Safety of hepatitis E vaccine in pregnancy.

Abstract

This comment discusses the critical public health challenge of hepatitis E in pregnancy and highlights the significant safety evidence gap for the HEV239 vaccine in this vulnerable group. Focusing on a landmark study from South Sudan by Nesbitt RC et al., we provide a critical appraisal of its findings, integrate them with prior evidence from clinical trials and animal studies, and discuss implications for vaccination policy in outbreak settings, particularly in fragile and conflict-affected contexts. The comment concludes that vaccination during pregnancy shows no detected increased risk of fetal loss, providing crucial real-world data to inform life-saving vaccination policies, while acknowledging remaining uncertainties.