Varicella Virus Vaccine

Pronunciation

(var i SEL a VYE rus vak SEEN)


U.S. Brand Names

Varivax®



Synonyms

Chicken Pox Vaccine; Varicella-Zoster Virus (VZV) Vaccine



Generic Available

No



Canadian Brand Names

Varilrix®; Varivax®



Use

Immunization against varicella in children 12 months of age and adults. 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



Pregnancy Risk Factor

C



Pregnancy Implications

Animal reproduction studies have not been conducted. Varivax® should not be administered to pregnant females and pregnancy should be avoided for 3 months following vaccination.



Lactation

Excretion in breast milk unknown/use caution



Contraindications

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; current febrile illness; pregnancy; I.V. injection



Warnings/Precautions

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 6 weeks after vaccination; vaccinated individuals should not have close association with susceptible high risk individuals (newborns, pregnant women, immunocompromised persons) for 6 weeks following vaccination. Children with HIV infection, who are asymptomatic and not immunosuppressed (CDC immunologic category 1) may receive live attenuated varicella vaccine at 12-15 months of age or older. No recommendations available for adults.



Adverse Reactions

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.

As reported in

1% of patients, unless otherwise specified:

>10%:

Central nervous system: Fever (10% to 15%)

Local: Injection site reaction (19% to 24%)

1% to 10%:

Central nervous system: Chills, fatigue, headache, irritability, malaise, nervousness, sleep disturbance

Dermatologic: Generalized varicella-like rash (4% to 5%), contact rash, dermatitis, diaper rash, dry skin, eczema, heat rash, itching

Gastrointestinal: Abdominal pain, appetite decreased, cold/canker sore, constipation, nausea, vomiting

Hematologic: Lymphadenopathy

Local: Varicella-like rash at the injection site (3%)

Neuromuscular & skeletal: Arthralgia, myalgia, stiff neck

Otic: Otitis

Respiratory: Cough, lower/upper respiratory illness

Miscellaneous: Allergic reactions, teething

<1%: Febrile seizure, pneumonitis

Postmarketing/case reports: Anaphylaxis, ataxia, Bell's palsy, cellulitis, cerebrovascular accident, dizziness, encephalitis, erythema multiforme, Guillain-Barré syndrome, Henoch-Sch&ouml;nlein purpura, herpes zoster, impetigo, nonfebrile seizure, paresthesia, pharyngitis, secondary skin infection, Stevens-Johnson syndrome, thrombocytopenia, transverse myelitis

Drug Interactions

Corticosteroids: In patients receiving high doses of systemic corticosteroids for

14 days, wait at least 1 month between discontinuing steroid therapy and administering vaccine.

DTaP: Vaccines may be administered together (using separate sites and syringes).

Haemophilus b conjugate vaccine (PedvaxHIB®): Vaccines may be administered together (using separate sites and syringes).

Immune globulin (including varicella zoster immune globulin): Do not administer together; vaccination should be deferred for at least 5 months following immune globulin administration; immune globulins should not be given for at least 2 months following vaccination (unless benefits of use outweigh benefits of vaccination).

Immunosuppressant medications: The effect of the vaccine may be decreased and the risk of varicella disease in individuals who are receiving immunosuppressant drugs may be increased.

MMR: Vaccines may be administered together (using separate sites and syringes); if vaccines are not administered simultaneously, doses should be separated by at least 30 days.

Salicylates: may increase the risk of Reye's following varicella vaccination; avoid use of salicylates for 6 weeks following vaccination.

Stability

Store powder in freezer at -15°C (5°F), protect from light; store diluent separately at room temperature or in refrigerator. Powder may be stored under refrigeration for up to 72 continuous hours prior to reconstitution; if not used within 72 hours, vaccine should be discarded. Use 0.7 mL of the provided diluent to reconstitute vaccine. Gently agitate to mix thoroughly. (Total volume of reconstituted vaccine will be ~0.5 mL.) Discard if reconstituted vaccine is not used within 30 minutes. Do not freeze reconstituted vaccine.



Mechanism of Action

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



Pharmacodynamics/Kinetics

Onset of action: Seroconversion: ~4-6 weeks

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

Dosage

SubQ:

Children 12 months to 12 years: 0.5 mL

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

Administration

Do not administer I.V.; inject immediately after reconstitution; inject SubQ into the outer aspect of the upper arm, if possible. Federal law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title and address be entered into the patient's permanent medical record.



Monitoring Parameters

Rash, fever



Patient Education

Report any adverse reactions to the prescriber or Vaccine Adverse Event Reporting System (1-800-822-7967); avoid pregnancy for 3 months following vaccination; avoid salicylates for 6 weeks after vaccination; avoid close association with susceptible high risk individuals following vaccination



Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Cold/canker sores.



Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions



Dosage Forms

Injection, powder for reconstitution [preservative free; single-dose vial]: 1350 plaque-forming units (PFU) [contains gelatin and trace amounts of neomycin]



References

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.

Centers for Disease Control, "Recommendations of the Advisory Committee on Immunization Practices (ACIP): General Recommendations on Immunization,"MMWR Recomm Rep, 1994, 43(RR-1):1-38.

Centers for Disease Control, "Simultaneous Administration of Varicella Vaccine and Other Recommended Childhood Vaccines - United States, 1995-1999,"MMWR Morb Mortal Wkly Rep, 2001, 50(47):1058-61.

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.

Pickering LK, ed, "American Academy of Pediatrics. Varicella-Zoster Infections,"2000 Red Book: Report of the Committee on Infectious Diseases, 5th ed, Elk Grove, IL: American Academy of Pediatrics, 2000, 624-38.

"2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected With Human Immunodeficiency Virus. USPHS/IDSA Prevention of Opportunistic Infections Working Group,"HIV Clin Trials, 2001, 2(6):493-554.

International Brand Names

Varilrix® (CA); Varivax® (CA)



Review Date: 1969-12-31 Reviewed By: Keywords: ,
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