The FDA approved a biologics license application for the tick-borne encephalitis (TBE) vaccine TICOVAC for individuals 1 year or older.
On August 13, 2021, the FDA approved a biologics license application for the tick-borne encephalitis (TBE) vaccine TICOVAC1 for individuals 1 year or older. The primary 3-dose vaccination series is recommended for individuals who plan to travel to TBE-endemic areas (primarily northern Europe and northern Asia) and should be completed at least 1 week prior to travel. The vaccine induces the production of anti-TBE antibodies, which are believed to confer protection against the virus.2
In clinical trials of healthy children aged 1 to 15 years (n = 3240) who received at least one 0.25-mL dose of the vaccine, the most common adverse reactions were local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%).2 Serious adverse events (SAEs) and death were reported in 62 and 1 participants, respectively; only 1 SAE (febrile convulsion 2 days post vaccination) was related to the vaccine, and no deaths were vaccine-related.
In clinical trials of adults aged 16 or older (n = 4427) who received at least one 0.5-mL dose of the vaccine, the most common adverse events were local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%).2 SAEs and death were reported in 54 and 2 participants, respectively; none of these events were related to the vaccine. Available human data are insufficient to establish the safety of this product in pregnant or lactating populations or its potential to cause carcinogenicity, genotoxicity, or impairment of fertility.2
A primary immunization series of the TBE vaccine consists of 0.25-mL doses for patients aged 1 to 15 years, and 0.5-mL doses for patients aged 16 years or older. The primary vaccination series for patients aged 1 to 15 consists of an initial dose, followed by a second dose in 1 to 3 months and a third dose in 5 to 12 months. For patients aged 16 or older, the vaccination series includes an initial dose followed by a second dose administered 14 days to 3 months later, and a third dose administered 5 to 12 months later. A booster dose can be considered if the patient completed their primary immunization series over 3 years ago and expected continued exposure or reexposure to TBE. The vaccine is administered by intramuscular injection and should be refrigerated between between 2 ºC and 8 ºC (36 ºF to 46 ºF).2