European Medicines Agency Watch [to 8 February 2014]
European Medicines Agency updates guidance for annual strain change of seasonal influenza vaccines
The European Medicines Agency has published an update to its guidance for the annual strain change of influenza vaccines. This update ensures that EU requirements for the annual strain change reflect current knowledge, and is consistent with the approach taken by other regulatory authorities globally.
The update introduces an improved system that allows strengthened and sustainable monitoring of an influenza vaccine’s performance over the years in a real-life setting.
From the influenza season 2014-2015 onwards, vaccine manufacturers will be required to submit for each vaccine appropriate measures for proactive surveillance of the safety and effectiveness to regulatory authorities for review. From the influenza season 2015-2016, with the new system in place, the Agency no longer requires routine submission of clinical trials for annual strain-change updates.
The Agency will publish interim guidance by March 2014 on the principles of safety monitoring commitments that should form part of the proactive surveillance