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Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study
Holly C Groom1, Stephanie A Irving1, Padma Koppolu1
1Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.
Insights
Hepatitis B vaccine (HepB) administered during pregnancy showed no increased risk for adverse maternal or infant outcomes. Most women receiving HepB during pregnancy did not have high-risk indications for vaccination.
Area of Science:
- Obstetrics and Gynecology
- Immunology
- Public Health
Background:
- Hepatitis B virus (HBV) infection during pregnancy poses risks to newborns, potentially causing lifelong health issues.
- Hepatitis B vaccine (HepB) is recommended for high-risk individuals, including pregnant women, but safety data during pregnancy is limited.
Purpose of the Study:
- To determine the frequency of HepB vaccination among pregnant women.
- To evaluate the safety of HepB vaccination during pregnancy by assessing maternal and infant outcomes.
Main Methods:
- A retrospective cohort study analyzed over 650,000 pregnancies from 2004-2015 using the Vaccine Safety Datalink (VSD).
- Pregnancies with HepB exposure were compared to those with other vaccine or no vaccine exposures.
- Maternal and infant safety outcomes were assessed, including gestational hypertension, diabetes, pre-eclampsia, delivery complications, and birthweight.
Main Results:
- HepB was administered in 2.1 per 1000 pregnancies, often early in gestation.
- Less than 3% of HepB-exposed pregnancies had documented high-risk indications for vaccination.
- No significant associations were found between HepB exposure and adverse maternal or infant outcomes.
Conclusions:
- Maternal HepB vaccination during pregnancy did not demonstrate an increased risk for the studied adverse events.
- The majority of women receiving HepB during pregnancy lacked clear high-risk indications.
- Further research may be warranted to understand vaccination patterns and optimize recommendations.
Introduction:
Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection, including pregnant women. Limited data are available on the safety of HepB administration during pregnancy.
Objectives:
To assess the frequency of maternal HepB receipt among pregnant women and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes.
Methods:
We examined a retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live birth outcomes from 2004 through 2015. Eligible pregnancies in women aged 12-55 years who were continuously enrolled from 6 months pre-pregnancy to 6 weeks postpartum in VSD integrated health systems were included. We compared pregnancies with HepB exposure to those with other vaccine exposures, and to those with no vaccine exposures. High-risk conditions for contracting HBV infection were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were also evaluated according to maternal HepB exposure status.
Results:
Among over 650,000 pregnancies in the study period, HepB was administered at a rate of 2.1 per 1000 pregnancies (n = 1399), commonly within the first 5 weeks of pregnancy. Less than 3% of the HepB-exposed group had a high-risk ICD-9 code indicating need for HepB; this was similar to the rate among HepB unvaccinated groups. There were no 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.
Conclusions:
Most women who received maternal HepB did not have high-risk indications for vaccination. No increased risk for the adverse events that were examined were observed among women who received maternal HepB or their offspring.
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