Spontaneous reporting of suspected narcolepsy after vaccination against pandemic influenza A (H1N1) in Germany.
Identifieur interne : 000048 ( Main/Exploration ); précédent : 000047; suivant : 000049Spontaneous reporting of suspected narcolepsy after vaccination against pandemic influenza A (H1N1) in Germany.
Auteurs : Doris Oberle [Allemagne] ; Jutta Pavel [Allemagne] ; Brigitte Keller-Stanislawski [Allemagne]Source :
- Pharmacoepidemiology and drug safety [ 1099-1557 ] ; 2017.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Allemagne (épidémiologie), Enfant, Facteurs de l'âge, Femelle, Humains, Incidence, Mâle, Méthodes épidémiologiques, Narcolepsie (), Narcolepsie (psychologie), Narcolepsie (épidémiologie), Nouveau-né, Sous-type H1N1 du virus de la grippe A, Systèmes de signalement des effets indésirables des médicaments, Sécurité, Vaccination (), Vaccination (effets indésirables), Vaccins antigrippaux (effets indésirables), Études cas-témoins, Évaluation des risques.
- MESH :
- effets indésirables : Vaccination, Vaccins antigrippaux.
- psychologie : Narcolepsie.
- épidémiologie : Allemagne, Narcolepsie.
- Adolescent, Adulte, Adulte d'âge moyen, Enfant, Facteurs de l'âge, Femelle, Humains, Incidence, Mâle, Méthodes épidémiologiques, Narcolepsie, Nouveau-né, Sous-type H1N1 du virus de la grippe A, Systèmes de signalement des effets indésirables des médicaments, Sécurité, Vaccination, Études cas-témoins, Évaluation des risques.
English descriptors
- KwdEn :
- Adolescent, Adult, Adverse Drug Reaction Reporting Systems, Age Factors, Case-Control Studies, Child, Epidemiologic Methods, Female, Germany (epidemiology), Humans, Incidence, Infant, Newborn, Influenza A Virus, H1N1 Subtype, Influenza Vaccines (adverse effects), Male, Middle Aged, Narcolepsy (chemically induced), Narcolepsy (epidemiology), Narcolepsy (psychology), Risk Assessment, Safety, Vaccination (adverse effects), Vaccination (statistics & numerical data).
- MESH :
- chemical , adverse effects : Influenza Vaccines.
- adverse effects : Vaccination.
- chemically induced : Narcolepsy.
- epidemiology : Germany, Narcolepsy.
- psychology : Narcolepsy.
- statistics & numerical data : Vaccination.
- Adolescent, Adult, Adverse Drug Reaction Reporting Systems, Age Factors, Case-Control Studies, Child, Epidemiologic Methods, Female, Humans, Incidence, Infant, Newborn, Influenza A Virus, H1N1 Subtype, Male, Middle Aged, Risk Assessment, Safety.
Abstract
PURPOSE
We aimed at investigating whether, in Germany, the number of individual case safety reports (ICSR) of confirmed narcolepsy following Pandemrix® vaccination notified to the Paul-Ehrlich-Institut (PEI, German Federal Institute for Vaccines and Biomedicines) was higher than expected when compared with the prepandemic background incidence rates.
METHODS
ICSR of narcolepsy after vaccination with Pandemrix® notified to the PEI until September 2016 were reviewed and validated according to the criteria of narcolepsy defined by the Brighton Collaboration (BC). Cases fulfilling the criteria of BC levels of diagnostic certainty 1 to 4a with symptoms onset after vaccination with Pandemrix® were eligible. Adjustment for underreporting was performed with cases of narcolepsy recruited within the scope of the German Narcolepsy Study using capture-recapture methods. An observed versus expected (OvE) analysis was conducted based on adjusted case numbers using risk windows for symptoms onset within 4 and 6 months following vaccination.
RESULTS
By the end of September 2016, a total of 85 ICSR of narcolepsy after vaccination with Pandemrix® had been notified to the PEI 52 of which were eligible. The OvE estimates for the 4 and 6 months risk windows were 3.8 (95% CI: 2.6-5.4) and 2.8 (95% CI: 2.0-3.9), respectively. The number of excess cases was higher in children and adolescents (15-fold and 11.7-fold increased OvE estimate) than in adults (2.1-fold and 1.5-fold increased estimate).
CONCLUSIONS
Compared with the prepandemic background incidence rate, the number of incident narcolepsy cases was 3.8-fold and 2.8-fold as high.
