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DOCUMENT BESUME
02846 - [A1993067]
The Swine Flu Program: An Unprecedented Venture in Preventive
medicine. HRD-77-115; B-164031(5). June 27, 1977. 86 pp. + 6
appendices (6 pp.).
Report to the Congress; by Elmer B. Staats, Comptroller General.
Issue Area: Health Programs: Early Diagnosis and Disease Control
(1201) .
Contact: Human Resources Div.
Budget Function: Health: Prevention and Control of Health
Problems (553).
Organization Concerned: Department of Health, Education, and
Welfare,
Congressional Relevance: House Committee on Interstate and
Foreign Commerce; Senate Committee on Human Resources;
Congress.
Authority: National Swine Flu Immunization Program of 1976 (P.L.
94-380; 42 U.S.C. 247b). Anti-Deficiency Act (31 U.S.C.
665(a)). Federal Tort Claims Act (28 U.S.C. 2671 et seq.).
P.L. 94-266.
The swine flu program was the Government's first
attempt at immunizing the entire U.S. population.
Findings/Conclusions: The Department of Health, Education and
Welfare (HEW) lost its gamble in this episode of preventive
medicine, but much can be learned from the program that should
be useful in planning future immunization programs and related
public health efforts. Legal liability continues to be a problem
in immunization programs. All vaccine released for use utimately
met Food and Drug Administration potency and safety standards.
Potential protection provided by the vaccine is difficult to
estimate. Not enough vaccine was produced or produced on time to
immunize everyone in the United States had there been a swine
flu outbreak. State readiness and implementation was never fully
tested. Costs may far exceed the $135 million appropriated.
Recommendations: HEW should establish key points in the program
process for formal program reevaluation; improve informed
consent procedures; improve potency testing; secure alternate
procurement if manufacturers lag behind schedules; and consider
all problems that arose in planning and implementing the
program. Congress should establish a national liability policy
before another mass immunization is needed. (DJM)](ViewImageLocal?handle=hein.gao/gaobaacmf0001&div=1&collection=&method=preview&ext=.png&size=3)