Guidelines for the safe development and production of vaccines to human pandemic influenza viruses and influenza viruses with pandemic potential, Annex 3, TRS No 1016

Overview

Careful risk assessment and strict biosafety and biosecurity precautions are needed in laboratory and manufacturing environments in order to ensure the safe handling of human pandemic influenza viruses, candidate vaccine viruses (CVVs) and influenza viruses with pandemic potential (IVPP) as the uncontrolled release of such viruses could have a significant impact on public health. Since the publication of this WHO guidance, experience in the use of both IVPP and pandemic influenza viruses in the development and production of CVVs has increased globally. This experience includes the development and testing of CVVs derived by reverse genetics (RG) from HPAI viruses – a development reflected in these revised WHO Guidelines.

These WHO Guidelines provide guidance to CVV-testing laboratories, vaccine manufacturers and NRAs on the safe development and production of human influenza vaccines in response to the threat of a pandemic. The document describes international biosafety expectations for pilot-scale and large-scale vaccine production and laboratory research. It is thus relevant to both vaccine development and vaccine manufacturing activities. It also specifies the measures to be taken to prevent or minimize the risk to workers involved in the development and production processes, and to prevent or minimize the risk of release of virus into the environment, including the risk of transmission to animals. Tests required to evaluate the safety of CVVs are also described. The document should be read in conjunction with the WHO Laboratory biosafety manual

Full version of the WHO Technical Report Series N° 1016