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

Rouleau, Isabelle; Serres, Gaston De; Skowronski, Danuta M.; Drolet, J. P.; Lemire, Chantal; Toth, Eveline; Landry, Monique

doi:10.1016/j.vaccine.2014.04.059

Cited by 14 publications

(10 citation statements)

References 25 publications

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“…27 A case-control study revealed higher rates of food allergy in affected subjects, but no evidence that the reactions were due to the AS03 adjuvant has been provided. 28 Until recently, only nonadjuvanted influenza A(H1N1)pdm09 and seasonal influenza vaccines were used in the United States.…”

Section: Adjuvantsmentioning

confidence: 99%

Vaccine-associated hypersensitivity

McNeil

DeStefano

2018

Journal of Allergy and Clinical Immunology

228

260

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Vaccine-associated hypersensitivity reactions are not infrequent; however, serious acute-onset, presumably IgE-mediated or IgG and complement-mediated anaphylactic or serious delayed-onset T cell-mediated systemic reactions are considered extremely rare. Hypersensitivity can occur because of either the active vaccine component (antigen) or one of the other components. Postvaccination acute-onset hypersensitivity reactions include self-limited localized adverse events and, rarely, systemic reactions ranging from urticaria/angioedema to full-blown anaphylaxis with multisystem involvement. Risk of anaphylaxis after all vaccines is estimated to be 1.31 (95% CI, 0.90-1.84) per million vaccine doses, respectively. Serious hypersensitivity reactions after influenza vaccines are particularly important because of the large number of persons vaccinated annually. Influenza vaccines are unique in requiring annual changes in the vaccines' antigenic composition to match the predicted circulating influenza strains. Recently, novel influenza vaccine types were introduced in the United States (recombinant vaccines, some with higher antigen content and a new adjuvanted vaccine). Providers should be aware of changing recommendations on the basis of recent published evidence for persons with a history of egg allergy to receive annual influenza vaccination. Further research is needed to elucidate the pathophysiology and risk factors for reported vaccine-associated adverse events. Further research is also needed to determine whether repeated annual inactivated influenza vaccination, the number of vaccine antigens administered at the same time, and the current timing of routine infant vaccinations are optimal for overall population well-being.

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Section: Adjuvantsmentioning

confidence: 99%

Vaccine-associated hypersensitivity

McNeil

DeStefano

2018

Journal of Allergy and Clinical Immunology

228

260

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“…An increased rate of anaphylaxis and other immediate hypersensitivity reactions was reported in Canada associated with an AS03 (trade name for a squalene-based immunologic adjuvant used in various vaccine products by GlaxoSmithKline) adjuvanted pandemic H1N1 influenza vaccine [ 107 ]. A case–control study revealed higher rates of food allergy in affected individuals, but no evidence that the reactions were due to this adjuvant has been provided [ 108 ]. No increased risk of allergic reactions was noted in a systematic review of the safety of the MF59 (trade name for a squalene-based immunologic adjuvant by Novartis) adjuvanted influenza vaccine in children used in Europe [ 109 ].…”

Section: Allergic Reactions To Vaccine Componentsmentioning

confidence: 99%

International Consensus (ICON): allergic reactions to vaccines

Dreskin

Halsey

Kelso

et al. 2016

World Allergy Organization Journal

170

146

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BackgroundRoutine immunization, one of the most effective public health interventions, has effectively reduced death and morbidity due to a variety of infectious diseases. However, allergic reactions to vaccines occur very rarely and can be life threatening. Given the large numbers of vaccines administered worldwide, there is a need for an international consensus regarding the evaluation and management of allergic reactions to vaccines.MethodsFollowing a review of the literature, and with the active participation of representatives from the World Allergy Organization (WAO), the European Academy of Allergy and Clinical Immunology (EAACI), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI), the final committee was formed with the purpose of having members who represented a wide-range of countries, had previously worked on vaccine safety, and included both allergist/immunologists as well as vaccinologists.ResultsConsensus was reached on a variety of topics, including: definition of immediate allergic reactions, including anaphylaxis, approaches to distinguish association from causality, approaches to patients with a history of an allergic reaction to a previous vaccine, and approaches to patients with a history of an allergic reaction to components of vaccines.ConclusionsThis document provides comprehensive and internationally accepted guidelines and access to on-line documents to help practitioners around the world identify allergic reactions following immunization. It also provides a framework for the evaluation and further management of patients who present either following an allergic reaction to a vaccine or with a history of allergy to a component of vaccines.

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“…[43][44][45] Though narcolepsy events associated with AS03 may also be linked to the influenza nucleoprotein, [46] isolated events of increased anaphylaxis have also been reported with AS03. [47,48] There have been isolated reports of deaths thought to be linked to FluAd, which contains MF59, in Italy where the vaccine was approved in 1997. [49,50] FluAd was approved by the FDA in 2015.…”

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confidence: 99%

Considerations for Size, Surface Charge, Polymer Degradation, Co‐Delivery, and Manufacturability in the Development of Polymeric Particle Vaccines for Infectious Diseases

Genito

Batty

Bachelder

et al. 2021

Advanced NanoBiomed Research

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Vaccines have advanced human health for centuries. To improve upon the efficacy of subunit vaccines they have been formulated into nano/microparticles for infectious diseases. Much progress in the field of polymeric particles for vaccine formulation has been made since the push for a tetanus vaccine in the 1990s. Modulation of particle properties such as size, surface charge, degradation rate, and the co‐delivery of antigen and adjuvant has been used. This review focuses on advances in the understanding of how these properties influence immune responses to injectable polymeric particle vaccines. Consideration is also given to how endotoxin, route of administration, and other factors influence conclusions that can be made. Current manufacturing techniques involved in preserving vaccine efficacy and scale‐up are discussed, as well as those for progressing polymeric particle vaccines toward commercialization. Consideration of all these factors should aid the continued development of efficacious and marketable polymeric particle vaccines.

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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

Cited by 14 publications

References 25 publications

Vaccine-associated hypersensitivity

Vaccine-associated hypersensitivity

International Consensus (ICON): allergic reactions to vaccines

Considerations for Size, Surface Charge, Polymer Degradation, Co‐Delivery, and Manufacturability in the Development of Polymeric Particle Vaccines for Infectious Diseases

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