Serum Institute of India-licensed shot is 2nd WHO-approved malaria vaccine in the world

The R21/Matrix-M malaria vaccine has been developed by the University of Oxford and the SII leveraging Novavax's adjuvant technology.


Published Oct 03, 2023 | 6:15 AMUpdatedOct 03, 2023 | 6:15 AM

Serum Institute of India has joined CEPI's vaccine manufacturing network. (Creative Commons)

The Serum Institute of India (SII) on Monday, 2 October, said the World Health Organisation (WHO) had approved a malaria vaccine, paving the way for the global rollout of the world’s second such vaccine.

The recommendation was based on preclinical 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, said the SII in a statement.

The R21/Matrix-M malaria vaccine, developed by the University of Oxford and the SII, leveraging Novavax’s adjuvant technology, has been recommended for use by the WHO.

The vaccine is licensed to the Pune-based SII, and the company has already established production capacity for 100 million doses per annum, which will be doubled over the next two years, it added.

Also read: SII announces Centre of Excellence in Hyderabad

More approvals expected soon

“For far too long, malaria has threatened the lives of billions of people across the globe, disproportionately affecting the most vulnerable amongst us,” noted SII CEO Adar Poonawalla.

This was why the WHO recommendation and approval of the vaccine marked a huge milestone in fighting malaria, he added.

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, the SII stated.

Currently, the vaccine has been licensed for use in Ghana, Nigeria, and Burkina Faso.

The vaccine was developed by the Jenner Institute at Oxford University and SII with support from the European and Developing Countries Clinical Trials Partnership, the Wellcome Trust, and the European Investment Bank.

Also read: Centre waives testing requirement for SII’s Cy-Tb injection