Heplisav-B Cleared for Use in Pregnancy, 2024

This page describes an update published in 2024. Check CDC's current hepatitis B vaccine recommendations before acting on it.

Vaccination is the main way to prevent hepatitis B virus infection, and hepatitis B vaccines have a four-decade record of safety, immune response and effectiveness. The Advisory Committee on Immunization Practices (ACIP) recommends hepatitis B vaccination for all adults aged 19–59, including pregnant people, and for adults 60 and older with risk factors; adults 60 and older without known risk factors may also be vaccinated. Pregnant people may receive any adult hepatitis B vaccine with enough data to judge its risks in pregnancy.

The label change

On September 11, 2024, the Food and Drug Administration (FDA) approved updated labeling for Heplisav-B, an adjuvanted recombinant hepatitis B vaccine, adding human pregnancy data to the section of its package insert on pregnancy.

The data came from a post-licensure observational study (DV2-HBV-28) of 75 pregnancies with known outcomes in people exposed to Heplisav-B from 28 days before conception through the end of pregnancy:

Ten of the pregnancies involved two doses in that window. No major birth defects were found, and miscarriages occurred below the estimated background rate. The data, mostly from people who received one dose shortly before conception or during pregnancy, do not suggest an increased risk of either major birth defects or miscarriage. The FDA approval allows Heplisav-B to be used to vaccinate pregnant people who need hepatitis B vaccination.

Recommendation

Clinicians should vaccinate pregnant people who need hepatitis B vaccination with Engerix-B, Heplisav-B, Recombivax HB or Twinrix.

Sources

• Sandul AL, Rapposelli K, Nyendak M, Kim M. "Updated Recommendation for Universal Hepatitis B Vaccination in Adults Aged 19–59 Years — United States, 2024." MMWR 2024;73(48).