Tackling vaccine inequity in 2023: have we made progress?

KEYWORDS:

• Access
• Epidemic preparedness and response (PPR)
• equity
• medical Innovation
• local manufacturing
• Pandemic Accord
• pandemics
• Research and development (R&D)
• resilience
• technology

1.

Nearly three years have passed since the COVID-19 pandemic that would upend our lives began. Described by Dr Tedros as ‘Vaccine Apartheid,’ our collective failure to make the breakthrough vaccines available equitably – prioritizing vaccinating the most vulnerable everywhere instead of wealthy countries first – should be a strong impetus for transformational change that can prevent the same happening in the future [1,2]. Equitable access to vaccines seems an agreed upon priority for future frameworks for better pandemic preparedness and response. But are we ‘walking the talk’?

The short answer is no. Given the difficulties to build consensus among World Health Organization (WHO) member states toward a binding Pandemic Accord, and the weak political declaration on Pandemic Prevention, Preparedness and Response adopted in October 2023 by the United Nations General Assembly, there is little indication that desperately needed change to put equity at the heart of the response will happen [3]. What is required is nevertheless clear: an end-to-end pharmaceutical ecosystem designed to deliver for public health, in which all regions have the ability to research, develop, manufacture and roll-out vaccines and other health technologies to address their health needs [4]. In combination with in-country preparedness and response capacity to get vaccines into people’s arms, such an approach would be transformational.

Yet, outstanding areas of controversy for the Pandemic Accord remain stuck along the classic lines of high-income countries (HIC) versus low- and middle-income countries (LMIC) interests, reflecting historic economic power imbalances between countries and the influence of pharmaceutical industry lobbies. They include control over research and development (R&D), including intellectual property rights, transfer of technology and knowhow, Access (to pathogens) and Benefit Sharing (ABS), all central to equity [3]. Without a breakthrough that would transform critical health technologies like vaccines and the underlying technology platforms into collectively governed common goods for health, rather than privately owned commodities that are traded in the global market for profit, we will repeat and further entrench health inequities [4].

Multiple reviews documented what went wrong during Covid-19, including the lack of control and agency of developing countries to access vaccines, an unwarranted belief in the benevolence of HIC to prioritize solidarity over self-interests, and failure to put equity, including gender equity, at the center [5–7]. Yet lessons learnt seem quickly forgotten. Especially in wealthy countries unaffected by vaccine access challenges, a business-as-usual discourse has already taken over. The same actors that failed to make COVID-19 vaccines globally available when most needed are positioning themselves at the center of the future preparedness and response ecosystem. These include GAVI, The Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) that together formed COVAX, and other partners involved in the Access to COVID-19 Accelerator (ACT-A) such as the Bill & Melinda Gates Foundation (BMGF), Wellcome, and WHO. Touting their status as global health actors working to increase access to health technologies in LMICs, they seek to be mandated, empowered, and financed to be in charge again – and promise to be even quicker. This is the main premise of the ‘100 Days Mission’ around which they coalesce [8]. Proclaiming equitable access as a priority, they have yet to demonstrate how they can achieve that without fundamentally changing their way of working. Despite documented challenges of the global health public-private partnerships set up during Covid-19, these remain the preferred operational model supported by G7 governments, the BMGF, Wellcome, and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) [9]. At a minimum, funding agreements for such public-private partnerships should contain binding conditionalities related to equitable access including sharing technologies and knowhow with a range of manufacturers in the Global South, and/or cost-plus pricing and transparency of the underlying R&D cost outlays.

The most popular among currently spearheaded solutions for tackling vaccine inequity is decentralizing vaccine manufacturing capacity. Multiple donor-driven initiatives are ongoing that invest in manufacturing infrastructure, skill-building, and technology transfer, especially in Africa [10]. Yet, most of these initiatives happen under narrow licenses by international vaccine producers, leaving the responsibility for and control over future R&D and innovation largely with them. While the African Union (AU) and Africa Centers for Disease Control and Prevention (Africa CDC)‘s plan for self-reliance mentions contributions to R&D and clinical trials, their main focus is establishing manufacturing capability and regulatory capacity to facilitate market access, which donors are ready to support. Without a similar focus on decentralizing innovative capacity and access to the underlying technologies and know-how, developing countries risk remaining in a dependency relationship when it comes to new technologies for health.

Doubling down on manufacturing wrongly assumes that equity is just a matter of having more vaccine doses produced in every region, and that increasing outputs suffices to achieve equity. While local production might minimize potential negative impacts of trade restrictions, COVID-19 vaccine inequities were in the first place the result of a dramatic failure in vaccine governance, especially in times of scarcity. Despite unprecedented public financing, vaccine production and supply were largely controlled by a handful of international companies that decided to whom to sell, when, and at what price, prioritizing financial returns over health equity. In addition, wealthy governments scooped up all early supplies to secure vaccines for their populations first, even buying up some doses produced in LMICs – undercutting the very concept of health equity, let alone health justice (Figure 1). At the same time, many local manufacturers that wanted to produce COVID-19 vaccines and help addressing the global supply crunch were refused the required licenses [11].

