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Am J Prev Med. 2010 Oct;39(4):296-304. doi: 10.1016/j.amepre.2010.05.022.

Evaluation of Guillain-Barré Syndrome among recipients of influenza vaccine in 2000 and 2001.

Author information

  • 1Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA. dale.burwen@fda.hhs.gov

Abstract

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.

PMID:
20837279
[PubMed - indexed for MEDLINE]
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