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 This quality module replaces the quality requirements of the guidelines listed under 'Superseded documents'.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

• 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