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

This document focuses on the requirements for annual enhanced safety surveillance to rapidly detect any increased local and systemic reactogenicity, or other unexpected adverse immune response that may arise during the influenza vaccine product life-cycle. It also outlines principles to be followed for improved continuous routine surveillance for influenza vaccines.

Keywords: Influenza, seasonal influenza vaccine, strain change, safety surveillance, risk management plan, vaccine reactogenicity, data reporting, post authorisation safety study

Current effective version

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

AdoptedReference Number: EMA/PRAC/222346/2014Legal effective date: 15/04/2014Summary:

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.

Document history - First version (current)

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

AdoptedReference Number: EMA/PRAC/222346/2014Legal effective date: 15/04/2014Summary:

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.

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

Draft: consultation closedConsultation dates: 07/03/2014 to 28/03/2014Reference Number: EMA/PRAC/135943/2014