Informal consultation on WHO biosafety risk assessment and guidelines for the production and quality control of novel human influenza candidate vaccine viruses and pandemic vaccines

Overview

At the beginning of an influenza pandemic it is necessary to produce Candidate Vaccine Viruses (CVVs) quickly and safely so that vaccine manufacture can begin expeditiously. CVVs are produced by only a few laboratories such as those associated with the World Health Organization’s (WHO) Global Influenza Surveillance and Response System (GISRS), manufacturers, national regulatory authorities and other specialist laboratories. Safety is a priority to protect operators and the environment. The facilities must be secure to ensure that CVVs and influenza viruses with pandemic potential (IVPP) do not escape from laboratories and affect animals and possibly reassort to threaten humans. The WHO Technical Report Series (TRS) No.941, Annex 5 (1) document published in 2007 gives expert guidance to specialist laboratories on the safe handling and production of CVVs and IVPP. In light of knowledge and experience gained over the past decade and in response to the request from stakeholders, WHO initiated the revision of the TRS No.941, Annex 5 in 2017. WHO organized a working group meeting, held in Geneva from 9 to 10 May 2017, to review up-todate 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 (2). A draft revised guideline was produced and made available subsequently for public consultation and reviewed by a broad group of experts including those from academia, industry and regulatory authorities, resulting in a further revised draft with a new structure and updated sections. WHO then organised this informal consultation meeting on 23-24 April, 2018, held in Geneva to discuss the new draft, the public comments received, and propose further improvements to the document. The outcomes of this meeting would help further development of the guidelines which will then be subject to a second round of public consultation and the final draft guidelines will be considered by the Expert Committee on Biological Standardization (ECBS) in October 2018.