title: Interwoven support: an historical survey of US federal programs enabling immunization.
abstract: The US Government (USG) can date its involvement with immunization to military and civilian efforts in 1777 and 1813 to prevent smallpox. USG involvement began accelerating with federal licensing of vaccine and antibody manufacturers in 1903. In addition to ongoing regulation of manufacturing and product quality, military and civilian arms of the USG have led research efforts into new or improved vaccines. These efforts have included diseases endemic in the United States, as well as medical countermeasures targeted against biological weapons, influenza pandemics, and emerging infectious diseases. Especially since the 1950s, the USG has provided increasing levels of funding to purchase vaccines and conduct vaccination programs. These programs have focused largely on children, although vaccination programs for adults have been expanded somewhat in recent years. Multiple agencies of the USG have convened various panels of accomplished external experts who have generated widely regarded recommendations on vaccine safety and efficacy and optimal immunization practices. USG programs for safety assessment, injury compensation, liability protection, and disease surveillance have been developed to assess needs, evaluate safety questions, ensure vaccine supply, and foster confidence in vaccination efforts. Debates on the extent of government involvement date back to the 1890 s and continue today. Several pivotal expansions of government involvement followed disease outbreaks or manufacturing accidents. This historical survey describes each of the major US federal programs in these categories, including references to applicable law.
authors.affiliation: Dalrymple & Associates, LLC, 1926N Street NW, Washington, DC 20036, USA. Electronic address: dackdal@rcn.com.
authors.forename: Dack W
authors.initials: DW
authors.lastname: Dalrymple
authors.affiliation: Merck Vaccines, 770 Sumneytown Pike, WP97-B364, West Point, PA 19426, USA. Electronic address: john_grabenstein@merck.com.
authors.forename: John D
authors.initials: JD
authors.lastname: Grabenstein
mesh_terms: D055808:Drug Discovery / Q000266:history* / Q000458:organization & administration*; D006291:Health Policy; D049671:History, 18th Century; D049672:History, 19th Century; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007114:Immunization / Q000266:history* / Q000379:methods*; D017589:Immunization Programs / Q000266:history*; D014481:United States
keywords: Government; Immunization; Legislation; Regulations; United States; Vaccines