FDA Approves Vaccine to Prevent Tick-Borne Encephalitis

The Food and Drug Administration (FDA) has approved TicoVac^™ (tick-borne encephalitis vaccine) for active immunization to prevent tick-borne encephalitis (TBE) in individuals 1 year of age and older.

Tick-borne encephalitis (TBE) is a viral infection of the brain and spine that is transmitted through the bite of an infected tick. TicoVac is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the TBE virus found in nature.

The approval was based on data from clinical trials that assessed the safety and immunogenicity of the vaccine across 2 age groups (1 to 15 years of age and 16 to 65 years of age). Results from these trials showed that after 3 doses of the vaccine, the pooled seropositivity rates were 99.5% in individuals 1-15 years old and 98.7 to 100% in those 16 years of age and older. The most common adverse reactions reported across both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to discuss recommendations on the safe and appropriate use of TicoVac. The vaccine is administered as a 3-dose series; each dose is either 0.25mL for individuals 1 to 15 years of age or 0.5mL for those 16 years of age and older. If an individual is expected to have ongoing exposure to TBE virus, then a booster dose (4th dose) may be administered at least 3 years after the primary immunization series.

The product is supplied as 0.25mL and 0.5mL prefilled syringes in 1-count and 10-count cartons.

References

1. U.S. FDA approves Ticovac™, Pfizer’s tick-borne encephalitis (TBE) vaccine. News release. Pfizer Inc. Accessed August 16, 2021. https://www.businesswire.com/news/home/20210813005441/en/U.S.-FDA-Approves-TICOVAC%E2%84%A2-Pfizer%E2%80%99s-Tick-Borne-Encephalitis-TBE-Vaccine. 
2. Ticovac [package insert]. New York, NY: Pfizer Inc.; 2021