Malaria vaccine co-developed by Serum Institute will bridge supply gap: Adar Poonawalla

To date, the R21/Matrix-M malaria vaccine has been licensed for use in Ghana, Nigeria and Burkina Faso.

Pune: As malaria vaccine developed by the University of Oxford and the Serum Institute of India (SII) has been recommended for use by the World Health Organisation (WHO), SII chief Adar Poonawalla said that the combined efforts of both of them have come to fruition.

“This will save thousands of lives in Africa afflicted by Malaria, and help bridge the vast gap between the demand and supply of vaccines to fight this terrible disease,” he wrote on X, as he thanked WHO for the milestone achieved.

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On Monday, the R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India has been recommended for use by the World Health Organisation (WHO) after meeting required safety, quality and effectiveness standards.

Following a rigorous, detailed scientific review by the WHO’s independent advisory body, the Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG), the R21/Matrix-M malaria vaccine has been recommended for use.

“The recommendation was based on pre-clinical and clinical trial data which showed good safety and high efficacy in four countries, at sites with both seasonal and perennial malaria transmission, making it the world’s second-ever WHO recommended vaccine for preventing malaria in children,” Serum Institute of India said in a statement on Monday.

The vaccine was developed by the Jenner Institute at Oxford University and Serum Institute of India with support from the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank.

To date, the R21/Matrix-M malaria vaccine has been licensed for use in Ghana, Nigeria and Burkina Faso.

“In combination with public health measures such as the use of insecticide-treated bed nets, this vaccine can help save and improve the lives of millions of children and their families,” SII added.

The vaccine has recently reached the primary one-year endpoint in a pivotal large-scale Phase III clinical trial  funded mainly by the Serum Institute of India, with Oxford University as the regulatory sponsor including 4,800 children across Burkina Faso, Kenya, Mali and Tanzania. The Phase III trial results are under peer review before publication.

Serum Institute of India further said that with the approval and recommendations by the WHO, additional regulatory approvals are expected to follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out as early as next year.