biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Productsbiopreparat-76Research ArticleОБЗОРЫREVIEWSПроцедура обновления штамма вакцины против гриппа в странах ЕС. Вопросы качестваUpdate of influenza vaccine strains in Europe. Quality issuesСолдатовА. А.SoldatovA. A.

Chief expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences

Soldatov@expmed.ruАвдееваЖ. И.AvdeevaZh. I.

Chief expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences, professor

noemail@neicon.ruБондаревВ. П.BondarevV. P.

Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences, professor

noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201720022018171312Copyright © Солдатов А.А., Авдеева Ж.И., Бондарев В.П., 20182018Солдатов А.А., Авдеева Ж.И., Бондарев В.П.Soldatov A.A., Avdeeva Z.I., Bondarev V.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/76

Несмотря на регулярно проводимые профилактические мероприятия, в 2009-2010 годах произошло развитие пандемии гриппа. Анализ опыта пандемии выявил недостатки регуляторных требований, касающихся как разработки новых вакцин против гриппа, так и процедуры замены/обновления сезонных штаммов вакцин против гриппа. Учитывая опыт пандемии гриппа, Европейским медицинским агентством по лекарственным средствам (ЕМА) в 2014-2016 годах были обновлены уже имеющиеся и разработаны новые рекомендации по оценке качества, проведению доклинических и клинических исследований при разработке вакцин против гриппа. Обновленные требования касаются не только вопросов оценки качества, но и процедуры замены/обновления актуальных штаммов сезонных, препандемических и пандемических вакцин против гриппа. Опыт, накопленный ЕМА, может быть полезен при подготовке отечественной нормативной базы, необходимой для повышения эффективности и безопасности вакцин против гриппа.

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.

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The authors declare that there are no conflicts of interest present.