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TICOVAC Highlights (tick-borne encephalitis vaccine,whole virus, inactivated)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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 USAGE

TICOVAC 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 ADMINISTRATION

For intramuscular use only.

  • 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 (2.1)

Primary Vaccination Schedule
1 through 15 years of age16 years of age and older
First doseDay 0Day 0
Second dose1 to 3 months after the first vaccination14 days to 3 months after the first vaccination
Third dose5 to 12 months after the second vaccination5 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 STRENGTHS

Suspension 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 REACTIONS

The 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)
  • 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 http://vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2021

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Report Adverse Event
Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.