Avian Flu Preparedness Planning

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Purpose of health policy or idea

Flu pandemics occurred three times in the last century: 1918 (Spanish Flu - H1N1), 1957 (Asian Flu - H2N2), and 1968 (Hong Kong Flu - H3N2).  The Spanish Flu turned out to be the most lethal, killing an estimated 50-100[MSOffice1]  million people worldwide.  Avian flu, influenza A subtype H5N1, has become a disease of global significance with the potential risk of evolving into a human flu pandemic because of the following characteristics:

• evidence of possible person-to-person transmission[MSOffice2] 
• recent spread to poultry outside
• concern of increasing mammalian pathogenicity (capability of causing disease)[MSOffice3], although there are still very few human cases.

Against this background, in November 2005 President Bush outlined a strategy that provides strategic direction for departments and agencies of the US Government. In addition, the Department of Health and Human Services (DHHS), the principal agency in the United States government for protecting the health and safety of all Americans, issued the HHS Pandemic Influenza Plan which is a blueprint preparedness planning document at the federal, state and local level. The strategy contains five main objectives:

1. Effective disease monitoring - surveillance and detection
2. Developing vaccines and vaccine production capacity
3. Stockpiling and development of antivirals
4. Coordinating federal, state and local preparation
5. Enhancing outreach and communications planning

Effective Disease Monitoring The National Institute of General Medical Sciences (NIGMS), a component of the National Institutes of Health, is running a scientific international research network developing computer-base simulations of pandemic flu and other infectious disease outbreaks which started in 2004. The network is part of the Models of Infectious Disease Agent Study (MIDAS), an ongoing NIGMS effort to use computer totalling techniques to better understand the spread of contagious diseases and the potential impact of public health measures. The network's pandemic influenza modelling project involves simulating outbreaks of a deadly flu strain in different regions of the world and evaluating effects of various intervention measures, such as vaccination or school closures, on containing or slowing disease spread. The intent of the project is to help health officials and policymakers to further improve and streamline existing preparedness plans.

International collaboration, involving the US Department of Health and Human Services with the World Health Organization (WHO), the United Nations Food and Agriculture Organization, the World Organization for Animal Health, the Institute Pasteur, and numerous governments, further tracks the spread of the  H5N1 virus, conducts epidemiological studies of human infection, and trains local specialists for early and accurate detection.

At the national level, the Departments of Agriculture, Interior, and Health and Human Services are increasing the monitoring and testing of migratory birds in order to provide early warnings of an outbreak. Within the US. Centers for Disease Control and Prevention (CDC) and United States Aid for International Development (USAID) plans exist to enter into an agreement with the Wildlife Conservation Society to provide additional monitoring.

In the US, individual states are responsible for collecting surveillance data about various infectious diseases that, by law, must be reported by health-care providers and public health facilities. The Council of State and Territorial Epidemiologists determines the list of diseases selected for reporting, but individual states determine the extent of information beyond the number of new cases that is collected and reported. Every week, the National Notifiable Disease Surveillance System indexes cases collected from state health reporting which then are compiled by CDC. CDC is strengthening local laboratory capacity and capability, improving their reporting systems and accelerating implementation of the national BioSense Program which collects real-time data from hospitals and other clinical-data sources.

Although case definition/ clinical observation of avian flu remains an important surveillance tool, better and faster tools are needed to respond to a possible outbreak. In February 2006, the Food and Drug Adiminstration (FDA) approved a new laboratory test to detect and diagnose human infections with avian influenza, the Influenza A/H5 Virus Real-time RT-PCR Primer and Probe Set.  This test, developed by CDC, provides preliminary results on suspected H5 influenza samples within four hours of receiving the sample.  The new laboratory test is being distributed to Laboratory Response Network (LRN)- designated laboratories to enhance early detection and surveillance activities as well as increase laboratory response capacity associated with a potential pandemic. Domestically, the LRN is a system of about 140 laboratories in all 50 states with special experience and training in molecular testing methods, special boi-safety facilities and containment procedures as well as communication networks connected to public health programs across the country.

Developing vaccines In March 2005, NIAID initiated clinical trials for testing an experimental vaccine against the H5N1 virus. The trial vaccine, developed from inactivated H5N1 viruses (reference virus) isolated in Southeast Asia in 2004, was tested in 451 healthy adults ages 18 to 64 to evaluate safety and immunogenicity. Preliminary results showed that the vaccine induced an immune response predictive of protection against the H5N1 virus. A similar trial of the H5N1 vaccine in persons 65 and older, which began in October 2005, has completed recruitment. Another similar trial in children ages two through nine years old opened in January 2006 and has also completed recruitment. However, H5N1 strains from human infections have shown that the virus has mutated and variants of H5N1 strains have emerged (antigenic drift). CDC has started developing a reference virus of a second distinct strain of H5N1 which is now circulating in Europe, Africa and parts of Asia.

