CDC: Heplisav-B joins recommended HBV vaccine options for pregnant patients
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Key takeaways:
- The CDC has added Heplisav-B to the approved list of hepatitis B vaccinations for pregnant persons.
- The researchers observed no major birth defects or increased risk for miscarriage.
Data from a postlicensure study support the CDC’s recommendation that Heplisav-B can now be administered to pregnant persons needing hepatitis B vaccination, as its use did not appear to increase risk for major birth defects or miscarriage.
According to the CDC, providers can now include Heplisav-B along with Energix-B, Recombivax HB and Twinrix as vaccination options for pregnant persons.
“The Advisory Committee on Immunization Practices recommends universal HepB vaccination for adults aged 19 to 59 years, including pregnant persons, and adults aged 60 years and older with risk factors for hepatitis B,” Amy L. Sandul, DHSc, MPH, associate director for science in the CDC’s division of viral hepatitis, and colleagues wrote in Morbidity and Mortality Weekly Report.
They added, “On September 11, 2024, the Food and Drug Administration approved a request to update the labeling for Heplisav-B vaccine with new indications for use among pregnant persons.”
The update was supported by data from a postlicensure, observational retrospective study of 75 pregnant persons exposed to Heplisav-B (Dynavax) before or during pregnancy, of whom 44 received the vaccine during the 28 days prior to conception, 24 during the first trimester, six during the second trimester and one during the third trimester. In addition, 10 pregnant persons received Heplisav-B twice during the study period.
According to Sandul and colleagues, no major birth defects were observed and the risk for miscarriage was “below the estimated background risk.”
They added, “Providers should vaccinate pregnant persons needing HepB vaccination with Engerix-B, Heplisav-B, Recombivax HB or Twinrix.”
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