Influenza vaccines - non-clinical and clinical module - Scientific guideline

This module covers the requirements for non-clinical and clinical data to support an initial marketing authorisation for a seasonal, pandemic or zoonotic vaccine; requirements for strain change applications; recommendations for characterisation of the immune response and related immunogenicity issues; situations in which pre-authorisation clinical studies of protective efficacy and/or post-authorisation studies of vaccine effectiveness are required; pre-authorisation and post-authorisation safety data; risk management plan and summary of product characteristics aspects. The guidance is relevant to influenza vaccines that contain: live attenuated influenza viruses; inactivated split, subunit or whole virion viruses; adjuvants. However the general principles may be broadly applicable.

Keywords: Vaccine platforms, mRNA, immunobridging, effectiveness, influenza, pandemic influenza, zoonotic vaccine, regulatory requirements

Current effective version

Influenza vaccines - non-clinical and clinical module

AdoptedReference Number: EMA/CHMP/VWP/457259/2014Summary:

This guideline on influenza vaccines has been organised with the aim of developing a modular guideline that covers the quality, regulatory, non-clinical and clinical aspects of the development of influenza vaccines. This non-clinical and clinical module is intended to replace five separate guidance documents that were in place previously.

Revision 1 - currently under consultation

Concept paper on the revision of the Non-clinical and Clinical Module of the influenza vaccines guideline

Consultation dates: 01/11/2023 to 30/01/2024Draft: consultation openSummary:

The proposed guideline will replace Guideline on influenza vaccines, non-clinical and clinical modules (EMA/CHMP/VWP/457259/2014). 

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support. 

Keywords: Vaccine platforms, mRNA, immunobridging, effectiveness, influenza, pandemic influenza, zoonotic vaccine, regulatory requirements

Document history

Influenza vaccines - non-clinical and clinical module

AdoptedReference Number: EMA/CHMP/VWP/457259/2014Summary:

This guideline on influenza vaccines has been organised with the aim of developing a modular guideline that covers the quality, regulatory, non-clinical and clinical aspects of the development of influenza vaccines. This non-clinical and clinical module is intended to replace five separate guidance documents that were in place previously.

Overview of comments received on 'Draft guideline on influenza vaccines: non-clinical and clinical module ' (EMA/CHMP/VWP/457259/2014)

Draft guideline on influenza vaccines: non-clinical and clinical module

Consultation dates: 31/07/2014 to 31/01/2015Draft: consultation closedReference Number: EMA/CHMP/VWP/457259/2014Summary:

As announced in the concept paper, the revision of the guidelines on influenza vaccines has been organised with the aim of developing one single influenza guideline that covers the regulatory, quality, non-clinical and clinical aspects. The present module covers the non-clinical and clinical requirements for new influenza vaccines.

Concept paper on the revision of guidelines for influenza vaccines

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

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

Superseded documents

Core summary of product characteristics for pandemic-influenza vaccines - Superseded

AdoptedLegal effective date: 01/08/2009Reference Number: EMEA/CHMP/VWP/193031/2004 Rev- 1

Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on live attenuated influenza vaccines - Superseded

Reference Number: CPMP/BWP/1765/99

Points to consider on the development of live attenuated influenza vaccines - Superseded

AdoptedLegal effective date: 31/08/2003Reference Number: EMEA/CPMP/BWP/2289/01