Varicella Vaccine, Live - PROVARIX
The First and Only Varicella Vaccine in China to Achieve WHO Prequalification
SINOVAC's Varicella Vaccine, Live, is the first and only varicella vaccine in China to have achieved World Health Organization (WHO) Prequalification (PQ), signifying that its quality, safety, and efficacy meet international standards.
It is also the only varicella vaccine in China whose protective efficacy data from a rigorous Phase III clinical trial (87.1% efficacy against confirmed varicella cases) has been incorporated into the nationally approved prescribing information, providing clear and credible evidence for the prevention of varicella.
l International Quality, Demonstrated Efficacy
First WHO PQ in China: The entire manufacturing process complies with international high standards, with quality recognized by the WHO.
Efficacy Data in Labeling: The efficacy conclusion is based on a pivotal Phase III randomized, double-blind, placebo-controlled clinical trial and is included in the NMPA-approved prescribing information, representing a high level of evidence.
High Protective Efficacy: Clinical trials showed that within 6 months post-vaccination, vaccine efficacy was 87.1% against confirmed varicella cases and could reach 100% against moderate or more severe cases[1].
l Purified Process, Controlled Safety
Purified Formulation: Contains no gelatin, human serum albumin, or antibiotics. Employs physical methods for viral harvest without the use of EDTA.
Stringent Production Environment: Manufactured entirely in high-standard Grade B+A cleanrooms to effectively control contamination risks.
Extensive Use Validation: Since market introduction, over 20 million doses have been administered in more than 20 countries/regions worldwide, with a good safety record.
Referen:
[1] Hao B, et al. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: a double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019;25(8):1026-1031.
Highlights of Prescribing Information
Product Name: Varicella Vaccine, Live
Composition and Description: This vaccine is prepared by inoculating the attenuated varicella-zoster virus (Oka strain) onto human diploid cells (SV-1 strain), followed by cultivation, viral harvest, and lyophilization with suitable stabilizers. It appears as a white friable mass and, after reconstitution, forms a clear liquid that may be slightly opalescent.
Active ingredient: Live varicella-zoster virus.Excipients: Sucrose, Sodium Glutamate, Sodium Chloride, Potassium Chloride, Disodium Hydrogen Phosphate, Potassium Dihydrogen Phosphate.
Target Population: Healthy varicella-susceptible individuals aged 12 months and above.
Action and Use: After vaccination, it stimulates the body to produce immunity against varicella-zoster virus. For the prevention of varicella.
Dosage Form and Strength: After reconstitution, each vial contains 0.5ml. Each single human dose is 0.5ml, containing live varicella-zoster virus not less than 3.3 lg PFU.
Immunization Schedule and Dose: Primary immunization requires 1 dose. A booster dose may be administered to individuals aged 12 years and below when necessary, based on local epidemic prevention and control needs. It is administered subcutaneously into the area of the deltoid muscle attachment on the upper arm.
Adverse Reactions: Very common: fever. Occasional: diarrhea, cough, and redness, pain, swelling at the injection site. For full details, please refer to the product prescribing information.
Contraindications: (1) Hypersensitivity to any component of the vaccine, including excipients. (2) Acute diseases, severe chronic diseases, acute exacerbation of chronic diseases, and febrile individuals. (3) Pregnant women. (4) Individuals with immunodeficiency, impaired immune function, or those receiving immunosuppressive therapy (including systemic corticosteroid therapy). (5) Individuals with a history of congenital immunodeficiency or those in close contact with family members having a history of congenital immunodeficiency diseases. (6) Individuals with encephalopathy, uncontrolled epilepsy, and other progressive neurological disorders.
Shelf Life: 24 months.
Marketing Authorization Number: Guo Yao Zhun Zi H20033903
Manufacturer: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Precautions, Clinical Trials, Storage, Packaging: For full details, please refer to the product prescribing information.
Reference:
[1] Hao B, et al. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: a double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019;25(8):1026-1031.
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