Inactivated viral vaccine

Ticovac (tick-borne encephalitis vaccine (inactivated))

Also marketed as FSME-Immun. An approved treatment for Tick-Borne Encephalitis.

FDA Approved (2021)by Pfizer
Preclinical
Phase 1
Phase 2
Phase 3
Approved
2021
Drug facts

The same compound appears under different names depending on the context. Here is how to identify Tick-borne encephalitis vaccine (inactivated) wherever you encounter it, plus the key facts at a glance.

Generic name
Tick-borne encephalitis vaccine (inactivated)
Brand names
Ticovac, FSME-Immun
Drug class
Inactivated viral vaccine
Manufacturer
Pfizer
How it's taken
Given as an injection into the upper arm or, in small children, the thigh.

The only FDA-approved vaccine against tick-borne encephalitis, a viral brain infection spread by ticks in Europe and northern Asia. Approved in August 2021 for people 1 year and older, it is given as a 3-dose series to travelers, expatriates and military families heading to affected areas, after more than 20 years of use in Europe under the name FSME-Immun.

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Where Tick-borne encephalitis vaccine (inactivated) fits

There is no treatment for tick-borne encephalitis, which makes the vaccine the only medical defense beyond tick avoidance. The CDC's Advisory Committee on Immunization Practices recommends it for people moving to or traveling in an affected area who will have extensive tick exposure based on their planned outdoor activities and itinerary, and for laboratory workers who handle the virus; it says the vaccine may be considered for other travelers who will spend time outdoors in tick habitat there. The virus does not circulate in US ticks, so there is no reason for people who stay in the United States to be vaccinated. Military families stationed in Germany account for about half of recorded US cases.

How Tick-borne encephalitis vaccine (inactivated) works

Ticovac contains tick-borne encephalitis virus grown in cell culture and then inactivated so it cannot cause infection, combined with an aluminum adjuvant that strengthens the immune response. After the series, the body makes neutralizing antibodies that block the virus if an infected tick bites later. In the studies on the FDA label, 99.5% of children 1 to 15 and 98.8% to 100% of adults had neutralizing antibodies 3 weeks after the third dose, and 90.6% of adults had them 1 week after it. The label notes that the antibody level needed for protection has not been defined. The vaccine is made from a European-subtype strain grown in chick embryo cells and contains a small amount of human albumin. It does not protect against Lyme disease, Powassan virus or any other tick-borne infection, and it has not been studied against Powassan, the closely related virus found in North America.

Mechanism: Inactivated whole-virus vaccine that trains the immune system to make neutralizing antibodies against tick-borne encephalitis virus

Side effects and safety

What patients report
Label warnings
  • Allergic reactions. Do not give to anyone with a severe allergic reaction to a previous dose or to any ingredient; treatment for anaphylaxis must be available.
  • Fainting. Syncope can follow any injected vaccine; sit or lie down for 15 minutes afterward.
  • Weakened immunity. People on immune-suppressing treatment may have a weaker response.
Most common in trials
Injection site pain and tendernessHeadacheTirednessMuscle painFever (more often in children 1 to 2 after the first dose)
Report a suspected reaction to VAERS at 1-800-822-7967 or vaers.hhs.gov, or Pfizer at 1-800-438-1985, or to the FDA at 1-800-FDA-1088.
In context

The most common side effects in adults are tenderness and pain at the injection site, headache, tiredness and muscle pain; in children 1 to 15, tenderness and pain at the injection site, headache and fever. Fever is more common in young children after the first dose. As with any injected vaccine, fainting and allergic reactions can occur, so the vaccine is given where those can be managed. People with a severe allergy to a previous dose or to any component should not receive it; the vaccine contains traces of chick protein, neomycin and gentamicin and a small amount of human albumin. Pfizer's label notes there are no adequate studies in pregnancy. European post-marketing reports include rare neurological events such as Guillain-Barre syndrome, whose frequency and relationship to the vaccine cannot be established from voluntary reports. Report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or to Pfizer at 1-800-438-1985.

This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.

Taking Tick-borne encephalitis vaccine (inactivated)

Given as an injection into the upper arm or, in small children, the thigh. The series is 3 doses. For adults and teens 16 and older: the second dose 14 days to 3 months after the first, and the third 5 to 12 months after the second. For children 1 to 15: the second dose 1 to 3 months after the first, and the third 5 to 12 months after the second. A booster is given at least 3 years after the third dose if exposure continues. The CDC advises completing the series at least 1 week before travel, and the accelerated 14-day gap between doses 1 and 2 exists for travelers who are short on time. In the United States it is ordered through a doctor or travel clinic; pharmacies rarely stock it.

Availability and cost

Why it costs what it costs

Travel vaccines are usually not covered by US insurance, and the full 3-dose series is typically paid out of pocket at a travel clinic. Ask the clinic for the per-dose price before starting, and ask whether doses can be completed abroad, where the same vaccine is widely available, if your travel dates do not allow the full series beforehand.

Clinical trial results

FDA approval rested on 2 decades of European use plus antibody studies: 99.5% of children 1 to 15 (Study 209) and 98.8% to 100% of adults (Studies 213 and 690601) had neutralizing antibodies after dose 3, and 3 years later 83% to 100% still did, depending on age, with 100% responding to a booster. In Austria, where the vaccine held 80% to 95% of the market from 2000 to 2011, effectiveness against hospitalized TBE after a complete series was estimated at 96% to 99% (Heinz et al., 2007 and 2013). Studies listed as active on ClinicalTrials.gov in October 2026 are in Europe and focus on booster intervals, response in older adults and antibody persistence rather than on new indications for the vaccine; separately, a Slovenian Phase 3 trial is testing dexamethasone as a treatment for people already sick with TBE (NCT07584525).

