The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
Currently Skimming:
6 Stages of Vaccine Development
6 Stages of Vaccine Development
Pages 109-127
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 109... ...
Finally, a surveillance system is established to monitor immunization coverage, efficacy, and any adverse health effects related to vaccine administration. The surveillance system also may detect fluctuations in disease incidence or new disease entities requiring a realignment of public health priorities.
|
From page 110... ...
Whatever priorities are set by the public sector, the ultimate decision to develop and manufacture a vaccine for general use in the United States rests entirely with the commercial vaccine manufacturers (see Chapters 3, 4 and 5 and Appendix H)
|
From page 111... ...
The committee believes that additional incentives can be provided to university-based researchers, commercial vaccine manufacturers, and biotechnology companies to stimulate the development of such technologies and their subsequent handoff from basic research to the product-development stages. Possible incentives are discussed in Chapter 7.
|
From page 112... ...
Phase I trials are shortterm studies involving a small number of subjects and are designed primarily to evaluate the safety of the candidate vaccine, its ability to induce an immune response (immunogenicity) , the optimal dose range, and the preferred route of administration to achieve the most effective immune response.
|
From page 114... ...
LICENSURE Vaccine manufacturers apply to the FDA for a license to manufacture a vaccine by submitting a Product License Application (PLA)
|
From page 115... ...
The committee addresses some of these regulatory concerns in Chapter 7. PRODUCTION Pilot Production Pilot production, which occurs at or near the end of the applied research phase, is a critical stage in vaccine development.
|
From page 116... ...
This is important if technical problems during scaleup are to be avoided, to ensure that the vaccine lots used in human efficacy studies will be similar to those produced commercially, and to facilitate the transfer of vaccine technology to commercial vaccine manufacturers in the United States and/or to manufacturers in developing countries. As part of the IND application process, pilot lots of vaccine are produced (using Good Laboratory Practices or, preferably, current Good Manufacturing Practices)
|
From page 117... ...
have been unavailable to multilateral organizations and members of the public sector seeking to develop those vaccines that have a high technical risk and that are likely to be of limited commercial value (Tore Godal, Director, UNDP/World Bank/WHO Special Program for Research and Training in Tropical Diseases, personal communication, 1993~. Contracting out pilot production to specialized private-sector firms is a limited option for both private-sector firms and the public sector, including the U.S.
|
From page 118... ...
lithe end result of the shortage of vaccine pilot production facilities is considerable delay (sometimes years) in producing pilot batches of required vaccines.
|
From page 119... ...
In these recent cases, sophisticated physical and biochemical characterizations of the vaccines and animal testing did not predict the reduced immunogenicity. The FDA is acutely aware of the problems inherent in scaleup for largescale vaccine manufacture and strongly encourages manufacturers to produce clinical material for phase III studies in a commercial production facility.
|
From page 120... ...
Several U.S. agencies have developed programs to help countries improve the quality of locally produced vaccines.
|
From page 121... ...
This would effectively commit the federal government to large-scale purchases of vaccine relatively early in the clinical testing phase and might give vaccine manufacturers the confidence to proceed with development (Institute of Medicine, 1986c)
|
From page 122... ...
In early 1993, the Clinton administration proposed that the federal government assume a larger role in purchasing childhood vaccines (the Comprehensive Childhood Immunization Act of 1993 [H.R.
|
From page 123... ...
the recognition of new infectious disease problems that require public health attention. Likewise, surveillance will be a fundamental component in monitoring the efficacies of CVI vaccines and any adverse reactions and contributing to the establishment of new vaccine development priorities.
|
From page 124... ...
On the basis of these and other experiences, scientists and public health experts must anticipate potential differences in vaccine efficacy when these vaccines are introduced in developing-world conditions. Appropriate and close monitoring of clinical trials under field conditions will be critical to the development and introduction of CVI vaccines.
|
From page 125... ...
Without the data obtained through surveillance, it is impossible to know where disease control efforts should be targeted or to evaluate the impact of ongoing intervention efforts. Inadequate disease surveillance leaves policymakers and public health professionals with no framework for generating and executing policies to prevent or contain the spread of infectious disease.
|
From page 126... ...
Transfer of vaccine technology to developing countries: The Latin American experience. Paper presented to the NIAID Conference on Vaccines and Public Health: Assessing Technologies and Policies for the Children's Vaccine Initiative, November 5-6.
|
From page 127... ...
Science 258:546-547. United Nations Development Program/World Bank/World Health Organization Special Program for Research and Training in Tropical Diseases (TDR)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.