Rapid assessment of enhanced safety surveillance for influenza vaccine.
Identifieur interne : 000020 ( Main/Exploration ); précédent : 000019; suivant : 000021Rapid assessment of enhanced safety surveillance for influenza vaccine.
Auteurs : A M Alguacil-Ramos [Espagne] ; A. Portero-Alonso [Espagne] ; E. Pastor-Villalba [Espagne] ; J. Muelas-Tirado [Espagne] ; J. Díez-Domingo [Espagne] ; A. Sanchis-Ferrer [Espagne] ; J A Lluch-Rodrigo [Espagne]Source :
- Public health [ 1476-5616 ] ; 2019.
Descripteurs français
- KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Effets secondaires indésirables des médicaments (épidémiologie), Enfant (MeSH), Enfant d'âge préscolaire (MeSH), Enregistrements (MeSH), Espagne (épidémiologie), Facteurs de risque (MeSH), Femelle (MeSH), Humains (MeSH), Jeune adulte (MeSH), Mâle (MeSH), Nourrisson (MeSH), Saisons (MeSH), Sujet âgé (MeSH), Surveillance post-commercialisation des produits de santé (MeSH), Systèmes de signalement des effets indésirables des médicaments (MeSH), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables).
- MESH :
- administration et posologie : Vaccins antigrippaux.
- effets indésirables : Vaccins antigrippaux.
- épidémiologie : Effets secondaires indésirables des médicaments, Espagne.
- Adolescent, Adulte, Adulte d'âge moyen, Enfant, Enfant d'âge préscolaire, Enregistrements, Facteurs de risque, Femelle, Humains, Jeune adulte, Mâle, Nourrisson, Saisons, Sujet âgé, Surveillance post-commercialisation des produits de santé, Systèmes de signalement des effets indésirables des médicaments.
- Wicri :
- geographic : Espagne.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Adverse Drug Reaction Reporting Systems (MeSH), Aged (MeSH), Child (MeSH), Child, Preschool (MeSH), Drug-Related Side Effects and Adverse Reactions (epidemiology), Female (MeSH), Humans (MeSH), Infant (MeSH), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Male (MeSH), Middle Aged (MeSH), Product Surveillance, Postmarketing (MeSH), Registries (MeSH), Risk Factors (MeSH), Seasons (MeSH), Spain (epidemiology), Young Adult (MeSH).
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- geographic , epidemiology : Spain.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- Adolescent, Adult, Adverse Drug Reaction Reporting Systems, Aged, Child, Child, Preschool, Female, Humans, Infant, Male, Middle Aged, Product Surveillance, Postmarketing, Registries, Risk Factors, Seasons, Young Adult.
Abstract
OBJECTIVES
The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.
STUDY DESIGN
It is a population-based descriptive study.
METHODS
Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed.
RESULTS
A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance.
CONCLUSIONS
Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles.
DOI: 10.1016/j.puhe.2018.12.013
PubMed: 30769245
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Electronic address: alguacil_ana@gva.es.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain; Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Portero Alonso, A" sort="Portero Alonso, A" uniqKey="Portero Alonso A" first="A" last="Portero-Alonso">A. 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Sanchis-Ferrer</name><affiliation wicri:level="1"><nlm:affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Lluch Rodrigo, J A" sort="Lluch Rodrigo, J A" uniqKey="Lluch Rodrigo J" first="J A" last="Lluch-Rodrigo">J A Lluch-Rodrigo</name><affiliation wicri:level="1"><nlm:affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author></analytic><series><title level="j">Public health</title><idno type="eISSN">1476-5616</idno><imprint><date when="2019" type="published">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Adverse Drug Reaction Reporting Systems (MeSH)</term><term>Aged (MeSH)</term><term>Child (MeSH)</term><term>Child, Preschool (MeSH)</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Infant (MeSH)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Product Surveillance, Postmarketing (MeSH)</term><term>Registries (MeSH)</term><term>Risk Factors (MeSH)</term><term>Seasons (MeSH)</term><term>Spain (epidemiology)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent (MeSH)</term><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Effets secondaires indésirables des médicaments (épidémiologie)</term><term>Enfant (MeSH)</term><term>Enfant d'âge préscolaire (MeSH)</term><term>Enregistrements (MeSH)</term><term>Espagne (épidémiologie)</term><term>Facteurs de risque (MeSH)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Jeune adulte (MeSH)</term><term>Mâle (MeSH)</term><term>Nourrisson (MeSH)</term><term>Saisons (MeSH)</term><term>Sujet âgé (MeSH)</term><term>Surveillance post-commercialisation des produits de santé (MeSH)</term><term>Systèmes de signalement des effets indésirables des médicaments (MeSH)</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Spain</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term><term>Espagne</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Adverse Drug Reaction Reporting Systems</term><term>Aged</term><term>Child</term><term>Child, Preschool</term><term>Female</term><term>Humans</term><term>Infant</term><term>Male</term><term>Middle Aged</term><term>Product Surveillance, Postmarketing</term><term>Registries</term><term>Risk Factors</term><term>Seasons</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Enfant</term><term>Enfant d'âge préscolaire</term><term>Enregistrements</term><term>Facteurs de risque</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Nourrisson</term><term>Saisons</term><term>Sujet âgé</term><term>Surveillance post-commercialisation des produits de santé</term><term>Systèmes de signalement des effets indésirables des médicaments</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Espagne</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.