CDC Adds Heplisav-B to Recommendations for HepB Vaccination During Pregnancy

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The CDC recently updated its recommendations for vaccination against hepatitis B (HepB) in pregnant women, adding Heplisav-B (HepB vaccine [recombinant], adjuvanted; Dynavax) to the currently recommended options. The addition, reported in Morbidity and Mortality Weekly Report,¹ followed the September 2024 FDA approval of an update to the Heplisav-B label that included data from a post-licensure, observational, retrospective cohort study of pregnant women who had received the vaccine.¹

The study, DV2-HBV-28, included data for 75 pregnant woman whose outcomes were known. Ten of the participants had received 2 doses of Heplisav-B between 28 days prior to conception through the end of pregnancy. Of the full cohort, 44 had received Heplisav-B during the 28 days before conception, 24 during the first trimester of pregnancy, 6 during the second trimester, and 1 during the third trimester. Of the 73 individuals who experienced exposure to Heplisav-B during the 28 days prior to conception through the first 20 weeks of gestation, 6 (8.2%) had a miscarriage (4 occurred in women exposed once and 2 in those exposed twice). There was a single stillbirth reported, in a participant exposed to Heplisav-B during the second trimester. The investigators observed no major birth defects. “These data, primarily in individuals who received one dose of Heplisav-B, do not suggest an increased risk of major birth defects and miscarriage,”² the addition to the Heplisav-B label reads.

As noted in the label, there is a risk to all pregnant individuals of birth defect, loss, or other adverse outcomes. In the US general population in clinically recognized pregnancies, in the US general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20%.² Based on the FDA approval, the CDC has now included Heplisav-B alongside Engerix-B (GSK), Recombivax HB (Merck), or Twinrix (GSK) as HepB vaccination recommendations that providers can administer to pregnant patients.¹

The safety, efficacy, and immunogenicity of HepB vaccines have been widely demonstrated over the past 40 years. Currently the Advisory Committee on Immunization Practices recommends HepB vaccination universally for adults aged 19–59 years, including pregnant persons, and adults aged 60 years and older at high-risk for HepB. ACIP also recommends HepB vaccination for adults 60 years and older without known risk factors for the infection.¹

References
1. Sandul AL, Rapposelli K, Nyendak M, Kim M. Updated recommendations for universal hepatitis B vaccination in adults aged 19-59 years – United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:1106. doi: 10.15585/mmwr.mm7348a3.dx.doi.org/10.15585/mmwr.mm7348a3
2. Heplisav-B. Package insert. Dynavax Technologies; 2024. Accessed December 18, 2024. https://www.heplisavbhcp.com/pdfs/Prescribing_Information_HEPLISAV-B_Hepatitis_B_Vaccine_Recombinant_Adjuvanted.pdf