Development history

The vaccine was developed in Austria and first licensed there in 1976, and under the name FSME-Immun it underpins Austria's national vaccination program, one of the most complete in Europe. Pfizer acquired it when it bought Baxter's marketed vaccines business in 2014. The FDA approved it as Ticovac on August 13, 2021, the first TBE vaccine licensed in the United States, and the CDC's advisory committee issued its recommendations for travelers and lab workers in 2023.

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Common questions about Tick-borne encephalitis vaccine (inactivated)

▸What is Tick-borne encephalitis vaccine (inactivated) (Ticovac)?

The only FDA-approved vaccine against tick-borne encephalitis, a viral brain infection spread by ticks in Europe and northern Asia. Approved in August 2021 for people 1 year and older, it is given as a 3-dose series to travelers, expatriates and military families heading to affected areas, after more than 20 years of use in Europe under the name FSME-Immun.

▸How does Tick-borne encephalitis vaccine (inactivated) work?

Ticovac contains tick-borne encephalitis virus grown in cell culture and then inactivated so it cannot cause infection, combined with an aluminum adjuvant that strengthens the immune response. After the series, the body makes neutralizing antibodies that block the virus if an infected tick bites later. In the studies on the FDA label, 99.5% of children 1 to 15 and 98.8% to 100% of adults had neutralizing antibodies 3 weeks after the third dose, and 90.6% of adults had them 1 week after it. The label notes that the antibody level needed for protection has not been defined. The vaccine is made from a European-subtype strain grown in chick embryo cells and contains a small amount of human albumin. It does not protect against Lyme disease, Powassan virus or any other tick-borne infection, and it has not been studied against Powassan, the closely related virus found in North America.

▸What are the side effects of Tick-borne encephalitis vaccine (inactivated)?

The most common side effects in adults are tenderness and pain at the injection site, headache, tiredness and muscle pain; in children 1 to 15, tenderness and pain at the injection site, headache and fever. Fever is more common in young children after the first dose. As with any injected vaccine, fainting and allergic reactions can occur, so the vaccine is given where those can be managed. People with a severe allergy to a previous dose or to any component should not receive it; the vaccine contains traces of chick protein, neomycin and gentamicin and a small amount of human albumin. Pfizer's label notes there are no adequate studies in pregnancy. European post-marketing reports include rare neurological events such as Guillain-Barre syndrome, whose frequency and relationship to the vaccine cannot be established from voluntary reports. Report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or to Pfizer at 1-800-438-1985.

▸How is Tick-borne encephalitis vaccine (inactivated) taken?

Given as an injection into the upper arm or, in small children, the thigh. The series is 3 doses. For adults and teens 16 and older: the second dose 14 days to 3 months after the first, and the third 5 to 12 months after the second. For children 1 to 15: the second dose 1 to 3 months after the first, and the third 5 to 12 months after the second. A booster is given at least 3 years after the third dose if exposure continues. The CDC advises completing the series at least 1 week before travel, and the accelerated 14-day gap between doses 1 and 2 exists for travelers who are short on time. In the United States it is ordered through a doctor or travel clinic; pharmacies rarely stock it.

▸Is Tick-borne encephalitis vaccine (inactivated) FDA approved?

Yes, Tick-borne encephalitis vaccine (inactivated) (Ticovac) is FDA approved (2021) for the treatment of Tick-Borne Encephalitis.

▸Do I need the tick-borne encephalitis vaccine for a trip to Europe?

Only if you will be spending time outdoors in tick habitat in an affected area, typically forests, fields and rural areas of central, eastern and northern Europe or northern Asia between April and November. The CDC recommends Ticovac for travelers who will have extensive tick exposure, such as hiking, camping, fieldwork or living there, and says it may be considered for others who will be outdoors in those areas. A city visit does not call for it. A travel clinic can match the recommendation to your itinerary.

▸Does Ticovac protect against Powassan virus or Lyme disease?

No. Ticovac targets tick-borne encephalitis virus, which is found in Europe and Asia, not in US ticks. It has not been shown to protect against Powassan virus, a related virus in North America, and it does nothing against Lyme disease, anaplasmosis, babesiosis or other tick-borne infections. There is no vaccine for Powassan, and no Lyme vaccine is currently approved in the United States.

▸How long does the Ticovac series take?

The standard series takes 6 to 15 months: 2 doses 14 days to 3 months apart (1 to 3 months for children), then a third 5 to 12 months later. Two doses give substantial short-term protection for a trip, and the CDC says to finish the second dose at least a week before travel. A booster is recommended after 3 years if you are still at risk.

This page is for informational purposes only and does not constitute medical advice. Drug information is sourced from public databases and peer-reviewed literature and may not reflect the most recent updates. Always discuss treatment options with your healthcare provider. Last reviewed: October 2026.

Follow Ticovac by email

We'll email you when Ticovac's FDA label changes, when the FDA acts on it, and when new trials for Tick-Borne Encephalitis open. Unsubscribe anytime.

You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Tick-Borne Encephalitis. Turn any of these off from the link in every email.

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