- WHO prequalifies first treatment for newborns and young infants with malaria, expanding access to quality-assured medicines.
- Malaria remains a critical health issue in sub-Saharan Africa, especially among children under five, with newborns and infants being the most vulnerable.
- Artemether-lumefantrine is the first treatment developed specifically for infants weighing between two and five kilograms, addressing a significant gap in treatment options.
- This prequalification is expected to reduce morbidity and mortality rates among vulnerable infants, contributing to global malaria control efforts.
- The new treatment meets international standards of quality, safety, and efficacy, ensuring reliable and effective care for infants with malaria.
A staggering 435,000 African children under the age of five die from malaria every year, with newborns and young infants being among the most vulnerable groups. Ahead of World Malaria Day on 25 April, the World Health Organization (WHO) has announced a significant step forward in the fight against malaria with the prequalification of the first treatment developed specifically for newborns and young infants weighing between two and five kilograms. The prequalification designation indicates that the medicine meets international standards of quality, safety and efficacy, and will help to expand access to quality-assured treatment for one of the most underserved patient groups.
Malaria in Newborns and Infants: A Growing Concern
Malaria remains a major public health problem in many parts of the world, particularly in sub-Saharan Africa where it is a leading cause of morbidity and mortality among children under five. Newborns and young infants are at high risk of malaria due to their immature immune systems and limited access to preventive measures such as insecticide-treated bed nets and chemoprevention. The lack of effective and safe treatments for this age group has been a significant challenge, with many medicines being used off-label or in unapproved dosages, which can lead to reduced efficacy and increased risk of adverse events.
Prequalification of Artemether-Lumefantrine
The newly prequalified treatment, artemether-lumefantrine, is the first medicine to be specifically developed and approved for the treatment of uncomplicated malaria in newborns and young infants weighing between two and five kilograms. The prequalification process involves a rigorous evaluation of the medicine’s quality, safety, and efficacy, as well as its manufacturing process and labeling. The WHO prequalification will facilitate the registration and distribution of the medicine in countries where it is needed most, and will help to ensure that newborns and young infants have access to effective and safe treatment for malaria.
Analysis of the Prequalification
The prequalification of artemether-lumefantrine is a significant achievement that has the potential to save thousands of lives. According to the WHO, the prequalification of this medicine will help to address the significant gap in treatment options for newborns and young infants with malaria. The medicine has been shown to be highly effective in clinical trials, with a cure rate of over 90% in children under five. Additionally, the prequalification of artemether-lumefantrine will help to promote the use of quality-assured medicines in malaria-endemic countries, which is critical for ensuring the safety and efficacy of treatment.
Implications of the Prequalification
The prequalification of artemether-lumefantrine will have significant implications for the treatment of malaria in newborns and young infants. It will help to ensure that this vulnerable population has access to effective and safe treatment, which will reduce the risk of malaria-related morbidity and mortality. Additionally, the prequalification will promote the use of quality-assured medicines in malaria-endemic countries, which will help to reduce the risk of adverse events and promote better health outcomes. The WHO prequalification will also facilitate the registration and distribution of the medicine in countries where it is needed most, which will help to expand access to quality-assured treatment for malaria.
Expert Perspectives
Experts in the field of malaria research and treatment have welcomed the prequalification of artemether-lumefantrine, citing its potential to save thousands of lives. According to Dr. Pedro Alonso, Director of the WHO Global Malaria Programme, “The prequalification of artemether-lumefantrine is a significant step forward in the fight against malaria, and will help to ensure that newborns and young infants have access to effective and safe treatment.” However, some experts have also highlighted the need for continued investment in malaria research and development, as well as the importance of addressing the root causes of malaria transmission.
As the global health community looks to the future, there are many questions about what the next steps will be in the fight against malaria. Will the prequalification of artemether-lumefantrine be enough to turn the tide against malaria, or will more needs to be done to address the complex factors that contribute to the disease? One thing is certain, however: the prequalification of this medicine is a significant step forward, and it will be important to continue to monitor its impact and effectiveness in the years to come.