The European Medicines Agency (EMA) has released the second module of a new overarching guideline on influenza vaccines for a six-month public consultation. The second module covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication in April 2014 of a module on the quality requirements.
The new modular guideline is intended to cover and update in one single, consolidated document the existing guidance on regulatory, quality, non-clinical, and clinical aspects of the development of all types of influenza vaccines, in all epidemiological situations, i.e., seasonal, pandemic, and pre-pandemic.
The EMA says the guidance been developed based on the experience gained from many years of seasonal vaccination campaigns, the 2009/2010 influenza A(H1N1) pandemic, requests for scientific advice received from vaccine developers, and applications for marketing authorization.The guidance provided applies to vaccines for which ample regulatory experience has been gained, as well as to some novel types of vaccines based on established surface antigens. The most notable changes introduced by the non-clinical and clinical module of the guideline include:
- new terminology for pandemic vaccines to replace the term "pandemic mock up vaccine" with "pandemic preparedness vaccines" and the term "pre-pandemic vaccines" with "zoonotic influenza vaccines;"
- revision of criteria for the assessment of immunogenicity in favor of a broader evaluation of immune responses rather than the use of seroprotection rate and hemagglutination inhibition as the main tests for evaluation;
- introduction of effectiveness studies for seasonal influenza vaccines as requirements in the post-authorization phase.
The guidance on enhanced safety surveillance for seasonal influenza vaccines, which was adopted as a stand-alone document in April 2014, will be annexed to this module following its finalization.
Comments on the draft non-clinical and clinical module of the influenza vaccines guideline are invited until January 31, 2015.