WHO Recommends R21/Matrix-M Malaria Vaccine for Wider Use

October 3, 2023

The World Health Organization (WHO) has recommended the R21/Matrix-M malaria vaccine, a product of collaboration between the University of Oxford and the Serum Institute of India, employing Novavax’s adjuvant technology. Following rigorous safety and efficacy evaluations by WHO’s expert committees, this vaccine has received the green light for use, marking a significant milestone in the fight against malaria.

WHO Approval and Next Steps

The WHO, after an exhaustive scientific review by its independent advisory bodies, SAGE and MPAG, has endorsed the R21/Matrix-M malaria vaccine.
The Serum Institute of India announced the WHO’s approval, with expectations of additional regulatory approvals in the near future.
Wider distribution of R21/Matrix-M vaccine doses is anticipated to commence as early as the next year.

Production and Scaling Up

The Serum Institute of India has already established production capabilities for 100 million vaccine doses annually, with plans to double this capacity over the next two years.
This substantial production capacity is vital for vaccinating individuals at high risk of malaria, effectively curbing the spread of the disease and safeguarding those who receive the vaccine.

The Role of Matrix-M Adjuvant

Matrix-M, an adjuvant developed by Novavax, plays a pivotal role in enhancing the vaccine’s effectiveness.
The Serum Institute holds the license to use Matrix-M in endemic countries, while Novavax retains commercial rights in non-endemic regions.

Collaborative Development

The R21/Matrix-M malaria vaccine was developed through a collaboration between the Jenner Institute at Oxford University and the Serum Institute of India.
Funding and support for its development came from organizations such as the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB).

Geographic Licensing and Phase III Trial

Licensing for the vaccine has been granted in Ghana, Nigeria, and Burkina Faso, reflecting its safety and efficacy.
A pivotal Phase III clinical trial, primarily funded by the Serum Institute of India with Oxford University as the regulatory sponsor, recently reached its one-year endpoint.
The trial involved 4,800 children across Burkina Faso, Kenya, Mali, and Tanzania, and the results are currently undergoing peer review.

Efficacy Data and Future Prospects

The vaccine demonstrated promising efficacy in Phase III trials, with a 75% effectiveness rate in areas with high seasonal malaria transmission and 68% in regions with more perennial transmission when administered according to age-based standards.
While there was some decline in efficacy over the first year of follow-up, a booster dose was found to restore efficacy, resulting in a vaccine efficacy of 74% over 18 months.
Adar Poonawalla, CEO of the Serum Institute of India, expressed commitment to expanding vaccine production to make it accessible to those in need.
John C. Jacobs, President and CEO of Novavax, highlighted the potential of this vaccine to save lives and control malaria, especially among children who are disproportionately affected by the disease.

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