Vaccine Information: VARIVAX

VARIVAX- varicella-zoster virus strain oka/merck live antigen injection, powder, lyophilized, for suspension
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

VARIVAX® is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.

2 DOSAGE AND ADMINISTRATION

Subcutaneous administration only

2.1 Recommended Dose and Schedule

Each 0.5 mL dose of VARIVAX is administered subcutaneously.

Children (12 months to 12 years of age)

The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age.

The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine and VARIVAX.

At least 1 month should elapse between a dose of measles-containing vaccine and a dose of VARIVAX if the vaccines are not given concurrently [see Clinical Studies (14.1)].

Adolescents (≥13 years of age) and Adults

Two doses of VARIVAX are administered at a minimum interval of 4 weeks [see Clinical Studies (14.1)].

2.2 Reconstitution Instructions

Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of VARIVAX because these substances may inactivate the vaccine virus. When reconstituting the vaccine, use only the sterile diluent supplied with VARIVAX. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus.

To reconstitute the vaccine, withdraw the total volume of supplied sterile diluent and inject into the lyophilized vaccine vial. Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white compact crystalline plug. VARIVAX, when reconstituted, is a clear, colorless to pale yellow liquid.

Withdraw the entire amount of reconstituted vaccine, inject the total volume and discard vial.

To minimize loss of potency, administer VARIVAX immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze reconstituted vaccine.

Do not combine VARIVAX with any other vaccine through reconstitution or mixing.

2.3 Method of Administration

Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.

3 DOSAGE FORMS AND STRENGTHS

VARIVAX is a suspension for injection supplied as a single-dose vial of lyophilized vaccine to be reconstituted using the accompanying sterile diluent [see Dosage and Administration (2.2) and How Supplied/Storage and Handling (16)]. A single dose after reconstitution is 0.5 mL.

4 CONTRAINDICATIONS

4.1 Severe Allergic Reaction

Do not administer VARIVAX to individuals with a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine.

4.2 Immunosuppression

Do not administer VARIVAX to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy.

Disseminated varicella disease and extensive vaccine-associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.

4.3 Moderate or Severe Febrile Illness

Do not administer VARIVAX to individuals with an active febrile illness with fever >101.3°F (>38.5°C).

4.4 Active Untreated Tuberculosis

Do not administer VARIVAX to individuals with active, untreated tuberculosis (TB).

4.5 Pregnancy

Do not administer VARIVAX to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm [see Use in Specific Populations (8.1) and Patient Counseling Information (17)].

5 WARNINGS AND PRECAUTIONS

5.1 Family History of Immunodeficiency

Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent.

5.2 Use in HIV-Infected Individuals

The Advisory Committee on Immunization Practices (ACIP) has recommendations on the use of varicella vaccine in HIV-infected individuals.

5.3 Risk of Vaccine Virus Transmission

Post-marketing experience suggests that transmission of varicella vaccine virus (Oka/Merck) resulting in varicella infection including disseminated disease may occur between vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella including healthy as well as high-risk individuals.

Due to the concern for transmission of vaccine virus, vaccine recipients should attempt to avoid whenever possible close association with susceptible high-risk individuals for up to six weeks following vaccination with VARIVAX. Susceptible high-risk individuals include:

  • Immunocompromised individuals;
  • Pregnant women without documented history of varicella or laboratory evidence of prior infection;
  • Newborn infants of mothers without documented history of varicella or laboratory evidence of prior infection and all newborn infants born at <28 weeks gestation regardless of maternal varicella immunity.

5.4 Immune Globulins and Transfusions

Immune Globulins (IG) and other blood products should not be given concomitantly with VARIVAX [see Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus replication and decrease the expected immune response.

The ACIP has specific recommendations for intervals between administration of antibody-containing products and live virus vaccines.

5.5 Salicylate Therapy

Avoid use of salicylates (aspirin) or salicylate-containing products in children and adolescents 12 months through 17 years of age for six weeks following vaccination with VARIVAX because of the association of Reye syndrome with salicylate therapy and wild-type varicella infection [see Drug Interactions (7.1)].

