European Medicines Agency issues recommendations for 2013/2014 seasonal flu vaccine composition
The European Medicines Agency has issued the European Union (EU) recommendations for the influenza virus strains that should be included in vaccines for the prevention of seasonal influenza next winter.
Trivalent vaccines for the 2013/2014 season should contain these virus strains:
- an A/California/7/2009 (H1N1)pdm09-like virus;
- an A(H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011;
- a B/Massachusetts/2/2012-like virus.
Quadrivalent vaccines containing two influenza-B viruses should also include a B/Brisbane/60/2008-like virus.
Every year, the EU recommendations are issued by the Biologics Working Party's Ad-hoc Influenza Working Party on the basis of observations by the World Health Organization (WHO). The Agency's Committee for Medicinal Products for Human Use (CHMP) adopted these recommendations on 21 March 2013.
In addition to recommendation on strains, vaccine viruses suitable for vaccine manufacture are also recommended, because the wild-type strains included in the general recommendation are often not suitable. Information on the suitable candidate vaccine viruses for the A/Victoria/361/2011 (H3N2)-like virus* will be published in April 2013. Several such viruses are under development and are currently being tested by the WHO.
Marketing-authorisation holders of centrally authorised seasonal flu vaccines should submit applications to change the composition once the complete recommendations have been published. The Agency has published revised guidance for the submission of these variations today for public consultation. This document describes the specific procedure, timelines and data requirements for these applications.
*Correction 09/04/2013: 'B/Wisconsin/1/2010-like' has been deleted.
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- Biologics Working Party Ad-hoc Influenza Working Group: Amended European Union recommendations for the seasonal-influenza-vaccine composition for the season 2013 / 2014 (2013-04-02)
- Revision of procedural advice on the submission of variations for annual update of human influenza-inactivated-vaccine applications in the centralised procedure (2013-03-22)