PEDIATRICS Vol. 100 No. 6 December 1997, pp. 1015-1020
Received Mar 18, 1997; accepted May 23, 1997.
In the last 20 years, two thirds of all new
vaccines provided worldwide have been produced by a US network of
independent industrial, governmental, and academic partners engaged in
vaccine research and development. Vaccines are complex products and the science of vaccinology is difficult. To achieve the full promise of
modern science and technology to prevent and treat disease by
immunization, the delicate fabric of America's cooperative and
collaborative vaccine research relationships must be sustained and
strengthened. The major partners are the federal government; four large
companies
two US-headquartered (Wyeth-Lederle Biologics and Vaccines
and Merck & Co), two foreign firms (SmithKline Beecham and Pasteur
Mérieux Connaught); and academia. Of the $1.4 billion that fund
US vaccine research and development annually, 46% comes from vaccine
sales, 36% from taxpayers, and 18% from risk capital. Vaccine
innovation could be strengthened by improved public and policy maker
understanding of the vaccine development network; declarations of
partnership; interactive dialog with federal advisory bodies; public
forums for government and industry to listen to patients, providers,
and researchers; sabbatical assignments between partners; mechanisms to
share industries' market research with public immunization programs;
continued active industry participation in the Advisory Committee on
Immunization Practices and the National Vaccine Advisory Committee;
increased collaboration between industry and the National Institutes of
Health for clinical research; harmonization of the Advisory Committee
on Immunization Practices vaccine recommendations and the Food and Drug
Administration package inserts; and public policies to foster the
partnership's collaboration and robustness. The optimal size and
configuration of the US vaccine enterprise should be debated only in
the context of a full understanding of how the current system works and
its record of effectiveness. These National Vaccine Advisory Committee
recommendations are directed at developing public policies to foster
and sustain vaccine innovation and ensure the timely introduction and
supply of new vaccines needed by this nation and the world.
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