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Varicella Virus Vaccine

Pronunciation

(var i SEL a VYE rus vak SEEN)

Index Terms

  • Chickenpox Vaccine
  • VAR
  • Varicella-Zoster Virus (VZV) Vaccine (Varicella)
  • VZV Vaccine (Varicella)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injectable, Subcutaneous [preservative free]:

Varivax: 1350 PFU/0.5 mL (1 ea)

Brand Names: U.S.

  • Varivax

Pharmacologic Category

  • Vaccine
  • Vaccine, Live (Viral)

Pharmacology

As a live, attenuated vaccine, varicella virus vaccine offers active immunity to disease caused by the varicella-zoster virus by inducing cell mediated and humoral immune responses

Onset of Action

Seroconversion occurred in 97% of healthy children ~4-6 weeks following a one dose regimen; using a two dose regimen, the seroconversion rate was 99.9% 6 weeks after the second dose. In adolescents≥13 years of age and adults, the seroconversion rate was ~75% 4 weeks after the first dose and 99% 4 weeks after the second dose

Duration of Action

Antibody titers detectable at 10 years postvaccination. Actual antibody titers vary by year and age group, but are ~99% to 100% for children at 10 years and 100% for adolescents and adults at 6 years postvaccination. Exposure to wild-type varicella may boost antibody levels.

Use: Labeled Indications

Varicella prevention: For the prevention of varicella in persons 12 months and older

The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for all children, adolescents, and adults who do not have evidence of immunity (CDC/ACIP [Marin, 2007]). Vaccination is especially important for:

• Healthcare personnel

• Household contacts of immunocompromised persons

• Persons living or working in environments where transmission is likely (teachers, child-care workers, residents and staff of institutional settings)

• Persons in environments where transmission has been reported

• Nonpregnant women of childbearing age

• Adolescents and adults in households with children

• International travelers

Use: Unlabeled

Postexposure prophylaxis: Vaccination within 3 days (possibly 5 days) after exposure to rash is effective in preventing illness or modifying severity of disease in persons without other evidence of immunity (CDC/ACIP [Marin, 2007]).

Contraindications

U.S. labeling: Severe allergic or anaphylactic reaction to the vaccine, neomycin, gelatin, or any component of the formulation; immunosuppressed or immunodeficient individuals including individuals with leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; persons with AIDs or other clinical manifestations of HIV; those receiving immunosuppressive therapy (including immunosuppressive doses of corticosteroids); history of primary and acquired immunodeficiency states; active, untreated tuberculosis; current febrile illness (per manufacturer labeling); pregnancy

Canadian labeling: Additional contraindications (not in U.S. labeling): Varivax III: Family history of congenital or hereditary immunodeficiency (unless immune competence of vaccine recipient is demonstrated); Varilrix: Primary or acquired immunodeficiency with a total lymphocyte count <1200/mm3

Dosing: Adult

Varicella immunization: SubQ:

US labeling: Two doses of 0.5 mL separated by ≥4 weeks (4 to 8 weeks apart per ACIP). Note: The ACIP recommends that all children and adults without evidence of immunity receive 2 doses of the vaccine; those who received only 1 dose of vaccine receive a second dose (CDC/ACIP [Marin 2007]).

Canadian labeling: Two single doses 0.5 mL separated by 4 to 8 weeks (Varivax III) or ≥6 weeks (Varilrix); Note: The NACI recommends that adolescents (≥13 years of age) and adults (<50 years of age) who received only 1 dose of vaccine receive a second dose (NACI 2012).

Postexposure prophylaxis (healthy, previously unvaccinated individuals) (off-label use): SubQ: 0.5 mL administered ideally within 72 hours postexposure but may be used up to 120 hours (5 days) postexposure (CDC/ACIP [Marin 2007])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Varicella immunization: SubQ:

US labeling:

Children ≥12 months: 0.5 mL; a second dose may be administered ≥3 months later

Note: The ACIP recommends the routine childhood vaccination be 2 doses, with the first dose administered at 12 to 15 months of age. The second dose should be administered at 4 to 6 years of age before school entry, but it may be administered earlier provided ≥3 months have elapsed after the first dose. Children ≥ 7 years and adolescents who received only 1 dose of vaccine should receive a second dose (CDC/ACIP [Marin 2007]). If the second dose was administered ≥4 weeks after the first dose, it may be considered as valid (ACIP [Robinson 2016]).

Adolescents ≥13 years: Refer to adult dosing.

Canadian labeling:

Children ≥12 months:

Varilrix: Two doses of 0.5 mL separated by ≥6 weeks

Varivax III: 0.5 mL as a single dose

Alternative recommendations (NACI, 2012): Two doses of 0.5 mL with first dose administered at 12 to 15 months of age. Separate doses by ≥3 months; however, if rapid protection is necessary, may administer second dose after ≥6 weeks.

Adolescents ≥13 years: Refer to adult dosing.

