Serum Institute’s R21/Matrix-M Malaria Vaccine Granted WHO Prequalification

December 23, 2023

In a significant milestone in the fight against malaria, the World Health Organization (WHO) granted prequalification to the R21/Matrix-M malaria vaccine developed by the University of Oxford and manufactured by the biotechnology company Serum Institute of India. The announcement, made on December 21, 2023, signifies that the vaccine meets WHO standards for quality, safety, and efficacy.

Key Achievements and Recommendations

The R21/Matrix-M malaria vaccine had earlier received the WHO’s recommendation for use in preventing malaria in children on October 2, 2023. The recent prequalification ensures that the vaccine adheres to rigorous evaluation processes, including testing of samples, data analysis, and WHO inspection of manufacturing sites.

Prequalification for Global Access

The WHO’s List of Prequalified Vaccines is a crucial step in making the vaccine more widely accessible. Prequalification is a prerequisite for vaccine procurement by the United Nations Child Rights body UNICEF and allows for funding support for deployment by Gavi, the Vaccine Alliance. The WHO’s evaluation also considers the vaccine’s suitability for the target population, usability with other products, and compliance with operational specifications for packaging and presentation.

Efficacy and Impact

The R21/Matrix-M vaccine has demonstrated high effectiveness, reducing malaria cases by an impressive 75 percent over one year in clinical trials. This success surpasses the performance of previous vaccines, providing renewed hope in the fight against the mosquito-borne disease. Serum Institute’s capacity to produce hundreds of millions of doses annually is a crucial factor in ensuring widespread availability.

Affordability and Accessibility

In addition to its efficacy, the R21 vaccine is expected to be more affordable, priced at around $5 per dose at high volumes. This affordability factor is crucial for enhancing accessibility in regions heavily affected by malaria, particularly in Africa. The vaccine’s approval follows the RTS,S/AS01 malaria shot, which received WHO approval in July 2022.

Global Impact and Malaria Statistics

Both the R21/Matrix-M and RTS,S/AS01 vaccines are anticipated to have a substantial public health impact when implemented alongside other recommended malaria control interventions. Malaria, which disproportionately affects children in the African region, claims nearly half a million lives each year. In 2022 alone, there were an estimated 249 million malaria cases globally, resulting in 608,000 malaria-related deaths across 85 countries.

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