Tuesday, January 31, 2006
As you are aware, the potential for a human influenza pandemic is a current public health concern with an immense potential impact. Pandemics are not new. There were three in the 20th century, the worst of which was the Spanish flu epidemic in 1918-1919 that is estimated to have killed over one half million people in the U.S. and 50 million worldwide. While we are focusing today on the impact of a possible pandemic of avian flu, many of the policy issues and preparedness measures that arise for avian flu apply as well to pandemics of other types of influenza, other infectious disease outbreaks and public health emergencies. To put the impact of a pandemic in context, the seasonal influenza that we have today causes an average of 36,000 deaths each year in the United States, mostly among the elderly, and adds more than 200,000 hospitalizations.
Scientists cannot accurately predict the severity and impact of an influenza pandemic, whether from the H5N1 virus currently circulating in birds in Asia and Europe, or the emergence of another influenza virus of pandemic potential. However, it is still useful to model possible scenarios based on analysis of past pandemics. In a report released in December 2005, the Congressional Budget Office presents the results of modeling a severe pandemic scenario similar to the 1918 Spanish flu outbreak and a more moderate outbreak resembling the flu pandemics of 1957 and 1968. In the severe scenario, roughly 90 million people become ill and 2 million die in the United States and the impact on the real Gross Domestic Product [GDP] is about a 5 percent reduction in the year following the outbreak. In the “mild” pandemic scenario, about 75 million people are infected in the U.S. and about 100,000 of them die. The impact on the GDP is approximately a 1.5 percent decline. While there is substantial uncertainty associated with these estimates, they illustrate the enormous public health threat of an influenza pandemic and the need for effective access to vaccines, treatments, and a robust public health infrastructure to meet the challenge.
There are several important points to note about an influenza pandemic:
The Current Status of H5N1 Virus in Asia
For an influenza virus to cause a pandemic, it must: (1) be a virus to which there is little or no pre-existing immunity in the human population; (2) be able to cause illness in humans; and, (3) have the ability for sustained transmission from person to person. So far, the HPAI H5N1 virus circulating in Asia and Europe meets the first two criteria but has not yet shown the capability for sustained transmission from person to person.
The highly pathogenic avian influenza A (H5N1) epizootic (or animal) outbreak in Asia that is now beginning to spread into Europe is not expected to diminish significantly in the short term. It is likely that H5N1 infection among birds has become endemic in certain countries in Asia and that human infections resulting from direct contact with infected poultry will continue to occur. So far, scientists have found no evidence to indicate that the virus has changed to make it easier to transmit from person to person. However, the animal outbreak continues to pose an important public health threat, because there is little preexisting natural immunity to H5N1 infection in the human population. It is quite certain that a threat anywhere in the world is a threat everywhere.
Working to Meet the Existing Threat
On November 1, 2005, the President requested an additional $7.1 billion in emergency appropriations for FY 2006, including appropriations for HHS totaling $6.7 billion to support implementation of the National Strategy for Pandemic Influenza (PDF).
In seeking this funding, the goals were to:
On December 30, 2005, President Bush signed into law the Department of Defense Appropriations Act of 2006 (Public Law No: 109-148) providing approximately $3.8 billion for pandemic influenza preparedness activities for FY2006, of which $3.3 billion was appropriated to HHS. The majority of the HHS appropriation will be spent in two major areas: the production of countermeasures (vaccines and antiviral drugs) and enhanced domestic preparedness. I would like to talk in depth about these areas, as well as describe other ongoing activities.
Roughly $1.76 billion of the HHS allocation will be spent on increasing vaccine production capacity. A portion of this funding will go to accelerate cell-based manufacturing technology. Because the surge capacity needed for a pandemic cannot be met by egg-based production alone, cell-based technology, which is insensitive to seasons and can be adjusted to vaccine demand, is a critical supplement to our nation’s surge capacity.
At the same time, HHS believes that it is vital that investments continue to be made to increase egg-based vaccine production capacity, given the years of experience and proven success with this technology. Therefore, HHS will fund projects to increase egg-based capacity, including buying pre-pandemic vaccine from existing egg-based manufacturers. In addition, HHS will retrofit existing non-flu manufacturing facilities for emergency production of influenza vaccine. In addition, HHS will support advanced development contracts for antigen sparing techniques. Antigen-sparing strategies, if successful, could extend the vaccine supply by decreasing the amount of vaccine needed to protect each individual. Finally, HHS intends to develop a vaccine registry to monitor vaccine use (safety/efficacy) and distribution.
