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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary
States and communities should have credible pandemic preparedness plans to respond to an outbreak within their jurisdictions.
The private sector should play an integral role in preparedness before a pandemic begins and should be part of the national response.
Individual citizens should be prepared for an influenza pandemic and be educated about individual responsibility to limit the spread of infection if they or their family members become ill.
Global partnerships will be leveraged to address the pandemic threat.
The NSPI implementation plan (see Figure 2-1), organized in stages that correspond to the pandemic phases in the World Health Organization (WHO) global framework for pandemic influenza (WHO, 2005b), provides a detailed prescription for how the government should plan and respond to a pandemic, Gellin said. The NSPI assigns responsibilities to various government agencies and departments in the areas of international efforts, transportation and borders, human and animal health, public safety, and government continuity. The implementation plan also outlines expectations for state and local governments, the private sector, and groups and individuals deemed critical to the nation’s infrastructure.
The core of the NSPI implementation plan is the specification of more than 300 actions to be taken by federal departments and agencies, Gellin explained. For each such item, the plan identifies lead and supporting agencies, outcome measures, and timelines for action. Within the area of human health, these actions include the enhancement of domestic and international disease surveillance, the procurement and distribution of countermeasures, the acceleration of research and development of vaccines, drugs, and diagnostics, and the development of international cooperation, capacity, and preparedness.
In order to demonstrate how this scheme translates into specific actions by government departments and agencies, Gellin focused on HHS and one of its areas of responsibility: pandemic vaccine development programs. He noted that HHS planning for pandemic vaccine production is governed by several assumptions. First, it is assumed that the entire global manufacturing capacity for influenza vaccine, currently estimated to be approximately 300 million doses per year, would be devoted to the production of vaccine against a pandemic strain. Second, the first trial of pre-pandemic H5N1 vaccine is assumed to require two doses per person at 90 micrograms per dose—as compared with the seasonal influenza vaccine, which requires 15 micrograms per dose—although it is possible that still-unproven antigen-sparing strategies could reduce this dosage. Third, it is assumed that the U.S. cannot rely on other countries to supply vaccine in a pandemic; the nation must therefore depend upon its sole domestic vaccine manufacturer, Sanofi-Pasteur, to supply all of its pandemic vaccine. If a pandemic commenced today and these assumptions proved correct, Sanofi-Pasteur could produce enough vaccine to immunize approximately 15 million people, or about five percent of the U.S. population. In 2005, in response to these calculations,