No

Vaccine

The American Association of Pediatrics recommends that the chickenpox vaccine should be given to all healthy children between 12 months and 18 years; children between 12 months and 13 years who have not been immunized or who have not had chickenpox should receive 1 vaccination while children 13-18 years of age require 2 vaccinations 4-8 weeks apart; the vaccine has been added to the childhood immunization schedule for infants 12-28 months of age and children 11-12 years of age who have not been vaccinated previously or who have not had the disease; it is recommended to be given with the measles, mumps, and rubella (MMR) vaccine

C

Clinical effects on the fetus: Varivax® should not be administered to pregnant females and pregnancy should be avoided for 3 months following vaccination

Breast-feeding/lactation: Use during breast-feeding should be avoided

Hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactoid reaction to neomycin; individuals with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; those receiving immunosuppressive therapy; primary and acquired immunodeficiency states; a family history of congenital or hereditary immunodeficiency; active untreated tuberculosis; febrile illness; pregnancy; I.V. injection

Children and adolescents with acute lymphoblastic leukemia in remission can receive the vaccine under an investigational protocol (215-283-0897); no clinical data are available or efficacy in children <12 months of age

Immediate treatment for anaphylactoid reaction should be available during vaccine use; defer vaccination for at least 5 months following blood or plasma transfusions, immune globulin (IgG), or VZIG (avoid IgG or IVIG use for 2 months following vaccination); salicylates should be avoided for 5 weeks after vaccination; vaccinated individuals should not have close association with susceptible high risk individuals (newborns, pregnant women, immunocompromised persons) following vaccination

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967.

>10%:

Central nervous system: Fever (14.7%)

Local: Induration/stiffness at the injection site (19.3%)

1% to 10%:

Central nervous system: Pain, irritability/nervousness, fatigue, disturbed sleep, headache, malaise, chills

Dermatologic: Redness, rash (at injection site - 3.4%), pruritus, generalized varicella-like rash (generalized - 3.8%)

Gastrointestinal: Diarrhea, loss of appetite, vomiting, abdominal pain, nausea

Hematologic: Hematoma

Neuromuscular & skeletal: Myalgia, arthralgia

Otic: Otitis

Respiratory: Upper respiratory illness, cough

Miscellaneous: Lymphadenopathy, allergic reactions

<1%: Febrile seizures (causality not established), pneumonitis

Clinical studies show that Varivax® can be administered concomitantly with MMR and limited data indicate that DTP and PedvaxHIB™ may also be administered together (using separate sites and syringes)

Increased effect: Salicylates may increase the risk of Reye's following varicella vaccination

Store in freezer (-15°C), store diluent separately at room temperature or in refrigerator; discard if reconstituted vaccine is not used within 30 minutes

As a live, attenuated vaccine, varicella virus vaccine offers active immunity to disease caused by the varicella-zoster virus

Onset of action: Approximately 4-6 weeks postvaccination

Duration: Lowest breakthrough rates (0.2% to 2.9%) exist in the first 2 years following postvaccination, with slightly higher rates in the third through the fifth year

S.C.:

Children 12 years to Adults: 2 doses of 0.5 mL separated by 4-8 weeks

Inject S.C. into the outer aspect of the upper arm, if possible

Rash, fever

Report any adverse reactions to the healthcare provider or Vaccine Adverse Event Reporting System (1-800-822-7967); avoid pregnancy for 3 months following vaccination; avoid salicylates for 5 weeks after vaccination; avoid close association with susceptible high risk individuals following vaccination

Obtain the previous immunization history (including allergic reactions) to previous vaccines; do not inject into a blood vessel; use the supplied diluent only for reconstitution; inject immediately after reconstitution

Powder for injection, lyophilized powder, preservative free: 1350 plaque forming units (PFU)/0.5 mL (0.5 mL single-dose vials)

Bernstein HH, Rothstein EP, Watson BM, et al, "Clinical Survey of Natural Varicella Compared With Breakthrough Varicella After Immunization With Live Attenuated Oka/Merck Varicella Vaccine," Pediatrics, 1993, 92(6):833-7.

"General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP)," MMWR Morb Mortal Wkly Rep, 1994, 43(RR-1):1-38.

Kuter BJ, Weibel RE, Guess HA, et al, "Oka/Merck Varicella Vaccine in Healthy Children: Final Report of a 2-Year Efficacy Study and 7-Year Follow-Up Studies," Vaccine, 1991, 9(9):643-7.