have offered an alternative beyond charity.

| COVAX'S EXPANDED MANDATE: MOVING FROM CHARITY TO EQUITY AND EMPOWERMENT
As the philosopher and current adviser to the director-general of the World Health Organization (WHO), Peter Singer, rightly points out, it is time to think about solutions beyond charity as an expression of the principle of benevolence. 30 Charity still has an important role in our imperfect world, but it is not sufficient. Vaccine donations can only be one first step; the next one would be to systematically pursue vaccine equity, that is, to give LMICs a chance to fairly participate in the collective effort of vaccine manufacturing and procurement.
Here, the underlying principle is the empowerment of LMICs.
To foster the empowerment of LMICs, it's worth looking at a pressing concern, that is, the slow rate of global vaccine production outside Europe and the US during the first two trimesters of vaccine rollout. Europe and the US together were responsible for most of the global vaccine exports. The diversification of production sites could be one of the key strategies to avoid extreme vaccine nationalism and bottleneck problems. One can assume that a higher number of production centres around the world would have a positive impact on the chances to get people vaccinated in LMICs, as vaccines would be less scarce. Obviously, this would not solve all coordination and infrastructure problems many LMICs still have, but could, nevertheless, be a very important first step. Apart from India, production facilities in LMICs barely exist up to the present day. 31 In 2021, Africa has imported 99% of its vaccines while lacking the pre-order purchasing capacity of richer nations. 32 One of COVAX's important pillars is to scale up vaccine manufacturing abroad and thereby to strengthen capacities, but little has happened so far within the facility. In some middle-income countries with strong research and development capacities, there is know-how for manufacturing vaccines, which could be used more effectively. In turn, countries and regions with a basic or incipient research infrastructure may require support for technology transfer between innovators and targeted production sites. COVAX has so far been mainly a procurement coalition, but the facility should also have a stronger role in initiating and enabling a more effective and rapid technology transfer, as well as more systemic capacity building regarding both manufacturing and vaccine rollout. 33 This may also benefit low-income countries that do not yet possess the capacity to produce vaccines but may substantially benefit from the empowerment of middle-income countries in their region. More specifically, a regional approach, where the wealthiest countries of a region take on production responsibilities for the very poor, might still be a step forward to achieve regional empowerment.   40 In what follows, we explore potential approaches to reform the current system.

