Official batch control of influenza vaccines: Is it still useful?
Identifieur interne : 000041 ( Main/Exploration ); précédent : 000040; suivant : 000042Official batch control of influenza vaccines: Is it still useful?
Auteurs : Evelyne Kretzschmar [Allemagne] ; Heide Muckenfuss [Allemagne] ; Michael Pfleiderer [Allemagne]Source :
- Vaccine [ 1873-2518 ] ; 2018.
Descripteurs français
- KwdFr :
- MESH :
English descriptors
- KwdEn :
- MESH :
- chemical , standards : Influenza Vaccines.
- standards : Government Agencies, Laboratories, Product Surveillance, Postmarketing, Vaccination.
- Germany, Humans, Quality Control.
Abstract
INTRODUCTION
The governmental quality control of human vaccines is a long established tradition in many European countries. In Germany, vaccines have been controlled by a governmental agency since 1935. In the beginning, vaccine production and control was a purely national activity. However, that changed fundamentally in 1994 when the so-called Official Control Authority Batch Release Network (OCABR) was implemented shortly after the establishment of the European Union. Today, Official Medicinal Control Laboratories (OMCLs) are part of the European OCABR Network. In many European countries, OMCLs experimentally test every batch of human vaccines before they enter the market. We wanted to gain insights into the benefits of batch release by the Network and address the question whether batch release is still useful. This question was investigated in the context of influenza vaccines.
METHODS
Notifications on influenza vaccines circulated from 2006 to 2016 within the OCABR network were compiled and organized into 32 cases. The impact of these findings was evaluated, and the communication pathways between companies and respective European control laboratories were examined.
RESULTS
Approximately 5850 batches were tested by the OMCL network between 2006 and 2016. Among these, notifications belonging to 32 cases were observed. The predominant proportion of the circulated notifications related to manufacturing issues. In most cases, the manufacturer itself had withdrawn the batches before they entered the market. However, in three cases, batches of insufficient quality were detected by the respective European Control Laboratory leading to withdrawal of 13 batches.
CONCLUSION
13 batches which did not meet the specifications of influenza vaccine were detected by the OMCL network between 2006 and 2016 which would not have been identified by the manufacturer. This demonstrates the impact of governmental batch release. Together with the intrinsic values of the OCABR system and keeping in mind that vaccines are given to healthy often young individuals, governmental batch release of influenza vaccines is still justified.
DOI: 10.1016/j.vaccine.2018.02.078
PubMed: 29580639
Affiliations:
Links toward previous steps (curation, corpus...)
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Electronic address: evelyne.kretzschmar@pei.de.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen</wicri:regionArea><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion></affiliation></author><author><name sortKey="Muckenfuss, Heide" sort="Muckenfuss, Heide" uniqKey="Muckenfuss H" first="Heide" last="Muckenfuss">Heide Muckenfuss</name><affiliation wicri:level="1"><nlm:affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen</wicri:regionArea><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion></affiliation></author><author><name sortKey="Pfleiderer, Michael" sort="Pfleiderer, Michael" uniqKey="Pfleiderer M" first="Michael" last="Pfleiderer">Michael Pfleiderer</name><affiliation wicri:level="1"><nlm:affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen</wicri:regionArea><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2018">2018</date><idno type="RBID">pubmed:29580639</idno><idno type="pmid">29580639</idno><idno type="doi">10.1016/j.vaccine.2018.02.078</idno><idno type="wicri:Area/Main/Corpus">000036</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000036</idno><idno type="wicri:Area/Main/Curation">000036</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000036</idno><idno type="wicri:Area/Main/Exploration">000036</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Official batch control of influenza vaccines: Is it still useful?</title><author><name sortKey="Kretzschmar, Evelyne" sort="Kretzschmar, Evelyne" uniqKey="Kretzschmar E" first="Evelyne" last="Kretzschmar">Evelyne Kretzschmar</name><affiliation wicri:level="1"><nlm:affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany. Electronic address: evelyne.kretzschmar@pei.de.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen</wicri:regionArea><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion></affiliation></author><author><name sortKey="Muckenfuss, Heide" sort="Muckenfuss, Heide" uniqKey="Muckenfuss H" first="Heide" last="Muckenfuss">Heide Muckenfuss</name><affiliation wicri:level="1"><nlm:affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen</wicri:regionArea><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion></affiliation></author><author><name sortKey="Pfleiderer, Michael" sort="Pfleiderer, Michael" uniqKey="Pfleiderer M" first="Michael" last="Pfleiderer">Michael Pfleiderer</name><affiliation wicri:level="1"><nlm:affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen</wicri:regionArea><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion><wicri:noRegion>63225 Langen</wicri:noRegion></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Germany (MeSH)</term><term>Government Agencies (standards)</term><term>Humans (MeSH)</term><term>Influenza Vaccines (standards)</term><term>Laboratories (standards)</term><term>Product Surveillance, Postmarketing (standards)</term><term>Quality Control (MeSH)</term><term>Vaccination (standards)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Agences gouvernementales (normes)</term><term>Allemagne (MeSH)</term><term>Contrôle de qualité (MeSH)</term><term>Humains (MeSH)</term><term>Laboratoires (normes)</term><term>Surveillance post-commercialisation des produits de santé (normes)</term><term>Vaccination (normes)</term><term>Vaccins antigrippaux (normes)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="standards" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Agences gouvernementales</term><term>Laboratoires</term><term>Surveillance post-commercialisation des produits de santé</term><term>Vaccination</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Government Agencies</term><term>Laboratories</term><term>Product Surveillance, Postmarketing</term><term>Vaccination</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Germany</term><term>Humans</term><term>Quality Control</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Allemagne</term><term>Contrôle de qualité</term><term>Humains</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION</b></p><p>The governmental quality control of human vaccines is a long established tradition in many European countries. In Germany, vaccines have been controlled by a governmental agency since 1935. In the beginning, vaccine production and control was a purely national activity. However, that changed fundamentally in 1994 when the so-called Official Control Authority Batch Release Network (OCABR) was implemented shortly after the establishment of the European Union. Today, Official Medicinal Control Laboratories (OMCLs) are part of the European OCABR Network. In many European countries, OMCLs experimentally test every batch of human vaccines before they enter the market. We wanted to gain insights into the benefits of batch release by the Network and address the question whether batch release is still useful. This question was investigated in the context of influenza vaccines.