Twinrix components (Hep A & Hep B vaccine)

Twinrix [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine. It is formulated without preservatives. Twinrix components are:

A 1-mL dose of vaccine contains:

  • 720 ELISA Units of inactivated hepatitis A virus
  • 20 mcg of recombinant HBsAg protein.

One dose of vaccine contains aluminum in the form of:

  • Aluminum phosphate (adjuvant)
  • Aluminum hydroxide (adjuvant)

It also cointains:

  • Amino acids
  • Sodium chloride
  • Phosphate buffer
  • Polysorbate 20
  • Water for injection

Residual from the manufacturing process:

  • Formalin
  • MRC-5 cellular proteins
  • Neomycin sulfate
  • Yeast protein

Twinrix is a bivalent vaccine containing the antigenic components used in producing Havrix (Hepatitis A Vaccine) and Engerix-B [Hepatitis B Vaccine (Recombinant)]. Twinrix is a sterile suspension for intramuscular administration that contains inactivated hepatitis A virus (strain HM175) and noninfectious HBsAg. The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg (Hepatitis B surface antigen) is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.

Source:
https://www.fda.gov/media/119351/download

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