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Summary:
The President's decision to proceed with smallpox immunization of military personnel and front-line civilian public health workers has galvanized public and congressional attention to federal vaccine policy. The issues raised by smallpox vaccination are essentially the same as those for vaccines for seemingly more mundane diseases. Vaccines are biologics: their basic components begin as living material. They introduce dead or weakened viruses or bacteria into a person or animal to stimulate an immune reaction that the body will remember if assaulted by the same pathogen in the future. There is no central authority for vaccine policy within the federal government. The Food and Drug Administration (FDA) is responsible for the regulation of vaccines and other biologics. Also involved in vaccine activities are other components of the Department of Health and Human Services (e.g., the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration), and the Departments of Defense, Veterans Affairs, and Homeland Security. Concerned about bioterrorist attacks in the United States, the 107th Congress approved several bills that included vaccine-related issues. Dozens of other vaccinerelated bills did not pass; some issues will likely be revisited during the 108th. The issues can be characterized as availability, safety and effectiveness, and access. Obstacles to vaccine availability -- such as production costs, concern for liability expenses, weak markets, and difficulties in predicting need -- often have economic roots. As mechanisms to enhance availability, Congress may consider financial incentives, public-private partnerships, improved coordination, and alternatives to safety and effectiveness documentation, such as fast-track approvals. A pillar of U.S. policy on drugs and vaccines is the protection of the individuals who use them. FDA does not license a product for sale in the United States until it is satisfied that the vaccine is safe and effective. Scientists, clinicians, Members of Congress, and the public must make decisions of vaccine safety despite uncertainties and varying perceptions of risk. To ameliorate the difficulties, Congress could address post-licensure adverse-event surveillance, education and risk communication, studies in pharmacoepidemiology and pharmacoeconomics; it has already worked to improve available mechanisms to compensate individuals injured by vaccinations. Successful development and production of safe and effective vaccines does not ensure that everyone who needs a vaccine gets it. Congress may take up the coordination of government childhood immunization programs and financing levels and strategies for vaccine-related care. Noting concern for health needs of developing countries, some Members seek to increase access to existing vaccines and to spur development of affordable vaccines for global threats such as HIV/AIDS, malaria, and tuberculosis. This report will be updated as warranted.
