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 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 NHS health care professionals who are logged in.
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.