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. 2012 Jun 1;175(11):1100-9.
doi: 10.1093/aje/kws195. Epub 2012 May 11.

Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010

Sharon K Greene  1 , Melisa Rett, Eric S Weintraub, Lingling Li, Ruihua Yin, Anthony A Amato, Doreen T Ho, Sarah I Sheikh, Bruce H Fireman, Matthew F Daley, Edward A Belongia, Steven J Jacobsen, Roger Baxter, Tracy A Lieu, Martin Kulldorff, Claudia Vellozzi, Grace M Lee
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Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010

Sharon K Greene et al. Am J Epidemiol. .

Abstract

An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted.

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Figures

Figure 1.
Figure 1.
Seasonality of influenza vaccination and Guillain-Barré syndrome (GBS) in the Vaccine Safety Datalink Project. A) Administration of seasonal trivalent inactivated (TIV) and monovalent inactivated (MIV) influenza vaccines during the 2006–2007 to 2009–2010 influenza seasons. B) Rate of first-in-1-year GBS diagnosis without regard to vaccination status during the 2006–2007 to 2008–2009 (averaged) and 2009–2010 influenza seasons.
Figure 2.
Figure 2.
Timing of the occurrence of Guillain-Barré syndrome (GBS) 1–127 days following receipt of monovalent inactivated influenza vaccine, Vaccine Safety Datalink Project, 2009–2010. The graphs show timing according to A) International Classification of Diseases, Ninth Revision (ICD-9) code diagnosis date (n = 31), B) ICD-9 diagnosis date for confirmed cases (n = 13), and C) onset date for confirmed cases (n = 13).
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