Regulatory information - EU recommendations for 2015/2016 seasonal flu vaccine composition
EMA annual recommendations are based on WHO observations
The European Medicines Agency has issued 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.
Trivalent vaccines for the 2015/2016 season should contain these three virus strains:
- an A/California/7/2009 (H1N1)pdm09-like virus
- an A/Switzerland/9715293/2013 (H3N2)-like virus
- a B/Phuket/3073/2013-like virus
For quadrivalent vaccines with two influenza B viruses, a B/Brisbane/60/2008-like virus in addition to the strains mentioned above is considered appropriate.
Detailed recommendations including the specific virus strains recommended are available in a report from the Biologics Working Party (BWP) ad-hoc Influenza Working Group.
These recommendations also apply to the manufacture of live attenuated influenza vaccines. However, the decision on suitable live attenuated influenza vaccines for the A/California/7/2009-like virus was postponed to April, due to lack of sufficient data presently available on suitability and yield of available candidate strains.
Every year, the 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 recommendations for the influenza season 2015/2016 were endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) on 26 March 2015.
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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