WHO Prequalifies R21/Matrix-M Malaria Vaccine Produced by Serum Institute of India

The World Health Organization (WHO) has officially granted prequalification status to the R21/Matrix-M malaria vaccine, an essential regulatory milestone that confirms the drug's safety, quality, and efficacy. Developed by scientists at the University of Oxford and manufactured at scale by the Serum Institute of India (SII), the vaccine becomes only the second malaria immunization product to achieve prequalification.

WHO prequalification serves as a prerequisite for multilateral procurement agencies, notably UNICEF and the Pan American Health Organization (PAHO), to purchase doses on behalf of developing nations. It also unlocks substantial financial subsidization through Gavi, the Vaccine Alliance, enabling governments in sub-Saharan Africa to integrate the vaccine into routine immunization programs.

Prequalification Milestone Unlocks Global Procurement Channels

Malaria remains one of the deadliest parasitic infections in human history, claiming more than 600,000 lives annually, with nearly 80 percent of fatal cases occurring among African children under the age of five. The R21 vaccine incorporates Novavax's proprietary saponin-based Matrix-M adjuvant, stimulating a potent and durable immune response against the mosquito-borne Plasmodium falciparum parasite.

Clinical trials conducted across Burkina Faso, Kenya, Mali, and Tanzania demonstrated that R21 achieves up to 77 percent efficacy over 12 months when administered in seasonal transmission settings prior to the rainy season. A booster dose given one year later maintains high protective antibody levels.

“Achieving WHO prequalification for R21 is a monumental breakthrough in global health equity, ensuring millions of life-saving vaccine doses reach vulnerable children across Africa.” — Adar Poonawalla, Chief Executive Officer of Serum Institute of India

Affordable Scalability to Protect Vulnerable Children Across Africa

A decisive advantage of the R21 vaccine lies in its production economics and manufacturing capacity. The Serum Institute of India, the world's largest vaccine manufacturer by volume, has already established dedicated production lines capable of manufacturing over 100 million doses annually at a price point below four dollars per dose.

The availability of two prequalified malaria vaccines—alongside the previously approved RTS,S—finally resolves chronic global supply constraints. Public health leaders project that widespread vaccination will avert tens of thousands of infant deaths each year as nationwide distribution begins across more than a dozen endemic countries.

Sources

• World Health Organization
• Serum Institute of India