Live Variola Virus Considerations for Continuing Research (2009) / Chapter Skim
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1 Introduction
1 Introduction
Pages 9-18
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From page 9... ...
In 1979, a commission of health experts certified that natural transmission of smallpox had ceased, and WHO endorsed the declaration a year later in 1980. This final eradication of smallpox represents a monumental event in the history of medicine and public health, and smallpox remains the only intentionally eradicated disease of humankind (Fenner et al., 1998; Tucker, 2001)
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From page 10... ...
Ten years have passed since the 1999 IOM report was issued, and much has since transpired that is relevant to the question of the utility of research using live variola virus. These developments include advances in science and biotechnology, incidents involving bioterrorism, increased investment in research and development on countermeasures, changes in the regulatory approval process, and the reinstitution of smallpox vaccination among civilian and military populations in the United States.
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From page 11... ...
• Adequate stocks of smallpox vaccine must be maintained if research is to be conducted on variola virus or if maintenance of a smallpox vaccination program is required. Live variola virus would be necessary if certain approaches to the development of novel types of smallpox vaccine were pursued.
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From page 12... ...
Advances made in the fields of molecular biology and genetics in the past 10 years could provide important tools to improve understanding of the structure of variola virus and the functions of its gene products. Additionally, given variola's specificity for the human species, studying live variola virus in cultured human cells in vitro -- including both cells that are targets for initial infection and spread and specialized cells that mediate the immune response -- holds the potential to yield new insights into the antiviral mechanisms of host cells and the biology of the human immune system.
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From page 13... ...
meeting, the WHO Advisory Committee on Variola Virus Research reports that access to the BSL-4 laboratories at CDC and VECTOR remains highly controlled and regulated; security procedures are reviewed by WHO, and in the United States by the U.S. Select Agent Program.
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From page 14... ...
. Regulations and Other Guidance Pertaining to Countermeasures for Smallpox Since the IOM's 1999 report was issued, a number of regulations and other guidance have been promulgated in the United States to guide and facilitate the development and licensure of additional countermeasures for the diagnosis, prevention, and therapy of bioterrorism threats, including smallpox.
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From page 15... ...
In addition, the document encourages the development of contemporary international reference materials as guidance for determining the potency of new vaccines and their immunogenicity in vaccinated individuals. study charge and approach In anticipation of the WHA meeting in 2010, CDC requested that the IOM convene a committee to conduct a study on the continued use of live variola virus stocks for research and public health purposes.
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From page 16... ...
The conclusions and recommendations will inform policy discussions in the United States and within the world community regarding the continued need to retain the official stocks of live variola virus for research purposes, and would provide a major review of completed, ongoing and planned research activities that should be undertaken. The committee shall specifically consider and offer recommendations perti nent to the utility of live variola virus in addressing potential unmet requirements including: • Advanced development through licensure and post-licensure of antivirals for use in treatment of variola virus infections.
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From page 17... ...
These chapters also address any unmet or future needs in applications of the research, in terms of both medical countermeasures and any additional knowledge that could potentially be gleaned from studying live variola virus. Research in the following areas is examined in turn: genomic analysis (Chapter 5)
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From page 18... ...
1999. Assessment of future scientific needs for live variola virus.
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