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

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Document details

Download document Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU
Reference number EMA/PRAC/222346/2014
Status adopted
First published 2014-04-15
Last updated 2014-04-15

Summary

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.