VARIVAX is indicated for vaccination against varicella in individuals from 12 months of age [see sections 4.2 and 5.1].
VARIVAX can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations [see sections 4.2, 4.5, and 5.1].
VARIVAX may also be administered to susceptible individuals who have been exposed to varicella. Vaccination within 3 days of exposure may prevent a clinically apparent infection or modify the course of the infection. In addition, there are limited data that indicate that vaccination up to 5 days after exposure may modify the course of the infection [see section 5.1].
Posology
The use of VARIVAX should be based on official recommendations.
Individuals less than 9 months of age
VARIVAX should not be administered to individuals less than 9 months of age.
Individuals from 9 months of age
Individuals should receive two doses of VARIVAX to ensure optimal protection against varicella [see section 5.1].
• Individuals from 9 to 12 months of age
In settings in which vaccination is initiated between 9 and 12 months of age, a second dose is needed and should be given after a minimum interval of 3 months [see section 5.1].
• Individuals from 12 months to 12 years of age
For individuals from 12 months to 12 years of age, at least one month must elapse between the first and second dose [see section 5.1].
Note: applicable official recommendations may vary regarding the need for one or two doses and the interval between doses of varicella-containing vaccines.
Individuals 12 months to 12 years of age with asymptomatic HIV infection [CDC Class 1] with an age-specific CD4+ T-lymphocyte percentage ≥25% should receive two doses given 12 weeks apart.
• Individuals from 13 years of age and older
Individuals from 13 years of age and older should receive two doses given 4-8 weeks apart. If the interval between doses exceeds 8 weeks, the second dose should be given as soon as possible [see section 5.1].
There are data available on protective efficacy for up to 9 years post-vaccination [see section 5.1]. However, the need for booster doses has not been determined yet.
If VARIVAX is to be administered to seronegative subjects before a period of planned or possible future immunosuppression [such as those awaiting organ transplantation and those in remission from a malignant disease], the timing of the vaccinations should take into account the interval after the second dose before maximal protection might be expected [see sections 4.3, 4.4, and 5.1].
There are no data on protective efficacy or immune responses to VARIVAX in seronegative persons over 65 years of age.
Method of administration
The vaccine is to be injected intramuscularly [IM] or subcutaneously [SC].
The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
DO NOT INJECT INTRAVASCULARLY.
Precautions to be taken before manipulating or administering the product: See section 6.6.
• Hypersensitivity to any varicella vaccine, to any of the excipients listed in section 6.1, or neomycin [which may be present as a trace residue, see sections 2 and 4.4].
• Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the hemic and lymphatic systems.
• Individuals receiving immunosuppressive therapy [including high doses of corticosteroids] [see section 4.8].
• Severe humoral or cellular [primary or acquired] immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinaemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+