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TicoVac FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 19, 2021.

FDA Approved: Yes (First approved August 13, 2021)
Brand name: TicoVac
Generic name: tick-borne encephalitis vaccine
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Tick-Borne Encephalitis Prophylaxis

TicoVac (tick-borne encephalitis vaccine) is an inactivated whole virus vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE) in individuals 1 year of age and older.

  • TBE is a viral infection of the brain and spine that is transmitted to humans through the bite of an infected tick. TicoVac may help reduce the risk of TBE for people traveling to endemic areas of Europe and Asia, potentially including military personnel serving in these locations.
  • TicoVac is administered via intramuscular injection.
  • TicoVac is given as a series of three doses. For children ages 1 to 15 years of age, the second dose is given 1-3 months after the first dose, and the third dose is given 5-12 months after the second dose. For individuals ages 16 years and older, the second dose is given 14 days-3 months after the first dose, and the third dose is given 5-12 months after the second dose.
  • A booster dose (fourth dose) may be given at least 3 years after completion of the primary immunization series if ongoing exposure or re-exposure to tickborne encephalitis virus (TBEV) is expected. 
  • Common adverse reactions include local tenderness and local pain. Additionally headache, fever, and restlessness were reported as common adverse reactions in children, and fatigue, headache, and muscle pain were reported as common adverse reactions in individuals 16 years of age and older.

Development timeline for TicoVac

DateArticle
Aug 13, 2021Approval FDA Approves TicoVac (tick-borne encephalitis vaccine) to Prevent Tick-Borne Encephalitis (TBE)
Feb 23, 2021FDA Accepts for Priority Review Pfizer’s Application for TicoVac™ (Tick-borne Encephalitis Vaccine)

Further information

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