BACKGROUND: The 1976-1977 swine influenza vaccine was associated with an elevated risk of Guillain-Barré Syndrome (GBS), especially within 6 weeks after vaccination. A 2004 IOM report concluded that evidence was inadequate to accept or reject a causal relationship between subsequent influenza vaccine formulations and GBS. Studies published after the IOM report have been limited by passively reported data or lack of validation of coded diagnoses. PURPOSE: To evaluate whether influenza vaccine is associated with GBS. METHODS: Controlled observational study using national data from the Medicare program, which ensures a predominantly elderly population. People included had a Medicare claim for influenza vaccination during September-December in 2000 or 2001. Medical records were reviewed to classify definite, probable, or possible GBS (or not a case) using a standardized case definition. In a risk interval design, the incidence rate of GBS during Weeks 0-6 after vaccination (exposed period) was compared to Weeks 9-14 after vaccination (comparison period). Data collection occurred during 2003-2007, and analysis was conducted during 2007-2009. RESULTS: Primary analysis included 22.2 million vaccinees, among whom 164 definite or probable GBS cases with onset during Weeks 0-6 or 9-14 were identified. The incidence rate ratio (IRR [95% CIs]) based on the GBS rate in the vaccine-exposed versus comparison periods, was 1.04 (0.76, 1.43) for combined years; 0.86 (0.52, 1.41) among people vaccinated in 2000; and 1.21 (0.79, 1.86) among people vaccinated in 2001. Secondary analysis additionally included 74 possible GBS cases; results were similar. CONCLUSIONS: Overall, the results do not support an association between influenza vaccine receipt and GBS among the elderly for the years studied (2000-2001 and 2001-2002 formulations). Published by Elsevier Inc.
BACKGROUND: The 1976-1977 swine influenza vaccine was associated with an elevated risk of Guillain-Barré Syndrome (GBS), especially within 6 weeks after vaccination. A 2004 IOM report concluded that evidence was inadequate to accept or reject a causal relationship between subsequent influenza vaccine formulations and GBS. Studies published after the IOM report have been limited by passively reported data or lack of validation of coded diagnoses. PURPOSE: To evaluate whether influenza vaccine is associated with GBS. METHODS: Controlled observational study using national data from the Medicare program, which ensures a predominantly elderly population. People included had a Medicare claim for influenza vaccination during September-December in 2000 or 2001. Medical records were reviewed to classify definite, probable, or possible GBS (or not a case) using a standardized case definition. In a risk interval design, the incidence rate of GBS during Weeks 0-6 after vaccination (exposed period) was compared to Weeks 9-14 after vaccination (comparison period). Data collection occurred during 2003-2007, and analysis was conducted during 2007-2009. RESULTS: Primary analysis included 22.2 million vaccinees, among whom 164 definite or probable GBS cases with onset during Weeks 0-6 or 9-14 were identified. The incidence rate ratio (IRR [95% CIs]) based on the GBS rate in the vaccine-exposed versus comparison periods, was 1.04 (0.76, 1.43) for combined years; 0.86 (0.52, 1.41) among people vaccinated in 2000; and 1.21 (0.79, 1.86) among people vaccinated in 2001. Secondary analysis additionally included 74 possible GBS cases; results were similar. CONCLUSIONS: Overall, the results do not support an association between influenza vaccine receipt and GBS among the elderly for the years studied (2000-2001 and 2001-2002 formulations). Published by Elsevier Inc.
Authors: Dale R Burwen; Sukhminder K Sandhu; Thomas E MaCurdy; Jeffrey A Kelman; Jonathan M Gibbs; Bruno Garcia; Marianthi Markatou; Richard A Forshee; Hector S Izurieta; Robert Ball Journal: Am J Public Health Date: 2012-02-16 Impact factor: 9.308
Authors: Sirarat Sarntivijai; Zuoshuang Xiang; Kerby A Shedden; Howard Markel; Gilbert S Omenn; Brian D Athey; Yongqun He Journal: PLoS One Date: 2012-11-28 Impact factor: 3.240
Authors: Sonja E Leonhard; Melissa R Mandarakas; Francisco A A Gondim; Kathleen Bateman; Maria L B Ferreira; David R Cornblath; Pieter A van Doorn; Mario E Dourado; Richard A C Hughes; Badrul Islam; Susumu Kusunoki; Carlos A Pardo; Ricardo Reisin; James J Sejvar; Nortina Shahrizaila; Cristiane Soares; Thirugnanam Umapathi; Yuzhong Wang; Eppie M Yiu; Hugh J Willison; Bart C Jacobs Journal: Nat Rev Neurol Date: 2019-09-20 Impact factor: 42.937