Guillain-Barré syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: Outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database

Alcalde-Cabero, E. ; Almazán-Isla, J. ; García López, F.J. ; Ara-Callizo, J. ; Avellanal, F. ; Casasnovas, C. ; Cemillán, C. ; Cuadrado, J.I. ; Duarte, J. ; Fernández-Pérez, M.D. ; FernándezÓscar ; Merino, J.A.G. ; Montero, R.G. ; Montero, D. ; Pardo, J. ; Rodríguez-Rivera, F.J. ; Ruiz-Tovar, M. ; De Pedro-Cuesta, J.

Resumen: Background: Studies have shown a slight excess risk in Guillain-Barré syndrome (GBS) incidence associated with A(H1N1)pdm09 vaccination campaign and seasonal trivalent influenza vaccine immunisations in 2009-2010. We aimed to assess the incidence of GBS as a potential adverse effect of A(H1N1)pdm09 vaccination. Methods: A neurologist-led network, active at the neurology departments of ten general hospitals serving an adult population of 4.68 million, conducted GBS surveillance in Spain in 2009-2011. The network, established in 1996, carried out a retrospective and a prospective study to estimate monthly alarm thresholds in GBS incidence and tested them in 1998-1999 in a pilot study. Such incidence thresholds additionally to observation of GBS cases with immunisation antecedent in the 42 days prior to clinical onset were taken as alarm signals for 2009-2011, since November 2009 onwards. For purpose of surveillance, in 2009 we updated both the available centres and the populations served by the network. We also did a retrospective countrywide review of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis from January 2009 to December 2011. Results: Among 141 confirmed of 148 notified cases of GBS or Miller-Fisher syndrome, Brighton 1-2 criteria in 96 %, not a single patient was identified with clinical onset during the 42-day time interval following A(H1N1)pdm09 vaccination. In contrast, seven cases were seen during a similar period after seasonal campaigns. Monthly incidence figures did not, however, exceed the upper 95 % CI limit of expected incidence. A retrospective countrywide review of the registry of hospital-discharged patients having ICD-9-CM code 357.0 (acute infective polyneuritis) as their principal diagnosis did not suggest higher admission rates in critical months across the period December 2009-February 2010. Conclusions: Despite limited power and underlying reporting bias in 2010-2011, an increase in GBS incidence over background GBS, associated with A(H1N1)pdm09 monovalent or trivalent influenza immunisations, appears unlikely.

Idioma: Inglés

DOI: 10.1186/s12883-016-0598-z

Año: 2016

Publicado en: BMC Neurology 16, 1 (2016), [13 pp]
ISSN: 1471-2377

Factor impacto JCR: 2.006 (2016)

Categ. JCR: CLINICAL NEUROLOGY rank: 124 / 194 = 0.639 (2016) - Q3 - T2

Factor impacto SCIMAGO: 1.093 - Medicine (miscellaneous) (Q1) - Neurology (clinical) (Q2)

Tipo y forma: Artículo (Versión definitiva)