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Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action

Identifieur interne : 000146 ( PascalFrancis/Corpus ); précédent : 000145; suivant : 000147

Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action

Auteurs : Charlotte I. S. Barker ; Matthew D. Snape

Source :

RBID : Pascal:14-0071052

Descripteurs français

English descriptors

Abstract

The 2009 influenza A H1N1 pandemic placed unprecedented demand on public health authorities and the vaccine industry. Efforts were coordinated internationally to maximise the speed of vaccine development, distribution, and delivery, and the European Union's novel fast-track authorisation procedures mandated increased postmarketing surveillance to monitor vaccine safety. Clinicians in Finland and Sweden later identified an apparent increase in the incidence of narcolepsy associated with a specific adjuvanted pandemic influenza vaccine. After extensive review, the European Medicines Agency confirmed the existence of this association, which has since been detected in England, Ireland, France, and Norway. Assessments of the causal mechanisms continue. In this Review, we discuss how the narcolepsy association was detected, and we present the evidence according to the causality assessment criteria for adverse events following immunisation. The lessons learnt emphasise the central role of alert clinicians in reporting of suspected adverse reactions, and the importance of internationally robust postmarketing surveillance strategies as crucial components in future mass immunisation programmes.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A03   1    @0 Lancet. Infect. dis. : (print)
A05       @2 14
A06       @2 3
A08 01  1  ENG  @1 Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action
A11 01  1    @1 BARKER (Charlotte I. S.)
A11 02  1    @1 SNAPE (Matthew D.)
A14 01      @1 Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford @2 Oxford @3 GBR @Z 1 aut. @Z 2 aut.
A14 02      @1 Oxford University Clinical Academic Graduate School, Medical Sciences Division, University of Oxford @2 Oxford @3 GBR @Z 1 aut.
A14 03      @1 NIHR Oxford Biomedical Centre @2 Oxford @3 GBR @Z 2 aut.
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C01 01    ENG  @0 The 2009 influenza A H1N1 pandemic placed unprecedented demand on public health authorities and the vaccine industry. Efforts were coordinated internationally to maximise the speed of vaccine development, distribution, and delivery, and the European Union's novel fast-track authorisation procedures mandated increased postmarketing surveillance to monitor vaccine safety. Clinicians in Finland and Sweden later identified an apparent increase in the incidence of narcolepsy associated with a specific adjuvanted pandemic influenza vaccine. After extensive review, the European Medicines Agency confirmed the existence of this association, which has since been detected in England, Ireland, France, and Norway. Assessments of the causal mechanisms continue. In this Review, we discuss how the narcolepsy association was detected, and we present the evidence according to the causality assessment criteria for adverse events following immunisation. The lessons learnt emphasise the central role of alert clinicians in reporting of suspected adverse reactions, and the importance of internationally robust postmarketing surveillance strategies as crucial components in future mass immunisation programmes.
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C03 01  X  ENG  @0 Narcolepsy @5 01
C03 01  X  SPA  @0 Narcolepsia @5 01
C03 02  X  FRE  @0 Immunoprophylaxie @5 04
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C03 06  X  FRE  @0 Grippe H1N1 @4 CD @5 96
C03 06  X  ENG  @0 H1N1 influenza @4 CD @5 96
C03 06  X  SPA  @0 Gripe H1N1 @4 CD @5 96
C03 07  X  FRE  @0 Virus grippal A(H1N1) @4 CD @5 97
C03 07  X  ENG  @0 Influenza A (H1N1) @4 CD @5 97
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C07 01  X  ENG  @0 Respiratory disease @5 37
C07 01  X  SPA  @0 Aparato respiratorio patología @5 37
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C07 04  X  SPA  @0 Sistema nervioso patología @5 39
C07 05  X  FRE  @0 Trouble neurologique @5 40
C07 05  X  ENG  @0 Neurological disorder @5 40
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C07 06  X  FRE  @0 Trouble du sommeil @5 41
C07 06  X  ENG  @0 Sleep disorder @5 41
C07 06  X  SPA  @0 Trastorno sueño @5 41
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Format Inist (serveur)

