title: Monitoring the safety of a smallpox vaccination program in the United States: report of the joint Smallpox Vaccine Safety Working Group of the advisory committee on immunization practices and the Armed Forces Epidemiological Board.
abstract: In December 2002, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and the Department of Defense Armed Forces Epidemiological Board formed a joint Smallpox Vaccine Safety Working Group (SVS WG) to provide independent safety oversight for smallpox vaccination safety-monitoring systems. From January 2003 through June 2004, the SVS WG reviewed individual and aggregate safety data on postvaccination adverse events. Serious adverse events were rare because of careful education, prevaccination screening, and strict attention to vaccination-site management. Recent vaccinees safely cared for high-risk patients, adhering to recommended site care. Human immunodeficiency virus-infected individuals without severe immunosuppression had uncomplicated vaccination reactions. Epidemiological studies supported a causal relationship between myocarditis and/or pericarditis and smallpox vaccination. Data supported neutrality regarding hypothesized causal associations between vaccination and dilated cardiomyopathy or ischemic cardiac disease. The SVS WG concurs with recommendations to defer from vaccination any person with >/=3 ischemic cardiac disease risk factors.
authors.affiliation: Children's Hospital and Regional Medical Center, Seattle, Washington, USA. john.neff@seattlechildrens.org
authors.forename: John
authors.initials: J
authors.lastname: Neff
authors.forename: John
authors.initials: J
authors.lastname: Modlin
authors.forename: Guthrie S
authors.initials: GS
authors.lastname: Birkhead
authors.forename: Gregory
authors.initials: G
authors.lastname: Poland
authors.forename: Rose Marie
authors.initials: RM
authors.lastname: Robertson
authors.forename: Kent
authors.initials: K
authors.lastname: Sepkowitz
authors.forename: Clyde
authors.initials: C
authors.lastname: Yancy
authors.forename: Pierce
authors.initials: P
authors.lastname: Gardner
authors.forename: Gregory C
authors.initials: GC
authors.lastname: Gray
authors.forename: Toby
authors.initials: T
authors.lastname: Maurer
authors.forename: Jane
authors.initials: J
authors.lastname: Siegel
authors.forename: Fernando A
authors.initials: FA
authors.lastname: Guerra
authors.forename: Tim
authors.initials: T
authors.lastname: Berger
authors.forename: W Dana
authors.initials: WD
authors.lastname: Flanders
authors.forename: Robert
authors.initials: R
authors.lastname: Shope
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D005260:Female; D006282:Health Personnel; D006801:Humans; D008297:Male; D032541:Mass Vaccination / Q000009:adverse effects*; D008875:Middle Aged; D008889:Military Personnel; D009205:Myocarditis / Q000209:etiology; D010493:Pericarditis / Q000209:etiology; D012189:Retrospective Studies; D018571:Sentinel Surveillance; D012900:Smallpox Vaccine / Q000009:adverse effects* / Q000592:standards; D014481:United States / Q000453:epidemiology; D014483:United States Dept. of Health and Human Services
chemical_list: C078786:DryVax vaccine; D012900:Smallpox Vaccine