Kampala — On April 13, Ghana became the first country to approve public use of the experimental R21/Matrix‑M malaria vaccine for children. This low‑dose vaccine can be manufactured at large scale and modest cost, potentially supplying hundreds of millions of doses to African nations burdened by malaria. Developed by the University of Oxford and produced by the Serum Institute of India’s PvT Ltd (SIIPL) using Novavax’s adjuvant technology, SIIPL holds the manufacturing and commercialization license for the vaccine.
The R21/Matrix‑M vaccine has undergone clinical trials in the United Kingdom, Thailand and several African countries. A phase III trial is currently enrolling 4,800 children across Burkina Faso, Kenya, Mali and Tanzania, with results expected later this year. Earlier phase IIb trials reported high efficacy: a booster dose given one year after a three‑dose primary series maintained efficacy above the World Health Organization’s target of 75 %, and a 2021 phase‑IIb result showed 77 % efficacy. Recent data from the large phase III trial also indicate strong efficacy and a reassuring safety profile. The vaccine’s potency derives from Novavax’s Matrix‑M, a saponin‑based adjuvant that enhances immune response by recruiting antigen‑presenting cells to the injection site and improving antigen presentation in local lymph nodes. This adjuvant has been successfully used in Novavax’s COVID‑19 vaccine and other development‑stage vaccines.
Adar Poonawalla, CEO of the Serum Institute of India, emphasized the difficulty of creating a vaccine that can substantially reduce the disease burden, pledging to scale up production to meet the needs of high‑burden countries and support global life‑saving efforts. Ghana’s regulatory clearance marks the first approval of R21/Matrix‑M anywhere in the world, a crucial step toward protecting Ghanaian and other African children from malaria.
In October 2021, the World Health Organization recommended broad deployment of another malaria vaccine, RTS,S/AS01e (Mosquirix), developed by GlaxoSmithKline with the PATH Malaria Vaccine Initiative. The WHO hailed the vaccine as a historic moment that could increase equity in malaria prevention, though health experts stressed that RTS,S, with about 30 % efficacy against severe malaria, must be combined with other interventions such as bed nets and seasonal chemoprevention. Professor Brian Greenwood of the London School of Hygiene and Tropical Medicine noted that, while RTS,S does not provide complete protection, it has great potential to reduce death and illness when used alongside other tools.
When early trial results for the Oxford‑developed R21 vaccine were published in September 2022, Professor Dyann Wirth, Richard Pearson Strong Professor of Infectious Diseases, cautioned that the data were still early. She explained that efficacy can vary with the timing of vaccination relative to the malaria transmission season, which typically peaks during rainy periods. Wirth called for further evaluation of R21 in real‑world settings, including the ongoing phase III trial that runs through December 2023 across four African countries, two of which experience year‑round transmission. While optimistic, she warned that early promise often diminishes when vaccines are deployed at scale. She expressed hope that a multi‑pronged strategy—combining vaccination with existing tools—could dramatically reduce child deaths from malaria.
The Oxford‑Serum Institute partnership that produced the R21/Matrix‑M vaccine also developed the Oxford‑AstraZeneca COVID‑19 vaccine. Professor Adrian Hill, chief investigator of the R21 programme and director of Oxford’s Jenner Institute, described the achievement as the culmination of 30 years of malaria vaccine research, delivering a high‑efficacy product that can be supplied at scale to the countries most in need.
Delese Darko, CEO of Ghana’s Food and Drugs Authority (FDA), announced that the R21/Matrix‑M vaccine will be used to immunise children aged five to 36 months. Ghana’s market authorisation, based on a satisfactory evaluation of quality, safety and efficacy data, reflects a 75 % success rate and a benefit‑risk balance that strongly favours use. “The vaccine has the potential to reduce under‑five mortality caused by malaria in Africa,” Darko said. Sammy Ohene, chairman of the FDA’s governing board, called the approval a monumental event for Ghana and the continent, noting that malaria remains a leading cause of death among infants. Official Ghana Health Service data indicate that about 20 000 children die of malaria each year, with 25 % under five years old. The World Health Organization reports that a child under five dies of malaria every minute, most deaths being preventable and treatable. In 2021, malaria caused 619 000 deaths worldwide, 77 % of them in children under five.
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