TABLE 3-3 The U.S. Domestic Vaccine Research, Development, and Utilization Process

RDU Activity

Major Support

Major Performers

Basic research

NIH, NSF

Academia

 

Private foundations

NIH

Applied research

NIH, CDC, FDA Private foundations Industry

Academia NIH, CDC, FDA Industry

(Transition to development)

FDA regulates

Pilot manufacturing

Industry

Industry

Preclinical testing

Industry, NIH, FDA

Industry, NIH, FDA, CDC, academia

IND application

Industry

Industry

Phase 1-3 clinical and field testing

Industry, NIH

Academia, CDC, NIH

Large-scale manufacturing

Industry

Industry

(Licensing)

FDA

Postlicensure operational testing

CDC, industry, FDA

CDC, academia, industry

Postlicensure safety evaluation

CDC, industry, FDA

CDC, FDA, industry

Purchasing and utilization

CDC, states, private medicine

CDC, states, private medicine

RDU, research, development, and utilization; NIH, National Institutes of Health; NSF, National Science Foundation; CDC, Centers for Disease Control; FDA, Food and Drug Administration; IND, application for investigational new drug.

given field can be strongly influenced by the level of NIAID and DoD funding, as is the case with HIV vaccine research.

The decision to move a vaccine candidate from laboratory research to industrial development is in the hands of the private sector vaccine manufacturers. It is based on an assessment of technical feasibility, estimated development costs, and market analysis (including the potential for liability problems). In most cases, public policy only indirectly influences the decision to pursue vaccine development and thus has little effect on the character of the vaccines that eventually enter the marketplace.

During the course of vaccine development but before licensure, there is a requirement for a series of studies to prove clinical safety and efficacy. Government support for this phase of the development process is becoming increasingly common and varies in extent, depending on the priorities of NIH and the willingness of the vaccine's developers to cooperate with



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