Virus Vaccine Live)
12 months to 12 years
Adolescents and Adults
13 years and older
|1st Dose||0.5-mL dose administered subcutaneously||0.5-mL dose administered subcutaneously on elected date|
|2nd Dose||If administered, 0.5-mL dose a minimum of 3 months after the first dose||0.5-mL dose to be administered a minimum of 4 weeks after the first dose|
Subcutaneous administration only
- VARIVAX is administered as an approximately 0.5-mL dose by subcutaneous injection into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh. Do not administer this product intravascularly or intramuscularly.
- To minimize loss of potency, administer VARIVAX immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes.
- Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of VARIVAX because these substances may inactivate the vaccine virus.
- To reconstitute the vaccine, first withdraw the total volume of provided sterile diluent into a syringe. Inject all of the withdrawn diluent into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe, inject the total volume (approximately 0.5 mL) of reconstituted vaccine subcutaneously, and discard vial.
Indications and Usage for VARIVAX
- VARIVAX® (Varicella Virus Vaccine Live) is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.
Do not administer VARIVAX to individuals with: a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine; immunosuppressed or immunodeficient individuals; an active febrile illness; active untreated tuberculosis; or those who are pregnant or planning to become pregnant in the next 3 months.
- Do not administer VARIVAX to individuals with: a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine; immunosuppressed or immunodeficient individuals; an active febrile illness; active untreated tuberculosis; or those who are pregnant or planning to become pregnant in the next 3 months.
- Vaccination should be deferred in individuals with a family history of immunodeficiency until it can be confirmed the individual is immunocompetent. Vaccine recipients should avoid close contact with high-risk individuals susceptible to varicella due to possible risk of transmission. Varicella vaccine virus transmission may occur between vaccine recipients and contacts susceptible to varicella including healthy individuals. Immune Globulins and other blood products should not be given concomitantly with VARIVAX. Avoid use of salicylates for 6 weeks following administration of VARIVAX to children and adolescents.
- Frequently reported (≥10%) adverse reactions in children ages 1 to 12 years who were monitored for 42 days include: injection-site complaints: 19.3%; fever ≥102.0°F (38.9°C) oral: 14.7%. Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older monitored for up to 42 days include: injection-site complaints: 24.4%; fever ≥100.0°F (37.8°C) oral: 10.2%. Other reported adverse reactions in all age groups include: varicella-like rash (injection site) and varicella-like rash (generalized).
- In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%).
- VARIVAX may establish latency of varicella zoster virus in immunocompetent individuals, with the potential for later development of herpes zoster.
- There are insufficient data to assess the rate of protection of VARIVAX against the serious complications of chickenpox in adults (eg, encephalitis, hepatitis, pneumonia), and during pregnancy (congenital varicella syndrome).
- The duration of protection from varicella infection after vaccination with VARIVAX is unknown.
- Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.
- A boost in antibody levels has been observed in vaccinees following exposure to wild-type varicella, which could account for the apparent long-term persistence of antibody levels in these studies.
- Due to the concern for transmission of vaccine virus, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to 6 weeks following vaccination.
- VARIVAX is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella.
- It is not known whether varicella vaccine virus is excreted in human milk.
Dosage and Administration
- Each 0.5 mL dose is administered subcutaneously.
- Children (12 months to 12 years of age): The first dose is administered between 12 and 15 months of age. The second dose is administered between 4 to 6 years of age. There should be a minimum interval of 3 months between doses.
- Adolescents (≥13 years of age) and Adults: Two doses are administered with a minimum interval of 4 weeks between doses.