Vaccines are biologics -- their basic components begin as living material -- that introduce"weakened or killed disease-causing bacteria, viruses, their components" (1) (such as proteins, recombinantproteins, or polysaccharides) or toxoids into a person or animal to stimulate an immune reaction thatthe body will remember if exposed to the same pathogen in the future. There is no central authority for vaccine policy within the federal government. In theDepartment of Health and Human Services (HHS), the National Vaccine Program Office (NVPO)coordinates vaccine-related activities and the FDA is responsible for the regulation of humanvaccines and other biologics. TheNational Vaccine Injury Compensation Program (VICP), which is jointly administered by the HealthResources and Services Administration (HRSA), where it is located, and the U.S. Court of FederalClaims and the U.S. Department of Justice, "provides compensation for injuries judged to have beencaused by certain vaccines." The Department of Defense (DOD)maintains research and development programs for vaccines against both naturally occurringinfectious diseases and bioweapons. The U.S. Agency for International Development (USAID) supports routine immunizationprograms in developing countries and works to reduce the impact of vaccine-preventable diseaseworldwide. Laws Approved by the 107th Congress

Concerned about bioterrorist attacks in the United States, the 107th Congress approvedseveral bills that included vaccine-related issues:
The USA PATRIOT Act ( P.L. Cost -- of research, development, production, regulation and oversight, for example -- underlies eachof these concerns. Reasonsgiven are mostly economic. Problems

Production Costs. Chiron wasslated to supply approximately half of the vaccine for U.S. use in the 2004-2005 flu season. (26) 

		Possible Legislative Solutions

Congress may consider at least four kinds of measures to enhance vaccine availability: financial incentives, public-private partnerships, improved coordination, and alternatives to safetyand effectiveness documentation. The Food and Drug Administration ModernizationAct of 1997 (FDAMA, P.L. Otherprovisions of the act address spending authority for medical countermeasure (such as vaccines)development and purchase. Safety and Effectiveness

A pillar of U.S. policy on drugs and vaccines is the protection of the individuals who usethem. Vaccines cannot be marketed within the United States without a license from FDA; and FDAdoes not license a product until it is satisfied that the vaccine is safe and effective and that themanufacturing process can produce it. Scientists, clinicians, Members of Congress, and public policy analysts continue to face choices onrisk -- hypothetical and real -- that do not offer clear alternatives. (49) 

		Possible Legislative Solutions

Improving Post-Licensure Adverse-EventSurveillance. Education and Risk Communication. Studies in Pharmacoepidemiology andPharmacoeconomics. Access

Successful development and production of a safe and effective vaccine does not ensure thateveryone who needs a vaccine gets it. Coordination of Government Financing Programs. Congress may consider funding levels and financing strategies for vaccine-related care inthe United States. Payment for Vaccination and Follow-Up Care. (62) 
Global Health. Some Members noted concern forpublic health needs of developing countries worldwide and the need to assist those countries in fightsagainst infectious diseases.
This report's focus is on vaccination, one of the most cost-effective methods available toprevent infectious diseases. Whether a vaccine's target is naturally occurring or present because ofhostile intent, the issues policy makers must deal with include vaccine development, production,availability, safety, effectiveness, and access. Vaccines are biologics: their basic components beginas living material. They introduce bacteria or dead or weakened viruses into a person or animal tostimulate an immune reaction that the body will remember if assaulted by the same pathogen in thefuture.
There is no central federal authority for vaccine policy. In the Department of Health andHuman Services (HHS), the National Vaccine Program Office (NVPO) coordinates vaccine-relatedactivities, and the Food and Drug Administration (FDA) is responsible for the regulation of vaccinesand other biologics. Also involved in vaccine activities are other components of HHS (e.g., theNational Institutes of Health, the Centers for Disease Control and Prevention, and the HealthResources and Services Administration), the Departments of Defense, Veterans Affairs, andHomeland Security, and the U.S. Agency for International Development.
Concerned about bioterrorist attacks in the United States, the 107th Congress passed severalvaccine-related measures and the 108th Congress continued with legislative and oversight activitiesregarding the development and purchase of vaccines against possible bioterrorist attacks and dealingwith 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 toenhance 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 usethem. FDA does not license a product for sale in the United States until it is satisfied that thevaccine is safe and effective. Scientists, clinicians, Members of Congress, and the public must makedecisions of vaccine safety despite uncertainties and varying perceptions of risk. To ameliorate thedifficulties, Congress could address post-licensure adverse-event surveillance, education and riskcommunication, studies in pharmacoepidemiology and pharmacoeconomics, and improving availablemechanisms to compensate individuals injured by vaccinations.
Successful development and production of safe and effective vaccines does not ensure thateveryone who needs a vaccine gets it. Congress may take up the coordination of governmentchildhood 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 toexisting vaccines and to spur development of affordable vaccines for global health threats. Thisreport will be updated as warranted.