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.’
Professor Jean Bosco Ouedraogo the Principal Investigator of the phase III trial site in Dandé (Burkina Faso) said : ‘The Phase III of the R21 vaccine trial has confirmed the results of the phase II and is now becoming the most promising malaria vaccine to prevent malaria. With this regulatory approval we are proud to see our research findings translated into policy. I remain convinced and confident that this vaccine will contribute to accelerate the agenda of malaria elimination in Africa where this disease continue to claim thousands of victims every year.’
The R21/Matrix-M malaria vaccine is a low-dose vaccine that can be manufactured at hundreds of millions of doses to satisfy the high demand of Africa endemic countries which are suffering a significant malaria burden.
Professor Adrian Hill, Chief investigator, R21/Matrix-M programme, and Director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine, said:
‘We welcome this further regulatory approval from another African country where malaria is a major health concern, and a low-cost high-efficacy vaccine, such as R21/Matrix-M, could have a transformative impact on malaria control. Early deployment of this vaccine would recognise the exceptional contributions the research teams in the country have made to the thorough safety and efficacy evaluations of this new product.’
John C. Jacobs, President and Chief Executive Officer, Novavax said: ‘We congratulate our partners at University of Oxford, Serum Institute of India, and the clinical investigators at Clinical research Unit of Nanoro in Burkina Faso for this significant achievement.’
‘Novavax is delighted to see our Matrix-M adjuvant contribute to a variety of partnerships to improve public health, and we are actively pursuing additional opportunities in which we can apply this technology with the aim to enhance additional vaccines.’
Dr Robert Lucien Kargougou the Ministry of Health in Burkina Faso said:
‘Malaria is one of the leading causes of childhood mortality in Burkina Faso. Following the first safety and efficacy data reported in 2021 in Nanoro with this vaccine, we were optimistic about the future licensure of the R21/Matrix-M vaccine and we are very happy to see it happened today. This vaccine would be an extremely important new tool that will contribute to accelerate the agenda of malaria elimination in Burkina Faso.’
Professor Adjima Thiombiano Ministry of High Education, Research and Innovation in Burkina Faso said:
‘I am proud of Burkina Faso researchers who made a great contribution to reach this important milestone. With this licensure, we provide the Ministry of Health with a new tool that would have a real impact on this disease affecting millions of children every year in our country.’