In order to facilitate the development of vaccines and increase vaccine production capacity, the FDA in March 2006 released a draft guidance for clinical data needed for licensure of new pandemic influenza vaccines. It also outlined new accelerated approval guidelines which allow for evaluation based on biological indicators (e.g., the immune response to vaccine) likely to demonstrate effectiveness.  Congress adopted legislation (PREP Act) granting industry greater liability protection when meeting a declared public health emergency to further encourage vaccine research and production activity. The strategic goal is to manufacture 20 million courses (number of doses needed to treat one person) of pre-pandemic vaccine and to create the capacity to manufacture 300 million courses of vaccine within six months of a pandemic outbreak in the US.

In addition, recently an FDA advisory committee held meetings to discuss novel approaches to developing influenza vaccines such as using cell technology and recombinant manufacturing.  They also recommended frequent interactions with vaccine manufacturers to provide both scientific and regulatory guidance, as well as FDA preparation of material for testing the potency of new vaccines.

Stockpiling antivirals Currently, avian flu is treated with varying efficacy, using between one and four different antivirals: amantadine, rimantadine, oseltamivir, and zanamivir. However, CDC studies have shown resistance of the H5N1 virus to both amantadine and rimantadine. The US Department of Health and Human Services is building a national stockpile of 81 million courses of the two antiviral drugs shown to be effective against the H5N1 virus, Tamiflu (oseltamivir) and Relenza (zanamivir). By the end of 2008, HHS will purchase 50 million courses and subsidize the states' purchase of 31 million courses by 25%. Of the national goal of 81 million courses, 75 million courses are to treat 25% of the US population while 6 million courses are to be used to contain an intitial outbreak in the US. Antivirals will be assigned to states and territories on a per-capita basis.  HHS is currently discussing storage and distribution plans with the states (centrally versus locally located entities). Considering predictive resistance to viral drugs over time, HHS committed $200 million to the development of additional antiviral drugs and expects to award contracts for the advanced development of promising antivirals by September 2006.

Coordinating federal, state and local preparation A state and local preparedness process was convened, based on the National Strategy for Pandemic Influenza directed by President Bush and the HHS Pandemic Influenza Plan.

This process involves political leaders at the state and local level, the private sector, church and school leaders and private individuals. In December 2005, Secretary Leavitt met with senior officals from all states and launched a series of preparedness summits to be held in every state. The goal of these summits is to enhance state and local preparedness. State preparedness plans should be consistent with the National Response Plan and the National Incident Management System. To date, 23 state pandemic planning summits have been completed.

It depends upon the source, but most recent estimates are up to 100 million with a huge part of that (up to 40 million) in India where there was a concurrent famine.

But, to the extent this has occurred, it has been very unusual.  The fact is that there is now a pandemic amongst birds across the world

What is the evidence for that?  There are still very, very few human cases.

Main points

Main objectives

These strategies are aimed at providing adequate and coherent planning assumptions for federal, state and local governments and public health operation to ensure an effective and efficient response to anticipated disruptions caused by an influenza pandemic.

Type of incentives

In December 2005, Congress passed the Defense Appropriations Bill which provides $3.8 billion for avian flu prepardness (sec 772). Funds totalling $3.3 billion are allocated to the Public Health and Social Services Emergency Fund to improve pandemic preparedness. Within that amount, $350 million is provided for upgrading state and local response capacity, particularly the planning and exercising of pandemic response plans by state and local officials. An initial grant of $100 million was awarded to the states in early January 2006 with each state receiving a minimum of $500,000, and additional allocation of funds by population. The remaining $250 million will be awarded later in the year according to benchmarks established to measure progress. $267 million are assigned for international activities, disease surveillance, vaccine registries, research, and clinical trials; and $50 million to increase laboratory capacity through the CDC.  

Groups affected

Federal, state and local government(s) and their agencies, public health communities, pharmaceutical industry

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral

Degree of innovation:  It took a long time to get the US government and state governments to do serious work on pandemic planning for influenza. In that sense the policy is innovative.

Degree of Controversy: Moderate - many think too much attention is being paid to what is only a "possible" pandemic.

Structural or Systemic Impact: This is a real plus - the US public health infrastructure has been very weak, as recognized from the time of 9/11.  Pandemic planning and the resources devoted to it should strengthen that infrastructure.

Public visibility: Moderately visible.  Most people are aware of the possibility of an influenza pandemic and the fact that planning is occurring.

Transferability: Significant - to the degree that much of the infrastructure can be used for other purposes - e.g., other emerging infectious diseases, bioterrorism, etc.

Political and economic background

As of today (March 13, 2006), H5N1 has spread to birds in 37 nations on three continents. More than 170 people have been infected and more than half of those infected died. CDC models conservatively indicate that a 'medium-level' influenza pandemic in the US could result in an estimated 89,000 to 207,000 deaths, 314,000 to 734,000 hospitalizations, and another 20 to 47 million people becoming ill. According to these models, the estimated economic impact would range from $71.3 to $166.5 billion in costs of medical care and value of lost workdays due to illness alone. Of all emerging infections, a global influenza pandemic is likely to result in widespread illness, death, and social disruption.  

