Statement by
Julie L. Gerberding, M.D., M.P.H.
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

Avian Influenza: Preparing for a Possible Influenza Pandemic
The Appropriations Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies
United States Senate

Tuesday, January 31, 2006

Mr. Chairman and members of the Subcommittee, I am pleased to be here today to describe the current status of avian influenza around the world; CDCís role in the Department of Health and Human Services (HHS) Pandemic Influenza Plan; and CDCís pandemic influenza preparedness activities. We appreciate the support of the Members of this Subcommittee provided so that funding was included in the fiscal year 2006 Department of Defense (DOD) Appropriations Bill for HHS and CDC. A pandemic flu outbreak would have profound impacts on almost every sector of our society. Such an outbreak would require a coordinated response at all levels of government Ė federal, state, and local Ė as well as the participation of the private sector and each of us as individuals. HHS and CDC have been leaders in this effort.

I am pleased to be here today with HHS Assistant Secretary for Health Dr. John Agwunobi who has articulated the pandemic preparedness planning underway. Both history and science clearly tell us that influenza pandemics are inevitable. The next pandemic could emerge from the current H5N1 strain affecting Asia and Europe, or it could emerge from another influenza strain. One of CDCís roles in protecting the nationís health is to provide ongoing surveillance information for the United States on influenza strains circulating throughout the world.

The Current Status of H5N1 Virus in Asia and Europe
Beginning in January 2004, the World Health Organization (WHO) confirmed reports of new outbreaks of highly pathogenic avian influenza (APAI) A H5N1 infection among poultry and waterfowl in several East Asian countries. In 2005, outbreaks of H5N1 disease also were reported among poultry in Russia, Ukraine, Kazakhstan, Turkey, and Romania, in Mongolia among wild, migratory birds, and in migrating swans in Croatia.

In 2004, sporadic human cases of avian influenza A (H5N1) were reported in Vietnam and Thailand. In 2005 additional human cases were reported in Cambodia, China, Indonesia, Thailand, and Vietnam. Turkey began reporting human cases in early January 2006. Cumulatively, as of January 30, 2006, 160 human cases have been reported from a total of 6 countries and laboratory confirmed by WHO. These cases have resulted in 85 deaths, a fatality rate of 53 percent among reported cases. Almost all cases of H5N1 human infection appear to have resulted from some form of direct or close contact with infected poultry, primarily chickens. In addition, a few persons may have been infected through very close contact with another infected person, but this type of transmission has not led to sustained transmission.

CDCís Pandemic Influenza Planning Preparedness Activities
On November 1, 2005, President Bush released The National Strategy for Pandemic Influenza, which outlines the roles of the Federal government, State and local governments, private and international partners, and individual citizens to prepare for and respond to an influenza pandemic. The following day, Secretary Leavitt introduced the HHS Pandemic Influenza Planóa blueprint for all HHS pandemic influenza preparedness and response planning. Under the rubric of the HHS Pandemic Influenza Plan, CDC is developing a fully executable operations plan that will provide specific policies and procedures for each key area of CDCís involvement in the overall national response to a potential influenza pandemic. The development of the plan includes input from state and local partners through both formal and informal mechanisms. We anticipate completion of the operations plan by the spring of 2006, after which agency practice simulation exercises will begin.

CDC has encouraged states to use its preparedness framework as the foundation for their pandemic influenza plans. State plans were submitted to CDC as part of their 2005 Public Health Emergency Preparedness Cooperative Agreements. Key elements of these plans include the use of surveillance, infection control, antiviral medications, community containment measures, vaccination procedures, and risk communications. To promote pandemic influenza planning and awareness at the state and local level, the Secretary is holding summits in all 50 states. These in-state summits will help the public health and emergency response community inform and involve their political, economic, agricultural and community leaders in this process. To date, summits have taken place in West Virginia, Vermont, Kentucky, Georgia, Rhode Island, Arizona, and Minnesota.

Congress recently included $350 million in the emergency appropriations to support efforts to upgrade state and local capacity to respond to pandemic influenza. On January 12, 2006, Secretary Leavitt announced plans for the release of the first $100 million of the funding. The remaining $250 million will be made available later this year when states and local governments have established benchmarks and met the performance objectives and timelines put forth in the guidance. These stipulations will be contained in an Agreement that each State Governor will sign with Secretary Leavitt at the summits.

