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[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)](ViewImageLocal?handle=hein.gao/gaobaacjg0001&div=1&collection=&method=preview&ext=.png&size=3)