Testimony

Thursday, March 2, 2006

Introduction
Mr. Chairman and members of the Subcommittee, I am pleased to be here today to describe the CDC�s role in international surveillance and containment, and our plans for domestic response, including domestic surveillance and containment, should an influenza pandemic virus reach the United States. I will focus on the current status of avian influenza around the world; CDC�s role in the Department of Health and Human Services (HHS) Pandemic Influenza Plan; and CDC�s specific pandemic influenza preparedness activities. We appreciate the support of the Members of this Subcommittee in supporting many of CDC�s international activities, including CDC�s Global AIDS program, as well as the support offered by Members of the Subcommittee to include funding for pandemic influenza 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 domestic and international response at all levels of government � federal, state, and local � as well as the participation of the private sector and each of us as individuals.

CDC has been a leader in the international pandemic influenza planning effort. We have drawn on our decades of experience working on annual and pandemic influenza surveillance, containment, and planning. CDC�s established international relationships and resources in countries involved in CDC�s Global Disease Detection program have, and will continue to, act as the cornerstone of CDC and HHS pandemic influenza efforts.

I appreciate the testimonies that my colleagues Dr. Fauci, Ambassador Powell, and Dr. Hill have given; together, we represent several components of the highly collaborative federal preparedness initiative. Both history and science clearly tell us that influenza pandemics are inevitable. The next pandemic could emerge from the current H5N1 strain that now affects numerous countries in Asia, Europe, the Middle East, and Africa. The next pandemic also could emerge from another influenza strain, and we must be ready for both of these possibilities. One of CDC�s roles in protecting the nation�s health is to provide ongoing international 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 (HPAI) 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 2006, H5N1 has continued to spread to wild birds or poultry in new countries in Europe and Africa. CDC continues to monitor the rapid spread of the H5N1 virus, in collaboration with the World Health Organization, the Food and Agriculture Organization, and other international partners.

In 2004, sporadic human cases of 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. The WHO now has confirmed human cases in Iraq and is carefully monitoring for human cases in other affected countries. Cumulatively, as of February 27, 2006, 173 human cases have been reported from a total of 7 countries and laboratory confirmed by WHO. These cases have resulted in 93 deaths, a fatality rate of 54 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. However, this type of transmission has not yet led to sustained transmission.

CDC Pandemic Influenza Planning Preparedness Activities
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 CDC�s 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 simulation exercises will begin. In addition, HHS is working with Homeland Security to plan how the President's national strategy will be implemented while maintaining continuity of operations during a pandemic.

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 summits will help the public health and emergency response community inform and involve their political, economic, agricultural and community leaders in this process.

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. The funding will be made available through the Public Health Emergency Preparedness Cooperative Agreement, which will require that grantees meet specific performance objectives. CDC is coordinating efforts around this pandemic influenza supplemental funding for state and local health agencies. The Agreement that each State Governor is being asked to sign with Secretary Leavitt at the summits outlines states� pandemic planning responsibilities.

International Collaboration
As a top priority this year, CDC is actively collaborating on pandemic influenza preparedness with target countries and regions where H5N1 is either endemic or emerging. Partners include the governments of countries where CDC has existing programs and where new Global Disease Detection and Response Centers are being established. In addition, CDC continues its longstanding partnership with the World Health Organization through its Secretariat in Geneva and regional offices around the world. These collaborative pandemic influenza preparedness activities are focused on 1) planning for a pandemic; 2) advancing scientific knowledge; 3) building surveillance infrastructure; 4) training rapid response teams and health care workers to contain outbreaks; and 5) applying effective risk communication practices.

Prevention
CDC�s prevention activities intend to increase the use and development of interventions known to prevent influenza. CDC�s roles in the research, development and manufacturing of vaccines and public health prevention activities as identified under the HHS Pandemic Influenza Plan encompass CDC�s 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; during the 2005-2006 influenza season, only one of four influenza vaccine manufacturers that sells in the U.S. market made 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.

