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TICOVAC (tick-borne encephalitis vaccine,whole virus, inactivated)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TICOVAC Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
TICOVAC™ is indicated for active immunization to prevent tick-borne encephalitis (TBE). TICOVAC is approved for use in individuals 1 year of age and older.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For intramuscular use only.
2.1 Dosage and Vaccination Schedule
- 1 through 15 years of...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
TICOVAC is a suspension for injection supplied as a 0.25 mL or 0.5 mL single-dose in pre-filled syringes.
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Contraindications
4 CONTRAINDICATIONS
Severe allergic reaction (e.g. anaphylaxis) to any component of TICOVAC [see Description (11)].
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic...
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Adverse Reactions
6 ADVERSE REACTIONS
In clinical studies, the most common adverse reactions in subjects 1 through 15 years of age who received TICOVAC were local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a...
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Description
11 DESCRIPTION
TICOVAC (tick-borne encephalitis vaccine) is a sterile, off-white, homogenous, opalescent suspension for intramuscular injection. TICOVAC is prepared from tick-borne encephalitis (TBE) virus propagated in...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Following administration, TICOVAC induces TBEV-neutralizing antibodies, which are believed to confer protection....
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
TICOVAC has not been evaluated for the potential to cause carcinogenicity,...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Immunogenicity
Primary Immunization Course
The...
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References
15 REFERENCES
- Heinz FX, Holzmann H, Essl A, et al. Field effectiveness of vaccination against tick-borne encephalitis. Vaccine 2007;25(43):7559–67.
- Heinz FX, Stiasny K, Holzmann H, et al. Vaccination and tick-...
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How Supplied/Storage and Handling
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16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TICOVAC is supplied in the following strengths and package configurations:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following:
- The potential benefits and risks of...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.