Phase IIb and phase III trials in Burkina Faso, have demonstrated high efficacy levels and a reassuring safety profile among children who received a three-dose primary regimen and one booster dose a year later. The vaccine has been approved for use in children aged 5 to 36 months, the age group at the highest risk of death from malaria. Burkina Faso is the third country in Africa, following Ghana and Nigeria, to authorize the vaccine, which will be manufactured and commercialized by the Serum Institute of India.
Oxford researchers and partners of the clinical Research unit of Nanoro, Burkina Faso, reported last year from a Phase IIb trial that a booster dose of R21/Matrix-M, at one year, following a primary three-dose regime, maintained high efficacy level against malaria and continued to meet the World Health Organization’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase-IIb trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial conducted in Burkina Faso, Kenya, Mali, and Tanzania and that has enrolled 4,800 children also confirm high levels of efficacy and a reassuring safety profile as reported in the Phase 2b trial in Burkina Faso. Most of the >5000 children enrolled across the phase II and III trials were recruited in Burkina Faso. Notably, Serum Institute of India has provided vaccines and sponsored Phase III licensure clinical trials, demonstrating its commitment to combatting malaria, having already established potential manufacturing capacities of more than 200 million doses annually.
The vaccine contains R21 antigen, developed by the University of Oxford specific to the malaria parasite and leverages Novavax’s Matrix-M™, a saponin-based adjuvant that enhances the immune response, making it more potent and durable. The authorizations are based on Phase IIb study results published in The Lancet Infectious Diseases, as well as confirmatory phase III results that are anticipated for future publication.
Professor Halidou Tinto, Director in Parasitology, Regional Director of IRSS, and the Principal Investigator of the R21 phase IIb and III trials in Nanoro said:
‘The regulatory licensure of a malaria vaccine with such unprecedented safety and efficacy levels is the most exciting milestone reached in my career of researcher in Africa. When we started the Phase II trial in May 2019, I never imagined that 4 years later we’ll reach such an historical decision that will contribute to save millions of lives in our continent and that is what makes us very proud.’