Please describe the currently available hepatitis B vaccines.

Three hepatitis B (HepB) vaccines are currently licensed and available in the United States. All of them contain recombinant hepatitis B surface antigen (HBsAg) produced in yeast cells. From 2021 until late 2024, PreHevbrio (VBI Vaccines), an additional 3-dose HepB vaccine option for adults, was available. PreHevbrio is a 3-antigen recombinant hepatitis B vaccine derived from mammalian (Chinese hamster ovary) cells; its use was discontinued for business reasons following VBI’s 2024 bankruptcy filing.

HepB vaccines are available as HepB-only formulations; two of them are also available in combination with other vaccines. Heplisav-B (Dynavax) is approved only for people 18 years of age and older. Engerix-B (GSK) and Recombivax HB (Merck) are approved for vaccination starting at birth and are available in both pediatric and adult formulations. For the 3-dose series of Engerix-B or Recombivax HB, people 0 through 19 years of age receive a 0.5 mL dose regardless of their height or weight; people 20 years of age and older receive a 1.0 mL dose.

Three combination vaccines that contain HepB are available in the United States. Pediarix (GSK) is approved for children 6 weeks through 6 years of age and contains HepB, DTaP, and inactivated poliovirus (IPV). Twinrix (GSK) is approved for adults 18 years of age and older and contains HepB and inactivated hepatitis A virus (HepA). Vaxelis (MCM Company) is approved for use in children 6 weeks through 4 years of age and contains HepB, DTaP, Hib, and IPV.