WHO Prequalifies Second Malaria Vaccine, R21/Matrix-M

The World Health Organisation (WHO) has pre-qualified the R21/Matrix-M vaccine for malaria prevention in children, making it the second approved vaccine after the RTS, S/AS01 vaccine which obtained prequalification status in July 2022.

WHO announced the development in a statement issued on Thursday, December 21, 2023.

The WHO’s decision, guided by its expert advisory groups, paves the way for broader access to this vital tool in fighting malaria. Prequalification signifies that the vaccine meets international standards for safety, efficacy, and quality, making it eligible for procurement by UNICEF and funding support from Gavi, the Vaccine Alliance.

Widespread implementation of these vaccines, alongside existing malaria control measures, is expected to have a significant public health impact, particularly in the African Region where the mosquito-borne disease claims the lives of nearly half a million children annually. With an estimated 249 million malaria cases and 608,000 deaths globally in 2022, the need for effective prevention tools remains critical.

The pre-qualification of the R21 vaccine, developed by Oxford University and manufactured by the Serum Institute of India, is poised to expand access to malaria prevention through vaccination. This is particularly impactful considering the high demand for malaria vaccines that has outstripped supply so far. With two pre-qualified options now available, African countries can expect increased vaccine availability to protect their vulnerable populations.

WHO’s Director of the Department of Regulation and Prequalification, Dr. Rogério Gaspar stressed the importance of prequalification in ensuring safe and effective vaccines for global immunisation programs. He highlighted the continuous evaluation of products for prequalification as a central aspect of their commitment to increasing access to quality health products.

On her part, Director of WHO’s Department of Immunisation, Vaccines, and Biologicals, Dr. Kate O’Brien, said, “Today marks a huge stride in global health as we welcome the prequalification of R21/Matrix-M, the second malaria vaccine recommended for children in malaria-endemic areas.

“This achievement underscores our relentless commitment to wiping out malaria which remains a formidable foe causing child suffering and death. This is another step toward ensuring a healthier, more resilient future for those who have lived for too long in fear of what malaria could do to their children. Together with our partners, we are united in the pursuit of a malaria-free future, where every life is shielded from the threat of this disease”.

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