Ghana approves University of Oxford's malaria vaccine ahead of key WHO review

Ghana is officially the first country to approve the University of Oxford’s malaria vaccine, marking a major win for the program after decades of research.

The African country's drug regulator approved the vaccine before its review could be completed with the World Health Organization (WHO). The shot, known as the R21/Matrix-M malaria vaccine, achieved 77% efficacy over 12 months of follow-up in a phase 2b trial. Those results made it the first malaria vaccine to meet the WHO’s 75% target for malaria vaccine efficacy.

Still, late-stage data on the vaccine have yet to be published.

The vaccine is manufactured by the Serum Institute of India and leverages Novavax's adjuvant technology called Matrix-M. It’s a low-dose shot that can be manufactured at “mass scale and modest cost,” according to a recent University of Oxford statement. The approval covers children aged 5 months to 36 months, who face the highest risk of malaria-caused fatalities.  

“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,” Prof. Adrian Hill, director of the University of Oxford’s Jenner Institute at the Nuffield Department of Medicine and chief investigator of the R21/Matrix-M vaccine program, said in the University of Oxford statement.

R21/Matrix-M is still being studied in phase 3 trials in Burkina Faso, Kenya, Mali and Tanzania. Late-stage data are expected later this year.

Elsewhere on the malaria vaccine landscape, GSK’s Mosquirix last September scored WHO prequalification after more than 30 years of research. It’s been available in Malwai, Kenya and Ghana since 2020 thanks to the WHO’s pilot launch program.

GSK recently inked a $170 million supply contract with the United Nations Children’s Fund (UNICEF) for 18 million doses over the next three years.

In 2021, WHO estimated a total of 5.3 million malaria cases in Ghana led to an estimated 12,500 deaths.