Burkina Faso like all West African countries has long grappled with the devastating impact of malaria, particularly among children under the age of five. Recent data reveals a troubling reality, with over 11 million reported cases and nearly 4,000 lives lost annually to the disease. However, the emergence of the R21/Matrix-M malaria vaccine offers a glimmer of hope in this dire health crisis. The World Health Organization (WHO) has approved this vaccine’s use in preventing malaria in children. Beyond Burkina Faso, it has also received licensing for deployment in other African nations like Ghana and Nigeria. This development marks a significant stride in conjunction with other public health measures, such as the use of insecticide-treated bed nets, to safeguard the well-being of millions of children and their families.
The R21/Matrix-MTM malaria vaccine, developed through a collaboration between the Jenner Institute at Oxford University and the Serum Institute of India, supported by organizations like the European & Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB), has showcased remarkable efficacy. The Multi-Stage Malaria Vaccine Consortium, a dedicated initiative focused on creating the first multistage vaccine for malaria targeting the Plasmodium falciparum parasite, has received over a decade of funding from EDCTP. This consortium, featuring researchers from Europe, Africa, and India, conducted extensive trials across Burkina Faso, Kenya, Sierra Leone, and Tanzania. A substantial €15 million grant from EDCTP fueled their efforts. The vaccine demonstrated its promise in the 2021 phase Ib/IIb trial conducted in Burkina Faso, led by Professor Halidou Tinto of the Institute of Research in Health Sciences (IRSS). The trial exhibited a vaccine efficacy of 77% in the higher-dose adjuvant group and 71% in the lower-dose adjuvant group over a 12-month follow-up period, with no significant vaccine-related adverse events. In 2022, a two-year follow-up of infants in Burkina Faso provided further hope. It revealed that a booster dose of R21/Matrix-M, administered one year after the primary regimen, maintained high levels of protection against clinical malaria, achieving an impressive 80% efficacy rate, aligning with the WHO’s preferred efficacy target. Additionally, the Nanoro Clinical Research Unit of the Health Sciences Research Institute (CNRTS/IRSS) made a significant announcement that the R21/Matrix-MTM malaria vaccine has received approval for use in Burkina Faso by the National Agency for Pharmaceutical Regulation (ANRP), specifically for children aged 5 to 36 months, the group most vulnerable to malaria-related mortality.
The majority of the 5,000 children involved in the Phase II and III trials are from Burkina Faso, where the Serum Institute of India has played a pivotal role by supplying the vaccines and funding the ongoing Phase III clinical trial. Notably, the institute has established an annual production capacity of over 200 million vaccine doses. The R21/Matrix-M vaccine combines the R21 antigen, specific to the malaria parasite, developed by the University of Oxford, with the Matrix-MTM adjuvant from Novavax, enhancing the vaccine’s immune response. Development Agenda gathered that the Health Ministry’s decision for vaccine approval draws from the results of the phase II study conducted by the Nanoro Clinical Research Unit in Burkina Faso, published in “The Lancet Infectious Diseases.” The significance of this milestone is evident in the words of Professor Halidou Tinto. He noted the potential to save millions of lives in Africa, reflecting on his research career’s most remarkable achievement on the continent. Professor Jean Bosco Ouédraogo, principal investigator of the phase III clinical trial, reinforced the vaccine’s promise in the fight against malaria and its potential to accelerate malaria elimination in Africa. Professor Adrian Hill, Chief Investigator of the R21/Matrix-M program and Director of the University of Oxford Jenner Institute recognized the vaccine’s potential to transform the battle against malaria. The Chairman and CEO of Novavax, John C. Jacobs, conveyed congratulations to the collaborative partners and their contributions to improving population health. Meanwhile, Dr. Robert Lucien Kargougou, the Minister of Health and Public Hygiene of Burkina Faso emphasized the vaccine’s importance in advancing the malaria elimination program in the country. Professor Adjima Thiombiano, Minister of Higher Education, Research, and Innovation of Burkina Faso, expressed pride in the contributions of local researchers and underscored the vaccine’s potential to impact the health of millions of children in the nation. The Serum Institute of India, with its capacity to produce and market the vaccine in commercial quantities, holds a crucial role in turning this promise into reality.