HEV Vaccine and Fetal Loss in Rural Bangladesh
Practical Solutions and Value
Vaccination is an important way to control hepatitis E virus (HEV), which is a significant cause of maternal and perinatal mortality worldwide. However, a study of pregnant women in Bangladesh receiving the HEV vaccine HEV239 showed a potential link to fetal losses. This analysis aims to provide a detailed understanding of this safety signal.
In a trial, non-pregnant women aged 16-39 in 67 villages in Bangladesh were randomly assigned to receive either HEV239 or a hepatitis B vaccine (Hepa-B). The study implemented regular pregnancy surveillance and follow-up to assess fetal loss outcomes. The analysis focused on different periods related to pregnancy and vaccination. Statistical models were used to evaluate the association between HEV239 receipt and fetal loss outcomes.
Among the 19,460 non-pregnant participants, 5011 pregnancies were identified within 2 years following vaccination and met the criteria for analysis. The results showed that receiving HEV239 shortly before or during pregnancy was associated with an increased risk of miscarriage. This finding raises potential safety concerns for the use of HEV239 in women of childbearing age.
This study was supported by the Research Council of Norway and Innovax.
Practical Implications: The study highlights the importance of carefully evaluating the safety of vaccines, especially in pregnant women. It emphasizes the need for thorough surveillance and monitoring of vaccine effects, particularly in reproductive-age women.
Value: Understanding the potential risks associated with the HEV vaccine in pregnant women is crucial for informing public health programs and ensuring the safe use of vaccines in this population.
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