</p></div><div type="abstract" xml:lang="en"><p><b>STUDY DESIGN</b></p><p>It is a population-based descriptive study.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">30769245</PMID><DateCompleted><Year>2019</Year><Month>04</Month><Day>18</Day></DateCompleted><DateRevised><Year>2019</Year><Month>04</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1476-5616</ISSN><JournalIssue CitedMedium="Internet"><Volume>168</Volume><PubDate><Year>2019</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Public health</Title><ISOAbbreviation>Public Health</ISOAbbreviation></Journal><ArticleTitle>Rapid assessment of enhanced safety surveillance for influenza vaccine.</ArticleTitle><Pagination><MedlinePgn>137-141</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0033-3506(18)30405-0</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.puhe.2018.12.013</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.</AbstractText><AbstractText Label="STUDY DESIGN" NlmCategory="METHODS">It is a population-based descriptive study.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Adverse events following immunization reports collected from 23rd October 2017 to 15th March 2018 were analyzed.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 55 adverse events for influenza vaccine were reported in season 2017/2018 with a reporting rate (RR) of 0.77 per 10,000 administered doses. Injection site reactions had a RR of 0.30 and 0.47 per 10,000 for subunit and adjuvanted vaccines, respectively. Differences per vaccine, sex, and risk group did not reach statistical significance.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Reported events of the two influenza vaccine types used were similar than in other seasons and consistent with their safety profiles.</AbstractText><CopyrightInformation>Copyright © 2019 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Alguacil-Ramos</LastName><ForeName>A M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain; Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain. Electronic address: alguacil_ana@gva.es.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Portero-Alonso</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pastor-Villalba</LastName><ForeName>E</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Muelas-Tirado</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Dirección General de Farmacia y Productos Sanitarios, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Díez-Domingo</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sanchis-Ferrer</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lluch-Rodrigo</LastName><ForeName>J A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Dirección General de Salud Pública, Conselleria de Sanidad Universal y Salud Pública, Valencia, Spain.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>02</Month><Day>13</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Public Health</MedlineTA><NlmUniqueID>0376507</NlmUniqueID><ISSNLinking>0033-3506</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</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="Y">Adverse Drug Reaction Reporting Systems</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><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="D011358" MajorTopicYN="Y">Product Surveillance, Postmarketing</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012042" MajorTopicYN="N">Registries</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012621" MajorTopicYN="N">Seasons</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013030" MajorTopicYN="N" Type="Geographic">Spain</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Adverse events</Keyword><Keyword MajorTopicYN="N">Immunization information system</Keyword><Keyword MajorTopicYN="N">Influenza</Keyword><Keyword MajorTopicYN="N">Surveillance</Keyword><Keyword MajorTopicYN="N">Vaccine</Keyword><Keyword MajorTopicYN="N">Vaccine safety</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year><Month>05</Month><Day>03</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2018</Year><Month>11</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2018</Year><Month>12</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2019</Year><Month>2</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2019</Year><Month>4</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2019</Year><Month>2</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">30769245</ArticleId><ArticleId IdType="pii">S0033-3506(18)30405-0</ArticleId><ArticleId IdType="doi">10.1016/j.puhe.2018.12.013</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Espagne</li></country></list><tree><country name="Espagne"><noRegion><name sortKey="Alguacil Ramos, A M" sort="Alguacil Ramos, A M" uniqKey="Alguacil Ramos A" first="A M" last="Alguacil-Ramos">A M Alguacil-Ramos</name></noRegion><name sortKey="Diez Domingo, J" sort="Diez Domingo, J" uniqKey="Diez Domingo J" first="J" last="Díez-Domingo">J. Díez-Domingo</name><name sortKey="Lluch Rodrigo, J A" sort="Lluch Rodrigo, J A" uniqKey="Lluch Rodrigo J" first="J A" last="Lluch-Rodrigo">J A Lluch-Rodrigo</name><name sortKey="Muelas Tirado, J" sort="Muelas Tirado, J" uniqKey="Muelas Tirado J" first="J" last="Muelas-Tirado">J. Muelas-Tirado</name><name sortKey="Pastor Villalba, E" sort="Pastor Villalba, E" uniqKey="Pastor Villalba E" first="E" last="Pastor-Villalba">E. Pastor-Villalba</name><name sortKey="Portero Alonso, A" sort="Portero Alonso, A" uniqKey="Portero Alonso A" first="A" last="Portero-Alonso">A. Portero-Alonso</name><name sortKey="Sanchis Ferrer, A" sort="Sanchis Ferrer, A" uniqKey="Sanchis Ferrer A" first="A" last="Sanchis-Ferrer">A. Sanchis-Ferrer</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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