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Content current as of October 12, 2026. AI-assisted draft; not yet reviewed by a licensed pharmacist. Current CDC schedules: immunization schedules.
- The disease and why it matters
- Video and figures
- Get CE credit
- Products available
- Who should get it
- Dosing and schedule, including catch-up
- Administration
- Storage and handling
- Contraindications and precautions
- Safety and adverse events
- Special populations
- Counseling pearls for the pharmacy counter
- Common patient questions
- References
The disease and why it matters
TBE virus is a single-stranded RNA flavivirus with three main subtypes (European, Siberian and Far Eastern), transmitted to humans through the bite of an infected Ixodes tick (primarily Ixodes ricinus for the European subtype and Ixodes persulcatus for the Far Eastern and Siberian subtypes). [1]
TBE is focally endemic in a region spreading from western and northern Europe to northern and eastern Asia, with approximately 5,000 to 10,000 cases reported from endemic countries each year; the main transmission season is April to November, typically peaking June to August in European countries. [1]
Approximately 3 of 4 infections are asymptomatic; the incubation period is typically 7 to 14 days (range 2 to 28 days); neuroinvasive disease (aseptic meningitis, encephalitis or meningoencephalomyelitis) is the most recognized manifestation; the European subtype has a case-fatality ratio below 2% with sequelae in 20% to 40%, whereas the Far Eastern subtype has reported case-fatality ratios of 20% to 40% among neurologic cases. [1]
During 2000 to 2023, 12 TBE cases were reported among U.S. civilian travelers; most infections result from tick bites acquired in forested areas during activities such as bicycling, birdwatching, camping, fishing, hiking, or collecting berries, flowers or mushrooms, and TBE risk is negligible for people who remain in urban or unforested areas and do not consume unpasteurized dairy products. [1]
Video and figures
Video
Get CE credit
No free accredited CE activities for this topic have been confirmed yet.
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Products available
FDA approved Pfizer's TICOVAC in 2021 as the first TBE vaccine for use in the United States; it is an inactivated whole-virus vaccine (marketed as FSME-IMMUN in Europe) with formulations for children (1 to 15 years) and adults (16 years and older), and five other TBE vaccines not licensed in the United States are available internationally. [1]
| Item | Statement |
|---|---|
| Manufacturer (FDA page) | Pfizer Ireland Pharmaceuticals [2] |
| Indication and age | Active immunization to prevent tick-borne encephalitis; approved for use in individuals 1 year of age and older [3] |
| Presentation | Suspension for injection supplied as a 0.25 mL or 0.5 mL single-dose in pre-filled syringes [3] |
| Route | Intramuscular use only [3] |
The FDA TICOVAC page is marked content current as of 09/07/2021, and the label posted on that page shows a placeholder revision date ("M/YYYY"); the label itself says its labeling may have been updated and directs readers to the manufacturer for the most recent prescribing information. [2] [3]
Who should get it
CDC / ACIP (Yellow Book 2026, tick-borne encephalitis chapter)
As of April 23, 2025
In 2022 ACIP approved recommendations for TBE vaccine use among people traveling or moving to a TBE-endemic area: the vaccine is recommended for persons who will have extensive tick exposure based on planned outdoor activities and itinerary, and may be considered for those who might engage in outdoor activities in areas where ticks are likely to be found, based on planned activities and itinerary, risk factors for a poor medical outcome, and personal perception and tolerance of risk. [1]
CDC VIS (December 7, 2023 edition)
As of December 7, 2023
The VIS says TBE vaccine is recommended for people moving or traveling outside the United States to a place where TBE virus spreads and who will have extensive exposure to ticks, may be considered for those who might take part in activities in areas where ticks are likely to be found, and is recommended for many laboratory workers who might be exposed to the TBE virus. [4]
Travelers most likely to be at greater risk include both shorter-term (less than 1 month) travelers with daily or frequent exposure and longer-term travelers with regular (a few times a month) exposure; repeated travel to endemic areas can also increase risk, and risk for severe disease is increased among certain populations (for example travelers aged 60 years or older). [1]
All travelers to TBE-endemic countries with risk of tick exposure should take precautions to avoid tick bites and avoid consumption of unpasteurized dairy products, because infection can follow ingestion of unpasteurized milk and milk products from infected goats, sheep or cattle. [1]
Dosing and schedule, including catch-up
| Age | Dose | Dose 2 | Dose 3 | Booster |
|---|---|---|---|---|
| 1 through 15 years | 0.25 mL [3] | 1 to 3 months after dose 1 [1] | 5 to 12 months after dose 2 | At least 3 years after completing the primary series if ongoing exposure is expected [1] |
| 16 years and older | 0.5 mL [3] | 14 days to 3 months after dose 1 [1] | 5 to 12 months after dose 2 | Same as above |
The label says a booster dose (fourth dose) may be given at least 3 years after completion of the primary series if ongoing exposure or re-exposure to TBEV is expected, and its patient-counseling section stresses completing the approved three-dose primary series before potential exposure; the Yellow Book says studies have demonstrated that after a primary series and a booster, high seropositivity rates are maintained for at least 10 years in children and healthy adults. [3] [1]