DOI: 10.1002/pds.4292
PubMed: 28809087
Affiliations:
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xml:lang="en">Spontaneous reporting of suspected narcolepsy after vaccination against pandemic influenza A (H1N1) in Germany.</title><author><name sortKey="Oberle, Doris" sort="Oberle, Doris" uniqKey="Oberle D" first="Doris" last="Oberle">Doris Oberle</name><affiliation wicri:level="1"><nlm:affiliation>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen</wicri:regionArea><wicri:noRegion>Langen</wicri:noRegion><wicri:noRegion>Langen</wicri:noRegion><wicri:noRegion>Langen</wicri:noRegion></affiliation></author><author><name sortKey="Pavel, Jutta" sort="Pavel, Jutta" uniqKey="Pavel J" first="Jutta" last="Pavel">Jutta Pavel</name><affiliation wicri:level="1"><nlm:affiliation>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen</wicri:regionArea><wicri:noRegion>Langen</wicri:noRegion><wicri:noRegion>Langen</wicri:noRegion><wicri:noRegion>Langen</wicri:noRegion></affiliation></author><author><name sortKey="Keller Stanislawski, Brigitte" sort="Keller Stanislawski, Brigitte" uniqKey="Keller Stanislawski B" first="Brigitte" last="Keller-Stanislawski">Brigitte Keller-Stanislawski</name><affiliation wicri:level="1"><nlm:affiliation>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen</wicri:regionArea><wicri:noRegion>Langen</wicri:noRegion><wicri:noRegion>Langen</wicri:noRegion><wicri:noRegion>Langen</wicri:noRegion></affiliation></author></analytic><series><title level="j">Pharmacoepidemiology and drug safety</title><idno type="eISSN">1099-1557</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Adverse Drug Reaction Reporting Systems</term><term>Age Factors</term><term>Case-Control Studies</term><term>Child</term><term>Epidemiologic Methods</term><term>Female</term><term>Germany (epidemiology)</term><term>Humans</term><term>Incidence</term><term>Infant, Newborn</term><term>Influenza A Virus, H1N1 Subtype</term><term>Influenza Vaccines (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Narcolepsy (chemically induced)</term><term>Narcolepsy (epidemiology)</term><term>Narcolepsy (psychology)</term><term>Risk Assessment</term><term>Safety</term><term>Vaccination (adverse effects)</term><term>Vaccination (statistics & numerical data)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Allemagne (épidémiologie)</term><term>Enfant</term><term>Facteurs de l'âge</term><term>Femelle</term><term>Humains</term><term>Incidence</term><term>Mâle</term><term>Méthodes épidémiologiques</term><term>Narcolepsie ()</term><term>Narcolepsie (psychologie)</term><term>Narcolepsie (épidémiologie)</term><term>Nouveau-né</term><term>Sous-type H1N1 du virus de la grippe A</term><term>Systèmes de signalement des effets indésirables des médicaments</term><term>Sécurité</term><term>Vaccination ()</term><term>Vaccination (effets indésirables)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Études cas-témoins</term><term>Évaluation des risques</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Vaccination</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Narcolepsy</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccination</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Germany</term><term>Narcolepsy</term></keywords><keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Narcolepsie</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Narcolepsy</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Vaccination</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Allemagne</term><term>Narcolepsie</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Adverse Drug Reaction Reporting Systems</term><term>Age Factors</term><term>Case-Control Studies</term><term>Child</term><term>Epidemiologic Methods</term><term>Female</term><term>Humans</term><term>Incidence</term><term>Infant, Newborn</term><term>Influenza A Virus, H1N1 Subtype</term><term>Male</term><term>Middle Aged</term><term>Risk Assessment</term><term>Safety</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Enfant</term><term>Facteurs de l'âge</term><term>Femelle</term><term>Humains</term><term>Incidence</term><term>Mâle</term><term>Méthodes épidémiologiques</term><term>Narcolepsie</term><term>Nouveau-né</term><term>Sous-type H1N1 du virus de la grippe A</term><term>Systèmes de signalement des effets indésirables des médicaments</term><term>Sécurité</term><term>Vaccination</term><term>Études cas-témoins</term><term>Évaluation des risques</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>PURPOSE</b></p><p>We aimed at investigating whether, in Germany, the number of individual case safety reports (ICSR) of confirmed narcolepsy following Pandemrix® vaccination notified to the Paul-Ehrlich-Institut (PEI, German Federal Institute for Vaccines and Biomedicines) was higher than expected when compared with the prepandemic background incidence rates.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>ICSR of narcolepsy after vaccination with Pandemrix® notified to the PEI until September 2016 were reviewed and validated according to the criteria of narcolepsy defined by the Brighton Collaboration (BC). Cases fulfilling the criteria of BC levels of diagnostic certainty 1 to 4a with symptoms onset after vaccination with Pandemrix® were eligible. Adjustment for underreporting was performed with cases of narcolepsy recruited within the scope of the German Narcolepsy Study using capture-recapture methods. An observed versus expected (OvE) analysis was conducted based on adjusted case numbers using risk windows for symptoms onset within 4 and 6 months following vaccination.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>By the end of September 2016, a total of 85 ICSR of narcolepsy after vaccination with Pandemrix® had been notified to the PEI 52 of which were eligible. The OvE estimates for the 4 and 6 months risk windows were 3.8 (95% CI: 2.6-5.4) and 2.8 (95% CI: 2.0-3.9), respectively. The number of excess cases was higher in children and adolescents (15-fold and 11.7-fold increased OvE estimate) than in adults (2.1-fold and 1.5-fold increased estimate).