WHO Prequalifies a Second Malaria Vaccine – WHO has added the R21/Matrix-M malaria vaccine to its list of prequalified vaccines. Following the recommendations of the Malaria Policy Advisory Group and the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, the World Health Organization (WHO) recommended its use in October 2023 for the prevention of 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.
The R21 vaccine is the second malaria vaccine prequalified by WHO, following the RTS,S/AS01 vaccine which obtained prequalification status in July 2022. Both vaccines are shown to be safe and effective in clinical trials, for preventing malaria in children. When implemented broadly, along with other recommended malaria control interventions, they are expected to have a high public health impact. Malaria, a mosquito-borne disease, places a particularly high burden on children in the African Region, where nearly half a million children die from the disease each year. Globally, in 2022, there were an estimated 249 million malaria cases and 608 000 malaria deaths across 85 countries.
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 immunization 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.
Dr Rogério Gaspar, Director of the Department of Regulation and Prequalification at WHO said: “Achieving WHO vaccine prequalification ensures that vaccines used in global immunization programmes are safe and effective within their conditions of use in the targeted health systems. WHO evaluates multiple products for prequalification each year and core to this work is ensuring greater access to safe, effective and quality health products”.
Dr Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines and Biologicals, 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.”
As part of the prequalification process, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe, effective and manufactured to international standards. WHO also ensures the continued safety and efficacy of prequalified vaccines through, for example, regular re-evaluation, site inspection and targeted testing. Prequalification supports the specific needs of national immunization programmes with regards to vaccine characteristics such as potency, thermostability, presentation, labelling and shipping conditions.