The World Health Organization (WHO) has added a new vaccine code-named R21/Matrix-M to its list of prequalified vaccines having initially recommended for use among children early in October.
According to a statement released on Thursday, the pre-qualification means larger access to vaccines as a key tool to prevent malaria in children with it being a prerequisite for vaccine procurement by UNICEF and funding support for deployment by Gavi, the Vaccine Alliance.
The pre-qualification of R21 developed by Oxford University and manufactured by Serum Institute of India follows that of the RTS, S/AS01 vaccine which obtained pre-qualification status in July 2022.
Both vaccines are shown to be safe and effective in clinical trials, for preventing malaria in children and now the WHO says when implemented broadly, along with other recommended malaria control interventions, they are expected to have a high public health impact.
Dr Rogério Gaspar, Director of the Department of Regulation and Prequalification, 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”.
However, the supply of these products is still low. According to an earlier dossier published by UNICEF, over the 2023-2025 period, GSK, the developer and manufacturer of RTS said they would produce approximately 18 million doses in total, with 4 million doses being available for supply from late 2023. The plan was to increase supply availability to 6 million doses in 2024, and 8 million doses in 2025.
Now, the availability of two WHO-recommended and pre-qualified malaria vaccines is expected to increase supply to meet the high demand from African countries and result in sufficient vaccine doses to benefit all children living in areas where malaria is a significant public health risk.
Dr Kate O’Brien, Director of the Department of Immunization, Vaccines and Biologicals, said the second vaccine also targets 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”, she said.
Meanwhile, as part of the prequalification process, WHO evaluates and determines whether vaccines are safe, effective and manufactured to international standards.
Prequalification also supports the specific needs of national immunization programmes about vaccine characteristics such as potency, thermostability, presentation, labelling and shipping conditions.
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.
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