Key result
HEV239 vaccination during pregnancy did not significantly increase the risk of fetal loss compared to no vaccination (7.2% vs 6.1%, RR 1.2).
Why the study?
Does the HEV239 vaccine increase the risk of fetal loss in pregnant women?
Does the HEV239 vaccine increase the risk of fetal loss in pregnant women?
The HEV239 vaccine appears safe during pregnancy with no increased risk of fetal loss, supporting its use in outbreak settings.
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.
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Zhang et al. (2026) conducted an editorial in Hepatitis E in pregnancy. HEV239 vaccine vs. Unvaccinated was evaluated on Fetal loss (RR 1.2, 95% CI 0.7-1.9). HEV239 vaccination during pregnancy did not significantly increase the risk of fetal loss compared to no vaccination (7.2% vs 6.1%, RR 1.2).
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