Regulatory information – Update of EMA recommendations for 2015/2016 seasonal flu vaccine composition

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27/05/2015

Regulatory information – Update of EMA recommendations for 2015/2016 seasonal flu vaccine composition

Update completes previous recommendations issued in March 2015

The European Medicines Agency (EMA) has issued an update of the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2015.

The updated recommendation now also contains a decision on a suitable A/California/7/2009-like virus strain for live, attenuated vaccines. This was initially postponed due to the lack of sufficient data available on suitability and yield of possible candidate strains when the original recommendation was published on the EMA website on 27 March 2015.

Details, including the specific virus strains recommended, are available in the recommendation of the Biologics Working Party (BWP) ad-hoc Influenza Working Group.

Every year, EMA’s ad hoc Influenza Working Group issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization (WHO).

The Agency recommends that marketing-authorisation holders submit applications to change the composition of centrally authorised seasonal flu vaccines by 15 June 2015.

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