Severe malaria, a life-threatening condition, may ensue rapidly if a bout of acute uncomplicated malaria is not promptly treated. The manifestations of severe malaria include severe anaemia, respiratory distress and end-organ damage.1 2
WHO recommends Injectable Artesunate (Inj AS) as the preferred medicine for treating severe malaria.
Increasing the availability of injectable artesunate
Since WHO prequalification in 2010, 209 million vials of Inj AS have been delivered to over 35 malaria-endemic countries. The majority of this volume was supplied by Fosun Pharma; since end 2018 another Inj AS product, from Ipca, was prequalified by WHO. In April of 2021, a third Inj AS product manufactured by Macleads obtained prequalification.
Several initiatives supported by MMV and partners have contributed to increasing access to this lifesaving intervention. In the Democratic Republic of the Congo (DRC) and Nigeria, two of the countries with the most severe malaria cases, a programme was undertaken to improve the availability of the drug. This helped give rise to other initiatives across the Sahel, including the Improving Severe Malaria Outcomes (ISMO) project, funded by UNITAID and led by MMV. As part of this multi-country project, almost six million vials of treatment were introduced across Cameroon, Ethiopia, Kenya, Malawi, Nigeria and Uganda. The treatments distributed were enough to treat between one to one and a half million of children. In addition, more than 18,000 healthcare workers were trained on the correct preparation and administration of Inj AS in over 2,082 healthcare facilities. This 3-year project ended in September 2016. It was built around a consortium of implementing and procurement partners, with the participation of CHAI and Malaria Consortium.
The scaling up of this medicine has continued ever since, with the addition of two manufacturers (Ipca and Macleads mentioned above) that have been prequalified, contributing to securing the supply of this lifesaving drug.
Monitoring results in real-world settings
MMV and partners also work to generate more data to support country introduction and roll-out.
Once such example is in work done with the African Collaborating Centre for Pharmacovigilance in Ghana to help generate more information on Inj AS in real world settings and to create a useful pharmacovigilance blueprint for countries to use.
Outcomes of a monitoring study (CEMISA) were gathered from over 1,000 patients in public health facilities in Ghana and Uganda over the course of 2016. The study found that Injectable AS is the most prescribed medicine in the management of severe malaria in Ghana and Uganda. However, adherence to the WHO recommendation of at least 3 doses of injectable anti-malarial in 24 h followed by a full course of ACT is low, at less than 30%.
Ongoing product innovation to simplify the preparation of Inj AS
Pursuing further innovation, and with the aim to make the preparation of Inj AS even more convenient for health workers, pharmaceutical partners are currently developing a novel formulation of Inj AS, in partnership with MMV. The new product under development will allow for reconstitution of artesunate powder in a single step, in contrast to the currently used product formulation which requires a two-step reconstitution (solvent and diluent).
MMV will support the correct use of these novel Inj AS products once they obtain WHO prequalification. To this end, MMV is developing training materials which are being tested in the field to ensure that these training materials meet the needs of the health workers and communities that will use them.
→Learn more about severe malaria from the Severe Malaria Observatory.
→Take a look at the interactive map to see where Inj As is registered.