Authors: Kreth, Hans W.¹; Lee, Bee-Wah²; Kosuwon, Pensri³; Salazar, Jose⁴; Gloriani-Barzaga, Nina⁵; Bock, Hans L.⁶; Meurice, François⁷

Source: BioDrugs, Volume 22, Number 6, 2008 , pp. 387-402(16)

Publisher: Adis International

Abstract:

Without vaccination, chickenpox (varicella) will affect almost every person in the world during their lifetime. The burden of disease due to varicella is often unrecognized. Varilrix™ is a varicella vaccine derived from the Oka strain of varicella virus. The vaccine, as a frozen formulation, was licensed for use in 1984 and was the first commercially available varicella vaccine. It subsequently became the first refrigerator-stable varicella vaccine; its development commenced in 1991 and it has been licensed for use since 1994. Varilrix™ is indicated for use in high-risk groups, potentially immunocompromised individuals, and healthy subjects in many countries. This article reviews data from extensive worldwide experience with the refrigerator-stable version of the vaccine, including information derived from its use in over 10 000 individuals participating in clinical trials investigating its immunogenicity, efficacy, effectiveness, and safety, as well as postmarketing data including its use in universal mass vaccination programs. Sixteen years of clinical and postmarketing experience with the same formulation represents the longest and most extensive experience with a refrigerator-stable varicella vaccine worldwide. Varilrix™, in conjunction with the trivalent measles-mumps-rubella vaccine Priorix™, has also been the basis for clinical development of the tetravalent measles-mumps-rubella-varicella vaccine (Priorix-Tetra™).

Keywords: Chickenpox; Herpes zoster; Postmarketing surveillance; Research and development; Varicella vaccines; Varicella zoster virus infections; Varicella zoster virus vaccine live

Document Type: Research article

Affiliations: 1: 1 Department of Pediatrics, University of Wuerzburg, Wuerzburg, Germany 2: 2 Department of Pediatrics, National University of Singapore, Singapore 3: 3 Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand 4: 4 Department of Pediatrics, University of the East-Ramon Magsaysay Memorial Medical Center, Manila, Philippines 5: 5 Department of Medical Microbiology, College of Public Health, University of the Philippines Manila, Manila, Philippines 6: 6 GlaxoSmithKline Biologicals, Singapore 7: 7 GlaxoSmithKline Biologicals, Rixensart, Belgium

Publication date: 2008-01-01

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