CDCís prevention activities intend to increase the use and development of interventions known to prevent influenza. CDCís roles in the research, development and manufacturing of vaccines and public health prevention activities as identified under the HHS Pandemic Influenza Plan encompass CDCís efforts towards our prevention goal.

Development and Manufacture of Vaccine
During an influenza pandemic, the existence of influenza vaccine manufacturing facilities functioning at full capacity in the United States will be critically important. The U.S. vaccine supply at present is particularly fragile; only one of four influenza vaccine manufacturers that sell in the U.S. market makes its vaccine entirely in the United States. In fiscal year 2006, appropriated resources to support pandemic preparedness will be used to encourage greater production capacity by enhancing the U.S.-based vaccine manufacturing surge capacity and developing antigen sparing technologies. This will help the United States prepare for a pandemic and further guard against annual shortages. One of the main efforts by HHS in pandemic preparedness is to expand the nationís use of influenza vaccine during inter-pandemic influenza seasons. In fiscal year 2006, $40 million was appropriated through the Vaccine For Children (VFC) program to purchase influenza vaccine for the national pediatric stockpile as additional protection against annual outbreaks of influenza. Increased annual production efforts should strengthen our capacity for vaccine production during a pandemic. We are also developing strategies to increase influenza vaccine demand and access by persons in high-risk groups that are currently recommended to receive vaccine each year.

Detection and Reporting
CDCís efforts are directed towards decreasing the time needed to classify an influenza outbreak, decreasing the time needed to detect and report an influenza outbreak with pandemic potential, and improving the timeliness and accuracy of communications regarding the threat posed by an influenza outbreak with pandemic potential. CDC focuses on detection and reporting by strengthening our national local laboratories, enhancing laboratory capacity and research, supporting our BioSense surveillance system and other real-time surveillance, studying human-animal interfaces to learn more about the zoonotic nature of pandemic influenza, and strengthening CDCís quarantine stations.

State Laboratory Preparedness
CDC is working to strengthen national local laboratory capacity by: (1) ensuring that states have sufficient epidemiologic and laboratory capacity both to identify novel viruses throughout the year and to sustain surveillance during a pandemic; (2) improving reporting systems so that information needed to make public health decisions is available quickly; (3) enhancing systems for identifying and reporting severe cases of influenza; (4) developing population-based surveillance among adults hospitalized with influenza; and, (5) enhancing monitoring of resistance to current antiviral drugs to guide policy for use of scarce antiviral drugs.

Collaboration with the Council for State and Territorial Epidemiologists (CSTE) has considerably improved domestic surveillance through making pediatric deaths associated with laboratory-confirmed influenza nationally notifiable, and by implementing hospital-based surveillance for influenza in children at selected sites. CDC will continue to work with CSTE to make all laboratory-confirmed influenza hospitalizations notifiable. Since 2003, interim guidelines have been issued to states and hospitals for enhanced surveillance to identify possible H5N1 infections among travelers from affected countries, and these enhancements continue. Special laboratory training courses to teach state laboratory staff how to use molecular techniques to detect avian influenza have been held.

Enhanced Laboratory Capacity and Research
In fiscal year 2006, emergency supplemental resources will support laboratory capacity and research at CDC. Close collaboration with many partners will be vital to enhancing laboratory capacity and research at CDC. The following are among the steps our agency is taking:

  • Applying advanced mass spectrometry techniques and analysis to examine structural changes in viral surface proteins that will help identify factors that alter the virulence of influenza viruses and to better characterize drifts and shifts in the influenza viruses.
  • Enhancing pandemic influenza research in collaboration with the Laboratory Response Network (LRN). This includes determining the potential for increasing stocks of diagnostic reagents for influenza and accelerating research and development for diagnostic tests.
  • Maintaining a library of pandemic influenza reference strains.
  • Enhancing laboratory capacity to increase throughput and working with international partners to address critical issues that may affect the timely sharing of data.

