The World Health Organization (WHO) has granted approval to a groundbreaking vaccine known as R21/Matrix-M, giving it the prestigious status of a prequalified vaccine. This significant endorsement, announced early in October, represents a crucial advancement in the fight against malaria, especially for children.
In a statement released on Thursday, WHO emphasized that this prequalification opens up broader access to the vaccine, playing a vital role in UNICEF’s vaccine procurement and facilitating deployment with the support of Gavi, the Vaccine Alliance.
The approval for R21, developed by Oxford University and produced by the Serum Institute of India, follows in the footsteps of the RTS, S/AS01 vaccine, which received prequalification in July 2022.
Rigorous clinical trials have confirmed the safety and effectiveness of both vaccines in preventing malaria in children. WHO suggests that when strategically implemented alongside recommended malaria control measures, these vaccines have the potential to make a significant impact on public health.
Dr. Rogério Gaspar, the distinguished Director of the Department of Regulation and Prequalification at WHO, explained, “Securing WHO vaccine prequalification ensures that vaccines used in global immunization efforts are not only safe but also effective under the specified conditions of use in the targeted health systems.
Our primary focus is on evaluating multiple products for prequalification annually, with the ultimate goal of ensuring improved access to health products that are both safe and of high quality.”
However, despite commendable progress in prequalification, the supply of these crucial vaccines remains somewhat limited. According to a document revealed by UNICEF, GSK, the creator of RTS, pledged to produce a modest quantity of approximately 18 million doses between 2023 and 2025.
Only 4 million doses are allocated for distribution starting late 2023, with plans to increase this supply to 6 million doses in 2024 and further to 8 million doses in 2025.
The fortuitous availability of two WHO-endorsed and prequalified malaria vaccines signals an increase in supply, poised to meet the growing demand from the African continent. This is a positive development for the prospect of accumulating sufficient vaccine doses, offering a solution for children in regions where malaria poses a severe public health threat.
Dr. Kate O’Brien, renowned Director of the Department of Immunization, Vaccines, and Biologicals, emphasized the significance of the second vaccine, focusing on children living in malaria-endemic areas. “This achievement underscores our unwavering commitment to eradicating malaria—a formidable adversary causing suffering and mortality in children. It signifies another step towards ensuring a stronger and healthier future for those who have endured the specter of malaria for too long. In collaboration with our partners, we stand united in the pursuit of a future free from the clutches of malaria, where every life is protected against this insidious disease,” she declared.
In line with the prequalification process, WHO rigorously evaluates the safety, efficacy, and adherence to international standards in vaccine manufacturing. This commitment is supported by tailoring vaccines to the unique needs of national immunization programs, including crucial aspects such as potency, stability, presentation, labeling, and shipping conditions.
Malaria, a disease transmitted by mosquitoes, takes a particularly heavy toll on the pediatric population in the African Region, where nearly half a million children succumb to its effects each year. Globally, 2022 witnessed an estimated 249 million malaria cases and 608,000 malaria-related deaths across 85 nations.