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EMA: Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU

13.03.2014
Seasonal influenza vaccines present several specific challenges for pharmacovigilance. These include mass immunisation in large population cohorts in a relatively short and fixed time period each year, seasonal factors (e.g. differentiating seasonal peaks in background illness from vaccine - induced effects) and multiplicity of seasonal vaccine products on the market with need for product-specific surveillance.