Intramuscular, SubcutaneousActive immunisation against varicella infectionAdult: As live attenuated varicella-zoster virus Oka/Merck strain containing ≥1,350 plaque-forming units (PFU) or Oka strain ≥103.3 PFU per 0.5 mL: 0.5 mL for 2 doses given 4-8 weeks apart via IM or SC inj in the deltoid area. Recommendations on immunisation schedule and route of administration may vary among countries or between individual products (refer to latest local or country-specific product guidelines).
Child: As live attenuated varicella-zoster virus Oka/Merck strain containing ≥1,350 plaque-forming units (PFU) or Oka strain ≥103.3 PFU per 0.5 mL: Primary immunisation: 9-11 months 0.5 mL for 2 doses given at least 3 months apart; 12 months to 12 years 0.5 mL for 2 doses given at least 1 month apart; ≥13 years Same as adult dose. Alternative dosing for live attenuated varicella-zoster virus Oka/Merck strain containing ≥1,350 PFU per 0.5 mL: 12 months to 12 years 0.5 mL for 2 doses, to be given at 12-15 months of age and 4-6 years of age; the 2nd dose may be given earlier provided at least 3 months have elapsed after the initial dose. Doses are given via IM or SC inj in the anterolateral area of the thigh (in younger children) or deltoid area (in older children and adolescents). Recommendations on immunisation schedule and route of administration may vary among countries or between individual products (refer to latest local or country-specific product guidelines).
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Reconstitute the vaccine vial using the total volume of the provided diluent (in vial, prefilled syringe, or ampoule). Gently agitate the vaccine vial to mix thoroughly.
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Hypersensitivity. Active untreated TB; active febrile illness (fever >38.5°C); family history of congenital or hereditary immunodeficiency (unless immune competence can be established); blood dyscrasias or any malignant neoplasms affecting the bone marrow or lymphatic systems (e.g. leukaemia, lymphoma). Severely immunocompromised patients, including those with severe humoural or cellular (primary or acquired) immunodeficiency. Pregnancy or women planning to get pregnant in the next 3 months.
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Defer vaccination for at least 5 months after blood transfusion, plasma transfusion and immunoglobulin (including varicella-zoster immunoglobulin) administration. Delay vaccination in patients with moderate or severe acute illness (with or without fever) until recovery from the acute phase of the illness. Transmission of varicella vaccine virus may occur rarely between vaccine recipients, with or without varicella-like rash, and susceptible contacts, including healthy individuals and high-risk individuals (e.g. immunocompromised individuals, pregnant women without evidence of immunity, newborns of mothers without evidence of immunity). Avoid use of salicylates for 6 weeks following vaccination. Children. Lactation.
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Significant: Syncope, anaphylactoid or hypersensitivity reaction, encephalitis, meningitis.
Blood and lymphatic system disorders: Lymphadenopathy.
Ear and labyrinth disorders: Otitis.
Eye disorders: Conjunctivitis.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, gastroenteritis, abdominal pain.
General disorders and administration site conditions: Fever; inj site reactions (e.g. erythema, rash, pain or soreness, swelling, haematoma); fatigue, malaise.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache, somnolence.
Psychiatric disorders: Irritability, sleep disorder.
Respiratory, thoracic and mediastinal disorders: URTI, cough, nasal congestion, rhinorrhoea, pharyngitis.
Skin and subcutaneous tissue disorders: Rash, varicella-like rash, contact dermatitis, erythema, pruritus, urticaria.
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IM/Parenteral/SC: Z (Due to the risk of congenital varicella syndrome, live varicella-zoster vaccines are contraindicated during pregnancy.)
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Avoid pregnancy for 1-3 months after vaccination. Avoid close contact with susceptible high-risk individuals (e.g. persons with weak immune system, pregnant women without evidence of immunity, newborns of mothers without evidence of immunity) for up to 6 weeks after vaccination, whenever possible.
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Monitor for rash and fever. Observe patient for anaphylaxis and syncope for 15 minutes after vaccination.
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Concomitant use with immunoglobulins may interfere with the expected immune response. May cause Reye's Syndrome when coadministered with salicylates.
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May result in temporary depression of tuberculin skin sensitivity causing false-negative tuberculin test results; the test may be given before vaccination, simultaneously on the same day, or at least 4 weeks after vaccination.
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Description:
Mechanism of Action: Varicella-zoster vaccine, a live attenuated vaccine, stimulates active immunity to disease caused by varicella-zoster virus by inducing both cell-mediated and humoral immune responses.
Onset: Seroconversion: Children: Approx 4-6 weeks after a single dose regimen; 6 weeks after the 2nd dose of a 2-dose regimen. Adolescents (≥13 years) and adults: 4 weeks.
Duration: Antibody titres: 10 years (postvaccination).
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Store between 2-8°C. Do not freeze. Protect from light. Storage recommendations may vary among countries and individual products (refer to specific product guidelines).
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Anon. Varicella Virus Vaccine Live. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 04/09/2024. Brayfield A, Cadart C (eds). Varicella-Zoster Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2024. GlaxoSmithKline NZ Limited. Varilrix Vaccine Powder for Injection with Diluent data sheet 2 September 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 02/08/2024. Joint Formulary Committee. Varicella-Zoster Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2024. Varicella Virus Vaccine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/08/2024. Varicella-Zoster Virus Vaccine, Live. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 04/09/2024. Varilrix Vaccine (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/08/2024. Varivax (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/08/2024. Varivax Live Injection, Powder, Lyophilized, for Suspension (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/08/2024. Varivax Powder and Solvent for Suspension for Injection in a Pre-filled Syringe (Merck Sharp & Dohme [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/08/2024.
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