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Inactivated TBE vaccine Pregnancy: UK SPC §4.6: 'There are no data from the use of TicoVac 0.5 ml in pregnant women.' Breast-feeding: 'It is unknown whether TicoVac 0.5 ml is excreted in human milk. Therefore, TicoVac 0.5 ml should only be administered during pregnancy and to breastfeeding women when it is considered urgent to achieve protection against TBE infection and after careful consideration of the risk-benefit relationship.'

Tick-borne encephalitis vaccine

Brand names: TicoVac

Tick-borne encephalitis vaccine is an inactivated viral vaccine used to provide active immunisation against tick-borne encephalitis, mainly for travellers to or residents of endemic areas with relevant exposure.

Adult dose

Dose: Active immunisation against tick-borne encephalitis — TicoVac 0.5 ml, persons from 16 years of age: 0.5 ml per dose. UK SPC §4.2 verbatim: 'The primary vaccination schedule is the same for all persons from the age of 16 onwards and consists of three doses of TicoVac 0.5 ml.' SCOPE OF THIS ENTRY: the source is the TicoVac 0.5 ml SPC, which is the presentation licensed from 16 years of age. The paediatric presentation (TicoVac Junior) is a separate product, is not described anywhere in this bundle and was NOT fetched — do not apply these figures to a child.
Route: Intramuscular injection into the upper arm (deltoid muscle). §4.2 verbatim: 'In exceptional cases only (in subjects with a bleeding disorder or in subjects receiving prophylactic anticoagulation), the vaccine may be administered subcutaneously (see sections 4.4 and 4.8). Care must be taken to avoid accidental intravascular administration (see section 4.4).'
Frequency: Conventional primary schedule (three doses of 0.5 ml): 1st dose at the elected date; 2nd dose 1 to 3 months after the 1st vaccination; 3rd dose 5 to 12 months after the 2nd vaccination. Rapid immunisation schedule: 1st dose at the elected date; 2nd dose 14 days after the 1st ('If there is a need to achieve an immune response rapidly, the second dose may be given two weeks after the first dose'); 3rd dose 5 to 12 months after the 2nd. BOOSTERS — persons 16 to less than 60 years: first booster 0.5 ml 3 years after the 3rd vaccination, then sequential booster doses of 0.5 ml every 5 years. Persons 60 years of age and older: all booster doses 0.5 ml every 3 years — 'In general, in individuals over 60 years of age the booster intervals should not exceed three years.'
The bundle's WHO entry remains a reference link only and contributed no dose. TIMING, §4.2: 'After the first two doses sufficient protection for the ongoing tick season is to be expected. After the third dose protection is expected to last for at least 3 years. To achieve immunity before the beginning of the seasonal tick activity, which is in spring, the first and second doses should preferably be given in the winter months. The vaccination schedule should ideally be completed with the third vaccination within the same tick season or at the least before the start of the following tick season.' INTERRUPTED SCHEDULES, §4.2: 'Extending the interval between any of the doses (primary vaccination schedule and booster doses) may leave subjects with inadequate protection against infection. However, in the case of an interrupted vaccination schedule of at least two previous vaccinations, a single catch-up dose is sufficient to continue the vaccination schedule.' IMPAIRED IMMUNITY, §4.2: 'There are no specific clinical data on which to base dose recommendations. However, consideration may be given to determining the antibody concentration at four weeks after the second dose and administering an additional dose if there is no evidence of seroconversion at this time. The same applies to any of the following doses.' No maximum dose is stated anywhere in the fetched text, so none is recorded. Some sections of the product information we used were incomplete — check the full SPC. §4.2 itself is complete.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, any of the excipients listed in section 6.1, or production residues (formaldehyde, neomycin, gentamycin, protamine sulfate)
  • Cross allergies with aminoglycosides other than neomycin and gentamycin should be considered
  • 'Severe hypersensitivity to egg and chick proteins (anaphylactic reaction after oral ingestion of egg protein) may cause severe allergic reactions in sensitized individuals'
  • 'TBE vaccination should be postponed if the person is suffering from a moderate or severe acute illness (with or without fever)'

