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Executive Summary

ACELLULAR PERTUSSIS VACCINE DEVELOPMENT SHOULD BE THE TOP PRIORITY of the National Vaccine Program, the program's coordinator, Alan Hinman, MD, suggested to the National Vaccine Advisory Committee on March 9. Speaking for an interagency task force that has developed a prioritized "wish list" of ten recommendations for the vaccine plan, Hinman said: "Pertussis clearly is our number one priority activity . . . ]and[ additional field trials for clinical efficacy of candidate acellular pertussis vaccines are highly desirable." Hinman mentioned that a "team" is slated to visit Thailand around March 20 to investigate the country as a potential site for a comparative trial that would study whole cell and acellular pertussis vaccines. The task force estimated the cost of a pertussis vaccine study at approximately $3-to-4 mil. a year for up to four years. The top-priority recommendation for a new pertussis vaccine study follows the recent rejection by Swedish regulators of a Biken acellular vaccine license application due to concerns with the vaccine's efficacy. That vaccine was the furthest along of the acellular products in clinical development. However, a member of the interagency's pertussis subcommittee, Roger Bernier, PhD, of the Division of Immunology at the Centers for Disease Control, noted that no concensus has been reached on the efficacy data from the Biken vaccine trials: "The regulatory officials in Sweden denied the license because they said the best efficacy for the Swedish trial was 45% for ]the acellular vaccine[. The principal investigator believes the best estimate is 80%." Bernier added: "There is a real need to try . . . to resolve how effective those vaccines in Sweden" were by extensive re-evaluation of the data from the completed trial. Bernier noted that several other organizations (companies, state and federal government) are currently engaged in pertussis vaccine clinical trials, including: Connaught/Biken, Merieux, Lederle/Takeda, Massachussetts, Michigan, and the National Institute of Child Health and Human Diseases (NICHD). Preclinical work is also being conducted by Connaught, Sclavo, the National Institutes of Health and FDA. In addition to the pertussis vaccine field trials, Hinman said the task force would like to see more basic and applied laboratory research on pertussis vaccines. Hinman cited mechanisms of pathogenesis of the disease as one area in which the task force would like to see more work done. The task force projects the costs of additional laboratory work in the pertussis vaccine area at $2.5 mil. per year. The task force "wish list" also includes: full implementation of the measles immunization program, at an estimated cost of up to $25 mil.; the development of conjugated vaccines for influenza and pneumonia; improvements in the vaccine adverse effect reporting system; the addition of a seventh Vaccine Evaluation Unit at the National Institute of Allergy and Infectious Diseases; an improved polio vaccine; expansion of inoculation programs for hepatitis B and other diseases where effective vaccines are available; expansion of adult immunization programs; expanded studies on serologic correlates for use in new tests to measure vaccine efficacy; and the elimination of tuberculosis, which has begun to make a comeback in recent years, especially in the AIDS population. The interagency group includes representatives from FDA, the National Institutes of Health, the Centers for Disease Control, the Agency for International Development and the Department of Defense. The 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. The childhood vaccine injury act allocates $31 mil. for the program in FY 1990 and $34 mil. in FY 1991. However, the Reagan Administration has given the program short shrift -- in FY 1989, the Administration budgeted only $500,000 for the program. Commenting on the FY 1990 National Vaccine Program budget proposal, the committee "expressed their regret about the FY 1990 $500,000 budget request for the NVP, because the amount was inadequate and because the committee had not been consulted or informed of this action." The admitted cost of implementing the interagency task force "wish list" goes well beyond the projected congressional allocations for the program.

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