NO : PASCAL 14-0071052 INIST
ET : Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action
AU : BARKER (Charlotte I. S.); SNAPE (Matthew D.)
AF : Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford/Oxford/Royaume-Uni (1 aut., 2 aut.); Oxford University Clinical Academic Graduate School, Medical Sciences Division, University of Oxford/Oxford/Royaume-Uni (1 aut.); NIHR Oxford Biomedical Centre/Oxford/Royaume-Uni (2 aut.)
DT : Publication en série; Niveau analytique
SO : Lancet. Infectious diseases : (print); ISSN 1473-3099; Royaume-Uni; Da. 2014; Vol. 14; No. 3; Pp. 227-238; Bibl. 102 ref.
LA : Anglais
EA : The 2009 influenza A H1N1 pandemic placed unprecedented demand on public health authorities and the vaccine industry. Efforts were coordinated internationally to maximise the speed of vaccine development, distribution, and delivery, and the European Union's novel fast-track authorisation procedures mandated increased postmarketing surveillance to monitor vaccine safety. Clinicians in Finland and Sweden later identified an apparent increase in the incidence of narcolepsy associated with a specific adjuvanted pandemic influenza vaccine. After extensive review, the European Medicines Agency confirmed the existence of this association, which has since been detected in England, Ireland, France, and Norway. Assessments of the causal mechanisms continue. In this Review, we discuss how the narcolepsy association was detected, and we present the evidence according to the causality assessment criteria for adverse events following immunisation. The lessons learnt emphasise the central role of alert clinicians in reporting of suspected adverse reactions, and the importance of internationally robust postmarketing surveillance strategies as crucial components in future mass immunisation programmes.
CC : 002B05C02C; 002B17A02
FD : Narcolepsie; Immunoprophylaxie; Vaccin; Prévention; Surveillance; Grippe H1N1; Virus grippal A(H1N1)
FG : Pathologie de l'appareil respiratoire; Virose; Infection; Pathologie du système nerveux; Trouble neurologique; Trouble du sommeil
ED : Narcolepsy; Immunoprophylaxis; Vaccine; Prevention; Surveillance; H1N1 influenza; Influenza A (H1N1)
EG : Respiratory disease; Viral disease; Infection; Nervous system diseases; Neurological disorder; Sleep disorder
SD : Narcolepsia; Inmunoprofilaxia; Vacuna; Prevención; Vigilancia; Gripe H1N1
LO : INIST-27478.354000505772130140
ID : 14-0071052

Links to Exploration step

Pascal:14-0071052

Le document en format XML

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<NO>PASCAL 14-0071052 INIST</NO>
<ET>Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action</ET>
<AU>BARKER (Charlotte I. S.); SNAPE (Matthew D.)</AU>
<AF>Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford/Oxford/Royaume-Uni (1 aut., 2 aut.); Oxford University Clinical Academic Graduate School, Medical Sciences Division, University of Oxford/Oxford/Royaume-Uni (1 aut.); NIHR Oxford Biomedical Centre/Oxford/Royaume-Uni (2 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Lancet. Infectious diseases : (print); ISSN 1473-3099; Royaume-Uni; Da. 2014; Vol. 14; No. 3; Pp. 227-238; Bibl. 102 ref.</SO>
<LA>Anglais</LA>
<EA>The 2009 influenza A H1N1 pandemic placed unprecedented demand on public health authorities and the vaccine industry. Efforts were coordinated internationally to maximise the speed of vaccine development, distribution, and delivery, and the European Union's novel fast-track authorisation procedures mandated increased postmarketing surveillance to monitor vaccine safety. Clinicians in Finland and Sweden later identified an apparent increase in the incidence of narcolepsy associated with a specific adjuvanted pandemic influenza vaccine. After extensive review, the European Medicines Agency confirmed the existence of this association, which has since been detected in England, Ireland, France, and Norway. Assessments of the causal mechanisms continue. In this Review, we discuss how the narcolepsy association was detected, and we present the evidence according to the causality assessment criteria for adverse events following immunisation. The lessons learnt emphasise the central role of alert clinicians in reporting of suspected adverse reactions, and the importance of internationally robust postmarketing surveillance strategies as crucial components in future mass immunisation programmes.</EA>
<CC>002B05C02C; 002B17A02</CC>
<FD>Narcolepsie; Immunoprophylaxie; Vaccin; Prévention; Surveillance; Grippe H1N1; Virus grippal A(H1N1)</FD>
<FG>Pathologie de l'appareil respiratoire; Virose; Infection; Pathologie du système nerveux; Trouble neurologique; Trouble du sommeil</FG>
<ED>Narcolepsy; Immunoprophylaxis; Vaccine; Prevention; Surveillance; H1N1 influenza; Influenza A (H1N1)</ED>
<EG>Respiratory disease; Viral disease; Infection; Nervous system diseases; Neurological disorder; Sleep disorder</EG>
<SD>Narcolepsia; Inmunoprofilaxia; Vacuna; Prevención; Vigilancia; Gripe H1N1</SD>
<LO>INIST-27478.354000505772130140</LO>
<ID>14-0071052</ID>
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