TicoVac Vaccine Description
Pfizer's TicoVac vaccine is marketed under the brand names FSME-Immun® (Encepur N) in Europe and TICOVAC™ in the U.S. It was developed using a master 'seed' virus similar to the tick-borne encephalitis (TBE) virus found in nature.
TicoVac (whole virus, inactivated) induces neutralizing antibodies against the tick-borne encephalitis virus, as the sequence and structure of the virus subtype match those found in nature. The virus is inactivated using formaldehyde, and therefore the vaccine cannot cause disease.
Pfizer's TBE vaccine protects known subtypes of the TBE virus in both children (from one year of age) and adults, including the European, Siberian, and Far Eastern subtypes.
On September 7, 2021, the U.S. FDA published STN: 125740 Tick-Borne Encephalitis Vaccine updated information and the BLA Clinical Review Memorandum. The UK published updated TicoVac vaccine information at this link. ATC code: J07BA01
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.'
U.S. CDC ACIP Presentations Regarding TicoVac Vaccine
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 indicated to prevent TBE in individuals one year of age 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 not known.
Tick-borne encephalitis, or TBE, is a human viral infectious disease involving the central nervous system. TBE is caused by the tick-borne encephalitis virus (TBEV), a member of the family Flaviviridae, and was initially isolated in 1937. Three sub-types are described: European or Western tick-borne encephalitis virus, Siberian tick-borne encephalitis virus, and Far eastern Tick-borne encephalitis virus (formerly known as Russian Spring-Summer encephalitis virus, RSSEV), says the U.S. CDC.
TicoVac Vaccine Dosage
TicoVac for individuals 16 years of age and older receive three doses of 0.5 ml suspension for injection in a prefilled syringe. TicoVac Junior is for individuals one year to 15 years of age receiving 0.25 ml. The first and second doses should be given at a 1 to the 3-month interval.
TicoVac Vaccine News
January 12, 2022 - The Advisory Committee on Immunization Practices reviewed various U.S. CDC presentations.
September 29, 2021 - Katherine Poehling, M.D. Chair, 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 - TICOVAC was approved by the U.S. Food and Drug Administration (FDA) for active immunization to prevent TBE in individuals one year of age and older. TICOVAC™is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas. Following today's FDA approval, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to discuss recommendations on the safe and appropriate use of TICOVAC.
May 4, 2021 - Pfizer Inc. (NYSE: PFE) reported financial results for first-quarter 2021 and raised 2021 guidance for revenues and Adjusted diluted EPS driven by the updated expectations for contributions to 2021 performance from BNT162b2 vaccine, as well as the strong performance of the business excluding BNT162b2, partially offset by anticipated additional R&D investments into vaccines to protect against COVID-19, as well as other mRNA-based development programs and COVID-19 antivirals. Pfizer also announced that the FDA accepted for Priority Review a Biologics License Application for its tick-borne encephalitis (TBE) vaccine, as submitted for active immunization to prevent TBE in individuals one year of age and older. If approved, TicoVac would be the first vaccine in the U.S. to help protect adults and children visiting or living in TBE endemic areas. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2021.
February 23, 2021 - Pfizer application to FDA for Priority Review has been accepted. Tick-Borne Encephalitis is a tick-borne viral infection that is endemic to Europe and Asia. TBE has been identified in more than 35 countries across Europe and Asia. However, it is not endemic in the USA.
February 19, 2020 - The WHO published 'Immunization is the best protection against tick-borne encephalitis.'
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 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.