Influenza vaccines - quality module - Scientific guideline

This document provides guidance on marketing authorisation applications for influenza vaccines and for strain updates of authorised influenza vaccines. It applies to inactivated non-adjuvanted vaccines and inactivated vaccines with adjuvant to be used in the seasonal, pre-pandemic or pandemic setting, and live attenuated seasonal influenza vaccines. This quality module replaces the quality requirements of the guidelines listed under 'Superseded documents'.

Keywords: Quality requirements, influenza vaccines, inactivated, LAIV, seasonal, zoonotic, pandemic preparedness, pandemic, annual strain update, pandemic strain update

Current effective version

Guideline on Influenza vaccines – Quality module Revision 1

Adopted Reference Number: EMA/CHMP/BWP/310834/2012 Rev. 1 Summary:

The need to update the current guidelines regarding the quality, non-clinical and clinical development of influenza vaccines was recognised in the wake of the 2009-2010 influenza pandemic, as the Agency conducted its “lessons learnt” exercise.

Document history

Guideline on Influenza vaccines – Quality module Revision 1

Adopted Reference Number: EMA/CHMP/BWP/310834/2012 Rev. 1 Summary:

The need to update the current guidelines regarding the quality, non-clinical and clinical development of influenza vaccines was recognised in the wake of the 2009-2010 influenza pandemic, as the Agency conducted its “lessons learnt” exercise.

Guideline on influenza vaccines – Quality module

Adopted Reference Number: EMA/CHMP/BWP/310834/2012 Legal effective date: 01/11/2014 Summary:

The guideline provides guidance on Marketing Authorisation Applications for influenza vaccines based on the types for which ample experience has been gained during seasonal vaccination campaigns as well as the 2009 H1N1 pandemic, namely inactivated non-adjuvanted vaccine and inactivated vaccine with squalene based adjuvant to be used in the seasonal, pre-pandemic or pandemic setting and live attenuated seasonal influenza vaccines, and for strain updates of authorised influenza vaccines.

Overview of comments received on guideline on influenza vaccines – Quality module

Reference Number: EMA/CHMP/BWP/78207/2014 Legal effective date: 01/11/2014

Draft guideline on influenza vaccines – quality module

Draft: consultation closed Consultation dates: 08/03/2013 to 08/08/2013 Reference Number: EMA/CHMP/BWP/310834/2012 Summary:

The purpose of this guideline is to provide guidance on development, manufacturing and control for marketing-authorisation applications for influenza vaccines. The quality module has been updated in the light of experience gained during the recent influenza pandemic and also consolidates the current existing guidelines for influenza vaccines.

Concept paper on the revision of guidelines for influenza vaccines

Draft: consultation closed Consultation dates: 22/09/2011 to 31/12/2011 Reference Number: EMA/CHMP/VWP/734330/2011 Summary:

The proposed guideline will replace a range of guidelines and notes for guidance.

Superseded documents

• Annex I variation application(s) content for live attenuated influenza vaccines
• Cell culture inactivated influenza vaccines (Annex to note for guidance on harmonisation of requirements for influenza vaccines)
• Development of live attenuated influenza vaccines
• Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation application
• Harmonisation of requirements for influenza vaccines
• Influenza vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context
• Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure
• Quality aspects on the isolation of candidate influenza vaccine viruses in cell culture
• Submission of marketing-authorisation applications for pandemic influenza vaccines through the centralised procedure