WHO approves first African malaria prevention medicine in pregnant women, infants
The first African manufacturer of a crucial antimalarial medicine used to protect children and expectant mothers from infection received a quality pre-qualification from the World Health Organization, or WHO.
By producing high-quality sulfadoxine-pyrimethamine locally, Kenyan producer Universal Corporation Ltd (UCL) will be able to support regional efforts to battle malaria (SP).
Pre-qualification was completed with assistance from MMV and funding provided by international health organisation Unitaid.
Pre-qualification is a service offered by WHO to evaluate the efficacy, safety, and quality of pharmaceuticals. By opening a procurement path for international scale-up partners, the quality assurance of UCL's SP product Wiwal® will increase access and assist build Africa's capacity to fight endemic illnesses.
"Unitaid welcomes the accreditation of UCL to produce this quality-assured antimalarial drug in Africa, where about 95% of all malaria-related illnesses and fatalities occur," said Dr. Philippe Duneton, Executive Director of Unitaid. Building stronger and more resilient health responses requires bolstering local pharmaceutical production where it is most needed.
Children under five make up 80% of all malaria deaths in Africa, making them among the most vulnerable to the disease along with expectant mothers.
Clinically, SP is a generally well-tolerated, efficient, and cost-effective medication used to prevent malaria. However, adequate delivery and scale-up of these interventions are hampered in part by insufficient and unstable supply, and, until now, have solely depended on imported or subpar medications.
According to Perviz Dhanani, Founder/MD of UCL, “UCL is committed to supplying the African continent with quality medicines that are most needed by the people who live here. We are not only the first pharmaceutical company to receive pre-qualification of sulfadoxine-pyrimethamine in Africa, but one of only five manufacturers in Africa to have received this quality certification for any product. We’re filling a much-needed gap.”
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.
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.
The news of Universal Corporation Ltd receiving a WHO Prequalification for sulfadoxine-pyrimethamine is incredible news,” said Ms Joy Phumaphi, Executive Secretary of the African Leaders Malaria Alliance and MMV Board member. “Ensuring the availability and accessibility of quality treatment for underserved communities, particularly women, newborns, and children who are disproportionately at high risk of death from malaria is a critical component to the full realization of the right to health.”