WHO Prequalifies First Malaria Treatment For Newborns And Infants: All You Need To Know

Last Updated:April 26, 2026, 19:06 IST

Previously, babies under 5 kg had to be treated with crushed adult or older-child tablets, leading to high risks of dosing errors, toxicity, and side effects. News18 explains

The World Health Organization (WHO) on April 24 prequalified Coartem Baby (artemether-lumefantrine), as the first malaria treatment specifically designed for newborns and young infants. It is developed by Novartis and the Medicines for Malaria Venture (MMV).

All you need to know, News18 explains.

Key Details of the Treatment

Target Population: Infants and newborns weighing between 2 kg and 5 kg.

Formulation: A child-friendly, dissolvable tablet that can be mixed with breast milk.

Flavour: Sweet cherry flavor to make administration easier for caregivers.

Pricing: Novartis is providing the treatment on a largely not-for-profit basis in malaria-endemic regions, according to WHO.

Why This is a Breakthrough

Previously, babies under 5 kg had to be treated with crushed adult or older-child tablets, leading to high risks of dosing errors, toxicity, and side effects.

The formula is specifically optimized for infants’ immature liver functions and unique metabolic needs.

WHO prequalification is the official “stamp of approval" that allows UN agencies and other international groups to buy and distribute the drug at scale.

Scientific Foundation: The CALINA Study

The approval was based on the CALINA study, a Phase II/III clinical trial that investigated the specific ratio and dose of artemether-lumefantrine required for babies under 5 kg. Ghana has already introduced the treatment, and it is expected to be rolled out across more African countries within weeks.

Three new diagnostic tests

Alongside this treatment, the WHO also prequalified three new rapid diagnostic tests (RDTs) on April 14, 2026, to detect “invisible" malaria strains that standard tests miss.

These were specifically developed to catch “invisible" malaria—strains of the P. falciparum parasite that have evolved to hide from standard tests.

Standard malaria tests look for a specific protein called HRP2 (Histidine-Rich Protein 2). However, in many regions (especially the Horn of Africa), the parasite has undergone a genetic mutation—a gene deletion—meaning it no longer produces HRP2. A patient could be deathly ill with malaria, but a standard test would show a “False Negative." In some areas, up to 80% of cases were being missed.

The three newly approved tests from the BIOCREDIT line (manufactured by Rapigen Inc.) use a different biological target to bypass this “invisibility cloak".

How they work

Instead of HRP2, these tests look for pLDH (Parasite Lactate Dehydrogenase), an essential enzyme that the parasite cannot easily stop producing.

WHO now recommends countries switch to these tests once 5% or more of local malaria cases show these gene deletions.

KEY FAQs

What has WHO approved?

The World Health Organization has prequalified its first-ever malaria treatment specifically for newborns and young infants, along with new diagnostic tests.

Why is this important?

It fills a major gap, as babies under 5 kg previously had limited safe, approved malaria treatment options.

What about the new tests?

The added diagnostics improve detection accuracy, especially in cases where standard markers may be missing or unreliable.

With agency inputs

News explainers WHO Prequalifies First Malaria Treatment For Newborns And Infants: All You Need To Know

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