EMA releases new flu vaccine guidance

Published: 24-Nov-2014
Regulatory

Covers initial marketing authorisation and subsequent updates of vaccine composition


Draft revised guidance on securing European Union (EU) marketing authorisations for influenza vaccines has been released by the European Medicines Agency (EMA). The agency has been updating its advice following lessons learned from the 2009–2010 influenza pandemic.

The new guidance covers initial marketing authorisation and subsequent updates of vaccine composition for seasonal, pre-pandemic or pandemic influenzas. It notes that while vaccines should take account of the twice-yearly World Health Organization (WHO) assessments of prevalent influenza strains, European manufacturers should also be able to vary vaccine composition considering viruses especially active in Europe.

The guidance also stresses that when companies want to vary a vaccine to include a new strain declared part of a pandemic by the WHO, then this 'variation will be reviewed under an accelerated timeframe' by regulators. Such consultations would be especially swift during a pandemic outbreak, and the Agency recommends that companies 'initiate discussions with competent authorities as early as possible...'

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