One of the main efforts by HHS in pandemic preparedness is to expand the nation�s use of influenza vaccine during inter-pandemic influenza seasons. The Vaccines for Children (VFC) program provides a reliable funding source to purchase influenza vaccine for all eligible children, which in turn supports the vaccination of children and increases the capacity to manufacture influenza vaccine. Additionally, in fiscal year 2006, $40 million was apportioned through the VFC program to purchase influenza vaccine for the national pediatric influenza vaccine stockpile as additional protection against annual outbreaks of influenza.

The FY 2006 appropriation also contained $29.7 million in no-year funding to contract with influenza vaccine manufacturers to increase the supply of bulk monovalent inactivated vaccines. This increase will help mitigate a trivalent influenza vaccine shortage by increasing the amount of monovalent bulk vaccines available for final manufacturing processing as necessary. The amount produced would be in addition to the manufacturer�s planned production quantity, and allows for a flexible mechanism for CDC to potentially expand and stabilize influenza vaccine supply in the United States

Detection and Reporting
CDC�s 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 domestic BioSense surveillance system and other real-time surveillance, studying human-animal interfaces to learn more about the zoonotic nature of pandemic influenza, and strengthening CDC�s 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 by 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
CDC�s 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, 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
In fiscal year 2006, CDC will 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. 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 other countries into the United States. This effort includes maintaining quarantine stations. CDC�s Quarantine Stations are actively involved in pandemic influenza preparedness at their respective ports of entry. We have expanded the nation�s 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 fiscal year 2006 funds are being coordinated 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
CDC�s 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
CDC�s comprehensive Global Disease Detection strategy is an integral part of CDC's established mandate for rapid response to international outbreaks. In fiscal year 2006, funding is included to expand international surveillance, diagnosis, and epidemic investigation efforts with WHO and other international partners. It is important that CDC build and improve the infrastructure at the central, provincial, and local levels for timely notification of suspected human avian influenza cases in countries that are either experiencing or are at risk for H5N1 outbreaks. Ultimately, we hope to be able to identify flu outbreaks in humans with laboratory confirmation of H5N1 (or any other influenza virus with pandemic potential) in a timely fashion. This capability will open the gates to monitoring the spread of the disease and give us a better chance to respond rapidly to contain pandemic influenza strains.

In fiscal year 2005, CDC funded twelve countries to maintain and enhance support to their ministries of health to develop capacity to prevent and control avian influenza. These countries include Cambodia, Vietnam, China, India, Indonesia, Kazakhstan, Malaysia, Mongolia, Pakistan, Philippines, Thailand, New Caledonia, and South Korea. CDC will continue to fund these activities, which include developing and maintaining full human AI surveillance capability for human cases of novel influenza viruses through training of staff from Ministries of health and local health authorities, and by enhancing Biosafety Level (BSL)-2 Laboratory capacity with necessary equipment, supplies, biosecurity standards and training and maintenance. In addition to these countries, CDC will fund an additional 10-15 countries that will target global gaps in influenza surveillance capacity especially Africa, Central America, and additional sites in Asia.

CDC will also support the World Health Organization (WHO), both at the Secretariat in Geneva, but also at the regional offices across the world, to expand and improve WHO�s global surveillance activities. In addition to its support to WHO, CDC will expand its existing emerging infections platforms, such as the international Global Disease Detection Platforms in Kenya, Thailand, Guatemala, and China, as well as the Regional Emerging Disease Intervention (REDI) Center in Singapore, field stations in Egypt and Peru; and at least one other African site to prioritize pandemic influenza. These sites will support global CDC and HHS influenza surveillance activities, as well as training, epidemiological investigations, and other support of international influenza activities, all in coordination with activities undertaken by the WHO Secretariat and its regional offices.

Antiviral Drugs
Acquiring, distributing, and using antiviral drugs is an essential preparedness activity for both seasonal and pandemic influenza. Congress provided funding 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.

Recovery
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. CDC�s work to improve the national healthcare system�s 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.

Conclusion
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: March 3, 2006

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