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R21/Matrix-M™ Malaria Vaccine Granted Prequalification by World Health Organization
The World Health Organization (WHO) announced today that it has prequalified the R21/Matrix-M™ malaria vaccine to prevent malaria disease in children caused by the P. falciparum parasite in endemic areas. Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and will enable global rollout of the vaccine.
Prequalification is based on WHO recommendation and advice from its Strategic Advisory Group of Experts and Malaria Policy Advisory Group, which reviewed data from a Phase 3 clinical trial conducted in four African countries with 4,800 children aged 5-36 months. A manuscript describing the results of the trial has been posted to Preprints with the Lancet and is currently undergoing peer review.
Developed by University of Oxford and Serum Institute of India, the vaccine leverages Novavax’s saponin-based Matrix-M adjuvant. The R21/Matrix-M vaccine is one of several ongoing collaborations involving Novavax’s adjuvant technology, including additional research in malaria and other infectious diseases in both humans and animals.
According to the WHO, there were 249 million cases of malaria in 2022. Approximately 94% of the cases were in Africa, with children under the age of five accounting for about 78% of deaths in the region.1
The vaccine is approved for use by regulators in Ghana, Nigeria and Burkina Faso.
More information about the R21/Matrix-M vaccine may be found here.
