USE OF HEPATITIS A VACCINE IN PREGNANCY

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(Date of issue: September 2016, Version: 3)

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 A vaccine use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Hepatitis A vaccine is an inactivated vaccine and is available in the United Kingdom as a monovalent vaccine, or in combination with hepatitis B or typhoid vaccines.

Hepatitis A is generally a short-lived, self-limiting infection and serious complications are uncommon, although 10-15% of symptomatic individuals can have prolonged or relapsing disease lasting up to six months. Hepatitis A vaccination is indicated for individuals at increased risk of contracting the infection, or of fulminant hepatitis should infection occur. Hepatitis A infection during pregnancy is not believed to pose a risk to embryofetal development, although there is some evidence that acute infection during the second and third trimesters of pregnancy is associated with gestational complications and preterm labour.

An analysis of data from two clinical trials found that women exposed to hepatitis A vaccine within the 90 days preceding conception were not at increased risk of spontaneous abortion compared to women exposed to HPV vaccine. Further large, well-controlled studies of women exposed to hepatitis A vaccine in early pregnancy are, however, required before an increase in risk can be ruled out. The published data on other pregnancy outcomes following gestational exposure to hepatitis A vaccines are too limited/absent to facilitate an evidence-based assessment of any increased risk. However, there is a large body of evidence to suggest that inactivated vaccines as a group are not associated with an increased incidence of adverse fetal effects when used in pregnancy.

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

Inadvertent exposure to hepatitis A vaccine at any stage in pregnancy would not usually 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.