Many years of experience with Engerix-B and Recombivax HB vaccines indicate no apparent risk for adverse events to a developing fetus. Current vaccines contain noninfectious HBsAg and pose no risk to the fetus. If the mother is being vaccinated because of a risk factor for HBV infection (for example, a healthcare worker, a person with a sexually transmitted disease, an injection drug user, a person with multiple sex partners), vaccination should be initiated as soon as the risk factor is identified during the pregnancy. HBV infection during pregnancy might result in severe disease for the mother and chronic infection for the newborn.
There are no clinical studies of Heplisav-B or PreHevbrio during pregnancy. Available human data on these products administered during pregnancy are insufficient to assess vaccine-associated risks in pregnancy. Until safety data are available for Heplisav-B or PreHevbrio, providers should continue to use Engerix-B, Recombivax HB, or Twinrix for individuals needing hepatitis B vaccination during pregnancy.