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WHO Prequalifies First Malaria Treatment for Newborns

The step unlocks public-sector access to a safe dose for the smallest patients.

Overview

  • WHO, which announced the move Friday, prequalified an artemether–lumefantrine formulation for babies weighing 2 to 5 kilograms.
  • Prequalification allows public health buyers and UN agencies to procure the therapy and helps countries authorize it even without local clinical trials.
  • The decision targets a long-standing gap in care for about 30 million babies born each year in malaria-endemic parts of Africa who faced dosing risks with older-child formulations.
  • WHO also prequalified three rapid diagnostic tests on April 14 that detect the parasite protein pf-LDH, addressing false negatives caused by pf-hrp2 gene deletions that have made some common tests miss cases.
  • WHO reports an estimated 282 million cases and 610,000 deaths in 2024, with children under five accounting for most deaths, even as 25 countries roll out vaccines and next‑generation mosquito nets expand use.