APA – Ouagadougou (Burkina Faso) – Following Ghana and Nigeria, Burkina Faso has approved the use of the R21/Matrix-M vaccine to combat malaria in children.
The National Pharmaceutical Regulation Agency (ANRP) has approved the malaria vaccine R21/Matrix-MTM for use in Burkina Faso, according to a press release from Nanoro’s Clinical Research Unit received by APA on Monday morning.
This approval follows clinical trials (involving 5,000 children) that demonstrated “high efficacy and a reassuring safety profile” in children aged 05 to 36 months, the age group most at risk of death from malaria, researchers said.
The R21/Matrix-M vaccine contains the R21 antigen (specific for the malaria parasite) developed by Oxford University and the Matrix-MTM adjuvant manufactured by Novavax.
This adjuvant “enhances the immune response, making it more potent and durable,” according to the research unit.
The licensing of a malaria vaccine is a major achievement for the principal investigator of the R21 Phase II and III trials at Nanoro.
“When we started the Phase II trial in May 2019, I never imagined that 4 years later we would make such a historic decision that will help save millions of lives on our continent, and that’s what makes us very proud today,” Professor Halidou Tinto enthused.
The transitional government welcomed this progress in the fight against malaria, one of the main causes of child mortality in Burkina Faso.
“Following the initial results on the safety and efficacy of this vaccine reported by the Nanoro Clinical Research Unit team in 2021, we were optimistic about its future registration and we are very pleased to see this become a reality today. This vaccine will be an extremely important new tool that will help accelerate the malaria elimination program in Burkina Faso,” said Dr. Robert Kargougou, Minister of Health.
The R21/Matrix-M vaccine will be manufactured and marketed by the Serum Institute of India (SII).
The Institute has already established an annual production capacity of over 200 million doses of this vaccine.
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