PandemieGrippaleV1, PascalFrancis, Checkpoint, bibRecord, 000249

Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1 pdm09) vaccine

Identifieur interne : 000249 ( PascalFrancis/Checkpoint ); précédent : 000248; suivant : 000250

Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1 pdm09) vaccine

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

Source :

Vaccine [ 0264-410X ] ; 2013.

RBID : Pascal:14-0016334

Descripteurs français

Pascal (Inist)
- Anaphylaxie, Adjuvant immunologique, Vaccin, Epidémiologie, Toxicité, Vaccination, Allergie, Grippe, Virus grippal A(H1N1).
Wicri :
- topic : Vaccin, Vaccination, Allergie.

English descriptors

KwdEn :
- Allergy, Anaphylaxis, Epidemiology, Immunological adjuvant, Influenza, Influenzavirus A(H1N1), Toxicity, Vaccination, Vaccine.

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 1 h 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 H1N1 pdm09 vaccine substantially exceeded that reported with seasonal influenza vaccines, a signal that warrants better understanding.

Affiliations:

Canada

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Le document en format XML

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<term>Immunological adjuvant</term>
<term>Influenza</term>
<term>Influenzavirus A(H1N1)</term>
<term>Toxicity</term>
<term>Vaccination</term>
<term>Vaccine</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Anaphylaxie</term>
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<term>Toxicité</term>
<term>Vaccination</term>
<term>Allergie</term>
<term>Grippe</term>
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<front><div type="abstract" xml:lang="en">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 1 h 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 H1N1 pdm09 vaccine substantially exceeded that reported with seasonal influenza vaccines, a signal that warrants better understanding.</div>
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<fC03 i1="02" i2="X" l="SPA"><s0>Coadyuvante inmunológico</s0>
<s5>06</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Vaccin</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Vaccine</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Vacuna</s0>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Epidémiologie</s0>
<s5>08</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Epidemiology</s0>
<s5>08</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Epidemiología</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Toxicité</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Toxicity</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Toxicidad</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Vaccination</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Vaccination</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Vacunación</s0>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Allergie</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Allergy</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Alergia</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Grippe</s0>
<s5>15</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Influenza</s0>
<s5>15</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Gripe</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Virus grippal A(H1N1)</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Influenzavirus A(H1N1)</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Immunopathologie</s0>
<s5>13</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Immunopathology</s0>
<s5>13</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Inmunopatología</s0>
<s5>13</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Virose</s0>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Viral disease</s0>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Virosis</s0>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Infection</s0>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Infection</s0>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Infección</s0>
</fC07>
<fN21><s1>013</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations><list><country><li>Canada</li>
</country>
</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="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="Menard">Suzanne Menard</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>
</country>
</tree>
</affiliations>
</record>

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   |wiki=    Sante
   |area=    PandemieGrippaleV1
   |flux=    PascalFrancis
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   |type=    RBID
   |clé=     Pascal:14-0016334
   |texte=   Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1 pdm09) vaccine
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	Serveur d'exploration sur les pandémies grippales
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Serveur d'exploration sur les pandémies grippales

Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1 pdm09) vaccine

Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1 pdm09) vaccine

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