Hepatitis B Vaccine Recombinant
Class: Vaccines
ATC Class: J0BB04
VA Class: IM100
Brands: Engerix-B, Recombivax HB
Hepatitis B Vaccine is also contained as an ingredient in the following combinations:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine
Introduction
Inactivated (recombinant) vaccine. Hepatitis B vaccine contains hepatitis B surface antigen (HBsAg) and is used to stimulate active immunity to hepatitis B virus (HBV) infection. Commercially available in the US as monovalent vaccines (HepB; Engerix-B, Recombivax HB). Also commercially available in a fixed-combination vaccine with Haemophilus influenzae type b (Hib) vaccine (Hib-HepB; Comvax), in a fixed-combination vaccine with hepatitis A virus vaccine (HepA-HepB; Twinrix), and in a fixed-combination vaccine that contains diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix).
Uses for Hepatitis B Vaccine Recombinant
Prevention of Hepatitis B Virus (HBV) Infection
Prevention of HBV infection in neonates, children, adolescents, and adults.
Acute HBV infection may be self-limited resulting in production of antibody to HBsAg (anti-HBs) and immunity against reinfection; however, it may progress to chronic HBV infection (especially in infants or young children, immunocompromised individuals, patients with diabetes) or fatal, fulminant hepatitis. Case fatality rate is 0.5–1.5% among those with acute HBV infection; highest fatality rates are in adults >60 years of age. Chronic HBV infection develops in ≥90% of infants infected perinatally, 25–50% of children infected at 1–5 years of age, and <5% of those infected at ≥5 years of age. Chronic infection is associated with persistent HBV replication in the liver and may result in liver cirrhosis, liver cancer, liver failure, and death. HBV is transmitted by percutaneous or mucosal exposure to hepatitis B surface antigen-positive (HBsAg-positive) blood, serum, plasma, semen, or saliva and can be transmitted perinatally from mother to infant at birth, usually as the result of blood exposures during labor and delivery.
USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all neonates and infants and all previously unvaccinated children and adolescents through 18 years of age be vaccinated against HBV infection, unless contraindicated. (See Contraindications under Cautions.)
ACIP, AAFP, American College of Obstetricians and Gynecologists (ACOG), and American College of Physicians (ACP) recommend that all unvaccinated adults at risk for HBV infection be vaccinated against HBV. (See Preexposure Vaccination Against Hepatitis B Virus [HBV] Infection in High-risk Groups under Uses.) ACIP also states that any unvacc
