title: The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines.
abstract: Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes.
authors.affiliation: European Centre for Disease Prevention and Control (ECDC), SE-171 83 Stockholm, Sweden. Electronic address: pierluigi.lopalco@ecdc.europa.eu.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Lopalco
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: DeStefano
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D016208:Databases, Factual; D017277:Drug Approval; D005060:Europe; D006801:Humans; D008004:Licensure; D011358:Product Surveillance, Postmarketing / Q000379:methods; D014481:United States; D014611:Vaccination; D014612:Vaccines / Q000592:standards
chemical_list: D014612:Vaccines
keywords: Vaccine effectiveness; Vaccine marketing authorisation; Vaccine safety; Vaccine trials