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
- Neomycin sulfate
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.).