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FDA Updates Heplisav-B Labeling to Include Data on Use in Pregnant Persons

• The FDA has updated the labeling for Heplisav-B to include human data indicating no increased risk of major birth defects or miscarriage. • The update is based on a postlicensure observational study (DV2-HBV-28) that included 75 pregnancies with known outcomes. • Providers can now administer Engerix-B, Heplisav-B, Recombivax HB, or Twinrix to pregnant persons needing Hepatitis B vaccination. • The Advisory Committee on Immunization Practices (ACIP) recommends universal HepB vaccination for adults aged 19–59 years, including pregnant individuals.

The Food and Drug Administration (FDA) has approved updates to the package insert for Heplisav-B [Hepatitis B vaccine (recombinant), adjuvanted], Section 8.1 (Pregnancy), based on new human data. This data suggests that Heplisav-B does not pose an increased risk for major birth defects or miscarriage when administered to pregnant individuals.
The update stems from a postlicensure observational retrospective cohort study (DV2-HBV-28) involving 75 pregnancies with known outcomes. This included 10 individuals who received Heplisav-B twice during the period from 28 days before conception through the end of pregnancy. Among all 75 pregnant individuals exposed to Heplisav-B before or during pregnancy, 44 received the vaccine during the 28 days before conception, 24 during the first trimester, six during the second trimester, and one during the third trimester.
The study found no major birth defects, and the risk of miscarriage was below the estimated background risk. According to the CDC, these data, primarily from individuals who received one dose of Heplisav-B during the 28 days before conception or during pregnancy, do not indicate an elevated risk for either major birth defects or miscarriage.

Implications for Vaccination

With the FDA's approval under section 351(a) of the Public Health Service Act, Heplisav-B can now be used to vaccinate pregnant individuals who require Hepatitis B vaccination. The Advisory Committee on Immunization Practices (ACIP) already recommends universal Hepatitis B (HepB) vaccination for adults aged 19–59 years, including pregnant persons, and adults aged ≥60 years with risk factors for hepatitis B. Adults aged ≥60 years without known risk factors for hepatitis B may also receive HepB vaccines.

Updated Recommendations

Healthcare providers are now advised to vaccinate pregnant individuals needing HepB vaccination with Engerix-B, Heplisav-B, Recombivax HB, or Twinrix.
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Reference News

[1]
Updated Recommendation for Universal Hepatitis B Vaccination in Adults Aged 19–59 Years - CDC
cdc.gov · Dec 6, 2024

FDA approved Heplisav-B vaccine for use in pregnant persons, finding no increased risk for major birth defects or miscar...

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