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Narcolepsy, 2009 A(H1N1) pandemic influenza, and pandemic influenza vaccinations: what is known and unknown about the neurological disorder, the role for autoimmunity, and vaccine adjuvants.

Identifieur interne : 000261 ( Main/Exploration ); précédent : 000260; suivant : 000262

Narcolepsy, 2009 A(H1N1) pandemic influenza, and pandemic influenza vaccinations: what is known and unknown about the neurological disorder, the role for autoimmunity, and vaccine adjuvants.

Auteurs : S Sohail Ahmed [Italie] ; Peter H. Schur [États-Unis] ; Noni E. Macdonald [Canada] ; Lawrence Steinman [États-Unis]

Source :

RBID : pubmed:24559657

Descripteurs français

English descriptors

Abstract

The vaccine safety surveillance system effectively detected a very rare adverse event, narcolepsy, in subjects receiving AS03-adjuvanted A(H1N1) pandemic vaccine made using the European inactivation/purification protocol. The reports of increased cases of narcolepsy in non-vaccinated subjects infected with wild A(H1N1) pandemic influenza virus suggest a role for the viral antigen(s) in disease development. However, additional investigations are needed to better understand what factor(s) in wild influenza infection trigger(s) narcolepsy in susceptible hosts. An estimated 31 million doses of European AS03-adjuvanted A(H1N1) pandemic vaccine were used in more than 47 countries. The Canadian AS03-adjuvanted A(H1N1) pandemic vaccine was used with high coverage in Canada where an estimated 12 million doses were administered. As no similar narcolepsy association has been reported to date with the AS03-adjuvanted A(H1N1) pandemic vaccine made using the Canadian inactivation/purification protocol, this suggests that the AS03 adjuvant alone may not be responsible for the narcolepsy association. To date, no narcolepsy association has been reported with the MF59®-adjuvanted A(H1N1) pandemic vaccine. This review article provides a brief background on narcolepsy, outlines the different types of vaccine preparations including the ones for influenza, reviews the accumulated evidence for the safety of adjuvants, and explores the association between autoimmune diseases and natural infections. It concludes by assimilating the historical observations and recent clinical studies to formulate a feasible hypothesis on why vaccine-associated narcolepsy may not be solely linked to the AS03 adjuvant but more likely be linked to how the specific influenza antigen component of the European AS03-adjuvanted pandemic vaccine was prepared. Careful and long-term epidemiological studies of subjects who developed narcolepsy in association with AS03-adjuvanted A(H1N1) pandemic vaccine prepared with the European inactivation/purification protocol are needed.

DOI: 10.1016/j.jaut.2014.01.033
PubMed: 24559657


Affiliations:


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Le document en format XML

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<div type="abstract" xml:lang="en">The vaccine safety surveillance system effectively detected a very rare adverse event, narcolepsy, in subjects receiving AS03-adjuvanted A(H1N1) pandemic vaccine made using the European inactivation/purification protocol. The reports of increased cases of narcolepsy in non-vaccinated subjects infected with wild A(H1N1) pandemic influenza virus suggest a role for the viral antigen(s) in disease development. However, additional investigations are needed to better understand what factor(s) in wild influenza infection trigger(s) narcolepsy in susceptible hosts. An estimated 31 million doses of European AS03-adjuvanted A(H1N1) pandemic vaccine were used in more than 47 countries. The Canadian AS03-adjuvanted A(H1N1) pandemic vaccine was used with high coverage in Canada where an estimated 12 million doses were administered. As no similar narcolepsy association has been reported to date with the AS03-adjuvanted A(H1N1) pandemic vaccine made using the Canadian inactivation/purification protocol, this suggests that the AS03 adjuvant alone may not be responsible for the narcolepsy association. To date, no narcolepsy association has been reported with the MF59®-adjuvanted A(H1N1) pandemic vaccine. This review article provides a brief background on narcolepsy, outlines the different types of vaccine preparations including the ones for influenza, reviews the accumulated evidence for the safety of adjuvants, and explores the association between autoimmune diseases and natural infections. It concludes by assimilating the historical observations and recent clinical studies to formulate a feasible hypothesis on why vaccine-associated narcolepsy may not be solely linked to the AS03 adjuvant but more likely be linked to how the specific influenza antigen component of the European AS03-adjuvanted pandemic vaccine was prepared. Careful and long-term epidemiological studies of subjects who developed narcolepsy in association with AS03-adjuvanted A(H1N1) pandemic vaccine prepared with the European inactivation/purification protocol are needed. </div>
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<DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName>
<QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000956" MajorTopicYN="N">Antigens, Viral</DescriptorName>
<QualifierName UI="Q000737" MajorTopicYN="Y">chemistry</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015551" MajorTopicYN="Y">Autoimmunity</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D002170" MajorTopicYN="N" Type="Geographic">Canada</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D004338" MajorTopicYN="N">Drug Combinations</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005060" MajorTopicYN="N" Type="Geographic">Europe</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName>
<QualifierName UI="Q000472" MajorTopicYN="N">pathogenicity</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
<QualifierName UI="Q000096" MajorTopicYN="N">biosynthesis</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009290" MajorTopicYN="N">Narcolepsy</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName>
<QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName>
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<MeshHeading>
<DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
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<DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName>
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<DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName>
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<DescriptorName UI="D024502" MajorTopicYN="N">alpha-Tocopherol</DescriptorName>
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<QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">Adjuvants</Keyword>
<Keyword MajorTopicYN="N">Autoimmune disease</Keyword>
<Keyword MajorTopicYN="N">H1N1 infection</Keyword>
<Keyword MajorTopicYN="N">Molecular mimicry</Keyword>
<Keyword MajorTopicYN="N">Narcolepsy</Keyword>
<Keyword MajorTopicYN="N">Vaccines</Keyword>
</KeywordList>
</MedlineCitation>
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<History>
<PubMedPubDate PubStatus="received">
<Year>2013</Year>
<Month>12</Month>
<Day>02</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2014</Year>
<Month>01</Month>
<Day>13</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2014</Year>
<Month>01</Month>
<Day>22</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2014</Year>
<Month>2</Month>
<Day>25</Day>
<Hour>6</Hour>
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<PubMedPubDate PubStatus="pubmed">
<Year>2014</Year>
<Month>2</Month>
<Day>25</Day>
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<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline">
<Year>2014</Year>
<Month>12</Month>
<Day>15</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">24559657</ArticleId>
<ArticleId IdType="pii">S0896-8411(14)00038-9</ArticleId>
<ArticleId IdType="doi">10.1016/j.jaut.2014.01.033</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations>
<list>
<country>
<li>Canada</li>
<li>Italie</li>
<li>États-Unis</li>
</country>
<region>
<li>Californie</li>
<li>Massachusetts</li>
</region>
</list>
<tree>
<country name="Italie">
<noRegion>
<name sortKey="Ahmed, S Sohail" sort="Ahmed, S Sohail" uniqKey="Ahmed S" first="S Sohail" last="Ahmed">S Sohail Ahmed</name>
</noRegion>
</country>
<country name="États-Unis">
<region name="Massachusetts">
<name sortKey="Schur, Peter H" sort="Schur, Peter H" uniqKey="Schur P" first="Peter H" last="Schur">Peter H. Schur</name>
</region>
<name sortKey="Steinman, Lawrence" sort="Steinman, Lawrence" uniqKey="Steinman L" first="Lawrence" last="Steinman">Lawrence Steinman</name>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Macdonald, Noni E" sort="Macdonald, Noni E" uniqKey="Macdonald N" first="Noni E" last="Macdonald">Noni E. Macdonald</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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