Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.

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.

• Authors: Holly C Groom, Stephanie A Irving, Padma Koppolu, Ning Smith, Gabriela Vazquez-Benitez, Elyse O Kharbanda, Matthew F Daley, James G Donahue, Darios Getahun, Lisa A Jackson, Alison Tse Kawai, Nicola P Klein, Natalie L McCarthy, James D Nordin, Lakshmi Sukumaran, Allison L Naleway
• Journal: Vaccine (Vaccine) Vol. 36 Issue 41 Pg. 6111-6116 (10 01 2018) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 30194002 (Publication Type: Journal Article, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright © 2018 Elsevier Ltd. All rights reserved.

Chemical References

• Hepatitis B Vaccines

Topics

• Adolescent
• Adult
• Child
• Female
• Hepatitis B (immunology, prevention & control)
• Hepatitis B Vaccines (administration & dosage, pharmacokinetics, therapeutic use)
• Humans
• Middle Aged
• Pregnancy
• Retrospective Studies
• Vaccination (adverse effects, methods)
• Young Adult