tetano
Editor, Senior Moderator
BMC Neurol. 2016 May 21;16(1):75. doi: 10.1186/s12883-016-0598-z.
[h=1]Guillain-Barr? 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.[/h] Alcalde-Cabero E[SUP]1[/SUP], Almaz?n-Isla J[SUP]1[/SUP], Garc?a L?pez FJ[SUP]1[/SUP], Ara-Callizo JR[SUP]2[/SUP], Avellanal F[SUP]1[/SUP], Casasnovas C[SUP]3[/SUP], Cemill?n C[SUP]4[/SUP], Cuadrado JI[SUP]5[/SUP], Duarte J[SUP]6[/SUP], Fern?ndez-P?rez MD[SUP]7[/SUP], Fern?ndez ?[SUP]8[/SUP], Merino JA[SUP]9[/SUP], Montero RG[SUP]10[/SUP], Montero D[SUP]11[/SUP], Pardo J[SUP]12[/SUP], Rodr?guez-Rivera FJ[SUP]13[/SUP], Ruiz-Tovar M[SUP]1[/SUP], de Pedro-Cuesta J[SUP]14[/SUP]; Spanish GBS Epidemiology Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Studies have shown a slight excess risk in Guillain-Barr? 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
[h=4]KEYWORDS:[/h] Guillain-Barr? syndrome; ICD-9-CM; Influenza A virus H1N1 subtype; Influenza vaccines; Public health surveillance; Safety
PMID: 27206524 [PubMed - in process] PMCID: PMC4875759 Free PMC Article
[h=1]Guillain-Barr? 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.[/h] Alcalde-Cabero E[SUP]1[/SUP], Almaz?n-Isla J[SUP]1[/SUP], Garc?a L?pez FJ[SUP]1[/SUP], Ara-Callizo JR[SUP]2[/SUP], Avellanal F[SUP]1[/SUP], Casasnovas C[SUP]3[/SUP], Cemill?n C[SUP]4[/SUP], Cuadrado JI[SUP]5[/SUP], Duarte J[SUP]6[/SUP], Fern?ndez-P?rez MD[SUP]7[/SUP], Fern?ndez ?[SUP]8[/SUP], Merino JA[SUP]9[/SUP], Montero RG[SUP]10[/SUP], Montero D[SUP]11[/SUP], Pardo J[SUP]12[/SUP], Rodr?guez-Rivera FJ[SUP]13[/SUP], Ruiz-Tovar M[SUP]1[/SUP], de Pedro-Cuesta J[SUP]14[/SUP]; Spanish GBS Epidemiology Study Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Studies have shown a slight excess risk in Guillain-Barr? 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
[h=4]KEYWORDS:[/h] Guillain-Barr? syndrome; ICD-9-CM; Influenza A virus H1N1 subtype; Influenza vaccines; Public health surveillance; Safety
PMID: 27206524 [PubMed - in process] PMCID: PMC4875759 Free PMC Article