A 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 in London on Thursday.
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 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.
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, CEO of the Serum Institute of India.
"The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives," he said.
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 technology has also been used in Novavax's Covid-19 vaccine and is a key component of other development-stage vaccines.
John C Jacobs, President and Chief Executive Officer, Novavax said, "We're thrilled that Novavax's Matrix-M adjuvant has contributed to the success of this promising and much-needed malaria vaccine.”It is our intention to unlock the potential of our adjuvant, both in the near term and over time, to continue to improve public health."
Meanwhile, SII is said to have already established potential manufacturing capacities of more than 200 million doses annually. The scientists behind the project see this as a critical step towards reducing over half a million malaria-related deaths annually and improving the health outcomes of millions of people in Africa and beyond.
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