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The Centers for Disease Control and Prevention (CDC) published today in the Federal Register an interim rule declaring the strain of influenza responsible for the 1918 pandemic as a select agent. There are currently 41 other agents and toxins listed as select agents under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
This action follows recent work done by CDC scientists to successfully reconstruct the 1918 virus in hopes of better understanding it. The virus was reconstructed to aid public health officials in preparing for the possibility of another pandemic of influenza. It will also be helpful to biomedical scientists as they seek to understand what made the virus so harmful and to develop better antiviral drugs and influenza vaccines.
"We've learned why this virus was so deadly and we know it's easily transmitted from person to person," said CDC director Julie Gerberding, MD, MPH. "But there is a lot we don't know so it's only logical that we take immediate steps to regulate this virus as a select agent as an added way to protect the public."
Under provisions outlined in the interim rule, all entities (e.g., scientists and researchers) that possess, use or transfer the 1918 strain of influenza or the eight key gene regions of the 1918 virus are required to register with the CDC. People, labs, and other facilities that work with select agents are required to ensure that they can safely handle the virus as outlined in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th edition. In addition, they are required to increase safeguards and security measures for the virus, including controlling access, screening personnel, and maintaining records to be included in a national database with records from others registered. The Act imposes criminal and civil penalties for inappropriate use of select agents and toxins.
In light of this groundbreaking scientific research done to recreate the 1918 pandemic influenza virus, CDC asked a workgroup of scientists from the National Institutes for Health (NIH), the Food and Drug Administration (FDA), the Department of
Defense, and the Department of Agriculture to determine if the newly created virus should be added to the select agent list. The group used four criteria to determine whether to include the 1918 strain on the select agent list: the effect on human health of exposure to the agent or toxin; the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans; the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and the needs of children and other vulnerable populations. Using these criteria, the workgroup unanimously agreed that the virus warranted select agent status.