The VIS gives the pediatric schedule as second dose 1 to 3 months after the first and the third dose 5 to 12 months after the second, with people 1 through 15 years receiving 0.25 mL and people 16 years and older 0.5 mL. [4]
Administration
- Each dose is given intramuscularly; bring the vaccine to room temperature before administration and shake well to thoroughly mix; after shaking it should be a homogenous off-white, opalescent suspension; do not administer if particulate matter or discoloration remains after shaking. [1] [3]
- Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration. [3]
Storage and handling
- Upon receipt, store refrigerated at 2 to 8 °C (36 to 46 °F); keep the syringe in the outer carton to protect from light; do not freeze; discard if the vaccine has been frozen. [3]
Contraindications and precautions
| Source | Statement |
|---|---|
| TICOVAC label | Severe allergic reaction (e.g., anaphylaxis) to any component of TICOVAC. [3] |
| Yellow Book | A severe allergic reaction to any component is a contraindication; a known severe hypersensitivity to egg or chicken protein (e.g., anaphylaxis after oral ingestion) is also a contraindication although the vaccine is prepared from virus propagated in chick embryo fibroblast cells and the ultracentrifugation process removes all but trace amounts of chick protein; immunocompromise and immunosuppression are precautions. [1] |
The TICOVAC label lists only severe allergic reaction to any component as a contraindication, whereas the Yellow Book also lists known severe hypersensitivity to egg or chicken protein; the label also states TICOVAC contains human albumin and that vaccination may not protect all individuals. [3] [1]
Safety and adverse events
The Yellow Book states that TICOVAC has been available internationally for more than 20 years with more than 75 million doses administered and no serious safety concerns identified; adverse events reported most commonly include tenderness and pain at the injection site in 10% or more of recipients, and serious adverse events are reported only rarely. [1]
Label rates: in subjects 1 through 15 years, local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%) and restlessness (9.1%); in subjects 16 through 65 years, local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%) and muscle pain (5.1%). [3]
Special populations
Pregnancy and lactation: no studies have assessed the safety of TICOVAC in pregnant or lactating women (Yellow Book); the label says there are no adequate and well-controlled studies in pregnant women, available human data are insufficient to establish the presence or absence of vaccine-associated risk, animal developmental and reproductive toxicity studies have not been conducted, and human data are not available on lactation. [1] [3]
Altered immunocompetence: some individuals with altered immunocompetence may have reduced immune responses to TICOVAC; the vaccine contains human albumin, which carries a theoretical risk of transmission of viral diseases and Creutzfeldt-Jakob disease according to the label (section 5.3). [3]
Counseling pearls for the pharmacy counter
- TBE virus can be found in parts of Europe and Asia but not in the United States; TBE is a rare disease in travelers, but people traveling to areas where the virus is found might be at risk; many infected people have no symptoms, but some get very sick, with later encephalitis or meningitis, long-term problems such as memory or concentration difficulties or paralysis, and in very severe cases death. [4]
- Vaccination is not a substitute for tick-bite prevention and for avoiding unpasteurized dairy products. [1]
- Complete the approved three-dose primary series before potential exposure to TBEV and report suspected adverse reactions to a healthcare professional. [3]
Common patient questions
A hiker is leaving for Austria in 3 weeks. Can the series be finished?
The label's primary schedule is three doses; for ages 16 years and older the second dose is 14 days to 3 months after the first and the third dose 5 to 12 months after the second, so the full series cannot be finished in 3 weeks; the label stresses completing the three-dose series before potential exposure. [3] [1]
Does a traveler who only visits Vienna and Prague need TBE vaccine?
The Yellow Book says TBE risk is negligible for people who remain in urban or unforested areas and do not consume unpasteurized dairy products. [1]
Which dose for a 10-year-old?
Children 1 through 15 years of age receive 0.25 mL per dose. [3]
A patient has anaphylaxis to eggs. Is Ticovac contraindicated?
The Yellow Book says a known severe hypersensitivity to egg or chicken protein (for example anaphylaxis after oral ingestion) is a contraindication to TBE vaccination. [1]
References
- Centers for Disease Control and Prevention. Tick-borne encephalitis. In: CDC Yellow Book: Health Information for International Travel, 2026 edition. Page dated April 23, 2025. Accessed October 12, 2026. https://www.cdc.gov/yellow-book/hcp/travel-associated-infections-diseases/tick-borne-encephalitis.html. Accessed October 12, 2026.
- U.S. Food and Drug Administration. TICOVAC product page (content current as of 09/07/2021). Accessed October 12, 2026. https://www.fda.gov/vaccines-blood-biologics/ticovac. Accessed October 12, 2026.
- TICOVAC (tick-borne encephalitis vaccine), suspension for intramuscular injection: prescribing information as posted on FDA's product page (revision date shown as a placeholder, "M/YYYY"). Pfizer Ireland Pharmaceuticals. U.S. Food and Drug Administration. Accessed October 12, 2026. https://www.fda.gov/media/151502/download?attachment. Accessed October 12, 2026.
- Centers for Disease Control and Prevention. Tick-borne encephalitis vaccine: what you need to know. Vaccine Information Statement, December 7, 2023. Accessed October 12, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/tbe.html. Accessed October 12, 2026.
For professional education. Check current labeling and guidance before acting. Not medical advice.
