“This article clarifies the regulatory issues surrounding influenza pandemic vaccine for the larger policy community and describes the need for regulatory harmonization. Vaccination would save lives in an influenza pandemic, but a lack of global manufacturing capacity will leave most of the world without access to vaccine. Capacity can be expanded if governments harmonize their regulatory policies. This article details the regulatory approaches taken by the United States, the European Union, and japan for pandemic vaccine development, three regions that produce the majority of the world’s seasonal influenza vaccine. They should quickly converge on regulatory requirements, intellectual property considerations, the use of recombinant DNA techniques for vaccine production, and technical issues about the composition of pandemic vaccine.”
By Gigi Kwik Gronvall and Luciana L. Borio
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Removing Barriers to Global Pandemic Influenza Vaccination
- June 27, 2011
- | Filed under Asia/Pacific, Europe, North America, Report, and 2001-2025
Report on technical consultation on H5N1 research issues
Approximately 60% of persons known to have been infected by the avian influenza A(H5N1) virus have died from their illness. To date, most known human infections have occurred through contact with, or exposure to, infected birds. The prospect that H5N1 viruses circulating in nature might evolve and acquire the ability to spread with ease from person to person is a serious public health concern.
Research on the genetic basis of the transmissibility of H5N1 by two groups (one in the Netherlands and the other a joint Japan/USA group) resulted in laboratory-modified H5N1 viruses capable of respiratory transmission between ferrets. These mammals are often used in influenza research because, in some respects, ferret influenza infection shows similarities to human influenza infection. The results of these two studies demonstrate that relatively few genetic changes in H5N1 viruses can enable transmission via the respiratory route in these animals, and, in turn, suggest that H5N1 viruses could become more easily transmissible from person to person. The findings suggest that such changes could occur in nature, but do not provide an estimate of the likelihood that they will occur.
- March 12, 2012
- | Filed under Europe, North America, Report, and 2001-2025
Research in the Life Sciences with Dual Use Potential: An International Faculty Development Project on Education About the Responsible Conduct of Science
In many countries, colleges and universities are where the majority of innovative research is done; in all cases, they are where future scientists receive both their initial training and their initial introduction to the norms of scientific conduct regardless of their eventual career paths. Thus, institutions of higher education are particularly relevant to the tasks of education on research with dual use potential, whether for faculty, postdoctoral researchers, graduate and undergraduate students, or technical staff. Research in the Life Sciences with Dual Use Potential describes the outcomes of the planning meeting for a two-year project to develop a network of faculty who will be able to teach the challenges of research in the life sciences with dual use potential.
- May 2, 2012
- | Filed under North America, Report, and 2001-2025
Research Policy and Management of Risks in Life Sciences Research for Global Health Security
Report of the meeting
Bangkok, Thailand
10-12 December 2007
This meeting report summarizes the recommendations, presentations and discussions made at the meeting on Research Policy and Management of Risks in Life Sciences Research, held in Bangkok, Thailand, on 10-12 December 2007. The selection of countries was made in collaboration with the WHO Regional Office for South-East Asia and the WHO Regional Office for the Western Pacific. Participants included representatives of public health authorities, national institutes of public health and national public health laboratories. Scientists, research policy experts and ethicists from international organizations, academia, nongovernmental organizations (NGOs) and WHO participated as facilitators.
This meeting report is part of the “Life science research and development and global health security” project. The project is aimed at raising awareness among WHO Member States about the potential implications of life science research and development (R&D) for global health security. It underlines the importance of carrying out life science R&D for improving the health of all people, as well as the potential risks linked with life science R&D. Such risks and opportunities should be assessed from a public health perspective.
- April 7, 2011
- | Filed under Africa, Asia/Pacific, Europe, Middle East, North America, South America, South Asia, Report, and 2001-2025
Responding to Dengue Fever in the U.S.: Lessons from Three Outbreaks
Since 2001, three autochthonous dengue fever outbreaks have occurred in the U.S. We sought to characterize and describe the responses to these
outbreaks, from the perspectives of public health and vector-control officials at the local, state, and federal levels. The outbreaks studied were: Hawaii (2001); Brownsville, Texas (2005); and Southern Florida (2009-present). Our analysis was aimed at assessing mitigation strategies
used during each of these outbreaks, and to identify policy implications for public health departments, vector control agencies, and clinicians in areas vulnerable to dengue and other mosquito-borne diseases.
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