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About VARIVAX® (Varicella Virus Vaccine (Live))

Updated on 14/09/2018

VACCINES

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Data presented below/hereafter focus on immunocompetent populations aged 12 months to 12 years.

A flexible approach to vaccine administration

VARIVAX is indicated for vaccination against chickenpox in individuals from 12 months of age. VARIVAX can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations.1

Two doses of VARIVAX should be given to ensure optimal protection against chickenpox:1

Individuals from 12 months to 12 years of age
At least 1 month must elapse between the first dose and the second dose.

  • VARIVAX can be administered to susceptible individuals who have been exposed to chickenpox.1
  • Vaccination within 3 days of exposure may prevent a clinically apparent infection or modify the course of infection.1
  • VARIVAX is the only chickenpox vaccine that offers a choice of intramuscular or subcutaneous administration.1
  • VARIVAX should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.1
  • The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents and adults.1
Intramuscular injection image
Subcutaneous injection image

VARIVAX offers effective protection against chickenpox2

VARIVAX is indicated for vaccination against chickenpox in individuals from 12 months of age. VARIVAX can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations.1

Two doses of VARIVAX should be given to ensure optimal protection against chickenpox:1

98%
EFFICACY
Two doses of VARIVAX
delivered 98% efficacy
against all severities
of chickenpox2

  • In a comparative study, 1102 children aged 12 months to 12 years were given 2 doses of VARIVAX 3 months apart and followed up for 10 years. The estimated vaccine efficacy against all severities of chickenpox was 98.3% (95% Cl: 97.3-99.0%)2
  • For 1 dose of VARIVAX, the estimated vaccine efficacy was 94.4% (95% Cl: 92.9-95.7%)2
  • Both 1 and 2 doses of VARIVAX were 100% efficacious against severe chickenpox2*
  • Persistence of varicella antibody was close to 100% throughout the 9-year follow-up for both 1 dose (n=277) and 2 doses (n=237) of VARIVAX2

The most common adverse events reported in the 42 days after each injection were soreness, erythema, swelling, rash, upper respiratory illness, cough, fatigue, irritability/nervousness, disturbed sleep
and diarrhoea.3

Please refer to the Summary of Product Characteristics for full details on the safety profile.

* Severe chickenpox is defined as >300 lesions and fever ≥102oF, oral equivalent.2

Contraindications1
Interactions with other medicinal products1
Adverse events1

Study designs

Ngai AL, et al.3
A multicentre study comparing the safety and immunogenicity profiles of one- and two-dose regimens of VARIVAX in healthy children aged 12 months to 12 years. The study aimed to determine whether two doses administered 3 months apart yielded improved seroconversion rates, antibody titres or cellular immune responses to varicella. 2196 children were randomised to receive one (n=1103) or two (n=1093) doses of VARIVAX. All participants were followed for clinical reactions for 42 days after each injection and participants were asked to report any cases of varicella or zoster at any time post-vaccination. Blood samples were obtained from all children within 2 weeks before the first injection and at approximately 6 weeks after each injection to determine immunogenicity of the vaccine. In a subset of the centres, blood samples were obtained from children who seroconverted 1 year after the first injection to ascertain persistence of antibody.

Kuter B, et al.2
A multicentre study to conduct a 9- to 10-year follow-up of a cohort of children who were randomised in 1991 to 1993 to receive either one (n=1114) or two (n=1102) doses of VARIVAX 3 months apart. The rate of varicella
>42 days post-vaccination, vaccine efficacy and the persistence of varicella antibody were compared to assess whether a two-dose regimen yielded any significant clinical advantage. Overall vaccine efficacy was estimated as 1 (observed average annual varicella incidence rate/age-adjusted expected annual varicella incidence rate).

References

  1. VARIVAX Summary of Product Characteristics.
  2. Kuter B, Matthews H, Shinefield H, et al. Ten year follow-up of healthy children who received one or two injections of varicella vaccine. Pediatr Infect Dis J. 2004;23(2):132–137.
  3. Ngai AL, Staehle BO, Kuter BJ, et al. Safety and immunogenicity of one vs. two injections of Oka/Merck varicella vaccine in healthy children. Pediatr Infect Dis J. 1996;15(1):49–54.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

VACC-1260996-0000 | Date of Preparation: September 2018