2 doses of VARIVAX
vaccine efficacy against
the varicella virus in
Estimated vaccine efficacy for VARIVAX® (Varicella Virus Vaccine Live) for the 10-year observation perioda
of developing varicella with a 2-dose
regimen vs a 1-dose regimen over 10
- aIn a clinical trial, a total of 2216 children 12 months to 12 years of age with a negative history of varicella were randomized to receive either 1 dose of VARIVAX or 2 doses of VARIVAX given 3 months apart. Subjects were actively followed for varicella, any varicella-like illness, or herpes zoster and any exposures to varicella or herpes zoster on an annual basis for 10 years after vaccination. Persistence of varicella-zoster virus antibody was measured annually for 9 years.
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.
Dosage and Administration
- Each dose is approximately 0.5 mL after reconstitution and is administered by subcutaneous injection.
- Children (12 months to 12 years of age): If a second dose is administered, there should be a minimum interval of 3 months between doses.
- Adolescents (≥13 years of age) and Adults: 2 doses, to be administered with a minimum interval of 4 weeks between doses.
Do not administer VARIVAX to individuals with: a history of 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, including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma, or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS, or receiving immunosuppressive therapy; any febrile illness or active infection, untreated tuberculosis; or those who are pregnant.
- Do not administer VARIVAX® (Varicella Virus Vaccine Live) to individuals with: a history of 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, including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma, or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS, or receiving immunosuppressive therapy; any febrile illness or active infection, untreated tuberculosis; or those who are pregnant.
- Evaluate individuals for immune competence prior to administration of VARIVAX if there is a family history of immunodeficiency. Vaccine recipients should avoid contact with high-risk individuals susceptible to varicella due to possible risk of transmission. Defer vaccination for ≥5 months following blood or plasma transfusions or administration of immune globulins. 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: fever ≥102.0°F (38.9°C) oral: 14.7%; injection-site complaints: 19.3%. Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older monitored for up to 42 days include: fever ≥100.0°F (37.8°C) oral: 10.2%; injection-site complaints: 24.4%. 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%).
- 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.