Guidelines on regulatory preparedness for human pandemic influenza vaccines, Annex 2, TRS 963

Overview

Strategies to shorten the time between emergence of a human influenza pandemic virus and the availability of safe and effective pandemic influenza vaccines are of the highest priority in global health security. One fundamental component of such a strategy is to promote convergence between national regulatory authorities on regulatory evaluations to assure the quality, safety and efficacy of human vaccines that will be used for pandemic influenza.

The goal of these workshops was to build a global network of key authorities engaged in and responsible for influenza vaccine regulation and to develop guidelines on regulatory preparedness for pandemic influenza vaccines. These guidelines have been prepared based on discussions at the three workshops and the information available at the time of writing. Although several regulatory dossiers have been evaluated, the scientific knowledge base concerning pandemic influenza vaccines is rapidly evolving. Therefore, the guidelines may be updated as new knowledge and approaches become available.

Full version of the WHO Technical Report Series N° 963