title: [Pandemic influenza vaccines. Concepts, European mock-up licenses, and acceptance criteria].
abstract: The concept of identifying appropriate scientific and regulatory principles to ensure rapid availability of pandemic influenza vaccines when needed were already developed starting in the year 2003. These principles allowed licensing of three so-called mock-up vaccines far ahead of any real presenting pandemic event. Those licenses (Marketing Authorizations) were immediately adapted to the novel H1N1 strain shortly after its identification in April 2009 ensuring that as early as September 2009 large parts of the German as well as of the EU population had access to licensed products which had undergone sufficient evaluation before first use in humans. In contrast, for pandemic vaccine concepts without a previously licensed mock-up version it generally took twice as much time to accumulate data supporting the granting of a Marketing Authorization. This article describes in detail the translation of concepts of producing, testing, and licensing of pandemic influenza vaccines into practice under real conditions.
authors.affiliation: Fachgebietsleiter Virusimpfstoffe, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland. pflmi@pei.de
authors.forename: M
authors.initials: M
authors.lastname: Pfleiderer
mesh_terms: D017277:Drug Approval / Q000458:organization & administration*; D015195:Drug Design; D005060:Europe / Q000453:epidemiology; D019981:Health Care Sector / Q000331:legislation & jurisprudence; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000096:biosynthesis / Q000627:therapeutic use*; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D008004:Licensure / Q000331:legislation & jurisprudence*; D058873:Pandemics / Q000517:prevention & control* / Q000706:statistics & numerical data
chemical_list: D007252:Influenza Vaccines