This vaccine is used for active immunization to prevent varicella (chickenpox) in individuals aged 12 months and older.

Varicella Virus Vaccine stimulates both cell-mediated and humoral immune responses against the varicella-zoster virus. The exact contribution of these immune responses in providing protection against varicella is not fully established.

Each 0.5 mL dose of Varicella Virus Vaccine is administered subcutaneously. Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh. 

Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measlescontaining vaccine and a dose of Varicella Virus Vaccine if the vaccines are not given concurrently.

Adolescents (≥13 years of age) and Adults: Two doses of Varicella Virus Vaccine are administered at a minimum interval of 4 weeks.

Reye’s syndrome has been reported in children and adolescents who received salicylates during natural varicella infection. Concurrent use of immune globulins or other blood products with Varicella Virus Vaccine may reduce the expected immune response. Vaccination with Varicella Virus Vaccine may also cause a temporary reduction in sensitivity to purified protein derivative (PPD) tuberculin skin tests.

Severe Allergic Reaction:
Do not administer Varicella Virus Vaccine to individuals with a history of anaphylaxis or severe allergic reaction to any component of the vaccine (including neomycin or gelatin) or after a previous dose of a varicella-containing vaccine.

Immunosuppression: Varicella Virus Vaccine should not be given to individuals with immunodeficiency or those who are immunosuppressed due to disease or medical treatment. Cases of disseminated varicella infection and extensive vaccine-related rash have been reported in such individuals when vaccinated inadvertently.

Moderate or Severe Febrile Illness: Do not administer the vaccine to individuals with active moderate or severe febrile illness (fever >38.5°C).

Active Untreated Tuberculosis: The vaccine should not be administered to individuals with active, untreated tuberculosis (TB).

Pregnancy: Do not administer Varicella Virus Vaccine to pregnant women or those planning pregnancy within the next 3 months. Natural varicella infection is known to cause harm to the fetus.

Common (≥10%) adverse reactions reported in children aged 1 to 12 years include:

• Fever ≥102.0°F (38.9°C) orally: 14.7%
• Injection-site reactions: 19.3%

Common (≥10%) adverse reactions reported in adolescents and adults aged 13 years and above include:

• Fever ≥100.0°F (37.8°C) orally: 10.2%
• Injection-site reactions: 24.4%

Other reported adverse reactions across all age groups include:

• Varicella-like rash at the injection site
• Generalized varicella-like rash

Varicella Virus Vaccine is contraindicated during pregnancy because it contains live attenuated virus. Natural varicella infection during pregnancy is known to cause congenital varicella syndrome. However, no increased risk of miscarriage, major birth defects, or congenital varicella syndrome has been observed in cases of inadvertent vaccination during pregnancy. There is no relevant animal data available.

It is unknown whether the vaccine virus is excreted in human breast milk. The benefits of breastfeeding should be weighed against the mother’s need for vaccination and any potential risks to the infant. For preventive vaccines, the maternal condition and risk of disease exposure should be considered.

Assess immune status before administering Varicella Virus Vaccine, especially in individuals with a family history of congenital or hereditary immunodeficiency. Avoid close contact with high-risk individuals who are susceptible to varicella, as the vaccine virus may be transmitted. Immune globulins (IG) and other blood products should not be administered concurrently with the vaccine. The use of salicylates should be avoided for 6 weeks after vaccination in children and adolescents.

Pediatric Use: There is insufficient clinical evidence regarding the safety and effectiveness of Varicella Virus Vaccine in children under 12 months of age.

Geriatric Use: Clinical studies have not included enough seronegative individuals aged 65 years and above to determine whether their response differs from that of younger individuals.

Vaccines, Anti-sera & Immunoglobulin

Store the vaccine at 2°C to 8°C. Do not freeze. Protect from light and keep out of reach of children.