Vaccines

VARIVAX

Therapeutic indications1

VARIVAX is indicated for vaccination against varicella in individuals from 12 months of age. 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.

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.

Posology and method of administration1

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.

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.

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. 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. There are data available on protective efficacy for up to 9 years post-vaccination. 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.

There are no data on protective efficacy or immune responses to VARIVAX in seronegative persons over 65 years of age.

Method of Administration1

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.

Adverse Event Reporting

Healthcare professionals are asked to report any suspected adverse reactions via

HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2

Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

IE-VVX-00009 |Date of preparation: January 2020