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

The interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU was developed in 2014. It focused on the requirements for annual enhanced safety surveillance to rapidly detect any increased local and systemic reactogenicity, or other unexpected adverse immune response that could arise during the influenza vaccine product life-cycle.

Since the publication of the interim guidance in 2014, the methodologies, technologies, systems and pharmacovigilance tools have evolved significantly. The current EU pharmacovigilance system with the standard pharmacovigilance activities is robust, fit for purpose and demonstrated to be efficient in promptly identifying and dealing with emerging issues during the COVID-19 pandemic. 

It is therefore considered that the EU pharmacovigilance system fulfils the goals set out by the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. 

In June 2025, the PRAC agreed that the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU (EMA/PRAC/222346/2014) is considered obsolete. For further details, please refer to the explanatory note below.

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

Current version

Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU

Adopted Reference Number: EMA/175359/2025

Document history - First version

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

Adopted Reference Number: EMA/PRAC/222346/2014 Legal effective date: 15/04/2014 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.

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

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