{ "id": "RL31793", "type": "CRS Report", "typeId": "REPORTS", "number": "RL31793", "active": false, "source": "EveryCRSReport.com, University of North Texas Libraries Government Documents Department", "versions": [ { "source": "EveryCRSReport.com", "id": 304459, "date": "2005-05-19", "retrieved": "2016-04-07T19:44:41.776029", "title": "Vaccine Policy Issues", "summary": "This report\u2019s focus is on vaccination, one of the most cost-effective methods available\nto prevent\ninfectious diseases. Whether a vaccine\u2019s target is naturally occurring or present because of\nhostile\nintent, the issues policy makers must deal with include vaccine development, production,\navailability, safety, effectiveness, and access. Vaccines are biologics: their basic components begin\nas living material. They introduce bacteria or dead or weakened viruses into a person or animal to\nstimulate an immune reaction that the body will remember if assaulted by the same pathogen in the\nfuture.\n \n There is no central federal authority for vaccine policy. In the Department of Health and\nHuman Services (HHS), the National Vaccine Program Office (NVPO) coordinates vaccine-related\nactivities, and the Food and Drug Administration (FDA) is responsible for the regulation of vaccines\nand other biologics. Also involved in vaccine activities are other components of HHS (e.g., the\nNational Institutes of Health, the Centers for Disease Control and Prevention, and the Health\nResources and Services Administration), the Departments of Defense, Veterans Affairs, and\nHomeland Security, and the U.S. Agency for International Development.\n \n Concerned about bioterrorist attacks in the United States, the 107th Congress passed several\nvaccine-related measures and the 108th Congress continued with legislative and oversight activities\nregarding the development and purchase of vaccines against possible bioterrorist attacks and dealing\nwith the sudden shortage of influenza vaccine at the outset of the 2004-2005 flu season.\n \n Obstacles to vaccine availability -- such as production costs, concern for liability expenses,\nweak markets, and difficulties in predicting need -- often have economic roots. As mechanisms to\nenhance availability, Congress may consider financial incentives, public-private partnerships,\nimproved coordination, and alternatives to safety and effectiveness documentation.\n \n A pillar of U.S. policy on drugs and vaccines is the protection of the individuals who use them. \nFDA does not license a product for sale in the United States until it is satisfied that the vaccine is\nsafe and effective. Scientists, clinicians, Members of Congress, and the public must make decisions\nof vaccine safety despite uncertainties and varying perceptions of risk. To ameliorate the difficulties,\nCongress could address post-licensure adverse-event surveillance, education and risk\ncommunication, studies in pharmacoepidemiology and pharmacoeconomics, and improving available\nmechanisms to compensate individuals injured by vaccinations.\n \n Successful development and production of safe and effective vaccines does not ensure that\neveryone who needs a vaccine gets it. Congress may take up the coordination of government\nchildhood immunization programs and financing levels and strategies for vaccine-related care. \nNoting concern for health needs of developing countries, some Members seek to increase access to\nexisting vaccines and to spur development of affordable vaccines for global health threats. This\nreport will be updated as warranted.", "type": "CRS Report", "typeId": "REPORTS", "active": false, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/RL31793", "sha1": "d6676d675a144417bf00b2924659a43a4227d85f", "filename": "files/20050519_RL31793_d6676d675a144417bf00b2924659a43a4227d85f.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/RL31793", "sha1": "904f85a18ca2f06fa79ecfadc1df27e45f0e5130", "filename": "files/20050519_RL31793_904f85a18ca2f06fa79ecfadc1df27e45f0e5130.pdf", "images": null } ], "topics": [] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc817259/", "id": "RL31793_2003May22", "date": "2003-05-22", "retrieved": "2016-03-19T13:57:26", "title": "Vaccine Policy Issues for the 108th Congress", "summary": null, "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20030522_RL31793_ba09bbd1d79da94f08c5ae7b0bde017334889425.pdf" }, { "format": "HTML", "filename": "files/20030522_RL31793_ba09bbd1d79da94f08c5ae7b0bde017334889425.html" } ], "topics": [] } ], "topics": [ "Economic Policy", "Foreign Affairs", "Health Policy", "Intelligence and National Security", "National Defense" ] }