Vaccine Info

TicoVac Tick-Borne Encephalitis (TBE) Vaccine

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Last reviewed
March 9, 2024

TicoVac Tick-Borne Encephalitis Vaccine Dosage, News, Side Effects, Usage

Pfizer's TicoVac™ (whole virus, inactivated) is an approved vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE) marketed under the brand names FSME-Immun® (Encepur N) in Europe and TICOVAC™ in the United States. It was developed using a master 'seed' virus similar to the TBE virus found in nature. TicoVac's formulation has changed over time, including removing thimerosal and transitioning the production virus seed from mouse brain suspension to chick embryo fibroblast cells.

TicoVac vaccination induces neutralizing antibodies against the virus, as the sequence and structure of the virus subtype match those found in nature. The virus is inactivated using formaldehyde; therefore, the vaccine cannot cause disease. TicoVac protects people from known TBE virus subtypes in children (from one year of age) and adults, including the European, Siberian, and Far Eastern subtypes. 

DrugBank Accession Number: DB16611

At New York-based Pfizer, Inc., 'we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines.'

TicoVac Approvals

The TicoVac vaccine has been used for over 20 years in Europe. On September 7, 2021, the U.S. Food and Drug Administration (FDA) published updated information on STN: 125740 (Pfizer Ireland Pharmaceuticals) TBE Vaccine and the BLA Clinical Review Memorandum. The U.K., Europe, and Canada published updated information on the TicoVac vaccine.

TicoVac Vaccine for Travel

International travelers are recommended to complete the primary TicoVac Immunization Series at least seven days before visiting areas with potential TBE exposure. The risk for exposure to infected ticks is highest for persons in areas where TBE is endemic during the primary TBE virus transmission season of April–November. Based on approximately 20–25 million U.S. citizen trips to countries with TBE risk each year, a mean of <1 diagnosed TBE case each year. In Europe, a median of 36 traveler cases (range = 25–65 cases) were reported annually during 2014–2020.

In 2024, TicoVac is available in the U.S. at certain pharmacies. Walgreens offers TicoVac vaccination appointments in select states.

U.S. CDC ACIP Presentations Regarding TicoVac Vaccine

In November 2023, the U.S. CDC published Morbidity and Mortality Weekly Report - Tick-Borne Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. Susan Hills, MBBS, MTH Medical Epidemiologist Arboviral Diseases Branch Centers for Disease Control and Prevention, presented on February 23, 2022: Work Group activities since the last meeting and recommendations for consideration and vote. The CDC voted in the affirmative. On January 12, 2022, the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) reviewed the following presentations: TICK-BORNE ENCEPHALITIS VACCINE Katherine Poehling, MD, MPH; TICK-BORNE ENCEPHALITIS VACCINE Susan Hills, MBBS, MTH; Evidence to Recommendations; Laboratory workers: Evidence to Recommendations - 46 laboratory-acquired infections globally, all before 1995.

TicoVac Vaccine Indication

TicoVac is a vaccine that prevents TBE in individuals one year and older. Tell your doctor if you or your child have ever been infected with or been vaccinated against Yellow fever, Japanese encephalitis, or Dengue viruses. Antibodies might be in your blood that can react with the Tick-Borne Encephalitis (TBE) Virus used in tests to measure your antibody levels. These tests could then give wrong results. The effect of TicoVac 0.5 ml during pregnancy or while breastfeeding is unknown.

TicoVac Vaccines Dosage

Primary Vaccination: Three doses. For intramuscular use only. Dosage and Vaccination Schedule - 1 through 15 years of age: each dose 0.25 mL; 16 years of age and older: each dose 0.5 mL. A booster dose (fourth dose) may be given at least three years after completion of the primary immunization.

TicoVac Vaccine Junior

TicoVac Junior is for individuals one to 15 years of age receiving 0.25 ml. The first and second doses should be given at a 1 to 3-month interval.

TicoVac Vaccine Effectiveness

According to the U.S. CDC, no randomized controlled trials (RCTs) have been conducted to demonstrate the efficacy of the TBE vaccine in preventing clinical diseases. Vaccine effectiveness (VE) studies for the TBE vaccine using a different schedule, with a previous vaccine formulation or with VE assessed in combination with another TBE vaccine or both, have been published; however, no studies assessing VE of the TBE vaccine alone in its current formulation and according to the U.S. licensed schedule exist. A correlate of protection has not been formally established, and no standardized reference reagents are available.

TicoVac Side Vaccine Interactions

TicoVac drug interactions are listed at this link.

TicoVac Vaccine News

November 10, 2023 - The U.S. CDC published: Tick-Borne Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023.

July 9, 2022 - Scientific Results published findings of a study of the VE in Germany of the ENCEPUR (Bavarian Nordic) and FSME-IMMUN (Pfizer).

February 23, 2022—The CDC's ACIP member Katherine Poehling, MD, MPH Chair, ACIP TBE Vaccine Work Group, presented an update before a committee vote. The update reviewed considerations for using the TBE vaccine and proposed recommendations for laboratory workers and persons who travel abroad.

September 29, 2021 - Katherine Poehling, M.D. The chair of the U.S. CDC's ACIP TBE Vaccine Work Group presented a review of information on TBE, including its epidemiology, clinical presentation, diagnosis, treatment, and outcomes.

August 13, 2021—The U.S. Food and Drug Administration (FDA) approved TICOVAC for active immunization to prevent TBE in individuals one year and older. 

December 1, 2014 - Pfizer acquires Baxter's vaccine portfolio, including Neis Vac-C and FSME-IMMUN/TicoVac.

January 30, 2003 - Study: Tolerability of modified tick-borne encephalitis vaccine FSME-IMMUN "NEW" in children: results of post-marketing surveillance. These results demonstrated that, in routine medical practice, the FSME-IMMUN "NEW" vaccine at a dose of 1.2 microg antigen/0.25 ml is safe for the first vaccination in children.

TicoVac Vaccine Clinical Trials

Pfizer's TBE vaccine has been involved in over 26 clinical studies over the past 20 years. In clinical trials, the safety and immunogenicity of TICOVAC™ were assessed across two age groups (1-15 years of age and >16 years of age). In these studies, seropositivity rates were 99.5% in 1-15-year-olds and 98.7-100% in adults >15 years following three doses. Clinical studies demonstrated that TICOVAC™ was generally well-tolerated, with no unexpected adverse events or vaccine-related serious adverse events observed. The most common adverse reactions across both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.

Clinical Trial NCT00890422: Evaluation of Immunogenicity of Different Tick-Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine (immunization) - Last Update Posted on April 29, 2009

Clinical Trial NCT00894686: Tick-borne encephalitis (TBE) Seropersistence After the First Booster and Response to the Second Booster in Children, Adolescents, and Young Adults.

Clinical Trial NCT00161863: Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years - Completed study - January 2003.

Clinical Trials

No clinical trials found