Discussion of Selected Issues Affecting Federal Immunization Activities

HRD-80-52: Published: Jun 6, 1980. Publicly Released: Jun 6, 1980.

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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.

Recommendation for Executive Action

  1. Status: Closed

    Comments: Please call 202/512-6100 for additional information.

    Recommendation: The Secretary of HEW should: (1) direct the Director of CDC to undertake studies to test the reliability of disease reporting and to measure the variability and extent of non-Federal immunization resources; (2) establish policies and procedures to improve future immunization program coordination; (3) direct the Director of CDC to develop methods to help standardize varying State mandatory immunization laws and to help improve their enforcement; (4) request whatever Federal funding is needed to attain and maintain desired immunization goals for all childhood diseases; (5) expedite data gathering to determine the potential costs and other effects of the proposed liability alternatives; (6) establish a systematic procedure to obtain, consider, and act on comments on "Important Information Statement" content from interested experts within and outside HEW and the Federal Government; (7) direct the Director of CDC and the Commissioner of the Food and Drug Administration to measure the reliability of existing vaccine reaction monitoring systems and to determine the feasibility of improving the reliability of existing systems; and (8) place the authority and responsibility for reaction data collection and dissemination with one agency or clearly divide and coordinate the responsibility.

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