| EMPOWERING LMICS: THE ROLE OF PATENT WAIVERS
Facing the problem of pharma's reluctance towards the expansion of production to other sites, knowledge transfer, and systematic capacity building, US President Biden announced on May 5, 2021, his support to the international petition to waive intellectual property rights to vaccines for the duration of the COVID-19 pandemic.
His aim was to allow other countries to produce and thus globally speed up the production of Pfizer-BioNTech and Moderna vaccines against COVID-19 disease. 41 This attempt has eventually been blocked by Japan, South Korea, the United Kingdom, and the European Union member states. 42 Governments remained deeply divided over this effort, also months after Biden's announcement: While China, Russia, the United States, and the World Health Organization supported an IP waiver on vaccines, the pharmaceutical industry together with the countries blocking the initiative held the view that an IP waiver would not accelerate vaccine production. 43 In this regard, many think that Biden's announcement has been a rather symbolic step. 44  Instead, WTO members states actively pushing for patent waivers should rather consider improving procedures and institutional design or help streamline the process for compulsory licensing on pharmaceutical products. 45 Meanwhile, EU had at least agreed on increased exports, a better use for compulsory licensing, and fewer export restrictions. 46 The question one may ask is whether patent waivers by themselves solve the scarcity problem or whether they are (only) one element to help scale up production and empower LMICs by systematically strengthening their capacities.
According to Hotez et al., the drive for intellectual property waivers partly stems from past experiences with HIV/AIDS drugs, where patent pools, patent waivers, and other liberalizing mechanisms favourably supported the equitable access to lifesaving drugs. 47 Yet, they point out 36 Maxmen, op. cit. note 30. 37 We acknowledge that manufacturing processes may significantly differ depending on the vaccine type produced; see Guetta-Jeanrenaud, et al., op. cit. note 31. 38 Maxmen, op.cit. note 30. 39 We acknowledge at this point that the manufacturing of Sputnik V might be easier that the debate about intellectual waivers of intellectual property rights still needs to be led with prudence. Even if waivers may have a positive effect on the global vaccine production, there is a potential caveat, as they may signal fewer incentives to innovators with respect to future pandemics. However, Hotez et al. also acknowledge that the proposal to timely limit waivers could mitigate this problem considerably.
Advocates put forward the argument that patent waivers (and their announcement) a priori increase the investments in LMICs and therefore manufacturing capacity to produce COVID-19 vaccines while assuring that patents are not breached. This is in part backed up by the legal certainty that patent waivers create in the current multilateral trading system. Patent waivers also signal that governments in HICs are serious about increasing access to COVID-19 vaccines. 48 It is certainly true that the current number of countries that can enter in COVID-19 vaccine production is limited, and capacity strengthening, especially in continents like Africa, Latin America, and Asia would be key to enhance production. This is, however, beyond the mere politics of patent wavers. But patent waivers can be a necessary step and may signal governments and institutions in LMICs to take the right measures towards the improvement of know-how and infrastructure needed to produce vaccines. In this regard, they can positively support LMICs in their empowerment to overcome the current dependencies in the domain of global health.
Another key argument against patent waiver scepticism concerns the type of vaccine produced. Javier Guzman, technical director at Management Sciences for Health, put forward that the debate has mainly focused on mRNA vaccines, but more manufacturers in LMICs are in the position to produce viral vectors and/or to contribute with the fill-and-finish stage of the process in which sterile vials are filled and capped. 49 In addition, conventional vaccines can increasingly be developed and produced, which could be another production source in middle-income countries (MICs). Technologically advanced MICs, such as many Latin American countries, could further advance and get prepared to produce mRNA vaccines and begin to build the necessary infrastructure for future pandemics. For instance, Argentina has produced the active ingredient of the AstraZeneca vaccine and Mexico has overseen the fill-and-finish process. 50 Now, these two countries and Brazil may also serve as a pilot when it comes to bolstering the mRNA vaccine production in LMICs. 51 It would be also worth discussing different models of patent waivers and/or sub-license agreements. For instance, pharma companies could give open licenses to other manufacturers (as it is currently done with the AstraZeneca vaccine) and be paid an initial amount of money for developing the drug in accordance with the obtained health impact. 52

| EMPOWERING LMICS: COVAX'S ROLE IN FACILITATING CAPACITY BUILDING AND TECHNOLOGY TRANSFER
Like the supporters of patent waivers, we think that temporarily suspended patents are a good first step to counteract dependencies of LMICs. Here, support should be provided especially to those LMICs that have an incipient infrastructure and manufacturing potential. While middle-income countries are more likely to have the capacities to effectively start producing vaccines in the shortterm, low-income countries without the necessary workforce and infrastructure would also benefit from neighbour countries that produce vaccines. The systematic strengthening of regional distribution mechanisms would be an important complementary measure to benefit especially low-income countries. In this sense, patents should no longer be considered a "sacred cow" in times of a pandemic. Given that many (past and future) pandemics have concerned and will concern LMICs, this strategy would be crucial to accelerate the To tackle these shortcomings, we suggested that the focus of reform should be the improvement of global cooperation with the goal of ensuring equitable access to vaccines. We argue that regional capacity building for vaccine manufacturing, technology transfer, the support of patent waivers, and the improvement of local infrastructure will be crucial. Note that at the beginning of the vaccine distribution process, various problems arose in regions, such as Latin America and Africa, regarding the transportation, storage, and even the application of vaccines due to lacking infrastructure and know-how. All these adversities were solved in a short time, which is an example of the learning process that these countries went through. 55 Following this logic, we suggest that COVAX, or a similar multilateral agency, should be further strengthened and improved in its current mandate, which will subsequently empower LMICs in their manufacturing capacity. While in a globalised world it may be unrealistic and even unreasonable for every country to be self-sufficient in producing vaccines, diversifying production sites regionally will nevertheless help the global community move away from a scheme based on the donations of rich countries to poorer countries.

ACKNOWLEDGMENTS
Open access funding provided by Universitat Zurich.