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Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1pdm09) vaccine.

Identifieur interne : 000373 ( Main/Exploration ); précédent : 000372; suivant : 000374

Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1pdm09) vaccine.

Auteurs : Isabelle Rouleau [Canada] ; Gaston De Serres ; Jean Philippe Drolet ; Danuta M. Skowronski ; Manale Ouakki ; Eveline Toth ; Monique Landry ; Suzanne Ménard ; Rémi Gagnon

Source :

RBID : pubmed:24144473

Descripteurs français

English descriptors

Abstract

BACKGROUND

Anaphylaxis after trivalent influenza vaccination is typically reported at a rate of <1 per million doses. In Quebec, Canada, anaphylaxis following administration of the monovalent AS03-adjuvanted H1N1pdm09 vaccine was reported through passive surveillance at a rate of 8 per million doses administered. This was 20 times higher than the reporting rate for non-adjuvanted trivalent vaccines administered during the six previous seasons. However, adequate estimation of the incidence of anaphylaxis is hindered by wide variations in definitions and diagnosis.

METHODS

Using the Brighton collaboration case definition of anaphylaxis, all cases with allergic symptoms (AS) reported to public health were reviewed to estimate the incidence of anaphylaxis following AS03-adjuvanted H1N1pdm09 vaccine.

RESULTS

Among 752 reports of allergic symptoms, 33 were initially reported as anaphylaxis of which 20/33 (60%) met the Brighton definition (19/20 with certainty levels 1 or 2). A total of 38 additional cases with onset within 1h of vaccination also met the Brighton definition of anaphylaxis (27 (71%) with certainty levels 1 or 2). The 58 cases meeting Brighton Level 1 or 2 criteria for anaphylaxis represent a 75% increase over the 33 passively reported and an incidence of 13 per million doses administered.

CONCLUSION

A substantial number of patients with early-onset allergic symptoms met the most specific levels of the Brighton case definition but were not reported as anaphylaxis. Based on this specific case definition, the incidence of anaphylaxis after AS03-adjuvanted H1N1pdm09 vaccine substantially exceeded that reported with seasonal influenza vaccines, a signal that warrants better understanding.


DOI: 10.1016/j.vaccine.2013.10.033
PubMed: 24144473


Affiliations:


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Le document en format XML

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<term>Adult (MeSH)</term>
<term>Aged (MeSH)</term>
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<term>Humans (MeSH)</term>
<term>Incidence (MeSH)</term>
<term>Influenza A Virus, H1N1 Subtype (immunology)</term>
<term>Influenza Vaccines (administration & dosage)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza, Human (prevention & control)</term>
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<term>Polysorbates (adverse effects)</term>
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<term>Risk Assessment (MeSH)</term>
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<term>Squalene (adverse effects)</term>
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<b>BACKGROUND</b>
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<p>Anaphylaxis after trivalent influenza vaccination is typically reported at a rate of <1 per million doses. In Quebec, Canada, anaphylaxis following administration of the monovalent AS03-adjuvanted H1N1pdm09 vaccine was reported through passive surveillance at a rate of 8 per million doses administered. This was 20 times higher than the reporting rate for non-adjuvanted trivalent vaccines administered during the six previous seasons. However, adequate estimation of the incidence of anaphylaxis is hindered by wide variations in definitions and diagnosis.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>Using the Brighton collaboration case definition of anaphylaxis, all cases with allergic symptoms (AS) reported to public health were reviewed to estimate the incidence of anaphylaxis following AS03-adjuvanted H1N1pdm09 vaccine.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>Among 752 reports of allergic symptoms, 33 were initially reported as anaphylaxis of which 20/33 (60%) met the Brighton definition (19/20 with certainty levels 1 or 2). A total of 38 additional cases with onset within 1h of vaccination also met the Brighton definition of anaphylaxis (27 (71%) with certainty levels 1 or 2). The 58 cases meeting Brighton Level 1 or 2 criteria for anaphylaxis represent a 75% increase over the 33 passively reported and an incidence of 13 per million doses administered.</p>
</div>
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<p>
<b>CONCLUSION</b>
</p>
<p>A substantial number of patients with early-onset allergic symptoms met the most specific levels of the Brighton case definition but were not reported as anaphylaxis. Based on this specific case definition, the incidence of anaphylaxis after AS03-adjuvanted H1N1pdm09 vaccine substantially exceeded that reported with seasonal influenza vaccines, a signal that warrants better understanding.</p>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Anaphylaxis after trivalent influenza vaccination is typically reported at a rate of <1 per million doses. In Quebec, Canada, anaphylaxis following administration of the monovalent AS03-adjuvanted H1N1pdm09 vaccine was reported through passive surveillance at a rate of 8 per million doses administered. This was 20 times higher than the reporting rate for non-adjuvanted trivalent vaccines administered during the six previous seasons. However, adequate estimation of the incidence of anaphylaxis is hindered by wide variations in definitions and diagnosis.</AbstractText>
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<AbstractText Label="RESULTS" NlmCategory="RESULTS">Among 752 reports of allergic symptoms, 33 were initially reported as anaphylaxis of which 20/33 (60%) met the Brighton definition (19/20 with certainty levels 1 or 2). A total of 38 additional cases with onset within 1h of vaccination also met the Brighton definition of anaphylaxis (27 (71%) with certainty levels 1 or 2). The 58 cases meeting Brighton Level 1 or 2 criteria for anaphylaxis represent a 75% increase over the 33 passively reported and an incidence of 13 per million doses administered.</AbstractText>
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</MeshHeading>
<MeshHeading>
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</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015994" MajorTopicYN="N">Incidence</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName>
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</MeshHeading>
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<MeshHeading>
<DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName>
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<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011792" MajorTopicYN="N" Type="Geographic">Quebec</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName>
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<Keyword MajorTopicYN="N">Anaphylaxis</Keyword>
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<Keyword MajorTopicYN="N">Influenza vaccines</Keyword>
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<Year>2013</Year>
<Month>05</Month>
<Day>08</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2013</Year>
<Month>09</Month>
<Day>13</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2013</Year>
<Month>10</Month>
<Day>08</Day>
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<ArticleId IdType="pubmed">24144473</ArticleId>
<ArticleId IdType="pii">S0264-410X(13)01409-6</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2013.10.033</ArticleId>
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<li>Canada</li>
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<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="Gagnon, Remi" sort="Gagnon, Remi" uniqKey="Gagnon R" first="Rémi" last="Gagnon">Rémi Gagnon</name>
<name sortKey="Landry, Monique" sort="Landry, Monique" uniqKey="Landry M" first="Monique" last="Landry">Monique Landry</name>
<name sortKey="Menard, Suzanne" sort="Menard, Suzanne" uniqKey="Menard S" first="Suzanne" last="Ménard">Suzanne Ménard</name>
<name sortKey="Ouakki, Manale" sort="Ouakki, Manale" uniqKey="Ouakki M" first="Manale" last="Ouakki">Manale Ouakki</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>
</noCountry>
<country name="Canada">
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<name sortKey="Rouleau, Isabelle" sort="Rouleau, Isabelle" uniqKey="Rouleau I" first="Isabelle" last="Rouleau">Isabelle Rouleau</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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