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

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Today, the peer-reviewed results of the Phase 3 efficacy trial of the R21/Matrix-M™ malaria vaccine were published. 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 pre-qualification of the R21/Matrix-M vaccine, paving the way for a global rollout expected to begin in mid-2024 by the Serum Institute of India. The availability of the R21/Matrix-M vaccine is expected to help close the huge demand gap for malaria vaccine doses to protect children against the disease.

Publication Report:

  • 75 percent efficacy when administered before high transmission season: In areas with highly seasonal malaria transmission (where malaria transmission is largely limited to 4 or 5 months each year), the R21/Matrix-M vaccine has been shown to reduce symptomatic cases of the disease. Malaria increased by 75 percent at 12 months after the 3-dose series.
  • 68 percent efficacy when administered on an age-based schedule in areas where malaria is persistently present at 12 months after the first 3 doses.
  • The most common adverse events with the vaccine were fever (47%) and pain at the injection site (19%).

Developed by the University of Oxford and the 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 studies in malaria and other infectious diseases in both humans and animals.

According to the most current WHO data, approximately 250 million cases of malaria were reported worldwide in 2022, resulting in more than 609,000 deaths. Most cases occur in Africa, with children under the age of five accounting for most deaths in the region.

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

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