HHS funding will also be allocated to acquire antiviral drugs. Currently two drugs, Oseltamivir (Tamiflu) and Zanamivir (Relenza) provide clinical benefit against all of the H5N1 virus strains currently circulating in Asia. HHS intends to complete the “20/20 plan” of achieving 20 million courses in FY 2006, with the goal of achieving 44 million courses by FY 2008, subject to the availability of funds. HHS also intends to purchase 6 million courses of antiviral for purposes of containment, if feasible, in the event of 1-2 isolated, domestic outbreaks. The plan calls for states to purchase the remaining 31 million treatment courses, for which the Federal government would subsidize 25 percent of the cost. Finally, HHS intends to fund the advanced development work on promising new antiviral drugs.
Other FY2006 funds will be used to enhance the Strategic National Stockpile by increasing the quantities of personal protective equipment (PPE), ventilators, and other medical supplies needed in a pandemic outbreak. Approximately $50 million will be spent on establishing and increasing laboratory surge capacity. Funding has also been designated for the advanced development of rapid detection tests for human avian influenza. With regard to domestic surveillance, HHS plans to accelerate CDC’s BioSense real-time surveillance system to enhance our ability to detect an outbreak early.
HHS will also direct funding to enhance international surveillance, expanding clinical trials in Southeast Asia, and implementing rapid outbreak response in currently affected countries. HHS plans to allocate funds for risk communications strategies and overall pandemic preparedness and planning within the Office of the Secretary.
State and Local Preparedness
Secretary Leavitt has since embarked on a nation-wide tour to support state and local pandemic preparedness and planning efforts. His tour has the ambitious goal of visiting 50 states and 10 U.S. territories within 120 days. Thus far, the Secretary has completed summits in Minnesota, Arizona, Rhode Island, Vermont, Georgia, West Virginia, and Kentucky. These summits have been attended by hundreds of people at each venue and have brought together physicians, hospital executives, transportation workers, business owners, town officials, police officers, rescue squad volunteers, members of the agriculture sector and many other community leaders. In some states, the summit was broadcast to audiences in remote locations across the state as well. The central goal of the Secretary’s visits is to raise awareness of pandemic preparedness in sectors which may have not been previously briefed on the current pandemic threat. The Secretary feels that it is essential that schools, universities, businesses, faith-based organizations, and various other community groups and organizations realize the impact that a pandemic may have on them.
In this regard, to assist in state and local preparedness, the Centers for Disease Control and Prevention has released a series of checklists to aid states in their preparation for a pandemic in a coordinated and consistent manner across all segments of society. At this time, a state and local government checklist, a business checklist, an individual & families checklist, and a checklist for community organizations have been released. The state and local government checklist, of note, is specifically aligned with the CDC Preparedness Goals and the HHS Pandemic Influenza Plan, Public Health Guidance for State and Local Partners. It delineates action items over a comprehensive range of issues, including community preparedness leadership and networking, surveillance, public health and clinical laboratories, healthcare and public health partners, infection control and clinical guidelines, vaccine distribution and use, antiviral drug distribution and use, community disease control and prevention, public health communications, and workforce support. In addition, there are a number of checklists pertaining to the education and healthcare communities that are in the clearance process and scheduled to be released in the coming weeks. CDC has also prepared a Pandemic Influenza Toolkit for health care providers which provides a compilation of resources and information to clinicians for their use in discussing pandemic influenza with patients and providing care in case of a flu pandemic in the United States. Finally, www.pandemicflu.gov, the U.S. government’s official Web site for information on pandemic flu and avian influenza, contains updated information on international developments, the status of state summits, and on activities that can be initiated by various sectors of government and community to prepare now for a pandemic.
Finally, at each State summit, the Secretary and the Governor will be signing an Agreement laying the foundation for the financial assistance to be provided to States and also clearly delineating areas for mutual cooperation between the federal government and States as we jointly prepare for a potential future pandemic. For example, HHS will be providing substantial technical assistance to States in the areas of pandemic planning and logistical support and assistance to state and local health departments, health care agencies, and hospitals. The CDC will be particularly involved in support for epidemiological and diagnostic services, and distribution and storage of vaccines and antiviral drugs.
Thank you for the opportunity to share this information with you. I am happy to answer any questions.
Last Revised: February 2, 2006