Indications and Usage for VARIVAX® (Varicella Virus Vaccine Live)

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

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 varicella 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 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, 2016. MMWR Morb Mortal Wkly Rep. 2017;66(33):874–882.
2.  Centers for Disease Control and Prevention (CDC). 2016 Adolescent Varicella Vaccination Coverage Report. http://www.cdc.gov/vaccines/imz-managers/coverage/teenvaxview/data-reports/varicella/reports/2016.html. Accessed August 29, 2017.
3.  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.
4.  Li S, Chan ISF, Matthews H, et al. Inverse relationship between six week postvaccination varicella antibody response to vaccine and likelihood of long term breakthrough infection. Pediatr Infect Dis J. 2002;21(4):337–342.
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.

ACIP Recommendations for Varicella Virus Vaccination

For all appropriate individuals who have had 1 dose

ACIP recommends a 2nd-dose of varicella vaccine3,6,a,b

Routine
recommendation
Catch-up
recommendation

12–15
mos
Dose 1
4–6
years
Dose 2
7–18
years
Catch-up 2nd dose
aACIP recommends a catch-up varicella vaccination for children, adolescents, and adults who previously had received 1 dose.3
bAlso recommended by AAP and AAFP.6
AAFP=American Academy of Family Physicians; AAP=American Academy of Pediatrics; ACIP=Advisory Committee on Immunization Practices.

Evaluate Their Vaccination Status

Check your patients’ charts. Every visit is a chance to evaluate their vaccination status3

Follow-up visit
Sports/camp visit
Back-to-school visit
Pre-college entry
VARIVAX® (Varicella Virus Vaccine Live): Evaluate Your Patients' Vaccination Status VARIVAX® (Varicella Virus Vaccine Live): Evaluate Your Patients' Vaccination Status
 

Indications and Usage for VARIVAX® (Varicella Virus Vaccine Live)

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

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 varicella 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 Prescribing Information. The Patient Information also is available.

VACC-1140714-0004 10/17