Recommendations to assure the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administration, Annex 4, TRS No 977

Overview

The WHO requirements for influenza vaccine (live) date from 1979. The purpose of these updated recommendations is to provide vaccine manufacturers and national regulatory authorities with applicable considerations and guidance in developing specific processes for assuring the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administration, including their nonclinical and clinical evaluation.

These recommendations apply to influenza vaccines (human, live attenuated) for intranasal administration using embryonated hen’s eggs as substrates. It is expected that these vaccines will be produced using cell cultures as substrates and guidance is also provided for this eventuality. These recommendations are not specific for a particular form of influenza vaccine virus attenuation used to prepare the final influenza virus vaccine product. They should apply to the production and quality control of viruses intended for use in the manufacture of influenza vaccine (human, live attenuated) for intranasal administration, including reassortant viruses prepared either by classical reassortment methods or by reverse genetics techniques.

The recommendations (with possible modifications) are meant to apply to influenza vaccines (human, live attenuated) for intranasal administration, produced with seasonal vaccine strains for use during the inter-pandemic period as well as vaccines produced with strains for use during pandemics. However, these recommendations cannot anticipate every situation that may arise, and alternative considerations may be needed for specific public health circumstances.

Full version of the WHO Technical Report Series N° 977