One of the most widely anticipated vaccines ever to be developed, RTS,S, or Mosquirix, is the very first licensed malaria vaccine, and as of last week, the first countries can now apply for it, through Gavi.
Taking 35 years to develop and coming more than a century after the search for a malaria vaccine first began, this really is a historic moment. But, if it is to fulfill its potential and have a truly global impact, then we need to start viewing this not just as the end of an incredibly long journey, but as the beginning of a new (and far faster) one. Because before vaccines can meaningfully start helping to defeat this terrible disease, significant challenges must still be overcome.
With malaria infecting over 240 million people a year globally and killing more than 620,000 of them, demand for this vaccine will be incredibly high. Yet, as is common with a new vaccine, the supply of RTS,S will initially be very limited, until manufacturing capacities are scaled up. So, in addition to the challenges of working out precisely how to integrate this complex new vaccine — which requires four doses, of which three doses are outside of the normal schedule — into existing immunization programs, and in ways that complement other malaria control interventions, sufficient, sustainable and affordable supply will also be critical. Not only will we need multiple suppliers, but also continued innovation on next-generation malaria vaccines that are even more effective. To make that happen we now need a similar pace of science, innovation and collaboration as we saw with COVID-19 vaccines.
When used with other interventions, malaria vaccines have genuine potential to mark a turning point in the fight against this terrible disease. Not only will they help save countless lives, but they can also bring about broader social and economic benefits that are huge. Because even when malaria doesn’t kill people, it is a constant drain on families living in hyperendemic regions, impacting the health and wealth of individuals, their families and communities and slowing economic growth, with billions of dollars across the world lost due to healthcare costs and productivity losses. This is one reason why demand will be so high.
However, while the rollout of this vaccine will eventually be made available to a broader range of African countries with moderate to high transmission of P. falciparum malaria — the deadliest species of malaria parasite against which RTS,S protects — to begin with, doses will go to just three countries: Ghana, Kenya and Malawi. This will help ensure the uninterrupted continuation of malaria vaccine programs in the national immunization programs of these countries, which are currently part of the World Health Organization’s Malaria Vaccine Implementation Pilots (MVIP).
In order to bring malaria transmission under control, it is clear a wide-scale deployment of affordable vaccines will be needed, particularly across Africa, which accounts for 95 percent of all cases. To this end, Gavi is investing more than $155 million until 2025 to help lower-income countries make malaria vaccines available to children since under-fives make up around 80 percent of all malaria deaths. But how far that support goes will depend very much upon the speed at which existing manufacturers scale up their production, the initial prices at which the vaccine is offered, how quickly other malaria vaccines can enter the market, and how fast regulatory pathways open up for new malaria vaccines.
In addition to more doses, to really turn the tide on malaria in the longer term, we also need improved vaccines, especially ones that are more effective at preventing malaria, including those with higher efficacy, longer duration of protection, and likely also vaccines that target other forms of malaria as well as vaccines for non-African strains. With a nascent malaria vaccine pipeline in place, there is hope for this. However, with most vaccine candidates still at an early stage of research and development, we now need that development, as well as regulatory pathways and manufacturing, to move with the sense of urgency that reflects the level of crisis and devastation that malaria continues to inflict on the world — we cannot wait another 35 years.
The problem is that historically the processes involved in the development, manufacture and regulatory approval of vaccines can move incredibly slowly, often taking more than a decade to bring a vaccine candidate to market. With COVID-19 vaccines we’ve seen that it doesn’t have to be that way, with manufacturers and regulators demonstrating incredible agility and moving at breakneck speed when there is urgent demand and a market for a vaccine. Given their huge potential to save lives, reduce sickness and the economic gains, we can, and we must do the same for malaria: The world has waited long enough.
Dr. Seth Berkley is CEO of Gavi, the Vaccine Alliance.