Developing vaccine policy: attributes of "just policy" and a proposed template to guide decision and policy making.

Scientists develop a vaccine to prevent a disease, collaborate ith manufacturers to establish its safety and efficacy and bring t to scale, and manufacturers then submit it for licensure by the ood and Drug Administration. Only then do federal public health uthorities, guided by the scientific evidence and expert opinion, ormulate recommendations for its use. In turn, such recommenations then serve as the foundation for policy developed and mplemented by state and local public health officials, legislators, nd sometimes judges. The process by which vaccine policy is eveloped and implemented is quite variable. Often the evidence s either not readily accessible or not well understood by all who ebate, make and implement policy. Only rarely are the values that uided policy makers explicitly stated so that providers and the ublic can weigh for themselves the inevitable trade-offs when alues conflict (e.g., protecting the public health and autonomy in edical decision making). As a result, rarely are all the data assemled in one document or location and explicit values made clear, uch that effective policy can then be designed, understood, and mplemented. Since the development of polio vaccines in the 1950s, vaccine olicy development has been in flux – from a time when expert pinion and empiricism guided the development of immunization olicy, to a time when policy making should be both evidenceased and transparent. In addition, today such policy is often ocused on the prevention of diseases or disease complications nfamiliar to the public, which imperil the health of both indiiduals and the communities in which they reside and to which hey travel. Vaccine policy is therefore relevant to the protection f public health and safety. In this paper we argue for a holistic olicy-making paradigm within which to design and deliver vacine policy that incorporates the elements of “just policy” and that alances individual autonomy in medical decision making with rotection of the health of the community, including those suseptible to vaccine-preventable diseases who cannot themselves e vaccinated. The intent of such a paradigm is to explicitly assemle all the data that inform policy decisions by engaging the best ossible content experts to make clear what we know and do not now, make obvious the need for additional areas of research, and evelop policy cognizant of the fullest elements of the scientific, conomic, legal, and sociologic base, along with explicit statements f the underlying risks and benefits, costs, assumptions, and values. Progress toward this idea involves transparent considerations of vidence, values, and economics in vaccine policy making. Further, e believe that to sustain the societal consensus needed to develop nd implement U.S. immunization policies in the 21st century the