Vaccine Policy Issues (CRS Report for Congress)
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| Release Date |
Revised May 19, 2005 |
| Report Number |
RL31793 |
| Report Type |
Report |
| Authors |
Susan Thaul, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
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.
