USE OF HEPATITIS B VACCINE IN PREGNANCY

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(Date of issue: May 2022, Version: 4)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on Hepatitis B vaccine use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Hepatitis B vaccine is an inactivated vaccine which is available in the United Kingdom as a single vaccine or as a combination vaccine against both hepatitis A and B. Hepatitis B is a blood-borne virus that is transmitted by parenteral exposure to infected blood or body fluids, including by sexual contact.

Pregnancy does not appear to alter the course of hepatitis B infection for the mother. Infection has not been associated with an increased risk of most adverse pregnancy outcomes, although increased rates of preterm delivery (often iatrogenic) have been noted. Perinatal transmission of the hepatitis B virus from mother to infant may result in infection of the neonate, with a high risk of chronicity.

Data relating to hepatitis B vaccination in pregnancy is provided by one population-based cohort study (n= 1,400 exposed pregnancies) and uncontrolled case reports, largely from post-marketing surveillance/adverse event reporting systems, which collectively include ~600 additional exposed pregnancies.

Overall, the available data do not raise concern of increased risks of adverse pregnancy outcomes following gestational exposure to hepatitis B vaccines. Data relating to non-live vaccines as a group are similarly reassuring

The Department of Health in the UK recommends that hepatitis B vaccine can be given to pregnant women if clinically indicated.

Exposure to hepatitis B vaccines at any stage in pregnancy would not be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.


This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.