WHO Working Group Meeting on Revision of WHO TRS No 941, Annex 5: WHO Biosafety Risk Assessment and Guidelines for the Production and Quality Control of Human Influenza Pandemic Vaccines

Overview

International biosafety expectations for pilot-scale and large-scale production of human vaccines in response to a pandemic influenza strain are crucially important to harmonize and facilitate the process of vaccine development and availability in a timely manner in the event of an influenza pandemic and in inter-pandemic work on pandemic preparedness. The World Health Organization (WHO) published the “biosafety risk assessment and guidelines for the production and quality control of human influenza pandemic vaccines” in 2007 in the Technical Report Series (TRS) No. 941, Annex 5. This guideline provides guidance to regulators, public health authorities, research laboratories and vaccine manufacturers on safe handling and testing of human pandemic influenza viruses during vaccine development, production and evaluation. 

Experience with viruses of pandemic potential and with pandemic viruses has increased globally since the publication of TRS 941, Annex 5. Therefore, WHO organized a working group meeting, held in Geneva from 9 to 10 May 2017, to review up-to-date practice and knowledge on the safe production of influenza vaccines, identify gaps in the current TRS and discuss key issues that need to be addressed in a revision.