A Comprehensive Monograph on the Tick-Borne Encephalitis Vaccine (Whole Virus, Inactivated) - TicoVac™ (DB16611)

Executive Summary

This report provides a comprehensive monograph on the Tick-borne encephalitis vaccine (whole virus, inactivated), identified by DrugBank ID DB16611, a biotech product marketed principally as TicoVac™ and FSME-Immun®. This vaccine represents the single most effective public health tool for the primary prevention of Tick-Borne Encephalitis (TBE), a potentially severe and life-threatening neuroinvasive disease for which no specific antiviral treatment exists. The vaccine is a formalin-inactivated, whole-virus preparation derived from the Tick-Borne Encephalitis Virus (TBEV) propagated in cell culture and adjuvanted with aluminum hydroxide.

The vaccine's mechanism of action is the induction of a robust humoral immune response, characterized by the production of TBEV-neutralizing antibodies. These antibodies are the primary correlate of protection and have been shown to provide cross-protective immunity against all three major TBEV subtypes (European, Siberian, and Far Eastern). The clinical development program, comprising extensive trials in both adult and pediatric populations, has consistently demonstrated high immunogenicity, with seropositivity rates exceeding 98% after the completion of a three-dose primary immunization series.[1]

Furthermore, the vaccine's efficacy is powerfully substantiated by decades of real-world use in national immunization programs, particularly in Austria, where field effectiveness in preventing hospitalized TBE has been estimated at over 96%.[1] The safety profile of the vaccine is well-characterized and favorable, with the most common adverse events being mild and transient local or systemic reactions. Its long history of use, with hundreds of millions of doses administered in Europe, provides an exceptionally high degree of confidence in its safety.[3]