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The Africa Centres for Disease Control and Prevention (Africa CDC) has hailed the approval of the world’s first malaria treatment designed specifically for newborns and infants weighing less than five kilograms. This development marks a major breakthrough in closing a long-standing treatment gap for Africa’s youngest children.
For decades, infants under five kilograms faced serious risks when battling malaria, as no safe, approved medication existed for their weight group. Caregivers and health workers were often forced to administer altered doses of drugs intended for older children, which carried dangers of overdose, underdose, and treatment failure. With this new formulation, Africa’s most vulnerable children will now have a safe and effective treatment option.
The milestone was made possible through the participation of eight African countries, Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda, whose involvement in clinical trials demonstrated Africa’s growing role in driving health research and innovation. Africa CDC emphasized that this achievement is a testament to the continent’s leadership in advancing solutions to its own public health challenges.
The New Formulation
The infant-friendly medicine is a new artemether-lumefantrin formulation, developed through collaboration between Novartis and the Medicines for Malaria Venture (MMV), under the PAMAfrica consortium. It was co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.
Approved by Swiss regulators, the medicine is expected to be rapidly endorsed by the participating African states under the Swissmedic Marketing Authorisation for Global Health Products procedure.
Key features of the treatment include:
• Safe dosage tailored for infants under five kilograms.
• Infant-friendly administration, dissolvable in breast milk with a sweet taste, making it easier for babies to take.
• Not-for-profit distribution model, with Novartis committing to ensure affordability and broad access across malaria-endemic regions.
Each year, nearly 30 million babies are born in malaria-affected areas, highlighting the urgent need for this advancement.
Africa CDC Director General Dr. Jean Kaseya described the approval as “a major step forward in ensuring that no child is left behind in the fight against malaria.” He stressed that the availability of this medicine represents hope for millions of families across Africa.
Similarly, Dr. Ngashi Ngongo, Principal Advisor to the Africa CDC Director General, emphasized that the development showcases
“the impact of Africa-led collaboration in delivering health solutions where they are needed most.”
To ensure the medicine reaches children who need it most, Africa CDC is working with Member States to:
• Revise treatment guidelines and train health workers.
• Strengthen monitoring systems to track safety and effectiveness.
• Expand local production and supply through the African Pooled Procurement Mechanism (APPM).
• Speed up regulatory processes via the African Medicines Regulatory Harmonization (AMRH) initiative.
Africa CDC reaffirmed its commitment to eliminating malaria across the continent. By combining scientific innovation, strong partnerships, and coordinated policies, the organization believes that a malaria-free Africa is achievable within the next generation.
“With the right investments and collaboration, we can make malaria history for every African child, regardless of weight, age, or location,” Dr. Kaseya concluded.