EMA Invites Comments on Guidance for Flu Vaccines

August 1, 2014
The Pharm Exec staff

Pharmaceutical Executive

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 European Medicines Agency (EMA) has released the second module of a new overarching guideline on influenza vaccines for a six-month public consultation.

The guidance 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 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 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 favour of a broader evaluation of immune responses rather than the use of seroprotection rate and haemagglutination inhibition as the main tests for evaluation;

  • introduction of effectiveness studies for seasonal influenza vaccines as requirements in the post-authorisation 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.

Further information here.