WHO Prequalifies First Malaria Treatment for Newborns and Infants
The World Health Organization (WHO) has prequalified Coartem® Baby, the first-ever antimalarial treatment specifically formulated for newborns and young infants weighing 2 to 5 kilograms. This milestone, announced by WHO and Novartis, addresses a critical gap in malaria care for the youngest and most vulnerable, facilitating global access through public sector procurement.
Key Highlights
- WHO prequalifies Coartem® Baby for infants 2-5kg.
- First antimalarial specifically formulated for newborns.
- Addresses critical long-standing treatment gap in malaria.
- Facilitates public sector procurement for wider access.
- Developed by Novartis in collaboration with MMV.
- Expected to significantly reduce infant malaria mortality.
In a significant advancement for global public health, the World Health Organization (WHO) has prequalified Coartem® (artemether-lumefantrine) Baby, marking it as the first and only antimalarial treatment specifically developed for newborns and young infants weighing between 2 and 5 kilograms. This crucial development, announced by Novartis and Medicines for Malaria Venture (MMV) on April 24, 2026, and subsequently by the WHO ahead of World Malaria Day on April 25, 2026, closes a long-standing and critical treatment gap for the youngest and most vulnerable malaria patients worldwide.
Historically, infants suffering from malaria who weigh less than 5 kilograms (or 4.5 kilograms, as per some reports) have been treated with formulations designed for older children. This practice carried significant risks, including potential for dosing errors, increased side effects, and toxicity due to improper dosage adaptation. The lack of a tailored treatment meant that a highly vulnerable population, often with underdeveloped metabolic systems, was exposed to suboptimal care, contributing to severe illness and mortality.
The newly prequalified Coartem® Baby is a formulation of artemether-lumefantrine, a highly effective artemisinin-based combination therapy (ACT) that is already a gold standard for malaria treatment in older children and adults. The innovation lies in its specific adaptation for very young infants, ensuring appropriate dosing, safety, and efficacy for this particular age group. Novartis, in collaboration with MMV, developed this treatment, making it available in a dissolvable granule form that can be mixed with breast milk or water, making it easier to administer to infants and reducing the risk of aspiration or incomplete dosing.
WHO prequalification is a stringent process that assesses the quality, safety, and efficacy of medical products for diseases such as malaria, HIV/AIDS, and tuberculosis. This designation is vital because it enables United Nations agencies and other public sector procurement bodies to inform their funding and purchasing decisions, thereby facilitating widespread access to the medicine in malaria-endemic regions globally. Novartis has committed to making Coartem® Baby available on a largely not-for-profit basis in these regions, underscoring the humanitarian focus of this development.
Malaria continues to be a devastating disease, with the most recent WHO data from 2024 estimating 282 million cases and 610,000 deaths worldwide, the majority of which occur in Africa. Children under five years old account for approximately three-quarters of malaria deaths in Africa, highlighting the urgent need for effective treatments for the youngest patients. Around 30 million babies are born each year in malaria-endemic areas of Africa alone, emphasizing the vast number of infants at risk who stand to benefit from this new treatment.
The introduction of Coartem® Baby represents a significant stride towards achieving malaria elimination goals. Dr. Daniel Ngamije Madandi, Director of Malaria and Neglected Tropical Diseases at the WHO, emphasized that this new formulation addresses a critical need as no antimalarial medicines were specifically developed for this weight category until now. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, highlighted the changing narrative in the fight against malaria, citing new vaccines, diagnostic tests, and adapted medicines like Coartem® Baby as crucial tools to turn the tide against the disease.
For India, where malaria remains a public health concern, particularly in specific regions, the availability of a dedicated infant malaria treatment is highly relevant. It can bolster national malaria control programs by providing healthcare providers with a safer and more effective option for their youngest patients, potentially reducing infant mortality and morbidity rates associated with the disease. The WHO's prequalification ensures that the product meets international quality standards, paving the way for its introduction into Indian public health systems through appropriate procurement channels. This development contributes to global health equity, ensuring that even the smallest and most vulnerable populations have access to essential, life-saving medicines.
Frequently Asked Questions
What is Coartem® Baby and why is its prequalification significant?
Coartem® Baby (artemether-lumefantrine) is the first and only antimalarial treatment specifically developed and prequalified by the WHO for newborns and young infants weighing between 2 and 5 kilograms. Its prequalification is significant because it addresses a critical, long-standing gap in malaria treatment for the youngest and most vulnerable patients, who previously relied on less suitable formulations.
What does 'WHO prequalification' mean for a medicine?
WHO prequalification is a rigorous process that evaluates the quality, safety, and efficacy of medical products. Achieving prequalification means the medicine meets international standards, which enables UN agencies and other public sector entities to procure it, thereby facilitating broader access in countries where it's most needed.
How will Coartem® Baby impact the fight against malaria in infants?
Coartem® Baby is expected to significantly improve malaria treatment outcomes for newborns and young infants by providing a safe, effective, and appropriately dosed medicine. This can lead to a reduction in infant malaria mortality and morbidity, especially in regions with high malaria burdens like Africa and parts of Asia, where millions of babies are born at risk each year.
Who developed Coartem® Baby and how will it be made available?
Coartem® Baby was developed by Novartis in collaboration with Medicines for Malaria Venture (MMV). Novartis has committed to making the treatment available on a largely not-for-profit basis in malaria-endemic regions to ensure equitable access through public sector procurement.
Why was there a need for a specific malaria treatment for infants under 5kg?
Previously, infants weighing under 5 kilograms often received modified doses of medicines intended for older children, leading to potential dosing errors, increased risk of side effects, and toxicity. A specific formulation was needed to ensure optimal efficacy and safety for this delicate patient group, whose physiology differs significantly from older children and adults.
