FOREIGN POLICY
Right now, enough material to make 20 million doses of a lifesaving malaria vaccine is sitting on a shelf in India, expected to go unused until mid-2024. Extrapolating from estimates by researchers at Imperial College London, these doses—enough for 5 million children—could save more than 31,000 lives, at a cost of a little more than $3,000 per life. But current plans by the World Health Organization to distribute the vaccine are unclear and have been criticized as lacking urgency.
Growing up in rural Zambia, I was infected with malaria multiple times. The worst case was when I was in primary school in the year 2000. As usual, the infection came with a high fever, shaking chills, and muscle aches. I had a severe pounding headache, and I remember a lot of vomiting.
Fortunately, I was given chloroquine as a treatment and recovered successfully. Even so, the severe side effects of the drug added another dimension of suffering. My whole body itched for days, to the point where I couldn’t sleep properly. (This is a very common reaction to the drug among Black Africans in particular.)
As painful as that bout of malaria was, I can hardly imagine the emotional toll this must have had on my mother, fearing I would become one of the more than 600,000 children killed by the disease that year. And while there have been victories in the fight in the two decades since then, the cost of the disease remains very high, with more than a thousand children dying from it each day in Africa.
This year, the World Health Organization (WHO) recommended the R21/Matrix-M vaccine, a much-needed expansion of the malaria response toolkit. An existing vaccine, RTS,S, has been given to over 1.7 million children in several African countries since 2019 and decreased all-cause mortality rate by an astonishing 13%. Given a baseline mortality rate of 74 per thousand children under five in Sub-Saharan Africa, that would have prevented the deaths of more than 16,000 children. If this holds true for R21, for every million children vaccinated, 9,620 deaths could be averted.
But thanks in part to limited supply, RTS,S cannot meet the demand. There are approximately 80 million children in Africa who are living in areas at risk of malaria transmission and are of a suitable age for vaccination. Only 18 million RTS,S doses are available for 2023 to 2025, enough for up to 4.5 million children. (Like R21, RTS,S vaccination requires four doses.)
Luckily, the new vaccine, R21, is much easier and cheaper to produce. The Serum Institute of India, which is the world’s largest vaccine manufacturer, estimates that it already has the capacity to manufacture more than 100 million doses per year and that this capacity will double by 2025. By one estimate, for every million children vaccinated with R21, 1.9 million cases of malaria will be prevented (since people are often infected multiple times) and more than 6,000 lives will be saved.
In other words, over the next year, if the Serum Institute of India alone can produce and supply 120 million initial doses, the world could potentially vaccinate 40 million children, saving roughly 240,000 of them from a painful death.
As it stands, we will not be deploying 120 million doses in the next year, or even a sizable fraction thereof. The WHO estimated that R21 delivery will start around mid-2024, and the most recent public forecasts are that fewer than 20 million doses will be delivered next year.
WHO, to its credit, has stated to the Financial Times that it “agree[s] that everything should be done to expedite” the use of malaria vaccines. For R21, WHO already utilized some of the available options to move things faster toward recommendation ahead of the conclusion of phase 3 trials. This strategic ingenuity has saved the world some years of a painful wait. The WHO deserves praise for the hard work it’s done already to accelerate this vaccine.
However, there’s another mechanism that could expedite the process—and it’s one that WHO has used recently. Because COVID-19 was deemed a public health emergency, a faster deployment route was used during the pandemic: emergency use listing (EUL). More than 1 billion doses of COVID-19 vaccines have been delivered in Africa over the past two years. As it stands for malaria and R21, no similar commitment has been made to distribute all available doses of R21 at COVID-speed.
Vaccine deployment and licensure is an incredibly complex scientific, legal, and logistical process involving numerous parties across international borders. Roughly speaking, after the WHO recommends vaccines (such as R21), it must also undertake a prequalification process and receive recommendations from its Strategic Advisory Group of Experts before UNICEF is allowed to purchase vaccines. Then Gavi—a public-private global health alliance—can facilitate delivery by national governments, which must propose their anticipated demand to Gavi and make plans to distribute the vaccines.
Prequalification can take as long as 270 days after approval. However, the COVID-19 vaccines were rolled out within weeks of WHO’s approval, using the separate EUL process rather than the more standard prequalification process that R21 is now undergoing.
For COVID-19 vaccines, EUL was available because the pandemic was undeniably an emergency. Given the staggering scale of deaths of children in sub-Saharan Africa every year, shouldn’t we also be treating malaria vaccine deployment as an emergency?
The R21 malaria vaccine does not legally qualify for EUL because malaria already has a preventive and curative toolkit available. My concern is that this normalizes the deaths of hundreds of thousands of children each year in Africa. No effort should be spared to save even just one child, regardless of how many other tools are also available.
Releasing the R21 vaccine today will still require significant lead time to begin mass deployment. But with so many lives on the line, intense scrutiny is justified. We owe the families with young children at risk an explanation as to why, even though a new malaria vaccine is available, it will not be treated with utmost speed like COVID-19 vaccines were.
For many, especially in the global north, malaria may not feel like an emergency, but it was an emergency for me and my mother when I contracted it as a child, and it will be an emergency to the millions and millions of children who will be infected next year.
Some African countries have already taken the initiative to approve the R21 malaria vaccine for use. Ghana, Burkina Faso, and Nigeria all made the decision to license the vaccine prior to approval from WHO.
Global health institutions need to support these countries by facilitating the rapid distribution of this vaccine and creating a public plan to vaccinate 40 million children before 2025. As Adrian Hill, the University of Oxford scientist whose work was key in developing R21, succinctly asked: “Why would you allow children to die instead of distributing the vaccine?”
