FAQs: H5N1 research issues

Q1: What has happened recently to raise concerns about H5N1 research?

Scientists have been trying to understand why the H5N1 virus does not transmit easily between humans and to learn what genetic changes could make it easily transmissible. H5N1 infection in humans is a serious public health concern. Human cases are sporadic but the fatality rate is about 60%.

Two groups of researchers have recently succeeded in creating forms of the influenza H5N1 virus in their laboratories that are more transmissible in mammals than naturally occurring H5N1 viruses. The studies used ferrets, a commonly used animal model for the study of human influenza.

The findings of the studies suggest that a only few changes in the genetic code of the H5N1 virus could result in a form of the virus that is more transmissible among mammals and cause illness.

The results have yet to be published, but the research has received considerable attention because some consider it an example of “dual-use research”—that is, research that advances scientific knowledge for the public good, but could also potentially be used for harm.

Q2: What is WHO doing to help resolve these issues?

WHO convened a small group of global health and influenza experts on 16–17 February 2012 to clarify key facts about the two studies and address the most urgent issues concerning the management of these laboratory-modified viruses and publication of the research studies. The technical consultation included lead researchers of the two studies, scientific journals interested in publishing the research, funders of the research, countries that provided the viruses, bioethicists and directors from WHO Collaborating-Centre laboratories specializing in influenza.

The group reached consensus to extend the temporary moratorium on research with new laboratory-modified H5N1 viruses, and to recognize that research on naturally-occurring H5N1 influenza virus must continue to protect public health.

The group also acknowledged the importance of increasing public awareness and understanding of the objectives of the research, and a review of biosafety and biosecurity aspects raised by the laboratory-modified viruses. The group agreed that after such steps are taken, the research should be published in full.

WHO will convene a discussion on many of the wider issues raised by these studies. This meeting is anticipated to be held in summer, 2012.

Q3: What were some of the reasons that public health and influenza experts at the meeting supported publication of these two research studies?

The studies show that the H5N1 influenza virus remains an important risk for causing a future pandemic. New scientific knowledge is critical to detect and control H5N1 viruses that could spread more easily among humans. The research findings will help improve influenza surveillance to protect public health, particularly in countries where the H5N1 virus may be circulating.

Earlier there were suggestions that the results from these studies should only be published in part (in “redacted” form). This means that the exact methods used to modify the viruses and some key results would be omitted. However, the group agreed that there is currently no practical way to distribute the key findings to people who may require them for public health purposes, while maintaining the confidentiality of the information. The group noted that novel scientific methods were not used in the studies and it would not be difficult for knowledgeable scientists to determine what had been done.

Q4: What does "surveillance" mean?

Public health surveillance is the continuous, systematic collection, analysis and interpretation of health-related data needed for the planning, implementation, and evaluation of public health practice. It is information for action. Surveillance can serve as an early warning system for impending public health emergencies, such as an influenza pandemic, document the impact of an intervention, or track progress towards specified public health goals. Surveillance can monitor or clarify the epidemiology of health problems, to allow priorities to be set and to inform public health policy and strategies.

Q5: How might these laboratory-modified viruses be used in the future? Can they be used to make vaccines or antiviral drugs?

The findings from these two studies can be used to improve public health surveillance, improve early detection of potentially pandemic H5N1 strains, and might aid the development of vaccines and the assessment of the potential value of other medical counter-measures, such as antiviral drugs.

Q6: The two genetically modified H5N1 viruses are currently stored in two research laboratories. Is there any risk to the public?

The laboratory-modified H5N1 viruses are currently stored in well-established research facilities that met or exceeded several sets of stringent biosafety and biosecurity standards.

Continued emphasis should be placed on ensuring and reinforcing safety and security in all laboratories where such work might take place in the future.