Comparison of Pandemrix and Arepanrix, two pH1N1 AS03-adjuvanted vaccines differentially associated with narcolepsy development

Jacob, Louis; Leib, Ryan D.; Ollila, Hanna; Bonvalet, Mélodie; Adams, Christopher M.; Mignot, Emmanuel

doi:10.1016/j.bbi.2014.11.004

Cited by 51 publications

(89 citation statements)

References 51 publications

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“…Most reports concern children, and focus on Pandemrix ® . Surprisingly, only very few reports were received for Arepanrix ® which has the same antigen and adjuvant as Pandemrix ® but Pandemrix ® was shown to have more neuramidase and nucleoprotein than Arepanrix ® [12,13], due to different production processes [1]. Arepanrix ® was widely used in other parts of the world such as Canada and Latin America and spontaneous reports in these countries should have appeared in the EUDRAVIGILANCE database as the vaccine was licensed also in the EU.…”

Section: Safety Of Pandemic Influenza Vaccinesmentioning

confidence: 94%

The narcolepsy-pandemic influenza story: Can the truth ever be unraveled?

Sturkenboom

2015

Vaccine

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Section: Safety Of Pandemic Influenza Vaccinesmentioning

confidence: 94%

The narcolepsy-pandemic influenza story: Can the truth ever be unraveled?

Sturkenboom

2015

Vaccine

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“…If this results in differences in immunogenicity, it might explain why the latter did not elicit an increase in narcolepsy rate [6][7][8]. It is also unclear why only a minority of the 20% of the population carrying the predisposing HLA genotype indeed developed disease after vaccination.…”

Section: Narcolepsy: Genetic and Immunohistochemical Studiesmentioning

confidence: 99%

“…Recently, the role of the viral vaccine component has been extensively examined, in particular considering the differences in narcolepsy incidence after vaccination with Arepanrix and Pandemrix [6][7][8]. However, the results of these studies were not known at the time of planning these Swedish research projects.…”

Section: Possibly Immune Mediatedmentioning

confidence: 99%

A coordinated cross‐disciplinary research initiative to address an increased incidence of narcolepsy following the 2009–2010 Pandemrix vaccination programme in Sweden

et al. 2015

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In response to the 2009-2010 influenza A(H1N1) pdm09 pandemic, a mass vaccination programme with the AS03-adjuvanted influenza A(H1N1) vaccine Pandemrix was initiated in Sweden. Unexpectedly, there were a number of narcolepsy cases amongst vaccinated children and adolescents reported. In this review, we summarize the results of a joint cross-disciplinary national research effort to investigate the adverse reaction signal from the spontaneous reporting system and to better understand possible causative mechanisms. A three-to fourfold increased risk of narcolepsy in vaccinated children and adolescents was verified by epidemiological studies. Of importance, no risk increase was observed for the other neurological and autoimmune diseases studied. Genetic studies confirmed the association with the allele HLA-DQB1*06:02, which is known to be related to sporadic narcolepsy. Furthermore, a number of studies using cellular and molecular experimental models investigated possible links between influenza vaccination and narcolepsy. Serum analysis, using a peptide microarray platform, showed that individuals who received Pandemrix exhibited a different epitope reactivity pattern to neuraminidase and haemagglutinin, as compared to individuals who were infected with H1N1. Patients with narcolepsy were also found to have increased levels of interferongamma production in response to streptococcusassociated antigens. The chain of patient-related events and the study results emerging over time were subjected to intense nationwide media attention. The importance of transparent communication and collaboration with patient representatives to maintain public trust in vaccination programmes is also discussed in the review. Organizational challenges due to this unexpected event delayed the initiation of some of the research projects, still the main objectives of this joint, cross-disciplinary research effort were reached, and important insights were acquired for future, similar situations in which a fast and effective task force may be required to evaluate vaccination-related adverse events.

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“…This prevents unnecessary vaccine loss. 98 Furthermore, decreasing antigen dose by the addition of adjuvants 99 can also increase the number of influenza vaccines. Development 100 of stabile vaccine formulations and effective adjuvants is thus 101 important.…”

mentioning

confidence: 99%

Current and next generation influenza vaccines: Formulation and production strategies

Soema

Kompier

Amorij

et al. 2015

European Journal of Pharmaceutics and Biopharmaceutics

245

233

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Vaccination is the most effective method to prevent influenza infection. However, current influenza vaccines have several limitations. Relatively long production times, limited vaccine capacity, moderate efficacy in certain populations and lack of cross-reactivity are important issues that need to be addressed. We give an overview of the current status and novel developments in the landscape of influenza vaccines from an interdisciplinary point of view. The feasibility of novel vaccine concepts not only depends on immunological or clinical outcomes, but also depends on biotechnological aspects, such as formulation and production methods, which are frequently overlooked. Furthermore, the next generation of influenza vaccines is addressed, which hopefully will bring cross-reactive influenza vaccines. These developments indicate that an exciting future lies ahead in the influenza vaccine field.

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Comparison of Pandemrix and Arepanrix, two pH1N1 AS03-adjuvanted vaccines differentially associated with narcolepsy development

Cited by 51 publications

References 51 publications

The narcolepsy-pandemic influenza story: Can the truth ever be unraveled?

The narcolepsy-pandemic influenza story: Can the truth ever be unraveled?

A coordinated cross‐disciplinary research initiative to address an increased incidence of narcolepsy following the 2009–2010 Pandemrix vaccination programme in Sweden

Current and next generation influenza vaccines: Formulation and production strategies

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