BioSense and Real-time Surveillance
CDCís BioSense program improves the nation's capabilities for monitoring community health by providing rapid access to timely data from hospitals and healthcare systems in several major metropolitan cities. It provides the immediate, continuous and comparable information needed to inform local, state, and national public health in participating areas, and to support national preparedness by using a network that includes hospital systems, Department of Veterans Affairs and Department of Defense facilities, poison control call centers, and the largest clinical laboratory in the United States. In responding to the threat of pandemic influenza with the support of additional funding in fiscal year 2006, CDC plans to further accelerate implementation of the BioSense program in 2006 by increasing the number of participating cities, the number of healthcare systems and real-time clinical data sources within those cites, and incorporating other existing health data sources of importance in monitoring influenza activity and the effectiveness of emergency response.

Human-animal Interface Studies
CDC will receive funds in fiscal year 2006 to support human-animal interface studies that will improve understanding of avian and other zoonotic-related influenza strains. CDC strategies in this area focus on studies of poultry and other domestic animals and on the potential impact of migratory wild birds. CDC will coordinate with partners to conduct epidemiological studies in countries that have documented H5N1 infection in poultry, especially those that also have confirmed human H5N1 cases. In addition, CDC works with its partners to coordinate surveillance between the human and animal health sectors in response to emerging zoonotic diseases of public health importance including avian influenza. In addition, CDC has established close working relationships with organizations such as the Wildlife Conversation Society, the American Zoological Association, and the International Species Information System to ensure that surveillance data about migratory bird and captive bird species can be shared in a timely and transparent manner to promote early detection of avian influenza.

Enhancement of Quarantine Stations
Under its delegated authorities, CDC is responsible for preventing the introduction, transmission, and spread of communicable diseases from foreign countries into the United States. This effort includes maintaining quarantine stations. Currently, CDCís Quarantine Stations are actively involved in pandemic influenza preparedness at their respective ports of entry. We have expanded the nationís Quarantine Stations; currently, CDC has a presence at 18 Quarantine Stations, and is working to fully staff these stations. HHS and the Department of Homeland Security (DHS) have recently established a Memorandum of Understanding setting out specific cooperation mechanisms to combat the introduction and spread of communicable diseases. These include DHS assistance with passive and, in certain instances, active surveillance of passengers arriving from overseas, as well as information sharing to assist in contact tracing of passengers with communicable or quarantinable diseases. HHS/CDC will provide training and other necessary support to reduce the potential of disease to enter the United States.

Informing the Public
Risk communication planning is critical to pandemic influenza preparedness and response, and funds are budgeted in fiscal year 2006 in the Office of the Secretary to support communication preparation in the case of a pandemic. HHS and CDC are committed to the scientifically validated tenets of outbreak risk communication. It is vital that comprehensive information is shared across diverse audiences, information is tailored according to need, and information is consistent, frank, transparent, and timely.

In the event of an influenza pandemic, clinicians are likely to detect the first cases; therefore messaging prior to a pandemic includes clinician education and discussions of risk factors linked to the likely sources of the outbreak, in addition to information targeted for specific groups, such as businesses and state and local officials. Given the likely surge in demand for healthcare, public communications must include instruction in assessing true emergencies, in providing essential home care for routine cases, and basic infection control advice. This comprehensive risk-communication strategy can inform the nation about the medical, social, and economic implications of an influenza pandemic, including collaborations with the international community.

Investigation and Control
CDCís investigation efforts focus on decreasing the time needed to identify causes, risk factors, and appropriate interventions for those affected by the threat of pandemic influenza and to decrease the time needed to provide countermeasures and health guidance to those affected by the threat of pandemic influenza. These efforts include activities that support rapid outbreak response and purchasing and stockpiling antiviral medications.

Rapid Outbreak Response
Rapid response to international outbreaks has been a part of CDC's mandate for decades, but recently published work suggesting challenges involved in slowing or containing an influenza pandemic makes the importance of such response more clear. For optimal response, a nascent influenza pandemic outbreak anywhere in the world must be recognized within 1 to 2 weeks and investigated and virologically confirmed within days. An unprecedented and well-coordinated response must be launched in stages in response to pre-planned trigger points, including deployment of dozens to hundreds of trained teams, public health messages, social isolation measures, movement restriction, treatment of patients, and tracing and prophylaxis of contacts.

