Havrix components (Hepatitis A Vaccine)

Havrix (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular
administration. Havrix components are:

  • Each 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on aluminum as aluminum hydroxide.
  • Each 0.5-mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed on aluminum as aluminum hydroxide.

Havrix contains the following excipients:

  • Amino acid supplement in a phosphate-buffered saline solution
  • Polysorbate 20

From the manufacturing process, Havrix also contains residual:

  • MRC-5 cellular proteins
  • Formalin
  • Neomycin sulfate

Havrix is formulated without preservatives. We also know other hepatitis vaccine e.g. Engerix-B that protects from hepatitis B and Twinrix that protects from hepatitis A and from hepatitis B.

The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).

Source:
https://www.fda.gov/media/119388/download

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