CDC

Heplisav-B approved for use in pregnant individuals

December 9, 2024

This CDC report summarizes the updated recommendations from the Advisory Committee on Immunization Practices (ACIP) and FDA's approval of Heplisav-B for use in pregnant persons. The update is based on a postlicensure observational retrospective cohort study (DV2-HBV-28) involving 75 pregnancies with known outcomes, including exposures to Heplisav-B before and during pregnancy.

Findings: The study found no major birth defects and a miscarriage risk below the estimated background risk among 75 pregnant persons exposed to Heplisav-B. The data primarily involved individuals who received one dose of Heplisav-B during the 28 days before conception or during pregnancy. These findings support the safety of Heplisav-B in pregnant persons, leading to FDA's approval to update the vaccine's package insert.

Impact on clinical practice: Clinicians may administer Engerix-B, Heplisav-B, Recombivax HB, or Twinrix to pregnant persons needing HepB vaccination.

Source:

Sandul AL, et al. (2024, December 5). CDC. Updated Recommendation for Universal Hepatitis B Vaccination in Adults Aged 19–59 Years — United States, 2024. https://www.cdc.gov/mmwr/volumes/73/wr/mm7348a3.htm