Author information
1
Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States. Electronic address: Holly.c.groom@kpchr.org.
2
Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.
3
HealthPartners Institute, Minneapolis, MN, United States.
4
Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, United States.
5
Marshfield Clinic Research Institute, Marshfield, WI, United States.
6
Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
7
Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.
8
Harvard Pilgrim Health Care Institute, Boston, MA, United States.
9
Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, CA, United States.
10
Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Abstract
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.