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HRD-77-102 1 (1977-06-27)

handle is hein.gao/gaobaacjg0001 and id is 1 raw text is: DOCUMENT 12SUR 02512 - A1852871] w ... . ,Y2.,,/2 [swine Influenza Program]. HRD-77-102; B-1611031(2) . June 27, 1977. 11 pp. Report to Rep. Henry A. Waxman; by Elmer B. Staats, Comptroller General. Issue Area: Consumer and Worker Protection* Regulation of B4.ological Products to Insure their Safety, Purity, Potency, and Efficacy (908) ; Health Programs: Early Diagnosis and Disease Control (1201). Contact. Human Resources Div. Budget Function: Health: Prevention and Control of Health Problems (553). Organizaticr Concermed: Department of Health, Education, and Welfare. Congressional Relevance: Rep. Henry A. Waxman. Authority: Federal Food, Drug, and Cosmetic Act (21 U.SIC. 355). Public Health Service Act, as amended (42 U.S.C. 26?). P.L. 94-380. 21 C.F.R. 601.25. The swine flu vaccine program was predicated on the conclusion by Department of Health, Education, and Welfare (HEW) officials that the vaccine would protect between 70% and 90% of those vaccinated against swine flu outbreak. Findings/Conclusions: This conclusion was based on a HEW review of antibody response data gathered during the 1976 swine flu vaccine trials and observations of the effectiveness of previous flu vaccines. Since scientists agree that experimental investigations involving deliberate exposure to a new virus strain, such as swine virus, nre very difficult to perform and could pose a potentially serious health hazard in the United States, this method was not used to determine the effectiveness of the swine flu vaccine. The swine flu vaccine's effectiveness was estimated through clinical trials that measured the participants' antibody level before and after recei,[ng the vaccine. HEW officials and other flu experts noted that information on possible long-term effects of flu vaccination is needed, but it would be diffi.ult to plan and it would probably not be feasible because no one knows what to lock for, As part of the swine flu immunization program, the Center for Disease control had responsibility for conducting short-term surveillance on vaccine recipients. In addition, the Center is supporting two studies i women who recieved the vaccine to identify unfavorable pregnancy outcomes. ISC)