title: Policy making for vaccine use as a driver of vaccine innovation and development in the developed world.
abstract: In the past 200years, vaccines have had unmistakable impacts on public health including declines in morbidity and mortality, most markedly in economically-developed countries. Highly engineered vaccines including vaccines for conditions other than infectious diseases are expected to dominate future vaccine development. We examine immunization vaccine policy as a driver of vaccine innovation and development. The pathways to recommendation for use of licensed vaccines in the US, UK, Canada and Australia have been similar, including: expert review of disease epidemiology, disease burden and severity; vaccine immunogenicity, efficacy and safety; programmatic feasibility; public demand; and increasingly cost-effectiveness. Other attributes particularly important in development of future vaccines are likely to include: duration of immunity for improved vaccines such as pertussis; a greater emphasis on optimizing community protection rather than direct protection only; programmatic implementation, feasibility, improvements (as in the case of development of a universal influenza vaccine); public concerns/confidence/fears related to outbreak pathogens like Ebola and Zika virus; and major societal burden for combating hard to treat diseases like HIV and antimicrobial resistant pathogens. Driving innovation and production of future vaccines faces enormous economic hurdles as available approaches, technologies and regulatory pathways become more complex. As such, cost-mitigating strategies and focused, aligned efforts (by governments, private organizations, and private-public partnerships) will likely be needed to continue to spur major advances in vaccine technologies and development.
authors.affiliation: Emory University School of Medicine, Division of Infectious Diseases, Atlanta, GA, USA. Electronic address: kseib@emory.edu.
authors.forename: Katherine
authors.initials: K
authors.lastname: Seib
authors.affiliation: Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, UK.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Pollard
authors.affiliation: Québec University Hospital Research Centre & Department of Social and Preventive Medicine, Laval University, Québec City, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: de Wals
authors.affiliation: Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia; Australian Technical Advisory Group on Immunisation, Australia.
authors.forename: Ross M
authors.initials: RM
authors.lastname: Andrews
authors.affiliation: National Centre for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, USA.
authors.forename: Fangjun
authors.initials: F
authors.lastname: Zhou
authors.affiliation: Biomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services, Washington, DC, USA.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hatchett
authors.affiliation: Emory University School of Medicine, Pediatric Infectious Diseases, Atlanta, GA, USA.
authors.forename: Larry K
authors.initials: LK
authors.lastname: Pickering
authors.affiliation: Emory University School of Medicine, Division of Infectious Diseases, Atlanta, GA, USA.
authors.forename: Walter A
authors.initials: WA
authors.lastname: Orenstein
mesh_terms: D019049:Developed Countries; D055808:Drug Discovery / Q000191:economics / Q000639:trends*; D006291:Health Policy; D006801:Humans; D017589:Immunization Programs / Q000458:organization & administration*; D011050:Policy Making; D014611:Vaccination
keywords: Australia; Canada; Innovation; United Kingdom; United States; Vaccine development