Tick-borne Encephalitis Vaccine Approaches US Approval

New York-based Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application for TicoVac™, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older.

The anticipated FDA Prescription Drug User Fee Act action date expected is August 2021.

To date, ticks infected with the TBE virus, a member of the family Flaviviridae, and was initially isolated in 1937, have been identified in more than 35 countries across Europe and Asia. The European CDC currently recommends TBE vaccination for people who live in or are traveling to these risk areas.

The U.S. CDC says, 'There is no specific drug therapy for TBE.' 

Pfizer’s TBE vaccine, marketed under the brand names TicoVac and FSME-Immun™ in Europe, is an inactivated whole virus vaccine developed using a master ‘seed’ virus is similar to the TBE virus found in nature. Therefore, it can induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

TicoVac 0.5 ml and TicoVac Junior 0.25 ml are to be given based on official recommendations regarding the need for, and timing of, vaccination against TBE.

As with all vaccines, TicoVac and TicoVac Junior may not protect everyone who is fully vaccinated. 

The vaccine helps protect all known subtypes of the TBE virus in both children (from one year of age) and adults, including the European, Siberian, and Far Eastern subtypes. If approved, TicoVac would be the first vaccine in the USA to help protect adults and children who are visiting or living in TBE endemic areas.

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