WHO Grants First Prequalification Approval for Infant-Specific Malaria Treatment
Introduction
The World Health Organization has granted prequalification approval to a new antimalarial formulation designed specifically for newborns and infants, marking a first in the agency's history. The decision, announced on April 24, applies to the drug artemether-lumefantrine.
Main Body
The WHO stated that the prequalification status confirms the medicine meets international standards of quality, safety, and efficacy. Artemether-lumefantrine is the first antimalarial product made specifically for the youngest patients of the mosquito-borne disease. Previously, infants received treatments intended for older children, a practice that had a higher risk of dosage errors, side effects, and toxicity. The importance of this development is clear from the global situation. According to WHO data from 2024, there were an estimated 282 million malaria cases and 610,000 deaths across 80 countries. Africa accounts for 95 percent of both cases and deaths, with children under five representing three-quarters of those deaths. The WHO noted that progress against malaria is hindered by drug resistance, insecticide resistance, diagnostic failures, and large cuts in foreign aid spending. The prequalification approval is expected to help public sector purchases and address a long-term treatment gap for approximately 30 million infants born each year in malaria-endemic regions of Africa. Furthermore, globally, 70 percent of countries lack strong regulatory systems to oversee medicines, vaccines, tests, and medical devices. The WHO prequalification program ensures that key health products for international procurement meet global standards for quality, safety, efficacy, and performance. WHO Director-General Tedros Adhanom Ghebreyesus spoke about this milestone. He noted that malaria has historically caused a lot of harm to children and communities. He stated that new vaccines, diagnostic tests, next-generation mosquito nets, and effective medicines—including those adapted for the youngest—are helping to change the direction of the disease. He further asserted that ending malaria within the current generation is a realistic goal, but it depends on continued political and financial commitment.
Conclusion
This prequalification approval is a specific action to reduce the risk of illness and death from malaria among the most vulnerable group. While the measure addresses an important lack of treatment, the WHO emphasizes that continued investment and improvements to the system are necessary to keep making progress toward eliminating malaria.