Indications and Usage for VARIVAX

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.

Dosage and Administration for VARIVAX® (Varicella Virus Vaccine Live)

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.

Selected Safety Information for VARIVAX® (Varicella Virus Vaccine Live)

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.

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.

Before administering VARIVAX® (Varicella Virus Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

1. Centers for Disease Control and Prevention (CDC). National, regional, state, and selected local area vaccination coverage among adolescents aged 13–17 years — United States, 2017. MMWR Morb Mortal Wkly Rep. 2018;67(33):909-917.
2. Centers for Disease Control and Prevention (CDC). Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007;56(RR-4):1-40.
3. Centers for Disease Control and Prevention (CDC). Catch-up immunization schedule for persons aged 4 months–18 years who start late or who are more than 1 month behind, United States, 2019. https://www.cdc.gov/vaccines/schedules/hcp/imz/catchup.html. Last reviewed: February 5, 2019. Accessed June 14, 2019.
4. Centers for Disease Control and Prevention (CDC). Vaccine storage and handling toolkit. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. Published January 2019. Accessed June 17, 2019.
5.  Centers for Disease Control and Prevention (CDC). National Center for Immunization and Respiratory Diseases. Vaccine Storage and Handling Toolkit. https://www.cdc.gov/vaccines/hcp/admin/storage/
toolkit/storage-handling-toolkit.pdf. Published June 2016. Accessed August 29, 2017.
6.  Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2017. http://www.cdc
.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Effective January 1, 2017. Accessed August 29, 2017.

2 doses of
VARIVAX
demonstrated
98% vaccine
efficacy against
the varicella
virus in
children

Vaccine Efficacy for VARIVAX® (Varicella Virus Vaccine Live)
Estimated vaccine efficacy for VARIVAX® (Varicella Virus Vaccine Live) for the 10-year
observation perioda

(n=1114) P<0.001

(n=1102) P<0.001

of developing varicella
with a 2-dose regimen vs
a 1-dose regimen over
10 years postvaccination

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.

Clinical Trials Have Shown 3.4x Lower Risk of Developing Varicella With a 2-Dose Vaccine Regimen In Clinical Trials, VARIVAX® (Varicella Virus Vaccine Live) Showed 98% Vaccine Efficacy

Indications and Usage for VARIVAX

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.

Dosage and Administration for VARIVAX® (Varicella Virus Vaccine Live)

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.

Selected Safety Information for VARIVAX® (Varicella Virus Vaccine Live)

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.

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.

Before administering VARIVAX® (Varicella Virus Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available.

US-VVX-00014 08/19