Regulatory information - EU recommendations for composition of 2016/2017 seasonal influenza vaccines
EU vaccine composition advice is based on WHO recommendations
The European Medicines Agency has issued the European Union (EU) r ecommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2016.
Trivalent vaccines for the 2016/2017 season should contain these three virus strains:
- an A/California/7/2009 (H1N1)pdm09-like virus
- an A/Hong Kong/4801/2014 (H3N2)-like virus
- a B/Brisbane/60/2008-like virus
For quadrivalent vaccines with two influenza B viruses, a B/Phuket/3073/2013-like virus in addition to the strains mentioned above is considered appropriate.
These recommendations also apply to the manufacture of live attenuated influenza vaccines.
Every year, the Ad hoc Influenza Working Group issues recommendations for the composition of seasonal influenza vaccines for the EU on the basis of recommendations from the World Health Organization (WHO). The EU recommendations for the influenza season 2016/2017 were endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) on 30 March 2016.
The Agency recommends that marketing-authorisation holders submit applications to change the composition of centrally authorised seasonal flu vaccines by 13 June 2016.