Measles, mumps, rubella and varicella virus vaccine

(MEE zels, mumpz, roo BEL a, & var i SEL a VYE rus vak SEEN)

• Chickenpox vaccine
• Measles
• MMRV
• Mumps
• Mumps, Rubella, Varicella, and Measles Vaccine
• Rubella
• Rubella, Varicella, Measles, and Mumps Vaccine
• VAR
• Varicella
• Varicella, Measles, Mumps, and Rubella Vaccine
• VZV Vaccine (Varicella)

A live, attenuated virus vaccine that induces active immunity to disease caused by the measles, mumps, rubella, and varicella-zoster viruses.

US labeling: Hypersensitivity to this vaccine, measles-, mumps-, rubella-, and/or varicella-containing vaccines, or any component of the formulation, including gelatin; history of anaphylactic reactions to neomycin; individuals with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; those receiving immunosuppressive therapy (including high-dose systemic corticosteroids); primary and acquired immunodeficiency states (including AIDs or symptomatic HIV; cellular immune deficiencies; hypogammaglobulinemic and dysgammaglobulinemic states); family history of congenital or hereditary immunodeficiency (until immune competence in the vaccine recipient is demonstrated); active untreated tuberculosis; current febrile illness with fever >38.5°C (>101.3°F); pregnancy

Canadian labeling: Priorix-Tetra: Hypersensitivity to this vaccine, measles-, mumps-, rubella-, and/or varicella-containing vaccines, or any component of the formulation, including neomycin; pregnancy; severe humoral or cellular (primary or acquired) immunodeficiency.

Powder for injection: Before reconstitution, store the lyophilized vaccine between -50°C and -15°C (-58°F and 5°F) in a reliably maintained freezer (eg, chest, frost-free) for up to 18 months. Use of dry ice may subject the vaccine to temperatures colder than -50°C (-58°F).

May store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours prior to reconstitution. Discard any vaccine stored at 2°C to 8°C (36°F to 46°F) that is not used within 72 hours of removal from -15°C (5°F) storage.

Protect the vaccine from light at all times.

Canadian products:

ProQuad: During shipment, vaccine must be maintained at a temperature between -50°C and +8°C (-58°F and 46°F). Use of dry ice may subject the vaccine to temperatures colder than -50°C. Before reconstitution, store refrigerated at a temperature of 2°C to 8°C (36°F to 46°F) or in a freezer at temperatures above -50°C (-58°F); if subsequently transferred to a refrigerator, the vaccine may be placed back in the freezer. May administered provided total (cumulative multiple excursions) time out of refrigeration (prior to reconstitution, at temperatures between 8°C and 25°C) does not exceed 14 hours. These are not, however, recommendations for storage. Protect the vaccine from light at all times.

Priorix-Tetra: Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original packaging in order to protect from light.

Reconstituted vaccine: Discard reconstituted vaccine if it is not used within 30 minutes. Do not freeze reconstituted vaccine. Protect from light at all times.

Canadian products:

ProQuad: Use as soon as possible after reconstitution. Discard if not used within 30 minutes. Store reconstituted vaccine in the vaccine vial in a dark place at room temperature. Do not freeze reconstituted vaccine.

Priorix-Tetra: Administer as soon as possible. May be refrigerated (2°C to 8°C; 36°F to 46°F) for up to 8 hours.

Diluent: Store diluent separately at room temperature (20°C to 25°C [68°F to 77°F]), or in a refrigerator (2°C to 8°C [36°F to 46°F]).

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).

• Febrile seizures: Children 12 to 23 months of age have been reported to have a higher risk of developing febrile seizures with the use of the combination product (MMRV) compared to administration of MMR and varicella separately. Because it is uncommon for a child to have their first febrile seizure after 4 years of age, the ACIP recommends the use of the combination MMRV vaccine for children receiving their first dose at ≥48 months or their second dose at any age. The ACIP recommends that children with a personal or family history of seizures be vaccinated with separate MMR and varicella vaccines, as opposed to the MMRV combination vaccine. For children receiving their first dose at 12 to 47 months of age, either the MMRV combination vaccine or separate MMR and varicella vaccines can be used. The ACIP prefers administration of separate MMR and varicella vaccines as the first dose in this age group unless the parent or caregiver expresses preference for the MMRV combination. Parents and caregivers should be provided with the benefits and risks of both options (CDC/ACIP [Marin 2010]).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. 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: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP 2011). Use is contraindicated with fever >38.5°C (>101.3°F).

• CNS disorders: Use with caution in patients with history of cerebral injury, seizures, or other conditions where stress due to fever should be avoided. Children with a personal or family history of seizures should be vaccinated with separate MMR and varicella vaccines, as opposed to the MMRV combination vaccine (CDC/ACIP [Marin 2010]).

• HIV: Safety and efficacy of this combination vaccine have not been established in patients with HIV infection. Use is contraindicated in patients with AIDS or symptomatic HIV.

• Thrombocytopenia: Use with caution in patients with thrombocytopenia and those who develop thrombocytopenia after first dose; thrombocytopenia may worsen.

• Tuberculosis: Defer vaccination in patients with active untreated tuberculosis. Use is contraindicated in patients with active untreated tuberculosis.

Concurrent drug therapy issues:

• Immune globulins: Recent administration of immune globulins may interfere with immune response. Guidelines with suggested administration intervals are available (NCIRD/ACIP 2011).

• Salicylates: Avoid use of salicylates for 6 weeks following 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 potential 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. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use is contraindicated in patients with immunosuppression, including those receiving immunosuppressive therapy (including high-dose systemic corticosteroids). 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]).

Dosage form specific issues:

• Albumin: Some products may contain albumin; products containing human albumin may carry a remote risk of viral transmission, including a theoretical risk of Creutzfeldt-Jakob disease transmission.

• Egg allergy: Vaccine contains trace amounts of chick embryo antigen. Use caution in patients with history of immediate hypersensitivity/anaphylactic reactions following egg ingestion. Generally, the vaccine can be safely administered to persons with an egg allergy (NCIRD/ACIP 2011).

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

• Neomycin: Manufactured with 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.

Other warnings/precautions:

• 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).

• Appropriate use: The safety and efficacy of this combination vaccine has not been established for postexposure prophylaxis.

• Blood products: Recent administration of blood or blood products may interfere with immune response. Guidelines with suggested administration intervals are available (NCIRD/ACIP 2011).

• 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: Vaccinated individuals should not have close association with susceptible high-risk individuals for 6 weeks following vaccination. High-risk individuals susceptible to the varicella virus include immunocompromised persons, pregnant women without evidence of immunity to varicella, newborns of mothers without evidence of varicella immunity, and infants born <28 weeks' gestation (regardless of maternal immunity); transmission of varicella virus may occur.