*11.3.3. Vaccination schedule*

All of several vaccination schedules consist of primary (basic) vaccination followed by booster doses. Complete primary (basic) vaccination comprises three doses, usually given with an interval of 1–3 months between first and second dose, and 5–12 months between the second and third dose. When protection is wanted to be achieved in a short time, "fast schedule" (second dose is administered earlier, usually 14 days instead of 1–3 months after the first dose) can be used in accordance with the manufacturers' instructions [12, 42]. The first booster dose is administered 3 years after completion of the primary vaccination; after that, one dose is required every 5 years except for persons aged >60 years (FSME IMMUN) or >50 years (Encepur) for whom boosters are recommended at 3 years intervals [131]. Immunization with the first two doses is preferably accomplished during the winter months to achieve protection before tick activity; however, vaccination can start at any time. A person who had not received the recommended doses according to the schedule but with longer intervals does not need to start vaccination again from the very beginning but just to continue with missing doses. Longer intervals between doses generally do not reduce antibody concentrations after completion of TBE vaccination, but protection in the period before the delayed dose is less consistent [137].

## *11.3.4. Mode of application and dosages*

TBE vaccine is administered intramuscularly into the deltoid muscle; in young children, it can be given in the muscles of anterolateral thigh. It may be administered simultaneously with other vaccines (live or inactivated) but not on the same place [131]. Doses (0.25 or 0.5 ml) depend upon the age of the recipient. The age limits for vaccines available in Europe differ. In persons <16 years old, the dose of the FSME‐IMMUN vaccine is 0.25 ml, whereas for persons ≥16 years, 0.5 ml is advised; the corresponding age limits for Encepur vaccine are <12 and ≥12 years, respectively.

## *11.3.5. Efficacy and safety*

Both European vaccines are safe and effective. Fourteen days after the second dose of basic vaccination protective antibodies develop in about 85% of the subjects, whereas after three doses, more than 98% of persons with normal immunity are protected [131]. As a rule the effectiveness of protection after vaccination against TBE is not verified by the detection of antibodies against TBEV in serum. However, the manufacturers of the vaccines and some authors recommend that in persons with immunodeficiency, the response to vaccination is assessed by serological testing approximately 4 weeks after the second dose, and that — if antibody response was not adequate — the second dose is repeated and followed by the third dose in accordance with the regular TBE vaccination timetable. Along with some proposals similar procedure may possibly refer also to the following doses. While such practice may appear reasonable, no convincing clinical data corroborate its usage.

TBE vaccine field effectiveness is estimated to be >98% in persons vaccinated in line with the advocated schedule, and >90% for those who received basic vaccination, but were later not vaccinated according to the planned timetable [138].

Side effects are mild and relatively rare. They are more frequent after the initial than with later doses of TBE vaccine. The most common side effects are local pain and tenderness on pressure at the injection site; redness and swelling occur less often. Short-term fever after vaccination is relatively common in young children but rare in adults. Neurological complications are very infrequent [131].

## *11.3.6. Contraindications and limitations*

## *11.3.6.1. Contraindications*

1 and strain K23, respectively), are prepared in a similar way (viruses are grown in chick embryo fibroblast cells, are inactivated by formaldehyde and are purified, adjuvant is aluminum hydroxide), are registered for adults and children aged 1 year and older (vaccines for children are called FSME‐IMMUN 0.25 ml Junior, and Encepur Kinder, respectively), and effectively prevent TBE caused by the European as well as Far-Eastern and Siberian subtype of TBEV [131]. In addition to the European vaccines, three vaccines based on Far-Eastern subtype of TBEV are registered: two are produced in Russia (TBE‐Moscow and EnceVir) and one in China [131].

36 Meningoencephalitis - Disease Which Requires Optimal Approach in Emergency Manner

All of several vaccination schedules consist of primary (basic) vaccination followed by booster doses. Complete primary (basic) vaccination comprises three doses, usually given with an interval of 1–3 months between first and second dose, and 5–12 months between the second and third dose. When protection is wanted to be achieved in a short time, "fast schedule" (second dose is administered earlier, usually 14 days instead of 1–3 months after the first dose) can be used in accordance with the manufacturers' instructions [12, 42]. The first booster dose is administered 3 years after completion of the primary vaccination; after that, one dose is required every 5 years except for persons aged >60 years (FSME IMMUN) or >50 years (Encepur) for whom boosters are recommended at 3 years intervals [131]. Immunization with the first two doses is preferably accomplished during the winter months to achieve protection before tick activity; however, vaccination can start at any time. A person who had not received the recommended doses according to the schedule but with longer intervals does not need to start vaccination again from the very beginning but just to continue with missing doses. Longer intervals between doses generally do not reduce antibody concentrations after completion of TBE vaccination, but protection in the period before the delayed dose is less consistent [137].

TBE vaccine is administered intramuscularly into the deltoid muscle; in young children, it can be given in the muscles of anterolateral thigh. It may be administered simultaneously with other vaccines (live or inactivated) but not on the same place [131]. Doses (0.25 or 0.5 ml) depend upon the age of the recipient. The age limits for vaccines available in Europe differ. In persons <16 years old, the dose of the FSME‐IMMUN vaccine is 0.25 ml, whereas for persons ≥16 years, 0.5 ml is advised; the corresponding age limits for Encepur vaccine are <12 and ≥12 years, respectively.

Both European vaccines are safe and effective. Fourteen days after the second dose of basic vaccination protective antibodies develop in about 85% of the subjects, whereas after three doses, more than 98% of persons with normal immunity are protected [131]. As a rule the effectiveness of protection after vaccination against TBE is not verified by the detection of antibodies against TBEV in serum. However, the manufacturers of the vaccines and some authors recommend that in persons with immunodeficiency, the response to vaccination is assessed by serological testing approximately 4 weeks after the second dose, and that — if

*11.3.3. Vaccination schedule*

*11.3.4. Mode of application and dosages*

*11.3.5. Efficacy and safety*

The main contraindications are as follows:


## *11.3.6.2. Limitations*

*Pregnancy, breast‐feeding*: Because information on the safety of TBE vaccine during pregnancy and lactation is inadequate, pregnant and lactating women should receive the vaccine only after a careful individual assessment of the potential risks and benefits. There is also no sufficient data on the safety of vaccination during lactation. However, since TBE vaccines are based on inactivated virus, the harm of breast-feeding child or fetus is unlikely.

*Autoimmune diseases*: While there is no indication that vaccination may deteriorate the course of autoimmune diseases or trigger autoimmunity, caution is required in persons with an autoimmune disease because data on the safety of vaccination in this group are limited [131].

#### *11.3.7. Storage*

The vaccine must be stored in a refrigerator at a temperature between 2 and 8°C. Storage at higher temperatures and freezing are not suitable [131].
