title: The safety profile of varicella vaccine: a 10-year review.
abstract: Varivax (varicella virus vaccine live [Oka/Merck]; Merck), a live attenuated varicella vaccine, is indicated for vaccination against varicella in appropriate individuals > or =12 months of age. The 10-year safety profile for Varivax is described using data submitted to Merck from routine global postmarketing surveillance, combined with information from a Varicella Zoster Virus Identification Program, which uses polymerase chain reaction (PCR) analysis to identify the presence and strain of VZV in selected specimens. There were 16,683 reports worldwide voluntarily submitted to Merck, for an overall reporting rate of 3.4 reports/10,000 doses of vaccine distributed. PCR analysis of vesicular rashes that occurred within the first 2 weeks after vaccination was more likely to identify wild-type varicella-zoster virus (VZV), whereas the presence of Oka VZV was generally associated with vesicular rashes that occurred 15-42 days after vaccination. Reports of breakthrough varicella that occurred >42 days after vaccination were associated with wild-type VZV. Among 697 herpes zoster reports, PCR analysis identified Oka VZV in 57 reports and wild-type VZV in 38 reports. There were no primary neurologic adverse events associated with Oka VZV. Secondary transmission of Oka VZV from vaccine recipients with postvaccination vesicular rashes was identified in 3 susceptible household contacts. Disseminated Oka VZV was identified in 6 immunocompromised patients and 1 patient with Down syndrome. This review has shown that the vaccine is generally safe and well tolerated.
authors.affiliation: Merck Research Laboratories, Clinical Risk Management and Safety Surveillance, North Wales, Pennsylvania 19454-1099, USA. susan_galea@merck.com
authors.forename: Susan A
authors.initials: SA
authors.lastname: Galea
authors.forename: Ann
authors.initials: A
authors.lastname: Sweet
authors.forename: Paul
authors.initials: P
authors.lastname: Beninger
authors.forename: Sharon P
authors.initials: SP
authors.lastname: Steinberg
authors.forename: Philip S
authors.initials: PS
authors.lastname: Larussa
authors.forename: Anne A
authors.initials: AA
authors.lastname: Gershon
authors.forename: Robert G
authors.initials: RG
authors.lastname: Sharrar
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D002644:Chickenpox / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D006562:Herpes Zoster / Q000453:epidemiology / Q000517:prevention & control / Q000821:virology; D014645:Herpesvirus 3, Human / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D015994:Incidence; D007223:Infant; D008875:Middle Aged; D009422:Nervous System Diseases / Q000453:epidemiology / Q000821:virology; D016133:Polymerase Chain Reaction; D011358:Product Surveillance, Postmarketing / Q000379:methods*
chemical_list: D019433:Chickenpox Vaccine