WHO guideline on mass drug administration of azithromycin to children under five years of age

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Around 5.3 million children under the age of five died in 2018. Most of these deaths occurred in low-income countries with the highest risk of death in sub-Saharan Africa. Sustainable Development Goal 3 aims to end all preventable deaths of newborns and children under the age of five by 2030. There is therefore a need to identify simple, feasible and cost-effective interventions to reduce child mortality in low- and middle-income countries. Mass drug administration of azithromycin (MDA-azithromycin) has been effective in containing trachoma and recent studies have suggested that MDA-azithromycin can reduce child mortality rates. MDA-azithromycin is an effective antibiotic for the treatment of acute lower respiratory tract and enteric infections. Although the exact mechanism(s) through which MDA-azithromycin reduces child mortality has not been clearly elucidated, it has been postulated that one route may be through a reduction in the incidence of these infections. In addition, MDA-azithromycin offers short-term protection against P. falciparum infection, responsible for malaria. By decreasing the incidence of these three major causes of mortality, it was hypothesised that MDA-azithromycin may have an impact on overall child mortality, especially in countries with high under-five mortality and a heavy burden of morbidity due to diarrhoea, pneumonia and malaria.

In its new guideline document,¹ the World Health Organization (WHO), aims to provide an evidence-informed recommendation on whether MDA-azithromycin, as a public health intervention for the reduction of under-five mortality, should (a) be rolled out universally in low-and middle-income countries, (b) be applied only in some situational contexts in low- and middle-income countries or (c) not be used at all. After carefully considering the balance of benefits and potential harm, values and preferences of the target population and ethical, acceptability and feasibility issues, the Guideline Development Group (GDG, independent of WHO) made two recommendations on implementing MDA-azithromycin.

Firstly, the GDG decided against a universal recommendation of MDA-azithromycin for low- and middle-income countries (strong recommendation). However, the GDG understands that the benefits appear to outweigh the harm in the settings originally observed, i.e., in sub-Saharan Africa where there is a high burden of infant and child mortality and high burden of disease owing to malaria, pneumonia and diarrhoea. The GDG therefore issued a second (conditional) recommendation for use of MDA-azithromycin in infants aged 1 to 11 months in these settings (targeting the sub-group in which the greatest benefit was observed) with a suggested regimen of 20mg/kg as a single dose every six months. The GDG recommends that infant and child mortality and antimicrobial resistance should be monitored on a continuous basis and that other ongoing child survival interventions be strengthened concurrently. This recommendation is applicable for two to three years from the publication of this guideline, at which point the guidelines are expected to be updated according to new emerging evidence.

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