Risk of Guillain-Barré syndrome following pandemic influenza A(H1N1) 2009 vaccination in Germany

Autor(es): Prestel Jürgen,Volkers Peter,Mentzer Dirk,Lehmann Helmar C,Hartung Hans-Peter,Keller-Stanislawski Brigitte,


Resumo: A prospective, epidemiologic study was conducted to assess whether the 2009 pandemic influenza A(H1N1) vaccination in Germany almost exclusively using an AS03-adjuvanted vaccine (Pandemrix) impacts the risk of Guillain-Barré syndrome (GBS) and its variant Fisher syndrome (FS). Potential cases of GBS/FS were reported by 351 participating hospitals throughout Germany. The self-controlled case series methodology was applied to all GBS/FS cases fulfilling the Brighton Collaboration (BC) case definition (levels 1-3 of diagnostic certainty) with symptom onset between 1 November 2009 and 30 September 2010 reported until end of December 2010. Out of 676 GBS/FS reports, in 30 cases, GBS/FS (BC levels 1-3) occurred within 150 days following influenza A(H1N1) vaccination. The relative incidence of GBS/FS within the primary risk period (days 5-42 post-vaccination) compared with the control period (days 43-150 post-vaccination) was 4.65 (95%CI [2.17, 9.98]). Similar results were found when stratifying for infections within 3 weeks prior to onset of GBS/FS and when excluding cases with additional seasonal influenza vaccination. The overall result of temporally adjusted analyses supported the primary finding of an increased relative incidence of GBS/FS following influenza A(H1N1) vaccination. The results indicate an increased risk of GBS/FS in temporal association with pandemic influenza A(H1N1) vaccination in Germany.


Palavras-Chave: Guillain-Barré syndrome; Pandemic influenza vaccination; Pharmacoepidemiology; Self-controlled case series


Imprenta: Pharmacoepidemiology and Drug Safety, v. 23, n. 11, p. 1192-1204, 2014


Identificador do objeto digital: 10.1002/pds.3638


Descritores: Guillain-Barre Syndrome - Pathogenesis ; Guillain-Barre Syndrome - Viral infections ; Guillain-Barre Syndrome - Virus ; Guillain-Barre Syndrome - Vaccine ; Guillain-Barre Syndrome - Epidemiology ; Guillain-Barre Syndrome - Public health


Data de publicação: 2014