Hepatitis B virus vaccine safety: report of an inter-agency group.

Abstract

This article summarizes the findings of the Inter-Agency Group to Monitor Vaccine Development, Production, and Usage on the safety of hepatitis B virus vaccine. Because this vaccine is prepared in the US from human plasma containing hepatitis surface antigen, concerns had been raised about its safety and efficacy. The Inter-Agency Group found the following: 1) immediate side effects are minimal after receipt of the vaccine, 2) no longterm reactions have been reported, 3) the purification and inactivation process is known to inactivate representatives of all known groups of animal viruses, 4) each lot is safety tested in primates, and 5) no known cases of hepatitis A or non-A/non-B hepatitis have been transmitted by the vaccine. The Group further found that no known occurrence of acquired immunodeficiency syndrome (AIDS) has been associated with the vaccine. The epidemiology of AIDS suggests an unidentified, uncharacterized blood-borne agent as a possible cause of the underlying immunologic deficit. Because AIDS occurs among populations that are sources of hepatitis B virus-positive plasma, this syndrome should be considered in regard to the inherent safety of hepatitis B virus vaccine. No cases of AIDS have been noted in vaccine-placebo trials involving homosexual men after 24 months of follow-up.