Indications and Usage
VAXIGRIP® is indicated for active immunization against influenza caused by the specific strains of influenza virus contained in the vaccine in adults and children 6 months of age and older.
Although the current influenza vaccine can contain one or more of the antigens administered in previous years, annual vaccination using the current vaccine is necessary because immunity declines in the year following vaccination.
Dosage and Administration
For intramuscular injection only.
- 6 months to >3 years old (not previously vaccinated with influenza vaccine) – Two doses (0.25 ml/0.5 ml each) at least 4 weeks apart
- 3 years to >9 years old (not previously vaccinated with influenza vaccine) – Two doses (0.5 ml each) at least 4 weeks apart
- 6 months to >9 years old (vaccinated with influenza vaccine in a previous season) – One dose (0.5 ml each)
- 9 years old up – One dose (0.5 ml)
Dosage Forms and Strengths
VAXIGRIP® is supplied as a slightly whitish, opalescent suspension in a vial, prefilled syringe or ampule and is available in packages of:
- 1 x 5 mL (Multidose) vial
- 1 x 0.25 mL (Single Dose) syringe with an attached (25G, 16 mm) needle
- 1 x 0.5 mL (Single Dose) syringe with an attached (25G, 16 mm) needle
- 1 x 0.5 mL (Single Dose) syringe co-packaged with two 25G needles of different lengths (16 mm and 25 mm)
- 1 x 0.5 mL (Single Dose) syringe without needle
- 1 x 0.5 mL (Single Dose) ampoule
- 5 x 0.5 mL (Single Dose) ampoule
Note: Not all pack sizes may be marketed.
VAXIGRIP® should not be administered to anyone with a history of severe allergic reaction to egg protein or any component of the vaccine or after previous administration of the vaccine or a vaccine containing the same components or constituents.
Warnings and Precaution
- VAXIGRIP should not be administered intravascularly or in the buttocks.
- Persons with serious acute febrile illness usually should not be vaccinated until their symptoms have abated. Those with mild non-serious febrile illness (such as mild upper respiratory tract infections) may be given influenza vaccine.
- Persons with any bleeding disorders, such as haemophilia or thrombocytopenia, or in persons on anticoagulant therapy, intramuscular injections.
- Immunocompromised persons (whether from disease or treatment) may not achieve the expected immune response.
- Immunization should be delayed in a patient with an active neurologic disorder, but should be considered when the disease process has been stabilized.
- Guillain-Barré syndrome has been reported after influenza vaccination. However, it is not known whether influenza vaccination specifically might increase the risk for recurrence of GBS.
- Because VAXIGRIP® does not contain infectious viral particles, it cannot cause influenza.
- The most common reactions occurring after vaccine administration are injection site pain, erythema and edema. The most common systemic reactions observed after vaccine administration are asthenia, headache and myalgia. Most of the adverse event reported after influenza vaccination are mild to moderate in intensity, resolving within 3 days.
Use in Specific Populations
- The use of VAXIGRIP® in infants under 6 months of age is not recommended.
- Data on the use of this vaccine in pregnant women are limited. VAXIGRIP® should be given to pregnant women only if clearly needed and following an assessment of the risks and benefits.
- It is not known whether VAXIGRIP® is excreted in human milk. Caution must be exercised when VAXIGRIP® is administered to a nursing mother.