The World Health Organization (WHO) has recently added the R21/Matrix-M malaria vaccine to its roster of prequalified vaccines, marking a pivotal advancement in the fight against malaria.

Following the recommendation by the WHO Strategic Advisory Group of Experts (SAGE) on Immunisation and the Malaria Policy Advisory Group in October 2023, this vaccine has gained WHO's endorsement for preventing malaria in children.

The prequalification status signifies a significant milestone as it facilitates broader access to vaccines, positioning them as a crucial tool in combating malaria among children. This status is a prerequisite for vaccine procurement by UNICEF and secures funding support from Gavi, the Vaccine Alliance, for deployment purposes.

The R21 vaccine becomes the second malaria vaccine to receive WHO's prequalification, following the RTS,S/AS01 vaccine, which attained prequalification status in July 2022. Clinical trials have validated the safety and efficacy of both vaccines in preventing malaria among children. When integrated into widespread use alongside other recommended malaria control measures, these vaccines are anticipated to yield substantial public health benefits.

Malaria poses a disproportionately high risk to children in the African Region, claiming the lives of nearly half a million children annually. Globally, in 2022 alone, there were an estimated 249 million malaria cases and 608,000 malaria-related deaths across 85 countries.

Developed by Oxford University and manufactured by the Serum Institute of India, the prequalification of the R21/Matrix-M malaria vaccine is poised to revolutionize access to malaria prevention through vaccination. The demand for these vaccines has been substantial, but supply limitations have persisted. With two WHO-recommended and prequalified malaria vaccines now available, the expected surge in supply aims to cater to the urgent demand from African nations, ensuring adequate vaccine doses for all children residing in malaria-prone areas.

Dr. Rogério Gaspar, Director of the WHO Department of Regulation and Prequalification, emphasized, “WHO’s vaccine prequalification ensures the safety and efficacy of vaccines used in global immunisation programs within targeted health systems.”

Dr. Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines, and Biologicals, hailed the prequalification of R21/Matrix-M as a monumental stride in global health. She emphasized the commitment to eradicating malaria, highlighting the vaccine's role in shielding children from the disease’s devastating impact.

Through meticulous evaluation against international standards, WHO’s prequalification process validates vaccine safety, effectiveness, and compliance with global manufacturing standards, ensuring greater access to quality health products. This achievement signifies a significant step forward in realizing a future free from the threats posed by malaria, fostering resilience and health for communities long burdened by the disease's impact.