title: Safety of pandemic (H1N1) 2009 monovalent vaccines in taiwan: a self-controlled case series study.
abstract: In Taiwan, new H1N1 monovalent vaccines without adjuvant and with MF59® adjuvant were used in the nationwide vaccination campaign beginning on November 1, 2009. From November 2009 through February 2010, the authors identified recipients of H1N1 vaccines who were diagnosed with adverse events of special interest (AESIs) in a large-linked safety database, and used the self-controlled case series (SCCS) method to examine the risk of each AESI in the 0-42 days after H1N1 vaccination. Of the 3.5 million doses of H1N1 vaccines administered and captured in the linked database, the SCCS analysis of Guillain-Barré syndrome (GBS) found an incidence rate ratio of 3.81 (95% confidence interval 0.43-33.85) within 0-42 days after nonadjuvanted H1N1 vaccination and no cases after MF59®-adjuvanted H1N1 vaccination. The risks of other AESIs were, in general, not increased in any of the predefined postvaccination risk periods and age groups. The databases and infrastructure created for H1N1 vaccine safety evaluation may serve as a model for safety, effectiveness and coverage studies of licensed vaccines in Taiwan.
authors.affiliation: Epidemic Intelligence Center, Taiwan Centers for Disease Control, Taipei, Taiwan.
authors.forename: Wan-Ting
authors.initials: WT
authors.lastname: Huang
authors.forename: Hsu-Wen
authors.initials: HW
authors.lastname: Yang
authors.forename: Tzu-Lin
authors.initials: TL
authors.lastname: Liao
authors.forename: Wan-Jen
authors.initials: WJ
authors.lastname: Wu
authors.forename: Shu-Er
authors.initials: SE
authors.lastname: Yang
authors.forename: Yi-Chien
authors.initials: YC
authors.lastname: Chih
authors.forename: Jen-Hsiang
authors.initials: JH
authors.lastname: Chuang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D020275:Guillain-Barre Syndrome / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D008875:Middle Aged; D011159:Population Surveillance; D011446:Prospective Studies; D012306:Risk; D013624:Taiwan; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines
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