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in clinical practice. Vaccine-related adverse reactions reported during clinical trials were assessed by the study investigators to be possibly, probably, or definitely vaccine-related and are summarized below.

In clinical trials {1-8}, VARIVAX was administered to over 11,000 healthy children, adolescents, and adults.

In a double- blind, placebo- controlled study among 914 healthy children and adolescents who were serologically confirmed to be susceptible to varicella, the only adverse reactions that occurred at a significantly (p<0.05) greater rate in vaccine recipients than in placebo recipients were pain and redness at the injection site {1}.

Children 1 to 12 Years of Age

One-Dose Regimen in Children

In clinical trials involving healthy children monitored for up to 42 days after a single dose of VARIVAX, the frequency of fever, injection- site complaints, or rashes were reported as shown in Table 1:

Table 1: Fever, Local Reactions, and Rashes (%) in Children 1 to 12 Years of Age 0 to 42 Days After Receipt of a Single Dose of VARIVAX
Reaction N % Experiencing Reaction Peak Occurrence During Postvaccination Days
Fever ≥102.0°F (38.9°C) Oral 8827 14.7% 0 to 42
Injection-site complaints 8916 19.3% 0 to 2
(pain/soreness, swelling and/or erythema, rash, pruritus, hematoma, induration, stiffness)
Varicella-like rash (injection site) 8916 3.4% 8 to 19
Median number of lesions 2
Varicella-like rash (generalized) 8916 3.8% 5 to 26
Median number of lesions 5

In addition, adverse events occurring at a rate of ≥1% are listed in decreasing order of frequency: upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching.

Pneumonitis has been reported rarely (<1%) in children vaccinated with VARIVAX.

Febrile seizures have occurred at a rate of <0.1% in children vaccinated with VARIVAX.

Two-Dose Regimen in Children

Nine hundred eighty-one (981) subjects in a clinical trial received 2 doses of VARIVAX 3 months apart and were actively followed for 42 days after each dose. The 2-dose regimen of varicella vaccine had a safety profile comparable to that of the 1-dose regimen. The overall incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was 25.4% Postdose 2 and 21.7% Postdose 1, whereas the overall incidence of systemic clinical complaints in the 42-day follow-up period was lower Postdose 2 (66.3%) than Postdose 1 (85.8%).

Adolescents (13 Years of Age and Older) and Adults

In clinical trials involving healthy adolescents and adults, the majority of whom received two doses of VARIVAX and were monitored for up to 42 days after any dose, the frequencies of fever, injection-site complaints, or rashes are shown in Table 2.

Table 2: Fever, Local Reactions, and Rashes (%) in Adolescents and Adults 0 to 42 Days After Receipt of VARIVAX
Reaction N % PostDose 1 Peak Occurrence inPostvaccination Days N % PostDose 2 Peak Occurrence inPostvaccination Days
Fever ≥100.0°F (37.8°C) Oral 1584 10.2% 14 to 27 956 9.5% 0 to 42
Injection-site complaints 1606 24.4% 0 to 2 955 32.5% 0 to 2
(soreness, erythema, swelling, rash, pruritus, pyrexia, hematoma, induration, numbness)
Varicella-like rash (injection site) 1606 3% 6 to 20 955 1% 0 to 6
Median number of lesions 2 2
Varicella-like rash (generalized) 1606 5.5% 7 to 21 955 0.9% 0 to 23
Median number of lesions 5 5.5

In addition, adverse events reported at a rate of ≥1% are listed in decreasing order of frequency: upper respiratory illness, headache, fatigue, cough, myalgia, disturbed sleep, nausea, malaise, diarrhea, stiff neck, irritability/nervousness, lymphadenopathy, chills, eye complaints, abdominal pain, loss of appetite, arthralgia, otitis, itching, vomiting, other rashes, constipation, lower respiratory illness, allergic reactions (including allergic rash, hives), contact rash, cold/canker sore.

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