Safety of AS03-adjuvanted influenza vaccines: A review of the evidence

Catherine Cohet,Robbert van der Most,Vincent Bauchau,Rafik Bekkat-Berkani,T. Mark Doherty,Anne Schuind,Fernanda Tavares Da Silva,Rino Rappuoli,Nathalie Garçon,Bruce L. Innis

Vaccine（2019）

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摘要

•Non-clinical studies raised no safety concerns regarding the use of AS03.•In clinical trials, AS03-adjuvanted influenza vaccines were generally well tolerated.•Post-licensure data showed a favourable benefit-risk profile in various populations.•The increased risk of narcolepsy with Pandemrix may not be directly linked to AS03.•Available safety data support the development and use of AS03-adjuvanted vaccines.

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关键词

Adjuvant system,Vaccine,Influenza,Reactogenicity,Safety,Pharmacovigilance

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