Local supply of a medicine used to prevent malaria across Africa received a boost recently, as the World Health Organization (WHO) issued a quality certification to the first African manufacturer of a key antimalarial drug used to prevent infection in pregnant women and children. Called prequalification, this certification will enable Kenyan manufacturer Universal Corporation Ltd (UCL) to support regional efforts to combat malaria through local production of high-quality sulfadoxine-pyrimethamine (SP). UCL’s pre-qualification was achieved with funding from global health agency Unitaid and support from MMV.

Malaria Mosquitoe

According to the latest World Malaria Report, released on 6 December 2021, there were an estimated 241 million cases of malaria and 627,000 resulting deaths worldwide in 2020. This represents about 14 million more cases in 2020 compared to 2019, and 69,000 more deaths. Approximately two-thirds of these additional deaths (47,000) were linked to disruptions in the provision of malaria prevention, diagnosis and treatment caused by the COVID-19 pandemic.

The WHO African Region continues to carry a disproportionately high share of the global malaria burden. In 2020, the region was home to 95% of all malaria cases and 96% of all deaths. About 80% of all malaria deaths in the region are among children under five years of age.

In 2020, six countries accounted for just over half of all malaria deaths worldwide: Nigeria (27%), the Democratic Republic of the Congo (12%), Uganda (5%), Mozambique (4%), Angola (3%) and Burkina Faso (3%).

Pre-qualification is a service provided by WHO to assess the quality, safety and efficacy of medicinal products. Quality assurance of UCL’s SP product Wiwal® opens a route for procurement by global scale-up partners that will improve access and help strengthen Africa’s ability to combat endemic diseases.

Unitaid welcomes the certification of UCL to produce this quality-assured antimalarial medicine in Africa, where about 95% of all illness and death from malaria occurs. Reinforcing local production of medicines where they are needed most is critical to building stronger and more resilient health responses,” said Dr Philippe Duneton, Executive Director of Unitaid.

Young children and pregnant women are among the most vulnerable to the burden of malaria, with children under five accounting for 80% of all malaria deaths in Africa. SP is a generally well-tolerated, effective, and affordable medicine used to prevent malaria, yet adequate delivery and scale-up of these interventions are hampered in part by inadequate and unstable supply and, until now, have completely relied on imported or poor-quality drugs.

The lack of pre-qualified manufacturers in Africa raises concerns about the quality of medicines and supply insecurities that compromise the treatment of chronic and infectious diseases – risks that were clearly revealed when COVID-19 disrupted global supply chains and left Africa with limited access to vital products. The production of quality medicines on the African continent is critical not only for the safety of Africa’s people but also for supporting regional supply availability and diversification in global production of medicines.

Increased supply of SP is crucial to the long-term success of Unitaid’s malaria chemoprevention strategy, which includes nearly US$ 160 million invested to date to optimize and scale up delivery of SP through seasonal delivery and intermittent preventive treatment in pregnant women and infants. With Unitaid funding, MMV is working to strengthen global supply chains and support appropriate use of quality medicines critical to the malaria response.

WHO approves sulfadoxine-pyrimethamine manufactured by Universal Corporation Limited to prevent Malaria in Africa