Today, the results of a Phase-3 efficacy study of the R21/Matrix-M™ malaria vaccine were published in The Lancet. The study was conducted at multiple sites in four African countries and involved 4,800 children aged 5 to 36 months.
The data from this study served as the basis for the recent prequalification of the R21/Matrix-M vaccine by the World Health Organization (WHO) and paved the way for global introduction, which is expected to begin in mid-2024 by the Serum Institute of India. The availability of the R21/Matrix-M vaccine is expected to help bridge the gap for the enormous need for malaria vaccine doses to protect children from the disease.
The publication reported:
- Efficacy of 75% when administered before the peak transmission season: In areas with highly seasonal malaria transmission (where malaria transmission is largely limited to 4 or 5 months per year), the R21/Matrix-M vaccine significantly reduced symptomatic malaria cases by 75% in the 12 months following a 3-dose series.
- Efficacy of 68% when age-specifically administered in regions with constant malaria occurrence in the 12 months following the first three doses.
- The most common adverse events related to the vaccine were fever (47%) and injection site pain (19%).
The vaccine, developed by the University of Oxford and the Serum Institute of India, contains the Novavax-developed saponin-based Matrix-M™ adjuvant. The R21/Matrix-M vaccine is one of several ongoing collaborations related to Novavax’s adjuvant technology, including additional research on malaria and other infectious diseases in humans and animals.
According to the latest WHO data, nearly 250 million malaria cases were reported worldwide in 2022, causing over 609,000 deaths. Most cases occurred in Africa, with children under five years old accounting for the vast majority of deaths in the region.
The vaccine has also been approved by regulatory authorities in Ghana, Nigeria, and Burkina Faso.