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

Rouleau, Isabelle; Serres, Gaston De; Drolet, J. P.; Skowronski, Danuta M.; Ouakki, Manale; Toth, Eveline; Landry, Monique; Ménard, Suzanne; Gagnon, Rémi

doi:10.1016/j.vaccine.2013.10.033

Cited by 33 publications

(27 citation statements)

References 18 publications

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“…In these 2 reports the rates were highest in women of childbearing age, and although the effect of a greater female tendency to report could not be ruled out in these passive surveillance studies, a biologic basis for the difference was hypothesized. 20,21 Importantly, in our population-based study female preponderance was seen only in adults and not in children. Fourteen (70%) of 20 female subjects were of childbearing age (ie, aged 10-50 years).…”

Section: Discussioncontrasting

confidence: 47%

“…The Bohlke et al 11 and Erlewyn-Lajeunesse et al 18 studies had small case numbers and did not report cases’ sex, and the Brotherton et al 19 report was an HPV4 vaccination campaign that targeted female subjects only. However, the Rouleau et al 20 safety study of 2009 pandemic H1N1 influenza vaccine found after adjusting for doses administered that female subjects were represented 3.9-fold more often than male subjects among their anaphylaxis reports, and among reports included in Tavares et al, 21 the proportion of anaphylaxis cases, which met Brighton Levels 1 to 3 was higher in female compared with male subjects (84% vs 16%). In these 2 reports the rates were highest in women of childbearing age, and although the effect of a greater female tendency to report could not be ruled out in these passive surveillance studies, a biologic basis for the difference was hypothesized.…”

Section: Discussionmentioning

confidence: 98%

“…19 Lastly, in a 2009 H1N1 vaccination campaign in Quebec, Canada, a reporting rate of anaphylaxis of 8 per million distributed doses was reported after 2009 AS03-adjuvanted pandemic H1N1 vaccine (Arepanrix; GlaxoSmithKline, Mississauga, Ontario, Canada). 20 A follow-up study conducted by the vaccine manufacturer of reports after Pandemrix (GlaxoSmithKline Biologicals S.A., Rixensart, Belgium) or Arepanrix to the worldwide safety database (62/72 reports after Arepanrix were from Canada) found no evidence the reporting rate was increased compared with rates for other vaccines. 21 Data from the Vaccine Adverse Event Reporting System in the United States, where only unadjuvanated 2009 H1N1 pandemic influenza vaccines were used, found a reporting rate of 1.4 per million doses.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…18-20 (The death from the Canadian report above did not meet the Brighton case definition for anaphylaxis. 20 ) In a review of reports after TIV in adults to the US Vaccine Adverse Event Reporting System from 1990-2005, of 371 deaths, 4 were reported as anaphylaxis; during this period, an estimated 747.1 million doses of TIV were administered. 23 In addition, a recent review of fatal anaphylaxis cases during 1999-2010, which used the National Center for Health Statistics Multiple Cause of Death Database, found 1446 (58%) 2458 anaphylaxis-related deaths were attributable to medications.…”

Section: Discussionmentioning

confidence: 99%

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Risk of anaphylaxis after vaccination in children and adults

McNeil

Weintraub

Duffy

et al. 2016

Journal of Allergy and Clinical Immunology

330

273

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Background Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children. Objective We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis. Methods Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines. Results We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a nonsignificant female predominance. Vaccine-specific rates included 1.35 (95% CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95% CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases). Conclusion Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat.

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Section: Discussioncontrasting

confidence: 47%

Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Risk of anaphylaxis after vaccination in children and adults

McNeil

Weintraub

Duffy

et al. 2016

Journal of Allergy and Clinical Immunology

330

273

View full text Add to dashboard Cite

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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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The Epidemiology of Anaphylaxis

Lin

2015

Clinic Rev Allerg Immunol

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Anaphylaxis is a dramatic expression of systemic allergy. The lifetime prevalence of anaphylaxis is currently estimated at 0.05-2 % in the USA and ~3 % in Europe. Several population-specific studies have noted a rise in the incidence, particularly in the hospitalizations and ER visits due to anaphylaxis. The variable signs and symptoms that constitute the diagnostic criteria for anaphylaxis, the differences in diagnostic algorithms, and the limitations in the current coding systems have made summarizing epidemiologic data and comparing study results challenging. Nevertheless, across all studies, the most common triggers continue to be medications, food, and venom. Various risk factors for more severe reactions generally include older age, history of asthma, and having more comorbid diseases. Interesting seasonal, geographic, and latitude differences have been observed in anaphylaxis prevalence and incidence rates, suggesting a possible role of vitamin D and sun exposure in modifying anaphylaxis risk. While the incidence and prevalence of anaphylaxis appear to be increasing in certain populations, the overall fatality rate remains relatively low.

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

Cited by 33 publications

References 18 publications

Risk of anaphylaxis after vaccination in children and adults

Risk of anaphylaxis after vaccination in children and adults

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

The Epidemiology of Anaphylaxis

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