Most women who receive the hepatitis B vaccine (HepB) during pregnancy do not have an increased risk for adverse events, according to study results published in Vaccine.

Currently, many women who receive HepB during pregnancy are not at high risk for contracting hepatitis B virus (HBV).

The study included a retrospective cohort of pregnancies from the Vaccine Safety Datalink (VSD) that resulted in live births from 2004 through 2015. Pregnancies in women age 12 to 55 who were continuously enrolled in VSD-integrated healthcare systems from 6 months pre-pregnancy to 6 weeks postpartum were included (n=650,000).

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The researchers compared pregnancies with HepB exposure with both pregnancies with other vaccine exposure and pregnancies with no vaccine exposure. They used ICD-9 codes to identify high-risk conditions for contracting HBV infection. In addition, maternal and fetal adverse events were evaluated based on HepB exposure status.

In the study cohort, HepB was administered at a rate of 2.1 pregnancies per 1000 (n=1399). Often, it was administered within the first 5 weeks of pregnancy.

In the HepB-exposed group, <3% had a high-risk ICD-9 code that indicated a need for HepB, with a similar rate in the HepB-unexposed groups.

The researchers did not find any significant associations between HepB exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, low birthweight, or small for gestational age infants.

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“Regardless of the vaccination intent, our findings are consistent with those of previously published studies and provide added reassurance that it is safe to administer HepB to pregnant women both with and without high-risk indications for vaccination,” the researchers wrote.


Groom HC, Irving SA, Koppolu P, et al. Uptake and safety of hepatitis B vaccination during pregnancy: a Vaccine Safety Datalink study. Vaccine. 2018;36(41):6111-6116.