Questions and answers on the Haemagglutination Inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - Scientific guideline

Based on the experience from recent evaluations of annual update applications for influenza vaccines (inactivated), both regulators and industry have requested further guidance about the regulatory requirements of HI testing as applied for the qualification of influenza seed virus preparations. Whilst some of the principles outlined below may be applicable to live attenuated influenza vaccines (LAIV), there are additional considerations towards the qualification of seed virus preparations using HI testing and hence LAIVs are outside the scope of this Q&A document.

Keywords: influenza vaccine (inactivated), Haemagglutination inhibition, seed virus

Current effective version

Questions and answers on the haemagglutination inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - First version

AdoptedReference Number: EMA/CHMP/BWP/426390/2017

Document history

Questions and answers on the haemagglutination inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - First version

AdoptedReference Number: EMA/CHMP/BWP/426390/2017

Overview of comments received on 'Questions and answers on the haemagglutination inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations' (EMA/CHMP/BWP/426390/2017) - First version

Reference Number: EMA/CHMP/BWP/652969/2018

Draft questions and answers on the haemagglutination inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - First version

Consultation dates: 01/02/2018 to 31/07/2018Draft: consultation closedReference Number: EMA/CHMP/BWP/426390/2017Summary:

Based on the experience from recent evaluations of Annual Update applications for influenza vaccines (inactivated), both regulators and industry have requested further guidance about the regulatory requirements of HI testing as applied for the qualification of influenza seed virus preparations. Whilst some of the principles outlined below may be applicable to live attenuated influenza vaccines (LAIV), there are additional considerations towards the qualification of seed virus preparations using HI testing and hence LAIVs are outside the scope of this Q&A document.