Figure 1. Different approaches to remedy structural inequality, using the lens of equality, equity, or justice.

In reality (Panel a), there are many situations in which people have unequal access to resources or opportunities, which can be the result of (any combination of) luck, privilege, merit, discrimination, power imbalance, historical factors, etc. Different types of approaches can be pursued toward remedying structural inequalities, adopting different lenses: 1) Equality (Panel b): every person receives the same type and amount of support; 2) Equity (Panel c): people receive the specific type and amount of support in response to their need and vulnerability; 3) Justice (Panel d): the underlying reasons for the initial inequality are removed. (Original figure created by Piero Olliaro).

To ensure equitable vaccine access in LMICs when and where needed, countries and local producers in the Global South must have ownership and decision-making over vaccine manufacturing technology and facilities, what they produce, and for whom. Moderna or BioNTech producing their proprietary vaccines in Africa does not build sustained regional capacity or resilience to respond to local health needs. Instead, it risks deepening dependencies on commercial interests that will always be prioritized over people’s health needs in shareholder-driven companies. In addition, many of the investments in local vaccine manufacturing, even with public funds, seem to assume that new producers will be able to successfully compete and be profitable in the global vaccine market. It ignores the cutthroat and oligopolistic nature of this market, with significant entry barriers and favoring the biggest players adopting economies-of-scale business models. In 2021, excluding COVID-19 vaccines, just four pharmaceutical corporations (MSD, GSK, Sanofi and Pfizer) captured 73% of the global vaccine market worth US$42 bn, while the single biggest producer by volume, the Serum Institute of India, barely captured 2% of the value while supplying 20% of all doses at near-cost prices [12]. It remains debatable whether increasing manufacturing competition in the low value-add segment of the market to supply LMICs can lead to increased equity, as current winner-takes-it-all market dynamics reward efficiency above everything else.

Health equity requires governing the ownership and control over the technologies and knowhow for the common good and along the entire value-chain to innovate, develop, and manufacture vaccines [4]. Researchers and developers in the Global South must have access to the means of medical innovation, not just be allowed to produce what others have created. They must have the ability to pursue vaccine innovation to address priority health needs in their country or region, rather than waiting until a company or the global health community brings such innovation to them as an act of charity or benevolence, if at all. That requires access to the technologies and knowhow, including ‘freedom to operate,’ the possibility to use existing science and technology without undue intellectual property constraint, as well as access to appropriate financing and skilled human resources to drive vaccine research and development for public health purpose, not profit. The WHO-initiated mRNA Technology Transfer Programme with its hub in South Africa that will share the technology and knowhow among at least 15 LMIC developers and producers, and collectively build a pipeline of mRNA products to address local health needs, represents an ambitious pilot to that effect [13].

Unless ownership and control over both vaccine knowledge and technology and vaccine supplies is democratized, the dependency on major commercial vaccine producers will continue. When asked to share COVID-19 technologies and knowhow with manufacturers in the Global South, most refused [11], or only did so to boost their own supply, or else under very restrictive conditions. For instance J&J entered into an agreement with South Africa’s Aspen to ‘fill-and-finish’ its COVID-19 vaccines, which were exported to Europe at a time when no vaccines were yet available in South Africa [14]. Leaked details on (confidential) technology transfer deals show their overly restrictive terms, which, for instance, only allows the technology recipient to produce a specific vaccine to supply a limited market (e.g. just a few countries). By prohibiting the broader use of the underlying technology to also develop or produce other or better adapted vaccines, they prevent countries from building resilience against future outbreaks. The request by South Africa and India, supported by more than 100 countries, to the World Trade Organization for a temporary waiver on intellectual property monopolies that would unlock their ability to locally produce and adapt COVID-19 countermeasures went unheeded, until it became too little, too late [15].

We are at a critical juncture. In the wake of the biggest global health crisis of our lifetime that also exposed the devastating consequences of structural inequality, countries are negotiating a Pandemic Accord and revising International Health Regulations (IHR). These binding international agreements could transform our collective ability to address future health emergencies and global health more equitably. It is time for wealthy countries to rebuild the trust that was so badly shaken during COVID-19 and start sharing critical technologies and knowhow that will allow LMICs to protect and promote their own health. Building on capabilities that already exist in multiple regions, LMICs can then start the road toward regional resilience, shaping equitable end-to-end ecosystems for R&D and manufacturing of health technologies to address regional needs, and make them common goods for health rather than profit-seeking market commodities.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

I would like to thank Piero Olliaro for the illustration and for his permission to use the drawings in this paper.

Additional information

Funding

This paper was not funded.