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

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Download document Questions and answers on the Haemagglutination Inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations
Reference number EMA/CHMP/BWP/426390/2017
Status draft: consultation open
First published 2018-02-01
Last updated 2018-02-01
Consultation start date 2018-02-01
Consultation end date 2018-07-31
Email address for submissions kaidi.koiv@ema.europa.eu

Summary

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.