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HomeClinical InformationClinical InformationACIP RecommendationsWhat is TicoVac®?What is TBE?Symptoms & Risk FactorsDemonstrated EffectivenessDosing & Administration ScheduleResourcesResourcesMaterialsVideosOrder TicoVac®
Prescribing Information Indication Patient Site
TicoVac® is the only FDA-approved TBE vaccine1,2
TicoVac® is an inactivated whole virus vaccine as a suspension for injection in a pre-filled syringe.2
  • TicoVac® 0.5 mL suspension for injection in a pre-filled syringe is indicated for the active (prophylactic) immunization of persons over 16 years of age against tick-borne encephalitis (TBE).2
  • TicoVac® 0.25 mL suspension for injection in a pre-filled syringe is indicated for the active (prophylactic) immunization of children aged 1 to 15 years against tick-borne encephalitis (TBE).2
  • TicoVac® may help protect against TBE virus subtypes found across Europe and Asia.3
TBEV Prevalence Increasing & Risk Areas Expanding4

In recent years, the prevalence of tick-borne encephalitis virus (TBEV) has increased, and more endemic areas have been reported.4

Two key factors include:
  • Improved monitoring and increased awareness of the possibility of TBE infection in patients diagnosed with encephalitis.4

  • Rising temperatures are leading to extended tick activity and an expanded geographical distribution of ticks, especially in Northern European countries.4
Over Two Decades of Vaccine Experience5,6

TicoVac® offers TBE vaccination based on over two decades of clinical experience in Europe.5,6

Overall field effectiveness in regularly vaccinated persons in Austria having received the primary series was 96–99% for the years 2000–2011.2,6,7

TicoVac® may help protect against the main TBE virus subtypes found in nature.3 Three main subtypes of TBE exist across Europe and Asia: European, Siberian, and Far Eastern.8 It is difficult to know which subtype your patients will come in contact with, so helping to protect against the main subtypes is important.​​​​​

Storage and Practical Information
  • TicoVac® is manufactured with a shelf life of 30 months.9,10
  • Store in the refrigerator (2-8 °C). Keep the vaccine syringe in the outer carton in order to protect from light. Do not freeze. Discard if the vaccine has been frozen.2
  • TicoVac® should be given by intramuscular (IM) injection.2
References:Centers for Disease Control and Prevention. Tickborne Encephalitis. Travelers’ Health. Accessed February 9, 2022. https://wwwnc.cdc.gov/travel/diseases/tickborne-encephalitis.TicoVac® (Tick-Borne Encephalitis Vaccine). Prescribing Information. New York, NY: Pfizer Inc. 2021.Orlinger KK, Hofmeister Y, Fritz R, et al. A tick-borne encephalitis virus vaccine based on the European prototype strain induces broadly reactive cross-neutralizing antibodies in humans. J Infect Dis. 2011;203(11):1556-1564. doi:10.1093/infdis/jir122Michelitsch A, Wernike K, Klaus C, Dobler G, Beer M. Exploring the Reservoir Hosts of Tick-Borne Encephalitis Virus. Viruses. 2019;11(7):669. doi:10.3390/v11070669Loew-Baselli A, Poellabauer EM, Pavlova BG, et al. Prevention of tick-borne encephalitis by FSME-IMMUN vaccines: review of a clinical development programme. Vaccine. 2011;29(43):7307-7319. doi:10.1016/j.vaccine.2011.07.089Heinz FX, Stiasny K, Holzmann H, et al. Vaccination and tick-borne encephalitis, central Europe. Emerg Infect Dis. 2013;19(1):69-76. doi:10.3201/eid1901.120458Heinz FX, Holzmann H, Essl A, Kundi M. Field effectiveness of vaccination against tick-borne encephalitis. Vaccine. 2007;25(43):7559-7567. doi:10.1016/j.vaccine.2007.08.024Bogovic P, Strle F. Tick-borne encephalitis: A review of epidemiology, clinical characteristics, and management. World J Clin Cases. 2015;3(5):430-441. doi:10.12998/wjcc.v3.i5.430FSME-IMMUN® 0.5 ml. Summary of Product Characteristics (European). Pfizer Inc. November 2018.​​​​​​​​​​​​​​FSME-IMMUN® 0.25 ml Junior. Summary of Product Characteristics (European). Pfizer Inc. November 2018.
Clinical Information WHAT IS TBE?

Tick-borne Encephalitis is a disease caused by a virus that can be spread by a bite from an infected tick or through consumption of unpasteurized dairy products.​​​​​​1

Learn more about TBE
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INDICATION AND USAGE TicoVac® is a vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE) and is approved for use in individuals 1 year of age and older.
IMPORTANT SAFETY INFORMATION
  • TicoVac® should not be given to anyone with a severe allergic reaction (e.g. anaphylaxis) to any component of TicoVac®.
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TicoVac®.
  • TicoVac® may not protect all individuals against TBE.
  • Some individuals with altered immunocompetence may have a reduced response to TicoVac®.
  • TicoVac® contains albumin, a derivative of human blood, and based on effective donor screening and product manufacturing processes carries an extremely remote and theoretical risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD).
  • In clinical studies, the most common adverse reactions in subjects 1 through 15 years of age who received TicoVac® were local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%).
  • In clinical studies, the most common adverse reactions in subjects 16 through 65 years of age who received TicoVac® were local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%).
  • Safety and effectiveness have not been established in pregnant women.​​​
Patients should always ask their healthcare providers for medical advice about adverse events.You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.
Indication TicoVac® is a vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE) and is approved for use in individuals 1 year of age and older.
Important Safety Information
  • TicoVac® should not be given to anyone with a severe allergic reaction (e.g. anaphylaxis) to any component of TicoVac®.
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TicoVac®.
  • TicoVac® may not protect all individuals against TBE.
  • Some individuals with altered immunocompetence may have a reduced response to TicoVac®.
  • TicoVac® contains albumin, a derivative of human blood, and based on effective donor screening and product manufacturing processes carries an extremely remote and theoretical risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD).
  • In clinical studies, the most common adverse reactions in subjects 1 through 15 years of age who received TicoVac® were local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%).
  • In clinical studies, the most common adverse reactions in subjects 16 through 65 years of age who received TicoVac® were local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%).
  • Safety and effectiveness have not been established in pregnant women.​​​
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967. Please see full prescribing information for TicoVac® here. Indication
TicoVac® is a vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE) and is approved for use in individuals 1 year of age and older.
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