Rethinking the Malaria Vaccine Business Model

[This article was originally published on Devex]

It is not for us to celebrate the continued existence of a disease that is theoretically preventable and treatable, yet causes about 241 million cases a year and more than 627,000 deaths. World Malaria Day is a moment to recognize what has been accomplished and learned over the past year. El Salvador and China were both certified as malaria-free by the World Health Organization and an additional 11.8 million children were protected by seasonal malaria chemoprevention, despite the COVID-19 pandemic.

Malaria remains a crushing burden to children in the region, claiming more than 260,000 lives annually.

These are measurable gains that are not diminished by the many challenges faced, particularly in sub-Saharan Africa, where progress has not only stalled, but the trajectory has worsened. Malaria remains a crushing burden to children in the region, claiming more than 260,000 lives annually. It was thus a historic moment when the WHO recommended RTS,S/AS01, the first malaria vaccine for widespread use among children in sub-Saharan Africa.

Soon after, Gavi, the Vaccine Alliance committed to the first tranche of funding for scale-up. However, it has been difficult to ensure access to a high volume, affordable and available vaccine supply. While part of the problem may be that this is not the ideal vaccine, historically the malaria community has achieved important progress with partially effective tools, used together.

The predicted shortfall in vaccine supply over the next few years exposes the underbelly of global health. In this case, it points to the persistent weakness in our ability to bridge the divide between great innovation and product development to scaled implementation. Like other neglected tropical diseases, the malaria vaccine does not have a global north market to offset development and manufacturing costs.

The malaria vaccine research community has been driven by public sector laboratories, with R&D investments trending downward since 2017.

The oft-asked question is why COVID-19 vaccines were magically developed in a year, while the malaria vaccine took more than 30 years? The pandemic vaccines leveraged experiences and investments based on other coronavirus and viral vaccines. On the other hand, the malaria parasite continues to invade, evade, attack, and evolve in complex ways. For COVID-19, the global investment in product research and development was about $6.6 billion and additional advance purchase agreements (signed prior to regulatory approval) are estimated at $52 billion. Meanwhile, the malaria vaccine research community has been driven by public sector laboratories, with R&D investments trending downward since 2017. These extreme differences explain markedly different drivers for industry engagement.

The challenges of creating a functional business model for innovation and supply of vaccines for diseases like malaria require new approaches. Some lessons can be learned from past attempts to bridge the investment divide – such as Product Development Partnerships — to catalyze innovations that would otherwise not be advanced by conventional models. Forms of advance market commitments, that if created, new vaccines would be purchased and used, could be another solution to market credibility

Direct agreements with countries as key partners in the development and manufacturing process have been announced, and if this comes to fruition, it is one approach that aligns both vaccine product development and manufacturing capacities in Africa.

New ideas are emerging and we must ensure the engagement of the next-generation of scientists and leaders from malaria-endemic countries. It is also time to invest in quality manufacturing capacity in these countries to tackle the supply challenges. The private sector can also create new solutions. An example is the leveraging of mRNA science and development experience, as well as corporate returns from COVID-19, into commitments to develop that technology for malaria. Direct agreements with countries as key partners in the development and manufacturing process have been announced, and if this comes to fruition, it is one approach that aligns both vaccine product development and manufacturing capacities in Africa. 

Most importantly, the demand and supply gap of the malaria vaccine leads us to the question of equity in resource allocation. WHO is coordinating the development of a prioritization framework so that countries can together make allocation decisions in the context of urgent need. Since malaria rates vary significantly across and within countries, the task of targeting the highest risk areas will demand significant coordination and customization of response strategies at an international and regional level.

The time to examine and drive the best ideas forward should have been a decade ago, but perhaps it took a pandemic to show us what could be possible. To meet the global malaria goals, we will need to create the keys to transition from good science to a prioritized and accessible global malaria vaccine effort that reflects the urgency and scale of the task.