title: Summary of knowledge gaps related to quality and efficacy of current influenza vaccines.
abstract: Influenza viruses are a public health threat, as they are pathogenic, highly transmissible and prone to genetic changes. For decades vaccination strategies have been based on trivalent inactivated vaccines, which are regulated by specific guidelines. The progress in scientific knowledge and the lessons learned from the A(H1N1)2009 pandemic have highlighted further the need to improve current guidelines, including the immunogenicity criteria set by the CHMP in 1997, and to promote the discussion on the shortcomings encountered, e.g. the evaluation of vaccine efficacy in the paediatric and elderly populations, the measurement of the naivety of a population, the impact of prior immunity on subsequent vaccinations, and the technical issues with the serological assays for detection of immunity and immunogenicity. The authors attempted to summarise and tackle key gaps in the existing evidence concerning quality and efficacy of influenza vaccines, aiming at favouring a common understanding and a coordinated approach across stakeholders.
authors: Vaccine Working Party of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA); Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany.
authors: Michael
authors: M
authors: Pfleiderer
authors: Paris Descartes University, School of Pharmacy, Health Safety and Public Health Department, Paris, France.
authors: Jean-Hugues
authors: JH
authors: Trouvin
authors: Vaccine Working Party of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA); Agence Fédérale des Médicaments et des Produits de Santé, Batiment EUROSTATION, bloc 2, place Victor Horta, 40/40, B-1060 Brussels, Belgium; Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
authors: Daniel
authors: D
authors: Brasseur
authors: Vaccine Working Party of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA); MTC, Karolinska Institutet, Stockholm, Sweden; Paediatric Committee of the European Medicines Agency (EMA).
authors: Marta
authors: M
authors: Gränstrom
authors: European Medicines Agency (EMA), 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom.
authors: Ragini
authors: R
authors: Shivji
authors: European Medicines Agency (EMA), 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. Electronic address: manuela.mura@ema.europa.eu.
authors: Manuela
authors: M
authors: Mura
authors: European Medicines Agency (EMA), 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom.
authors: Marco
authors: M
authors: Cavaleri
mesh_terms: D006801:Humans; D007252:Influenza Vaccines / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D016896:Treatment Outcome; D064166:Vaccine Potency
chemical_list: D007252:Influenza Vaccines
keywords: Influenza vaccination; Pandemic; Serological criteria; Stakeholders; Vaccine efficacy