The Risk of Guillain-Barré Syndrome Associated with Influenza A (H1N1) 2009 Monovalent Vaccine and 2009-2010 Seasonal Influenza Vaccines: Results from Self-Controlled Analyses.

Autor: Tokars, Jerome I, Lewis, Paige, DeStefano, Frank, Wise, Matthew, Viray, Melissa, Morgan, Oliver, Gargiullo, Paul, Vellozzi, Claudia
Zdroj: Pharmacoepidemiology & Drug Safety; May2012, Vol. 21 Issue 5, p546-552, 7p
Abstrakt: ABSTRACT Purpose The Centers for Disease Control and Prevention Emerging Infections Program implemented active, population-based surveillance for Guillain-Barré syndrome (GBS) following H1N1 vaccines in 10 states/metropolitan areas. We report additional analyses of these data using self-controlled methods, which avoid potential confounding from person-level factors and co-morbidities. Methods Surveillance officers identified GBS cases with symptom onset during October 2009-April 2010 and ascertained receipt of H1N1 vaccines. We calculated self-controlled relative risks by comparing the number of cases with onset during a risk interval 1-42 days after vaccination with cases with onset during fixed (days 43-84) or variable (days 43-end of study period) control intervals. We calculated attributable risks by applying statistically significant relative risks to an independent estimate of GBS incidence. Results Fifty-nine GBS cases received H1N1 vaccine with or without seasonal vaccine. The relative risk was 2.1 (95%CI 1.2, 3.5) by the variable-window and 3.0 (95%CI 1.4, 6.4) by the fixed-window analyses. The corresponding attributable risks per million doses administered were 1.5 (95%CI 0.3, 3.4) and 2.8 (95%CI 0.6, 7.4). Conclusions These attributable risks are similar to those of some previous formulations of seasonal influenza vaccine (about one to two cases per million doses administered), suggesting a low risk of GBS following the H1N1 vaccine that is not clearly higher than that of seasonal influenza vaccines. Published 2012. This article is a US Government work and is in the public domain in the USA. [ABSTRACT FROM AUTHOR]
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