Phase 3 trial of new malaria vaccine reveals promising results in protecting children

Today, peer-reviewed results from a Phase 3 efficacy trial of the R21/Matrix-M™ malaria vaccine were published in The Lancet. The study was conducted across multiple sites in four African countries with 4,800 children aged 5-36 months.

Data from this trial served as the basis for the World Health Organization’s (WHO) recent prequalification of the R21/Matrix-M vaccine, paving the way for a global rollout that is expected to commence in mid-2024 by Serum Institute of India. Availability of the R21/Matrix-M vaccine is expected to help close the gap for the vast demand for malaria vaccine doses to protect children against the disease.

The publication reported:

  • Efficacy of 75 percent when administered prior to the high 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 was shown to reduce symptomatic cases of malaria by 75 percent during the 12 months following a 3-dose series.
  • Efficacy of 68 percent when administered in an age-based schedule in regions where malaria is present perennially during the 12 months following the first 3 doses.. 
  • The most common adverse events with the vaccine were fever (47%) and injection site pain (19%).

Developed by University of Oxford and Serum Institute of India, the vaccine contains 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 most current WHO data, almost 250 million cases of malaria were reported globally in 2022, causing upwards of 609,000 deaths. Most cases occurred in Africa, with children under the age of five accounting for the vast majority of deaths in the region.

The vaccine has also been licensed by regulators in Ghana, Nigeria and Burkina Faso. 

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