Hepatitis E vaccination in women of childbearing age: safety and tolerability outcomes

Abstract

Hepatitis E virus is a major cause of acute viral hepatitis and is endemic in Pakistan, where it contributes substantially to morbidity and mortality among women of childbearing age. The Hecolin vaccine is a potentially useful preventive measure, but data on its safety in this population remain limited. This study assessed the safety and tolerability of hepatitis E vaccination in non-pregnant women of childbearing age. This prospective, multicenter observational study was conducted at Jinnah Postgraduate Medical Centre and Atiya General Hospital, Karachi, Pakistan, from September 2023 to September 2025. Using non-probability convenience sampling, 375 non-pregnant women aged 16–43 years, stratified into 16–22 and 23–43-year subgroups, received at least one vaccine dose and were followed for 21 days. Data were collected by structured questionnaire and analyzed with descriptive statistics and the Chi-square test, with p ≤ 0.05 considered significant. Among the 375 non-pregnant women (mean age 24.47 ± 5.44 years), 72 (19.2%) were married and 303 (80.8%) unmarried; occupations included students (39.5%), housewives (24.8%), caretakers (14.7%), teachers (6.9%), office workers (5.6%), laborers (5.3%), and doctors (3.2%), and 369 (98.4%) resided in Sindh. Adverse effects were mild, transient, and most frequent after the first dose fever (3.7%), flu-like symptoms (4.8%), headache (1.9%), and cold sores (0.3%) all declining on subsequent follow-ups, with no serious adverse events and similar tolerability across age groups. Hepatitis E vaccination is safe, well-tolerated, and acceptable in non-pregnant women of reproductive age in endemic settings, supporting its inclusion in public health programs to reduce hepatitis E-related morbidity and mortality. Further studies should assess long-term protection and safety in pregnancy.