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Smallpox virus destruction and the implications of a new vaccine
1Center for Biosecurity of UPMC, Baltimore, Maryland 21202, USA. dahzero@aol.com
Abstract:
The World Health Assembly is scheduled to decide in May 2011 whether the 2 known remaining stockpiles of smallpox virus are to be destroyed or retained. In preparation for this, a WHO-appointed committee undertook a comprehensive review of the status of smallpox virus research from 1999 to 2010. It concluded that, considering the nature of the studies already completed with respect to vaccine, drugs, and diagnostics, there was no reason to retain live smallpox virus except to satisfy restrictive regulatory requirements. The committee advised that researchers and regulators define alternative models for testing the vaccines and drugs. Apart from other considerations, the costs of new products are significant and important. These include prospective expenditures required for the development, manufacture, testing, and storage of new products. This commentary provides approximations of these costs and the incremental contribution that a newly developed vaccine might make in terms of public health security.
Insights
The World Health Assembly will decide on retaining or destroying the remaining smallpox virus. Research indicates no need to keep live virus, recommending alternative testing models for vaccines and drugs.
Area of Science:
- Virology
- Public Health
- Biosecurity
Background:
- The World Health Assembly (WHA) is set to decide the fate of the two remaining live variola virus (smallpox) stockpiles in May 2011.
- A WHO-appointed committee reviewed smallpox virus research from 1999-2010 to inform this decision.
Purpose of the Study:
- To evaluate the necessity of retaining live smallpox virus for ongoing research.
- To assess the costs associated with developing, manufacturing, and testing new smallpox countermeasures.
- To determine the public health security benefits of a new smallpox vaccine.
Main Methods:
- Comprehensive literature review of smallpox virus research (1999-2010).
- Analysis of completed studies on vaccines, drugs, and diagnostics.
- Estimation of prospective expenditures for new product development and storage.
Main Results:
- Existing research suggests no compelling scientific reason to retain live smallpox virus, beyond regulatory compliance.
- Significant costs are associated with the development, manufacture, testing, and storage of new medical countermeasures.
- Alternative in vitro and in vivo models for testing are recommended to replace the need for live virus.
Conclusions:
- The continued retention of live smallpox virus is not scientifically justified based on current research.
- Developing alternative testing methodologies is crucial for future vaccine and drug development.
- The potential public health security gains from new countermeasures warrant careful cost-benefit analysis.
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