Update of WHO biosafety risk assessment and guidelines for the production and quality control of human influenza vaccines against avian influenza A(H7N9) virus

Overview

This document updates WHO guidance to national regulatory authorities and vaccine manufacturers on the safe production and quality control of human influenza vaccines produced in response to a pandemic threat. It details international biosafety expectations for both pilot-scale and large-scale production, and quality control of vaccines against avian influenza A(H7N9) virus now causing human infections in China. The updated guidance applies to both candidate vaccine development and to production activities for inactivated and live attenuated influenza vaccines. The general guidance in this document should be supplemented by specific risk assessments that should be carried out by laboratories or manufacturers intending to work with H7N9 virus-derived candidate vaccine viruses (CVV) and are to be updated as new characteristics of the viruses become available.