Vaccine Policy Issues

Publication Date: May 2005

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

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Abstract:

This report's focus is on vaccination, one of the most cost-effective methods available to prevent infectious diseases. Whether a vaccine's target is naturally occurring or present because of hostile intent, the issues policy makers must deal with include vaccine development, production, availability, safety, effectiveness, and access. Vaccines are biologics: their basic components begin as living material. They introduce bacteria or dead or weakened viruses 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 federal authority for vaccine policy. In the Department of Health and Human Services (HHS), the National Vaccine Program Office (NVPO) coordinates vaccine-related activities, and 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 HHS (e.g., the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration), the Departments of Defense, Veterans Affairs, and Homeland Security, and the U.S. Agency for International Development.

Concerned about bioterrorist attacks in the United States, the 107th Congress passed several vaccine-related measures and the 108th Congress continued with legislative and oversight activities regarding the development and purchase of vaccines against possible bioterrorist attacks and dealing with the sudden shortage of influenza vaccine at the outset of the 2004-2005 flu season.

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.

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, and improving 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 health threats. This report will be updated as warranted.