Discussion of Selected Issues Affecting Federal Immunization Activities

The Department of Health, Education, and Welfare's (HEW) immunization programs were reviewed. Specifically addressed were the HEW childhood disease and flu immunization programs' effectiveness, liability, adverse vaccine reactions, and vaccine supply.

The Center for Disease Control (CDC), the Food and Drug Administration's Bureau of Biologics, and the National Institutes of Health's National Institute of Allergy and Infectious Diseases are primarily responsible for the HEW immunization programs. To date, three flu immunization programs have been conducted. These included the swine flu program during the 1976-77 flu season and two smaller programs during the 1978-79 and 1979-80 flu seasons. In reviewing these programs, GAO found that: (1) HEW statistics show that Federal immunization activities have had a significant influence in reducing childhood disease levels; (2) a comprehensive policy that stipulates the circumstances under which the Federal Government will assume liability for public immunization programs does not yet exist; (3) in several instances, pertinent data were excluded from vaccine information forms and recommended administrative procedures were not followed; (4) current adverse reaction monitoring systems have limited value in showing the risks associated with vaccination; and (5) current vaccine supplies seem adequate and manufacturers contend that they will continue providing vaccine.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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