In response to this challenge, CDC has developed a comprehensive Global Disease Detection (GDD) strategy. In fiscal year 2006, funding is included to expand international surveillance, diagnosis, and epidemic investigation efforts. Additional funding in fiscal year 2006 will build rapid outbreak response capability in 15 avian influenza affected countries. The strategy is integrated with WHO and other international partners. Regional workshops and other efforts have already begun that build local infrastructure for epidemiologic and laboratory disease detection, develop rapid outbreak and response teams, and establish and maintain appropriate stockpiles. The Investigation and Control goals during the next 3 to 9 months are focused on detection and rapid outbreak response to an avian influenza A (H5N1) outbreaks in Southeast Asia, Eastern Europe, and other affected areas. In the longer term, our rapid outbreak response will be focused on virtually any infectious disease threat anywhere in the world.

Antiviral Drugs
Acquiring, distributing, and using antiviral drugs is an essential preparedness activity for both seasonal and pandemic influenza. Congress provided funding of $525 million in fiscal year 2006 to purchase and maintain the materials for the Strategic National Stockpile (SNS), including antivirals. Recent studies at CDC have shown that 91% of currently circulating human strains of seasonal influenza in the U.S. and H5N1 isolates from people in Asia during the past two years indicate that these viruses are resistant to the cheaper and more available class of antiviral medications, the adamantanes, but are sensitive to the neuramidase inhibitor class of drugs such as oseltamivir (Tamiflu®) and zanamivir (Relenza®). Ongoing surveillance and monitoring of the status of antiviral sensitivity is absolutely critical as CDC continues its work to procure additional influenza countermeasures for the SNS. Information on antiviral sensitivity is important for developing the most up-to-date public health policy for effective use of antiviral medications.

The U.S. healthcare system will be severely stressed by an influenza pandemic. In addition to critical preparation needed to respond successfully to the acute medical care needs of the population, the healthcare system will also need to resume normal services as rapidly as possible. CDCís work to improve the national healthcare systemís capacity to respond is also included under this goal.

Healthcare System
Healthcare facilities need to be prepared for the potential rapid pace and dynamic characteristics of a pandemic. Medical surge capacity is limited, and could be vastly outpaced by demand. However, all facilities should be equipped and ready to safely provide care for a limited number of patients infected with a pandemic influenza virus early in a pandemic. Thereafter, recovery of necessary staffing and supply lines will be essential in order to provide for the large number of patients that would require care in the setting of escalating transmission. Preparedness activities of healthcare facilities need to be synergistic with those of other pandemic influenza planning efforts.

CDC has developed, with input from state and local health departments and healthcare partners, including other federal agencies, guidance that provides healthcare facilities with recommendations for developing plans to respond to an influenza pandemic and guidance on the use of appropriate infection control measures to prevent transmission during patient care. Development of and participation in tabletop exercises over the past two years have identified gaps and provided recommendations for healthcare facilities to improve their readiness to respond and recover after a pandemic, as an integrated part of the overall planning and response efforts of their local and state health departments. The healthcare system has made great strides in preparation for a possible pandemic, but additional planning still needs to occur.

The investment required in preparing for an influenza pandemic is resource and time intensive. Iterative consideration and evaluation of activities funded by the US Government are necessary to assure the development of best practices approaches to pandemic preparation.

Although much has been accomplished, from a public health standpoint, more preparation is needed to prepare for the public health response to a possible human influenza pandemic. As the President mentioned during the announcement of his National Strategy for Pandemic Influenza, our first line of defense is early detection. Although the present avian influenza H5N1 strain in Asia and Europe does not have the capability of sustained person-to-person transmission, we are concerned that it could develop this capacity. Because early detection means having more time to respond, it is critical for the United States to work with domestic and global partners to expand and strengthen the scope of early-warning surveillance activities used to detect the next pandemic.

Thank you for the opportunity to share this information with you. I am happy to answer any questions.

Last Revised: February 2, 2006