title: Design of a robust infrastructure to monitor the safety of the pandemic A(H1N1) 2009 vaccination program in Taiwan.
abstract: On November 1, 2009, Taiwan began a nationwide pandemic A(H1N1) 2009 vaccine ("H1N1 vaccine") program to control the influenza pandemic. Timely assessment of immunization safety during this mass vaccination campaign was a public health priority. Therefore, the government developed a national postlicensure safety surveillance strategy to identify and evaluate new, unexpected, or prioritized adverse events in recipients of H1N1 vaccine in near real-time. We describe the design and methodology of this new safety assessment infrastructure, address challenges encountered, and its potential future use for routine vaccine pharmacovigilance in Taiwan.
authors.affiliation: Taiwan Centers for Disease Control, 6, Linsen S. Road, Taipei City 10050, Taiwan. muagi@cdc.gov.tw
authors.forename: Wan-Ting
authors.initials: WT
authors.lastname: Huang
authors.forename: Wen-Wen
authors.initials: WW
authors.lastname: Chen
authors.forename: Hsu-Wen
authors.initials: HW
authors.lastname: Yang
authors.forename: Wan-Chin
authors.initials: WC
authors.lastname: Chen
authors.forename: Yen-Nan
authors.initials: YN
authors.lastname: Chao
authors.forename: Yu-Wen
authors.initials: YW
authors.lastname: Huang
authors.forename: Jen-Hsiang
authors.initials: JH
authors.lastname: Chuang
authors.forename: Hsu-Sung
authors.initials: HS
authors.lastname: Kuo
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D004196:Disease Outbreaks / Q000517:prevention & control*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D032541:Mass Vaccination / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D013624:Taiwan / Q000453:epidemiology
chemical_list: D007252:Influenza Vaccines