EU recommendations for 2018/2019 seasonal flu vaccine composition
NewsCorporate
EU advice based on WHO recommendations
The European Medicines Agency (EMA) has issued the European Union (EU) Biologics Working Party (BWP) ad-hoc influenza working group: Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2018/2019 for the prevention of seasonal influenza from autumn 2018.
Trivalent vaccines for the 2018/2019 season should contain these three virus strains:
- an A/Michigan/45/2015 (H1N1)pdm09-like virus;
- an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus;
- a B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage).
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, 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 recommendations for the influenza season 2018/2019 were endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) at their March meeting.
The Agency recommends that marketing authorisation holders submit applications to change the composition of centrally authorised seasonal flu vaccines by 18 June 2018.