The R21/Matrix-M malaria vaccine is now included in the WHO's list of vaccines that are prequalified. Following the recommendations of the Malaria Policy Advisory Group and the WHO Strategic Advisory Group of Experts (SAGE) on Immunisation, the WHO recommended its use in October 2023 to prevent malaria in children. Prequalification is a requirement for UNICEF to purchase vaccinations and for Gavi, the Vaccine Alliance, to provide finance support for their deployment, which means that more children will have access to vaccines as a crucial tool in the fight against malaria.
Following the RTS,S/AS01 vaccine, which received prequalification status in July 2022, the R21 vaccine is the second malaria vaccine that the WHO has prequalified. Clinical trials have demonstrated the safety and efficacy of both vaccinations in preventing childhood malaria. They are anticipated to have a significant influence on public health when widely applied in conjunction with other suggested interventions for the control of malaria. The African Region bears a disproportionately high burden of malaria, a mosquito-borne disease that claims the lives of about half a million children annually. An estimated 249 million cases of malaria and 608 000 malaria-related fatalities occurred worldwide in 85 countries in 2022.
Prequalification of the second malaria vaccine in history, created by Oxford University and produced by Serum Institute of India, is about to increase access to immunisation for the prevention of malaria. Vaccines against malaria are in high demand, but there hasn't been a lot of supplies available. It is anticipated that the availability of two malaria vaccines that are prequalified and recommended by the WHO will boost supply to satisfy the high demand from African nations and provide enough doses of the vaccine to protect all children residing in places where malaria poses a serious risk to public health.
"Achieving WHO vaccine prequalification ensures that vaccines used in global immunisation programmes are safe and effective within their conditions of use in the targeted health systems," stated Dr. Rogério Gaspar, Director of the Department of Regulation and Prequalification at WHO. The primary goal of WHO's annual prequalification evaluation of several items is to increase access to high-quality, safe, and effective healthcare products.
"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," stated Dr. Kate O'Brien, Director of the World Health Organization's Department of Immunisation, Vaccines and Biologicals. This accomplishment highlights our unwavering dedication to eliminating malaria, which continues to be a deadly and debilitating disease for children. This is another step in the direction of giving those who have lived for far too long in terror of what malaria could do to their children a healthier, more resilient future. We are unified in our quest for a world free of malaria, where no life is threatened by the illness, along with our partners.
WHO uses international standards as part of the prequalification process to thoroughly assess and establish if vaccinations are safe, effective, and produced in accordance with international standards. WHO also makes sure that prequalified vaccines remain safe and effective by conducting focused testing, site inspections, and routine reevaluations, among other measures. Prequalification provides vaccine qualities like potency, thermostability, presentation, labelling, and shipping conditions to meet the unique requirements of country immunisation schemes.
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