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Risk factors associated with anaphylaxis and other allergic-like events following receipt of 2009 monovalent AS03-adjuvanted pandemic influenza vaccine in Quebec, Canada.

Identifieur interne : 000264 ( Main/Exploration ); précédent : 000263; suivant : 000265

Risk factors associated with anaphylaxis and other allergic-like events following receipt of 2009 monovalent AS03-adjuvanted pandemic influenza vaccine in Quebec, Canada.

Auteurs : Isabelle Rouleau [Canada] ; Gaston De Serres [Canada] ; Danuta M. Skowronski [Canada] ; Jean Philippe Drolet [Canada] ; Chantal Lemire [Canada] ; Eveline Toth [Canada] ; Monique Landry [Canada]

Source :

RBID : pubmed:24793951

Descripteurs français

English descriptors

Abstract

INTRODUCTION

In Quebec, Canada, receipt of the 2009 AS03-adjuvanted pandemic H1N1 vaccine was associated with increased risk of anaphylaxis and other allergic-like events (ALE), especially among women of childbearing age. In response to this safety signal, a case-control study was conducted to identify potential risk factors.

METHODS

A total of 435 ALE (50 anaphylaxis) occurring <24h following pandemic vaccination were compared to 849 age-gender matched controls randomly selected from the provincial Pandemic Influenza Vaccination Registry. More than 60 potential risk factors were evaluated through phone interviews and included demographic information, medical history, medication use or acute respiratory illnesses (ARI) concurrent with vaccination and other risk factors associated with general allergy. Odds ratios (ORs) with 95% confidence intervals were estimated with unconditional logistic regression.

RESULTS

Factors associated with increased risk of anaphylaxis included concurrent ARI (18% cases vs. 4% controls, ORadj 7.67, 95%CI: 3.04-13.37), food allergy (26% cases vs. 4% controls, ORadj 3.84, 95%CI: 1.51-9.74) and vaccination during the first four weeks of the campaign (66% cases vs. 50% controls, ORadj 2.16, 95%CI: 1.10-4.25) whereas alcohol exposure (≥1 drink/week) was associated with reduced risk (29% cases vs. 42% controls, ORadj 0.26, 95%CI: 0.13-0.57). These factors were also significantly associated with any ALE but the strength of association was weaker. Allergy to components found in the vaccine (e.g., egg, thimerosal) was infrequent and did not significantly differ between cases and controls.

CONCLUSION

Increased anaphylaxis and other allergic-like events observed in association with AS03-adjuvanted pandemic H1N1 vaccine remain mostly unexplained despite extensive risk factor review. However, prior to mass vaccination with similar formulations this safety signal warrants further consideration and better understanding. In particular, the predominance among women of childbearing age may be a clue to underlying biological or hormonal influences on adverse immunological responses to vaccine.


DOI: 10.1016/j.vaccine.2014.04.059
PubMed: 24793951


Affiliations:


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Le document en format XML

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<term>Adverse Drug Reaction Reporting Systems (MeSH)</term>
<term>Anaphylaxis (chemically induced)</term>
<term>Anaphylaxis (epidemiology)</term>
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<p>
<b>INTRODUCTION</b>
</p>
<p>In Quebec, Canada, receipt of the 2009 AS03-adjuvanted pandemic H1N1 vaccine was associated with increased risk of anaphylaxis and other allergic-like events (ALE), especially among women of childbearing age. In response to this safety signal, a case-control study was conducted to identify potential risk factors.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>A total of 435 ALE (50 anaphylaxis) occurring <24h following pandemic vaccination were compared to 849 age-gender matched controls randomly selected from the provincial Pandemic Influenza Vaccination Registry. More than 60 potential risk factors were evaluated through phone interviews and included demographic information, medical history, medication use or acute respiratory illnesses (ARI) concurrent with vaccination and other risk factors associated with general allergy. Odds ratios (ORs) with 95% confidence intervals were estimated with unconditional logistic regression.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>Factors associated with increased risk of anaphylaxis included concurrent ARI (18% cases vs. 4% controls, ORadj 7.67, 95%CI: 3.04-13.37), food allergy (26% cases vs. 4% controls, ORadj 3.84, 95%CI: 1.51-9.74) and vaccination during the first four weeks of the campaign (66% cases vs. 50% controls, ORadj 2.16, 95%CI: 1.10-4.25) whereas alcohol exposure (≥1 drink/week) was associated with reduced risk (29% cases vs. 42% controls, ORadj 0.26, 95%CI: 0.13-0.57). These factors were also significantly associated with any ALE but the strength of association was weaker. Allergy to components found in the vaccine (e.g., egg, thimerosal) was infrequent and did not significantly differ between cases and controls.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSION</b>
</p>
<p>Increased anaphylaxis and other allergic-like events observed in association with AS03-adjuvanted pandemic H1N1 vaccine remain mostly unexplained despite extensive risk factor review. However, prior to mass vaccination with similar formulations this safety signal warrants further consideration and better understanding. In particular, the predominance among women of childbearing age may be a clue to underlying biological or hormonal influences on adverse immunological responses to vaccine.</p>
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<NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<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="D000707" MajorTopicYN="N">Anaphylaxis</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D004342" MajorTopicYN="N">Drug Hypersensitivity</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="D053118" MajorTopicYN="N">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="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011792" MajorTopicYN="N" Type="Geographic">Quebec</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">Adverse effects</Keyword>
<Keyword MajorTopicYN="N">Anaphylaxis</Keyword>
<Keyword MajorTopicYN="N">Hypersensitivity</Keyword>
<Keyword MajorTopicYN="N">Influenza vaccine</Keyword>
<Keyword MajorTopicYN="N">Pandemic influenza</Keyword>
<Keyword MajorTopicYN="N">Risk factors</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="received">
<Year>2014</Year>
<Month>02</Month>
<Day>17</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2014</Year>
<Month>04</Month>
<Day>04</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2014</Year>
<Month>04</Month>
<Day>17</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2014</Year>
<Month>5</Month>
<Day>6</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="pubmed">
<Year>2014</Year>
<Month>5</Month>
<Day>6</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2014</Year>
<Month>12</Month>
<Day>15</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">24793951</ArticleId>
<ArticleId IdType="pii">S0264-410X(14)00597-0</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2014.04.059</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations>
<list>
<country>
<li>Canada</li>
</country>
<region>
<li>Colombie-Britannique</li>
</region>
<settlement>
<li>Vancouver</li>
</settlement>
</list>
<tree>
<country name="Canada">
<noRegion>
<name sortKey="Rouleau, Isabelle" sort="Rouleau, Isabelle" uniqKey="Rouleau I" first="Isabelle" last="Rouleau">Isabelle Rouleau</name>
</noRegion>
<name sortKey="De Serres, Gaston" sort="De Serres, Gaston" uniqKey="De Serres G" first="Gaston" last="De Serres">Gaston De Serres</name>
<name sortKey="Drolet, Jean Philippe" sort="Drolet, Jean Philippe" uniqKey="Drolet J" first="Jean Philippe" last="Drolet">Jean Philippe Drolet</name>
<name sortKey="Landry, Monique" sort="Landry, Monique" uniqKey="Landry M" first="Monique" last="Landry">Monique Landry</name>
<name sortKey="Lemire, Chantal" sort="Lemire, Chantal" uniqKey="Lemire C" first="Chantal" last="Lemire">Chantal Lemire</name>
<name sortKey="Skowronski, Danuta M" sort="Skowronski, Danuta M" uniqKey="Skowronski D" first="Danuta M" last="Skowronski">Danuta M. Skowronski</name>
<name sortKey="Toth, Eveline" sort="Toth, Eveline" uniqKey="Toth E" first="Eveline" last="Toth">Eveline Toth</name>
</country>
</tree>
</affiliations>
</record>

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