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Notifications on influenza vaccines circulated from 2006 to 2016 within the OCABR network were compiled and organized into 32 cases. The impact of these findings was evaluated, and the communication pathways between companies and respective European control laboratories were examined.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Approximately 5850 batches were tested by the OMCL network between 2006 and 2016. Among these, notifications belonging to 32 cases were observed. The predominant proportion of the circulated notifications related to manufacturing issues. In most cases, the manufacturer itself had withdrawn the batches before they entered the market. However, in three cases, batches of insufficient quality were detected by the respective European Control Laboratory leading to withdrawal of 13 batches.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>13 batches which did not meet the specifications of influenza vaccine were detected by the OMCL network between 2006 and 2016 which would not have been identified by the manufacturer. This demonstrates the impact of governmental batch release. Together with the intrinsic values of the OCABR system and keeping in mind that vaccines are given to healthy often young individuals, governmental batch release of influenza vaccines is still justified.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">29580639</PMID><DateCompleted><Year>2018</Year><Month>09</Month><Day>11</Day></DateCompleted><DateRevised><Year>2018</Year><Month>09</Month><Day>11</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>36</Volume><Issue>17</Issue><PubDate><Year>2018</Year><Month>04</Month><Day>19</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Official batch control of influenza vaccines: Is it still useful?</ArticleTitle><Pagination><MedlinePgn>2364-2370</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(18)30275-5</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2018.02.078</ELocationID><Abstract><AbstractText Label="INTRODUCTION">The governmental quality control of human vaccines is a long established tradition in many European countries. In Germany, vaccines have been controlled by a governmental agency since 1935. In the beginning, vaccine production and control was a purely national activity. However, that changed fundamentally in 1994 when the so-called Official Control Authority Batch Release Network (OCABR) was implemented shortly after the establishment of the European Union. Today, Official Medicinal Control Laboratories (OMCLs) are part of the European OCABR Network. In many European countries, OMCLs experimentally test every batch of human vaccines before they enter the market. We wanted to gain insights into the benefits of batch release by the Network and address the question whether batch release is still useful. This question was investigated in the context of influenza vaccines.</AbstractText><AbstractText Label="METHODS">Notifications on influenza vaccines circulated from 2006 to 2016 within the OCABR network were compiled and organized into 32 cases. The impact of these findings was evaluated, and the communication pathways between companies and respective European control laboratories were examined.</AbstractText><AbstractText Label="RESULTS">Approximately 5850 batches were tested by the OMCL network between 2006 and 2016. Among these, notifications belonging to 32 cases were observed. The predominant proportion of the circulated notifications related to manufacturing issues. In most cases, the manufacturer itself had withdrawn the batches before they entered the market. However, in three cases, batches of insufficient quality were detected by the respective European Control Laboratory leading to withdrawal of 13 batches.</AbstractText><AbstractText Label="CONCLUSION">13 batches which did not meet the specifications of influenza vaccine were detected by the OMCL network between 2006 and 2016 which would not have been identified by the manufacturer. This demonstrates the impact of governmental batch release. Together with the intrinsic values of the OCABR system and keeping in mind that vaccines are given to healthy often young individuals, governmental batch release of influenza vaccines is still justified.</AbstractText><CopyrightInformation>Copyright © 2018 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kretzschmar</LastName><ForeName>Evelyne</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany. Electronic address: evelyne.kretzschmar@pei.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Muckenfuss</LastName><ForeName>Heide</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pfleiderer</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Paul-Ehrlich-Institut, Department of Virology, Section Viral Vaccines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2018</Year><Month>03</Month><Day>23</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D005858" MajorTopicYN="N">Germany</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006077" MajorTopicYN="N">Government Agencies</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007753" MajorTopicYN="N">Laboratories</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011358" MajorTopicYN="N">Product Surveillance, Postmarketing</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011786" MajorTopicYN="N">Quality Control</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">EDQM</Keyword><Keyword MajorTopicYN="Y">Influenza vaccination</Keyword><Keyword MajorTopicYN="Y">OCABR network</Keyword><Keyword MajorTopicYN="Y">Official control authority batch release</Keyword><Keyword MajorTopicYN="Y">Paul-Ehrlich-Institut</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>09</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2018</Year><Month>02</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2018</Year><Month>02</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2018</Year><Month>3</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2018</Year><Month>9</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2018</Year><Month>3</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">29580639</ArticleId><ArticleId IdType="pii">S0264-410X(18)30275-5</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2018.02.078</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li></country></list><tree><country name="Allemagne"><noRegion><name sortKey="Kretzschmar, Evelyne" sort="Kretzschmar, Evelyne" uniqKey="Kretzschmar E" first="Evelyne" last="Kretzschmar">Evelyne Kretzschmar</name></noRegion><name sortKey="Muckenfuss, Heide" sort="Muckenfuss, Heide" uniqKey="Muckenfuss H" first="Heide" last="Muckenfuss">Heide Muckenfuss</name><name sortKey="Pfleiderer, Michael" sort="Pfleiderer, Michael" uniqKey="Pfleiderer M" first="Michael" last="Pfleiderer">Michael Pfleiderer</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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