title: "Prepandemic" immunization for novel influenza viruses, "swine flu" vaccine, Guillain-Barré syndrome, and the detection of rare severe adverse events.
abstract: The availability of immunogenic, licensed H5N1 vaccines and the anticipated development of vaccines against "swine" influenza A(H1N1) have stimulated debate about the possible use of these vaccines for protection of those exposed to potential pandemic influenza viruses and for immunization or "priming" of populations in the so-called "prepandemic" (interpandemic) era. However, the safety of such vaccines is a critical issue in policy development for wide-scale application of vaccines in the interpandemic period. For example, wide-scale interpandemic use of H5N1 vaccines could lead to millions of persons receiving vaccines of uncertain efficacy potentially associated with rare severe adverse events and against a virus that may not cause a pandemic. Here, we first review aspects of the 1976 National Influenza Immunization Programme against "swine flu" and its well-documented association with Guillain-Barré syndrome as a case study illustration of a suspected vaccine-associated severe adverse event in a mass interpandemic immunization setting. This case study is especially timely, given the recent spread of a novel influenza A(H1N1) virus in humans in Mexico and beyond. Following this, we examine available safety data from clinical trials of H5N1 vaccines and briefly discuss how vaccine safety could be monitored in a postmarketing surveillance setting.
authors: The Wellcome Trust, London, United Kingdom.
authors: David
authors: D
authors: Evans
authors: Simon
authors: S
authors: Cauchemez
authors: Frederick G
authors: FG
authors: Hayden
mesh_terms: D004196:Disease Outbreaks / Q000266:history / Q000517:prevention & control*; D020275:Guillain-Barre Syndrome / Q000139:chemically induced / Q000266:history*; D049673:History, 20th Century; D006801:Humans; D017589:Immunization Programs / Q000266:history*; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000266:history; D007251:Influenza, Human / Q000453:epidemiology / Q000266:history / Q000517:prevention & control; D011358:Product Surveillance, Postmarketing; D014481:United States / Q000453:epidemiology
chemical_list: D007252:Influenza Vaccines