University of Oxford developed and Serum Institute of India (SII) manufactured and scaled up “high efficacy” malaria vaccine has been licensed for use in Ghana by Africa’s Food and Drugs Authority, the university announced on Thursday.
The approval is unusual as it comes before the publication of final-stage trial data.
The R21/Matrix-M vaccine, leveraging Novavax’s adjuvant technology, has been approved for use in children aged 5 to 36 months — the age group at the highest risk of death from malaria. It marks the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country.
This is the first time a major vaccine has been approved in an African country ahead of rich nations, Oxford scientist Adrian Hill said. “Particularly since Covid, African regulators have been taking a much more proactive stance, they’ve been saying...we don’t want to be last in the queue,” Hill said.
“This marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most,” said Professor Adrian Hill, chief investigator of the programme and director of the Oxford University’s Jenner Institute at the Nuffield Department of Medicine.
“As with the Oxford-AstraZeneca Covid-19 vaccine, our partnership with the Serum Institute of India has been key to successful very large-scale manufacturing and rapid development,” he said.
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The R21/Matrix-M malaria vaccine is a low-dose vaccine that can be manufactured at a mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden.
“Malaria is a life-threatening disease that disproportionately affects the most vulnerable populations in our society and remains a leading cause of death in childhood. Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult,” said Adar Poonawalla, chief executive officer of the Serum Institute of India.
The R21/Matrix-M vaccine was initially designed and developed at the University of Oxford and has undergone clinical trials in the UK, Thailand, and several African countries, including an ongoing Phase III trial in Burkina Faso, Kenya, Mali and Tanzania that has enrolled 4,800 children. Results from these trials are expected to be reported later this year.
The vaccine contains Novavax’s Matrix-M, a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This tech has also been used in Novavax’s Covid-19 vaccine and is a key component of other development-stage vaccines.