</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Compared with the prepandemic background incidence rate, the number of incident narcolepsy cases was 3.8-fold and 2.8-fold as high.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28809087</PMID><DateCompleted><Year>2018</Year><Month>06</Month><Day>27</Day></DateCompleted><DateRevised><Year>2018</Year><Month>12</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1099-1557</ISSN><JournalIssue CitedMedium="Internet"><Volume>26</Volume><Issue>11</Issue><PubDate><Year>2017</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Pharmacoepidemiology and drug safety</Title><ISOAbbreviation>Pharmacoepidemiol Drug Saf</ISOAbbreviation></Journal><ArticleTitle>Spontaneous reporting of suspected narcolepsy after vaccination against pandemic influenza A (H1N1) in Germany.</ArticleTitle><Pagination><MedlinePgn>1321-1327</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/pds.4292</ELocationID><Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">We aimed at investigating whether, in Germany, the number of individual case safety reports (ICSR) of confirmed narcolepsy following Pandemrix® vaccination notified to the Paul-Ehrlich-Institut (PEI, German Federal Institute for Vaccines and Biomedicines) was higher than expected when compared with the prepandemic background incidence rates.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">ICSR of narcolepsy after vaccination with Pandemrix® notified to the PEI until September 2016 were reviewed and validated according to the criteria of narcolepsy defined by the Brighton Collaboration (BC). Cases fulfilling the criteria of BC levels of diagnostic certainty 1 to 4a with symptoms onset after vaccination with Pandemrix® were eligible. Adjustment for underreporting was performed with cases of narcolepsy recruited within the scope of the German Narcolepsy Study using capture-recapture methods. An observed versus expected (OvE) analysis was conducted based on adjusted case numbers using risk windows for symptoms onset within 4 and 6 months following vaccination.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">By the end of September 2016, a total of 85 ICSR of narcolepsy after vaccination with Pandemrix® had been notified to the PEI 52 of which were eligible. The OvE estimates for the 4 and 6 months risk windows were 3.8 (95% CI: 2.6-5.4) and 2.8 (95% CI: 2.0-3.9), respectively. The number of excess cases was higher in children and adolescents (15-fold and 11.7-fold increased OvE estimate) than in adults (2.1-fold and 1.5-fold increased estimate).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Compared with the prepandemic background incidence rate, the number of incident narcolepsy cases was 3.8-fold and 2.8-fold as high.</AbstractText><CopyrightInformation>Copyright © 2017 John Wiley & Sons, Ltd.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Oberle</LastName><ForeName>Doris</ForeName><Initials>D</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-4279-629X</Identifier><AffiliationInfo><Affiliation>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pavel</LastName><ForeName>Jutta</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Keller-Stanislawski</LastName><ForeName>Brigitte</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>08</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Pharmacoepidemiol Drug Saf</MedlineTA><NlmUniqueID>9208369</NlmUniqueID><ISSNLinking>1053-8569</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C556153">pandemrix</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016907" MajorTopicYN="N">Adverse Drug Reaction Reporting Systems</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004812" MajorTopicYN="N">Epidemiologic Methods</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005858" MajorTopicYN="N">Germany</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015994" MajorTopicYN="N">Incidence</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007231" MajorTopicYN="N">Infant, Newborn</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053118" MajorTopicYN="Y">Influenza A Virus, H1N1 Subtype</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009290" MajorTopicYN="N">Narcolepsy</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName><QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012449" MajorTopicYN="N">Safety</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Germany</Keyword><Keyword MajorTopicYN="N">narcolepsy</Keyword><Keyword MajorTopicYN="N">pandemic influenza A (H1N1) vaccine</Keyword><Keyword MajorTopicYN="N">passive surveillance</Keyword><Keyword MajorTopicYN="N">pharmacoepidemiology</Keyword><Keyword MajorTopicYN="N">spontaneous reporting</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>10</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>07</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>07</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2018</Year><Month>6</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28809087</ArticleId><ArticleId IdType="doi">10.1002/pds.4292</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li></country></list><tree><country name="Allemagne"><noRegion><name sortKey="Oberle, Doris" sort="Oberle, Doris" uniqKey="Oberle D" first="Doris" last="Oberle">Doris Oberle</name></noRegion><name sortKey="Keller Stanislawski, Brigitte" sort="Keller Stanislawski, Brigitte" uniqKey="Keller Stanislawski B" first="Brigitte" last="Keller-Stanislawski">Brigitte Keller-Stanislawski</name><name sortKey="Pavel, Jutta" sort="Pavel, Jutta" uniqKey="Pavel J" first="Jutta" last="Pavel">Jutta 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