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Home » Directories » FDA Approved Drugs » Ticovac (tick-borne encephalitis (TBE) vaccine)

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Ticovac (tick-borne encephalitis (TBE) vaccine)

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Contact Information

Contact: Pfizer
Website: http://labeling.pfizer.com/ShowLabeling.aspx?id=15600

Currently Enrolling Trials

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    General Information

    Ticovac (tick-borne encephalitis (TBE) vaccine) in designed to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

    Ticovac is specifically indicated for active immunization to prevent tick-borne encephalitis (TBE). TICOVAC is approved for use in individuals 1 year of age and older.

    Ticovac is supplied as a suspension for intramuscular injection. The Dosage and Vaccination Schedule is as follows:

    • 1 through 15 years of age: each dose 0.25 mL
    • 16 years of age and older: each dose 0.5 mL

    Primary Vaccination: Three doses

      1 through 15 years of age 16 years of age and older
    First dose Day 0 Day 0
    Second dose 1 to 3 months after the first vaccination 14 days to 3 months after the first vaccination
    Third dose 5 to 12 months after the second vaccination 5 to 12 months after the second vaccination

    Complete the primary immunization series at least 1 week prior to potential exposure to TBEV (tick-borne encephalitis virus).

    A booster dose (fourth dose) may be given at least 3 years after completion of the primary immunization series if ongoing exposure or re-exposure to TBEV is expected.

    Mechanism of Action

    Ticovac (tick-borne encephalitis (TBE) vaccine) in designed to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature. Following administration, Ticovac induces TBEV-neutralizing antibodies, which are believed to confer protection. However, a protective antibody level has not been defined.

    Side Effects

    Adverse effects associated with the use of Ticovac may include, but are not limited to, the following:

    • Individuals 1 through 15 years of age:
      • local tenderness
      • local pain
      • headache
      • fever
      • restlessness
    • Individuals 16 through 65 years of age:
      • local tenderness
      • local pain
      • fatigue
      • headache
      • muscle pain

    Clinical Trial Results

    The FDA approval of Ticovac was based on clinical trials evaluating the safety and immunogenicity of Ticovac, which was assessed across two age groups (1-15 years of age and >16 years of age). In these studies, seropositivity rates were 99.5% in 1-15 year olds and 98.7-100% in adults >15 years following three doses.

    Approval Date: 2021-08-01
    Company Name: Pfizer
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