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Executive Summary

PERTUSSIS VACCINE DEVELOPMENT ALLOCATED $4.5 MIL. in the House/Senate fiscal 1990 budget agreement for the National Vaccine Program. The program's budget is part of the HHS appropriations bill, HR 2990. The conference agreed on appropriations of $6 mil. for the program, $4.5 mil. of which is to be used exclusively for "basic and applied research and clinical trials of pertussis vaccines," according to the report accompanying the bill. The remaining $1.5 mil. is to be applied to support the program office. The agreement was reached Oct. 5. "Development, testing and approval of new acellular petussis vaccines are the highest priority of the vaccines program," the report notes. The report adds: "neither limited fiscal resources nor limited opportunities for appropriate field testing sites should be wasted in a diffuse approach. Therefore, the conferees expect that the National Vaccine Program Interagency Group will coordinate all pertussis trials funded through the National Vaccine Program or other funding sources in the department [HHS]." The full House approved the conference agreement Oct. 11; the Senate, Oct. 19. The interagency task force recommended assigning acellular pertussis vaccines a top priority at a National Vaccine Advisory Committee meeting in March ("The Pink Sheet" March 13, T&G-4). The recommendation followed the rejection by Swedish regulators of a Biken acellular vaccine license application due to concerns with the vacine's efficacy. The vaccine was the furthest along of the acellular products in clinical development. By funding other trials, the conferees said they "do not wish to impede possible approval of any acellular pertussis vaccines currently under review by the Food and Drug Administration." No product licensing applications for acellular pertussis vaccines have cleared the agency. In addition to Connaught/Biken, acellular pertussis vaccines are also under development by Lederle/Takeda, Institut Merieux and the National Institute of Child Health and Human Diseases. The interagency group acts as the implementing arm of the National Vaccine Program, which was established by the National Childhood Compensation Injury Act of 1986. The National Vaccine Advisory Committee was created to advise the program's director -- the NIH assistant secretary for health. With regard to the vaccine injury compensation program, the report states that the House conferees have agreed to a Senate amendment permitting HHS to use injury trust fund monies for the program's administrative costs. Extra funding for administrative expenses was one of several recommendations for improving the program made by Childhood Vaccine Advisory Commission Chairman Stephen Lawton in a Sept. 20 letter to HHS Secretary Sullivan. Lawton expressed substantial concern with the program's ability to function as intended by Congress due to a lack of support by HHS and the Justice Department. At a recent commission meeting on the status of the program, he said: "The commission determined that, at present, the program is in serious jeopardy. Neither HHS nor Justice is participating fully in the program, despite legal responsibilities to do so. Yet, the U.S. Claims Court continues to process petitions for compensation without formal participation by these departments."

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