Hepatitis b Vaccine

Products

Hepatitis B vaccine is licensed as an injectable in many countries (e.g., Engerix-B, combination products).

Structure and properties

The vaccine contains a the highly purified surface antigen HBsAg of hepatitis B virus. HBsAg is produced by biotechnological methods. It is a membrane protein localized on the viral envelope of hepatitis B virus.

Effects

Hepatitis B vaccine (ATC J07BC01) protects the vast majority of vaccinees from highly contagious hepatitis B by eliciting a specific immune response. Because hepatitis D occurs only in association with hepatitis B, the vaccine additionally protects against hepatitis D.

Indications

For active immunization against hepatitis B virus (HBV) infections according to current regulatory recommendations. Hepatitis B vaccination is one of the recommended basic immunizations in many countries, ideally to be given between the ages of 11 and 15 years. General vaccination of adolescents has been recommended since 1998. Vaccination is already possible in infants.

Dosage

According to the SmPC. The drug is usually injected intramuscularly. Depending on age and vaccination schedule, either two, three, or four administrations (doses) are required.

Contraindications

  • Hypersensitivity to components of the vaccine
  • Acute infectious diseases accompanied by fever.

For complete precautions, see the drug label.

Adverse effects

The most common possible adverse effects include local reactions at the injection site such as pain, swelling, and redness, fatigue, drowsiness, irritability, headache, malaise, and fever. Severe allergic reactions are extremely rare.