R21/Matrix-M Malaria vaccine with Novavax’s adjuvant technology receives WHO Recommendation.

The vaccine contains R21 antigen developed by University of Oxford, specific to the malaria parasite, and Novavax’s Matrix-M, a saponin-based adjuvant that enhances the immune response, making it broader and more durable. The filing was submitted to the WHO by Oxford and the vaccine is being developed and manufactured by Serum Institute of India.

The recommendation is a required step on the pathway to the WHO’s prequalification (PQ) of the vaccine, which aims to ensure the safety and efficacy of vaccines through extensive inspection and assessment of data. PQ designation is necessary for United Nations agencies (e.g., UNICEF) and Gavi to procure the vaccine for eligible countries.

This is the first recommendation from WHO to support the use of a vaccine containing Novavax’s Matrix-M adjuvant in children as young as five months of age. It is based on a review of evidence that included results from a Phase 3 clinical trial conducted in four African countries with 4,800 children aged 36 months to five years. These results were shared in a manuscript that was posted on Preprints with the Lancet, and is in review for publication under the peer review process. The R21/Matrix-M vaccine is one of several ongoing collaborations involving Novavax’s adjuvant technology, including additional research in malaria, tuberculosis and other infectious diseases in both humans and animals.