Institution: | 1. WHO Center for Vaccinology and Neonatal Immunology, University of Geneva, CMU, 1 rue Michel-Servet, 1211 Geneva 4, Switzerland;2. GlaxoSmithKline Vaccines, Rixensart, Belgium;3. Novartis Vaccines and Diagnostics, Via Fiorentina 1, 53100 Siena, Italy;4. Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892-0001, USA;5. Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA;6. Federal Agency for Medicines and Health Products, EMA – CHMP, Belgium;7. IABS Human Vaccines Committee, France |
Abstract: | Vaccination represents one of the greatest public health triumphs; in part due to the effect of adjuvants that have been included in vaccine preparations to boost the immune responses through different mechanisms. Although a variety of novel adjuvants have been under development, only a limited number have been approved by regulatory authorities for human vaccines. This report reflects the conclusions of a group of scientists from academia, regulatory agencies and industry who attended a conference on the current state of the art in the adjuvant field. Held at the U.S. Pharmacopeial Convention (USP) in Rockville, Maryland, USA, from 18 to 19 April 2013 and organized by the International Association for Biologicals (IABS), the conference focused particularly on the future development of effective adjuvants and adjuvanted vaccines and on overcoming major hurdles, such as safety and immunogenicity assessment, as well as regulatory scrutiny. More information on the conference output can be found on the IABS website, http://www.iabs.org/. |