Postexposure prophylaxis (healthy, previously unvaccinated individuals) (off-label use): Children ≥12 months and Adolescents: SubQ: 0.5 mL administered ideally within 72 hours postexposure but may be used up to 120 hours (5 days) postexposure (CDC/ACIP [Marin 2007])

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling

Reconstitution

Use the total volume of the provided diluent to reconstitute vaccine. Gently agitate to mix thoroughly. (Total volume of reconstituted vaccine will be ~0.5 mL.) Administer vaccine within 30 minutes of preparation.

Administration

For SubQ injection only; inject in the outer aspect of upper arm or the anterolateral thigh. Do not administer IV or IM. Administer immediately following reconstitution. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). US 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.

Storage

Prior to reconstitution and during shipping, store vaccine in freezer at -50°C to -15°C (-58°F to 5°F). Use of dry ice may subject vaccine to temperatures colder than -58°F (-50°C). Vaccine may be stored under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 72 hours. Protect from light. Store diluent at room temperature of 20°C to 25°C (68°F to 77°F) or in refrigerator. Gently agitate to mix thoroughly. (Total volume of reconstituted vaccine will be ~0.5 mL.) Administer immediately following reconstitution, discard reconstituted vaccine if not used within 30 minutes.

Canadian formulations:

Varilrix: Prior to reconstitution, store vaccine under refrigeration at 2°C to 8°C (36°F to 46°F). Vaccine not affected by freezing. Store diluent at 25°C (77°F) or under refrigeration. Following reconstitution, vaccine may be stored for 90 minutes at 25°C (77°F) or up to 8 hours under refrigeration. Discard if not used within recommended times.

Varivax III: Maintain vaccine at -50°C to 8°C (-58°F to 46°F) during transport. Prior to reconstitution, vaccine may be stored in a freezer at temperatures above -50°C (-58°F) or under refrigeration at 2°C to 8°C (36°F to 46°F). Vials transferred from freezer to a refrigerator may be placed back in freezer as long as they have not been reconstituted. Store diluent at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration. Administer immediately following reconstitution; discard reconstituted vaccine if not administered within 90 minutes.

Drug Interactions

5-ASA Derivatives: May enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Consider therapy modification

Acyclovir-Valacyclovir: May diminish the therapeutic effect of Varicella Virus Vaccine. Management: When possible, avoid use of acyclovir or valacyclovir within the 24 hours prior to administration of the varicella vaccine, and avoid use of these antiviral agents for 14 days after vaccination. Avoid combination

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification

Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Consider therapy modification

Famciclovir: May diminish the therapeutic effect of Varicella Virus Vaccine. Management: When possible, avoid use of famciclovir within the 24 hours prior to administration of the varicella vaccine, and avoid use of famciclovir for 14 days after vaccination. Avoid combination

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Immune Globulins: May diminish the therapeutic effect of Vaccines (Live). Management: Consult full interaction monograph for dose interval recommendations. This interaction does not apply to oral Ty21a typhoid vaccine or others listed as exceptions. Consider therapy modification

Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; Dexamethasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of methotrexate should be avoided. Consider therapy modification

Salicylates: May enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. Reye's Syndrome may develop. Consider therapy modification

Smallpox Vaccine Live: May enhance the adverse/toxic effect of Varicella Virus Vaccine. It may be difficult to determine which vaccine caused skin lesions or other adverse effects. Consider therapy modification

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Consider therapy modification

Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination

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 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

>10%:

Local: Injection site reaction (19% to 33%)

Miscellaneous: Fever (10% to 15%)

1% to 10%:

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

Dermatologic: Varicella-like rash (1% to 6%), rash at injection site (varicella-like; 1% to 3%), contact dermatitis, dermatitis, diaper rash, eczema, miliaria, pruritus, urticaria, xeroderma

Gastrointestinal: Abdominal pain, constipation, decreased appetite, diarrhea, nausea, period of tooth development, vomiting

Genitourinary: Herpes labialis

Hematologic & oncologic: Lymphadenopathy

Hypersensitivity: Hypersensitivity reaction

Neuromuscular & skeletal: Arthralgia, myalgia, neck stiffness

Otic: Otitis

Respiratory: Cough, respiratory tract disease (lower/upper)

<1% (Limited to important or life-threatening): Anaphylactic shock, anaphylaxis, aplastic anemia, anterior uvetitis (children; Krall 2014), aseptic meningitis, ataxia, Bell's palsy, cerebrovascular accident, encephalitis, erythema multiforme, febrile seizures, Guillain-Barré syndrome, hemiparesis (acute), hepatitis, herpes zoster, IgA vasculitis, keratitis (children; Krall 2014), necrotizing retinitis (immunocompromised patients), pneumonitis, seizure (nonfebrile), Stevens-Johnson syndrome, thrombocytopenia (including immune thrombocytopenia), transverse myelitis, varicella (disseminated or vaccine strain)

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP, 2011).

