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.
About the Authors
A. A. Soldatov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
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
Russian Federation
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
Zh. I. Avdeeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
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
Russian Federation
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
V. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences, professor
Russian Federation
Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products. Doctor of Medical Sciences, professor
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Review
For citations:
Soldatov A.A., Avdeeva Zh.I., Bondarev V.P. Update of influenza vaccine strains in Europe. Quality issues. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(1):3-12. (In Russ.)
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