EMA Updates Recommendations for Flu Vaccine Strains

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-02-2015 12:21


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 March 27, 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, the 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 OrganizationExternal link icon (WHO).

The agency recommends that marketing-authorization holders submit applications to change the composition of centrally authorized seasonal flu vaccines by June 15, 2015.

Source: EMA


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