• Syncope: Syncope has been reported with use of injectable vaccines and may be accompanied by transient visual disturbances, weakness, or tonic-clonic movements. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP, 2011).

Disease-related concerns:

• Acute illness: Although fever is a contraindication per the manufacturer, current guidelines allow for administration to patients with mild acute illness with or without low grade fever (CDC/ACIP [Marin, 2007]).

• Altered immunocompetence: Use of this vaccine is contraindicated in persons who are immunosuppressed or immunodeficient. In general, live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible (IDSA [Rubin, 2014]).

• HIV: Although the manufacturer contraindicates administration to persons with HIV, guidelines for use are available. Children with HIV infection with age-specific CD4+ T-lymphocyte percentages ≥15% may receive live attenuated varicella vaccine. Vaccination may be considered for children >8 years, adolescents and adults with CD4+ T-lymphocyte counts ≥200 cells/microliter (CDC/ACIP [Marin, 2007]).

Concurrent drug therapy issues:

• Antibody-containing products: Varicella vaccine and antibody-containing products (eg, immune globulin, blood products) should not be administered simultaneously. Guidelines with suggested administration intervals are available (NCIRD/ACIP, 2011).

• Antiviral drugs: Medications active against the herpesvirus family (eg, acyclovir, famciclovir, valacyclovir) may interfere with the varicella vaccine; avoid varicella vaccination to a patient who has received these antivirals 24 hours before vaccination; avoid use of these antiviral agents for 14 days after varicella vaccination (ACIP [Kim 2016]).

• Salicylates: Avoid salicylates in children and adolescents 12 months through 17 years of age for 6 weeks after vaccination; varicella may increase the risk of Reye's syndrome.

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components (NCIRD/ACIP, 2011).

Dosage form specific issues:

• Albumin: Products may contain albumin.

• Gelatin: Products may contain gelatin. Use is contraindicated in patients with a history of anaphylactic/anaphylactoid reaction to gelatin.

• Neomycin: Products may contain neomycin. Use is contraindicated in patients with history of anaphylactic/anaphylactoid reactions to neomycin. Contact dermatitis due to neomycin is not a contraindication to the vaccine (CDC/ACIP [Marin, 2007]).

Other warnings/precautions:

• Appropriate use:

- Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin, 2014).

- Varilrix (Canadian availability; not available in U.S.): Approved for use in high-risk patients (eg, acute leukemia, chronic disease, organ transplantation) if complete remission ≥12 months (acute leukemia), lymphocyte count ≥1200/mm3 and evidence of immune competence can be demonstrated prior to vaccination. Canadian National Advisory Committee on Immunization (NACI) suggests that Varivax III may also be used for select groups (NACI, 2012). Consult product labeling and/or NACI for specific recommendations regarding appropriate use in high risk patients.

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP, 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula, 2009).

• Congenital or hereditary immunodeficiency: Defer use in patients with a family history of congenital or hereditary immunodeficiency until immune competence in the vaccine recipient is demonstrated (CDC/ACIP [Marin, 2007]).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP, 2011).

• Transmission of virus: The manufacturer notes that vaccinated individuals should not have close association with susceptible high-risk individuals for 6 weeks following vaccination. High-risk individuals include immunocompromised persons, pregnant women without evidence of immunity, newborns of mothers without evidence of immunity, and all infants born <28 weeks' gestation (regardless of maternal immunity). However, the CDC notes that transmission of the virus is rare and recommends that vaccine recipients who develop a vaccine-related rash avoid contact with susceptible individuals at high risk for complications until the lesions are resolved (crusted over or fade away) or until no new lesions appear for 24 hours. According to the CDC guidelines, having a pregnant household member is not a contraindication to vaccination (CDC/ACIP [Marin, 2007]).

Monitoring Parameters

Rash, fever; monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion (NCIRD/ACIP 2011).

Pregnancy Considerations

Varicella virus vaccine is contraindicated for use in pregnant females and pregnancy should be avoided for 3 months (per manufacturer labeling; 1 month per ACIP) following vaccination. Varicella disease during the 1st or 2nd trimesters may result in congenital varicella syndrome. The onset of maternal varicella infection from 5 days prior to 2 days after delivery may cause varicella infection in the newborn. All women should be assessed for immunity during a prenatal visit; those without evidence of immunity should be vaccinated upon completion or termination of pregnancy (CDC/ACIP [Marin, 2007]). Based on information collected from 1995-2013 using the manufacturer’s pregnancy registry, of 820 women who received a varicella containing vaccine, there were no infants born with abnormalities consistent with congenital varicella syndrome. Any exposures to the vaccine during pregnancy or within 3 months prior to pregnancy should be reported to the manufacturer (Merck & Co, 877-888-4231) or to VAERS (800-822-7967) as suspected adverse reactions.

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience irritability or injection site pain, edema, or irritation. Have patient report immediately to prescriber chickenpox-like rash, shingles, wheezing, or shortness of breath (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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