HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use TICOVAC safely and effectively. See full prescribing information for TICOVAC.
TICOVAC (Tick-Borne Encephalitis Vaccine), Suspension for intramuscular injection Initial U.S. Approval: 2021 INDICATIONS AND USAGETICOVAC is a vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE). TICOVAC is approved for use in individuals 1 year of age and older. (1) DOSAGE AND ADMINISTRATIONFor intramuscular use only. - •
- 1 through 15 years of age: each dose 0.25 mL
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- 16 years of age and older: each dose 0.5 mL
Primary Vaccination: Three doses (2.1) Primary Vaccination Schedule |
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| 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 |
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 tick-borne encephalitis virus (TBEV) is expected. DOSAGE FORMS AND STRENGTHSSuspension for injection supplied as a 0.25 mL or 0.5 mL single-dose in pre-filled syringes. (3) CONTRAINDICATIONS- •
- Severe allergic reaction (e.g. anaphylaxis) to any component of TICOVAC. (4)
ADVERSE REACTIONSThe most common adverse reactions are as follows: - •
- 1 through 15 years of age: Local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%). (6.1)
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- 16 through 65 years of age: Local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or https://vaers.hhs.gov. See 17 for PATIENT COUNSELING INFORMATION. Revised: 7/2023 |