Indication

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.

VARIVAX is contraindicated during pregnancy. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination. All exposures to VARIVAX during pregnancy or within 3 months prior to conception should be reported as suspected adverse reactions by contacting Merck at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

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 and state vaccination coverage among adolescents aged 13–17 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(33):850–858.
2.  Centers for Disease Control and Prevention (CDC). 2015 Adolescent Varicella Vaccination Coverage Report. http://www.cdc.gov/vaccines/imz-managers/coverage/teenvaxview/data-reports/varicella/reports/2015.html. Accessed September 1, 2016.
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. http://www.cdc.gov/vaccines/recs/storage/toolkit/
storage-handling-toolkit.pdf. Published May 2014. Accessed September 1, 2016.
6.  Centers for Disease Control and Prevention (CDC). Recommended immunization schedules for persons aged 0 through 18 years—United States, 2016. http://www.cdc
.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Effective January 1, 2016. Accessed September 1, 2016.

Storage and Handling

Condition on arrival

  • Vaccine should be frozen.

Handling

  • DO NOT FREEZE reconstituted vaccine.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine when reconstituted is a clear, colorless to pale yellow liquid.

Storage

  • Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between -58°F and +5°F (-50°C and -15°C).
  • Before reconstitution, protect from light.
  • Any freezer (eg, chest, frost-free) that reliably maintains a temperature between -58°F and +5°F (-50°C and -15°C) and has a separate sealed freezer door is acceptable for storing VARIVAX.
  • May be stored at refrigerator temperature (36°F to 46°F, 2°C to 8°C) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 36°F to 46°F (2°C to 8°C) which is not used within 72 hours of removal from +5°F (-15°C) storage should be discarded.
  • The diluent should be stored separately at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator.

General Tips

  • Vaccine should be frozen. If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 877.VAX.MERCK (877.829.6372).5
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally. Dormitory-style freezers are not acceptable for the storage of varicella vaccine.5
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Helpline at 800.MERCK.90 (800.637.2590), Monday through Friday, 8:00 AM to 7:00 PM ET.

See CDC.gov for additional general vaccine tips
CDC=Centers for Disease Control and Prevention.

Indication

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

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.

VARIVAX is contraindicated during pregnancy. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination. All exposures to VARIVAX during pregnancy or within 3 months prior to conception should be reported as suspected adverse reactions by contacting Merck at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

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

VACC-1140714-0003 02/17