Havrix (Hepatitis A Vaccine, Inactivated) is a noninfectious hepatitis
A vaccine developed and manufactured by Smith Kline Beecham Biologicals.
The virus (strain HM175) is propagated in MAC5 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. Havrix contains a sterile
suspension of inactivated virus; 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.).
Havrix is supplied as a sterile suspension for intramuscular administration.
The vaccine is ready for use without reconstitution; it must be shaken
before administration to assure a uniform suspension. After shaking, the
vaccine is a homogeneous white turbid suspension.
Each 1 mL adult dose of vaccine consists of not less than 1440 EL.U.
of viral antigen, adsorbed on 0.5 mg of aluminum, as aluminum hydroxide.
There are two pediatric dose formulations, each with its own dosing schedule
(see DOSAGE AND ADMINISTRATION).
The formulations are: not less than 360 EL.U. of viral antigen/0.5 mL;
not less than 720 EL.U. of viral antigen/0.5 mL. Each dose is adsorbed
onto 0.25 mg of aluminum, as aluminum hydroxide.
The vaccine preparations also contain 0.5% (w/v) of 2-phenoxyethanol
as a preservative. Other excipients are: amino acid supplement (0.3% w/v)
in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL).
Residual MAC5 cellular proteins (not more than 5 mcg/adult
dose) and traces of formalin (not more than 0.1 mg/mL) are present.