Update of influenza vaccine strains in Europe. Quality issues

Abstract

In 2009-2010 there was an influenza pandemic that occurred despite all preventive measures. Analysis of this pandemic revealed some gaps in the regulatory requirements applied both to the development of new influenza vaccines and to the change/update of the seasonal influenza vaccine strains. Taking into account the lessons learned from this pandemic the European Medicines Agency revised the existing guidelines in 2014-2016 and proposed new recommendations on quality evaluation and conduct of non-clinical and clinical trials in the development of influenza vaccines. The revised requirements encompass not only quality evaluation issues, but also changes/update of strain composition of seasonal, pre-pandemic and pandemic influenza vaccines. The experience acquired by the Agency can help update the Russian regulatory framework in order to improve efficacy and safety of influenza vaccines.

Keywords

• вакцины против гриппа (сезонные, пандемические, препандемические)
• аттенуированные вакцины (аттенуированные вакцинные штаммы)
• замена сезонного штамма
• influenza vaccines (seasonal, pandemic, pre-pandemic)
• attenuated vaccines (attenuated vaccine strains)
• seasonal strain change