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Initiators of idea/main actors

• Regierung

Approach of idea

The approach of the idea is described as:
new:

Actors and positions

Regierung
Policymakers (Congress, Department of Health and Human Services)	sehr unterstützend		stark dagegen
State and local governments	sehr unterstützend		stark dagegen
Pharmaceutical Industry	sehr unterstützend		stark dagegen

Actors and influence

Regierung
Policymakers (Congress, Department of Health and Human Services)	sehr groß		kein
State and local governments	sehr groß		kein
Pharmaceutical Industry	sehr groß		kein

Positions and Influences at a glance

Adoption and implementation

It is not clear that IT/ electronic surveillance systems are sufficiently advanced to support smooth policy implementation.  The decentralized structure of US administration of public health will probably foster problems in connecting policies/ initiatives of the Department of Health and Human Services with public health institutions, hospitals, and laboratories across the country, too.  These factors are likely to impede a coherent adoption and implementation process.

Review mechanisms

Halbzeitevaluation, Abschlussevaluation (intern), Abschlussevaluation (extern)

Dimensions of evaluation

Struktur, Prozess, Ergebnis

Results of evaluation

Not yet done.

Expected outcome

Any degree of preparedness for a pandemic is better than none.  The question is how much preparedness will the US be able to develop with the amounts being allocated?  That question, though it can be posed, cannot really be answered.  The only likely undesirable effect is that if a pandemic does not materialize in the near future, the public may weary of expending resources on preparation.  It will be argued, partially correctly, that pandemic preparation diverts resources from other immediate needs.  Ideally, the US government will commit to long term preparation for an influenza pandemic, whether or not it is the H5N1 virus that ultimately causes it and whether or not it occurs in the next 1-3 years.

Potentially significant - it will depend upon the degree to which cost-effective approaches to pandemic and interpandemic influenza are developed as a result of the increased funding in this area.

References

Sources of Information

Department of Health and Human Services, Centers For Disease Control and Prevention: Influenza. Internet address: www.cdc.gov/programs/infect07.pdf (accessed 03/24/2006).

Department of Health and Human Services: Pandemic Planning Update, A Report from Secretary Michael O. Leavitt, March 13, 2006. Internet address: www.pandemicflu.gov/plan/pdf/panflu20060313.pdf (accessed 03/24/2006)

Edler, A.., Avian flu (H5N1): its epidemiology, prevention, and implications for anaesthesiology, in: Journal of Clinical Anaesthesia (2006) 18, 1-4.

Homeland Security Council: National Strategy For Pandemic Influenza, November 2005. Internet address: www.whitehouse.gov/homeland/pandemic-influenza.html (accessed 02/15/2006)

Meltzer M. I. et al., The Economic Impact of Pandemic Influenza in the United States: Priorities for Intervention. Internet address: www.cdc.gov/ncidod/eid/vol5no5/meltzer.htm (accessed 04/04/06)

National Defense Authorization Act for Fiscal Year 2006. Internet address:  http://thomas.loc.gov/cgi-bin/query/C?c109:./temp/~c109zGfxoB (accessed 03/24/2006)

National Institutes of Health (NIH): NIAID Initiates Trial of Experimental Avian Flu Vaccine, March 23, 2005. Internet address: www.cdc.gov/flu/avian/gen-info.vaccines.htm (accessed 03/20/2006)

The House of Representatives, Committee On Appropriations: Conferees Approve Defense-Disaster Assistance-Avian Flu Preparedness Package, December 18, 2005. Internet address: http://appropriations.house.gov/index.cfm?FuseAction=PressReleases.Detail&PressRelease_id=538&Month=12&Year=2005 (accessed 03/24/2006)

U.S. Food and Drug Administration, FDA News, March 2, 2006: FDA Initiatives Helps Expedite development of seasonal and Pandemic Flu Vaccines. Internet address: www.fda.gov/bbs/topics/NEWS/2006/NEW01330.html (accessed 03/26/2006)

United States Department of Health & Human Services, News Release: FDA Approves New Laboratory Test To Detect Human Infections With Avian Influenza A/H5 Viruses. Internet address: www.hhs.gov/news/press/2006pres/20060203.html (accessed 02/15/2006)

United States Department of Health & Human Services, News Release: HHS Announces $100 Million to Accelerate State and Local Pandemic Influenza Preparedness Efforts. Internet address: www.hhs.gov/news/press/2006pres/20060112.html (accessed 01/27/2006)

US Department of Health and Human Services: NIH News, National Institutes of Health, National Institute of General Medical Sciences (NIGMS): New Teams Join Network to Model Pandemic Flu, Other Infectious Outbreaks. Internet address: www.hih.gov/news/pr/feb2006/nigms-01.htm (accessed 2/15/2006)

Author/s and/or contributors to this survey

Brigitta Spaeth-Rublee, The Commonwealth Fund (reviewed by Steve C. Schoenbaum, MD, The Commonwealth Fund)

Empfohlene Zitierweise für diesen Online-Artikel:

Brigitta Spaeth-Rublee, The Commonwealth Fund (reviewed by Steve C. Schoenbaum, MD, The Commonwealth Fund). "Avian Flu Preparedness Planning". Health Policy Monitor, April 2006. Available at http://www.hpm.org/survey/us/c7/1