The Institut de Recherche en Sciences de la Santé (IRSS) announced today that the R21/Matrix-M malaria vaccine has been approved for use in children by Burkina Faso’s regulatory agency, Agence Nationale de la Regulation Pharmaceutique (ANRP).

Burkina Faso, where Phase 2b and Phase 3 trials demonstrated high efficacy levels and a reassuring safety profile among children who received a three-dose primary regimen and one booster dose a year later, is the third country in Africa, following Ghana and Nigeria to authorize the vaccine, which will be manufactured and commercialized by Serum Institute of India.

The vaccine contains R21 antigen developed by University of Oxford specific to the malaria parasite and leverages Novavax’s Matrix-M, a saponin-based adjuvant that enhances the immune response, making it more potent and durable. The authorizations are based on Phase 2b trial results published in The Lancet Infectious Diseases, as well as confirmatory Phase 3 results that are anticipated for future publication.

“Novavax is delighted to see our Matrix-M adjuvant contribute to a variety of partnerships to improve public health, and we are actively pursuing additional opportunities in which we can apply this technology with the aim to enhance vaccines,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “We congratulate our partners at University of Oxford, Serum Institute of India, and the clinical investigators at IRSS for this significant achievement.”

The R21/Matrix-M vaccine work is one of several ongoing collaborations in which Novavax’s adjuvant technology is being leveraged, including additional research in malaria, tuberculosis, and other infectious diseases in both humans and animals. The Company recently announced a collaboration with the Bill & Melinda Gates Medical Research Institute in which Matrix-M will be provided for use in preclinical vaccine research.