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