Side effects

  • FREQUENCY CAVEAT: the §4.8 clinical-trial table uses four unlabelled frequency columns (Very common >= 1/10; Common >= 1/100 to < 1/10; Uncommon >= 1/1,000 to < 1/100; Rare >= 1/10,000 to < 1/1,000) and the column alignment was lost when the section was captured as flat text, so which reaction sits in which column CANNOT be verified from this bundle and no frequency is asserted below. Frequencies are per vaccination, pooled from 7 clinical studies with TicoVac 0.5 mL (2.4 micrograms) in subjects aged 16 through 65 years
  • Clinical trials — blood and lymphatic system disorders: lymphadenopathy. Immune system disorders: hypersensitivity
  • Clinical trials — nervous system disorders: headache; somnolence. Ear and labyrinth disorders: vertigo
  • Clinical trials — gastrointestinal disorders: nausea; vomiting; diarrhoea; abdominal pain
  • Clinical trials — musculoskeletal and connective tissue disorders: myalgia; arthralgia
  • Clinical trials — general disorders and administration site conditions: injection site reactions e.g. injection site pain; fatigue; malaise; pyrexia; injection site haemorrhage; injection site reactions such as erythema, induration, swelling, pruritus, paraesthesia and warmth
  • Post-marketing surveillance — the SPC states these are all at the calculated maximum frequency 'rare' ('the calculated frequency "rare" represents the theoretical maximum frequency for these events'): herpes zoster (triggered in pre-exposed patients); precipitation or aggravation of autoimmune disorders (e.g. multiple sclerosis); anaphylactic reaction; demyelinating disorders (acute disseminated encephalomyelitis, Guillain-Barre syndrome, myelitis, transverse myelitis); encephalitis; convulsions; aseptic meningitis; meningism; sensory abnormalities and motor dysfunction (facial palsy/paresis, paralysis/paresis, neuritis, hypoesthesia, paraesthesia); neuralgia; optic neuritis; dizziness
  • Post-marketing surveillance, other systems (same 'rare' maximum): visual impairment, photophobia, eye pain; tinnitus; tachycardia; dyspnoea; urticaria, rash (erythematous, maculopapular), pruritus, dermatitis, erythema, hyperhidrosis; back pain, joint swelling, neck pain, musculoskeletal stiffness including neck stiffness, pain in extremity; gait disturbance, chills, influenza-like illness, asthenia, oedema, injection site joint movement impairment such as joint pain, nodule and inflammation
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • §4.2: in persons with an impaired immune system (including those undergoing immunosuppressive therapy) 'consideration may be given to determining the antibody concentration at four weeks after the second dose and administering an additional dose if there is no evidence of seroconversion at this time. The same applies to any of the following doses.'
  • §4.2: care must be taken to avoid accidental intravascular administration
  • PARTIAL — §4.4 was not retrieved in full in this bundle; monitoring guidance beyond the points quoted above was not captured

Clinical monograph

How it works

It contains inactivated tick-borne encephalitis virus that stimulates the production of protective neutralising antibodies without causing infection.

Prescribing in practice

  • It is contraindicated in those with a confirmed severe allergic reaction to a previous dose or to a vaccine component, including egg in egg-allergic individuals as relevant.
  • A multi-dose primary course is needed for reliable protection, so timing should allow completion before travel.
  • Vaccination complements but does not replace personal measures to avoid tick bites in endemic regions.

Monitoring

Observe for immediate hypersensitivity after each dose and ensure the primary course and boosters are completed for continued protection.

Counselling the patient

  • Continue to use insect repellent, cover up and check for ticks in affected areas.
  • You need the full course of injections for proper protection.
  • Report any significant reaction before the next dose is due.

Evidence & guidelines

Recommendations on use for travellers to endemic areas are set out in UK Health Security Agency immunisation guidance (the Green Book).

Reference: UKHSA Green Book Ch.31; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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