Tick-borne encephalitis vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Suspension for injection in a pre-filled syringe containing inactivated tick-borne encephalitis virus vaccine.
Drugs List
Therapeutic Indications
Uses
Tick-borne encephalitis - prophylaxis
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Dosage
Adults
Three 0.5 ml doses by intramuscular injection according to the following schedule:
First dose
Administer on an elected date
Second dose
Administer 1 to 3 months after the first dose. If a rapid immune response is required, the second dose may be administered 2 weeks after the first dose; this gives 90% protection.
Third dose
Administer 5 to 12 months after the second dose.
To achieve immunity before the beginning of the seasonal tick activity (spring), it is recommended that the first and second doses are administered during winter. The third dose should be given during the same tick season or at least before the start of the following tick season.
If the interval between doses is extended, patients may have inadequate protection against infection in the interim period.
Booster dose
The first booster dose should be given no more than 3 years after the third dose.
Subsequent booster doses may be given at 3 to 5 year intervals if the patient has continued exposure to infection.
Elderly
(See Dosage; Adult)
In general, in individuals over 60 years of age the interval between booster doses should not exceed 3 years.
Children
Children aged 1 to 16 years
Three 0.25 ml doses by intramuscular injection according to the following schedule:
First dose
Administer on an elected date
Second dose
Administer 1 to 3 months after the first dose. If a rapid immune response is required, the second dose may be administered 2 weeks after the first dose; this gives 90% protection.
Third dose
Administer 5 to 12 months after the second dose.
To achieve immunity before the beginning of the seasonal tick activity (spring), it is recommended that the first and second doses are administered during winter. The third dose should be given before the start of the following tick season.
If the interval between doses is extended, patients may have inadequate protection against infection in the interim period.
Booster dose
A booster dose should be given no more than 3 years after the third dose. Sequential booster doses should be given following national recommendations, but not less than 3 years after the last booster dose. Based on local epidemiology and experience, intervals of 3 up to 5 years for sequential boosters have been nationally recommended.
Additional Dosage Information
Patients with an impaired immune system (including patients undergoing immunosuppressive therapy)
If protection levels (determined by antibody concentration) have not been achieved 4 weeks after the second dose, this dose should be repeated. The same applies to any of the subsequent doses.
The need for subsequent booster doses may be assessed by serological tests at intervals. In general, in these patients the interval between booster doses should not exceed 3 years.
Administration
By intramuscular injection into the upper arm (deltoid muscle).
In children up to 18 months of age, or dependent on a child's development and nutrition states, the vaccine is administered into the anterolateral thigh.
Contraindications
Acute illness
Children under 1 year
Precautions and Warnings
Autoimmune disease
Elderly
Immunosuppression
Breastfeeding
Coagulopathy
History of cerebral disorders
Immunodeficiency syndromes
Pregnancy
Does not protect against Borrelia infections
Postpone immunisation if there is active or suspected infection
Advise patient dizziness may affect ability to drive or operate machinery
Advise visual disturbances may affect ability to drive or operate machinery
Impaired response possible in immunocompromised patients
Not all available brands/formulations are licensed for use in children
Vaccine may not be effective in 100% of patients
May contain trace amounts of formaldehyde
May contain trace amounts of gentamicin
May contain trace amounts of neomycin
May contain trace amounts of protamine
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Evaluate risk of exposure to tick-borne encephalitis
Fever may occur after 1st dose - treat appropriately
Follow national immunisation guidelines
Infection may occur if bitten by tick between 1st and 2nd dose
Non-severe allergy to egg protein does not contraindicate the administration of this vaccine. If these patients are treated, appropriate supervision is required and facilities to manage hypersensitivity reactions should be readily available.
Where serological testing is necessary to determine the need for subsequent doses, assays should be performed in an experienced, qualified laboratory. This is because false positive results may occur due to the cross-sensitivity with pre-existing antibodies. These antibodies may result from previous exposure to or vaccination against other flaviviruses (Japanese encephalitis, Yellow fever, Dengue virus).
Consider antipyretic prophylaxis or treatment in children with a history of high fever following vaccinations or fever convulsions.
In cases of known or suspected autoimmune disease (e.g. multiple sclerosis, iridocyclitis), the risk of possible infection with tick-borne encephalitis should be weighed against the risk of the autoimmune disease being exacerbated.
Tick-borne encephalitis may not be prevented if a tick-bite occurs before or 2 weeks after the first dose.
A tick-bite may also cause other infections, including an infection with Borrelia bacteria, which has similar symptomatology to tick-borne encephalitis infection. If clinical symptoms of tick-borne encephalitis occur, investigate for the possibility of alternative causes.
Pregnancy and Lactation
Pregnancy
Use tick-borne encephalitis vaccine with caution during pregnancy.
Schaefer (2015) comments that no evidence of embryonic effects have been noted when using this vaccine during pregnancy.
In the publication 'Immunisation against infectious diseases' (The Green Book) it states that there has been little evidence of risk when using an inactivated virus/ bacterial vaccine or toxoids. The tick-borne encephalitis vaccine has not been directly associated with adverse outcomes during pregnancy. .
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use tick-borne encephalitis vaccine with caution during breastfeeding.
It is not known whether this vaccine is excreted into human breast milk.
In the publication 'Immunisation against infectious diseases' (The Green Book) it states that there is no risk in vaccinating breastfeeding women with inactivated viral vaccines.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal pain
Acute disseminated encephalomyelitis
Anaphylaxis
Arthralgia
Aseptic meningitis
Asthenia
Back pain
Chills
Convulsions
Decreased appetite
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Encephalitis
Erythema
Erythema at injection site
Erythematous rash
Exacerbation of autoimmune disease
Eye pain
Facial nerve paresis
Facial palsy
Fatigue
Gait abnormality
Guillain-Barre syndrome
Haemorrhage (injection site)
Headache
Hemiparesis
Hemiplegia
Hyperhidrosis
Hypersensitivity reactions
Hypoesthesia
Induration (injection site)
Influenza-like syndrome
Joint inflammation
Joint pain
Joint swelling
Local pain (injection site)
Lymphadenopathy
Maculopapular rash
Malaise
Meningism
Motor disturbances
Myalgia
Myelitis
Nausea
Neck pain
Neuralgia
Neuritis
Nodules (injection site)
Oedema
Optic neuritis
Painful extremities
Paraesthesia
Paralysis
Paresis
Photophobia
Polyneuropathy
Pruritus
Pyrexia
Reactivation of herpes zoster
Restlessness
Sensation of warmth
Sensory disturbances
Sleep disorders
Somnolence
Stiffness
Swelling (injection site)
Tachycardia
Tinnitus
Transverse myelitis
Urticaria
Vertigo
Vesicular dermatitis
Visual disturbances
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last full review: December 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.
Paediatric Formulary Committee. BNF for Children 2016-2017. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2016.
Summary of Product Characteristics: TicoVac 0.5 ml Suspension for injection in a prefilled syringe. Pfizer Limited. Revised July 2016.
Summary of Product Characteristics: TicoVac Junior 0.25 ml Suspension for injection in a pre-filled syringe. Pfizer Limited. Revised July 2016.
Immunisation against infectious disease - The Green Book.
Available at https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last accessed: December 15, 2016.
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