title: Beyond efficacy: The full public health impact of vaccines.
abstract: There is an active discussion in the public health community on how to assess and incorporate, in addition to safety and measures of protective efficacy, the full public health value of preventive vaccines into the evidence-based decision-making process of vaccine licensure and recommendations for public health use. The conference "Beyond efficacy: the full public health impact of vaccines in addition to efficacy measures in trials" held in Annecy, France (June 22-24, 2015) has addressed this issue and provided recommendations on how to better capture the whole public health impact of vaccines. Using key examples, the expert group stressed that we are in the midst of a new paradigm in vaccine evaluation, where all aspects of public health value of vaccines beyond efficacy should be evaluated. To yield a wider scope of vaccine benefits, additional measures such as vaccine preventable disease incidence, overall efficacy and other outcomes such as under-five mortality or non-etiologically confirmed clinical syndromes should be assessed in addition to traditional efficacy or effectiveness measurements. Dynamic modelling and the use of probe studies should also be considered to provide additional insight to the full public health value of a vaccine. The use of burden reduction and conditional licensure of vaccines based on collection of outcome results should be considered by regulatory agencies.
authors.affiliation: Hospices Civils de Lyon, Groupement Hospitalier Edouard Herriot, 5 Place d'Arsonval, 69437 Lyon Cedex 03, France. Electronic address: mitra.elahi@chu-lyon.fr.
authors.forename: Mitra
authors.initials: M
authors.lastname: Saadatian-Elahi
authors.affiliation: Institute of Public Health, University of Heidelberg, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Horstick
authors.affiliation: Emory Global Health Institute, Emory University, Atlanta, GA, United States.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Breiman
authors.affiliation: Agence de Médecine Préventive, Paris, France.
authors.forename: Bradford D
authors.initials: BD
authors.lastname: Gessner
authors.affiliation: Duke-NUS Graduate Medical School, 8 College Road, Singapore 169857, Singapore.
authors.forename: Duane J
authors.initials: DJ
authors.lastname: Gubler
authors.affiliation: Fondation Mérieux, 17 rue Bourgelat, 69002 Lyon, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Louis
authors.affiliation: National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors.forename: Umesh D
authors.initials: UD
authors.lastname: Parashar
authors.affiliation: Fundación Carlos Slim, Mexico.
authors.forename: Roberto
authors.initials: R
authors.lastname: Tapia
authors.affiliation: Fondation Mérieux, 17 rue Bourgelat, 69002 Lyon, France.
authors.forename: Valentina
authors.initials: V
authors.lastname: Picot
authors.affiliation: Sanofi Pasteur, Vaccination Policy Department, 2 Avenue du Pont Pasteur, 69367 Lyon Cedex 07, France.
authors.forename: Jean-Antoine
authors.initials: JA
authors.lastname: Zinsou
authors.affiliation: Sanofi Pasteur, Vaccination Policy Department, 2 Avenue du Pont Pasteur, 69367 Lyon Cedex 07, France.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Nelson
mesh_terms: D003226:Congresses as Topic; D005602:France; D006801:Humans; D008004:Licensure; D011634:Public Health; D016032:Randomized Controlled Trials as Topic; D014612:Vaccines / Q000592:standards*
chemical_list: D014612:Vaccines
keywords: Beyond vaccine efficacy; Conference report; Vaccine effectiveness; Vaccine efficacy; Vaccine preventable disease incidence; Vaccine probe analysis