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National Strategy for Pandemic Influenza Implementation Plan One Year Summary

Limiting the Domestic Spread of a Pandemic and Mitigating Disease, Suffering, and Death

Should an influenza pandemic reach the United States, our primary focus will be to safeguard the health of the U.S. population. Our ability to accomplish this goal will require:(1) effective surveillance for influenza outbreaks, including improved diagnostic tests; (2) the rapid development, production, and distribution of vaccine; (3) the targeted and effective use of antiviral medications; (4) the application of community mitigationmeasures; (5) the expansion of hospital and medical care capability; and (6) effective communication of risk reduction strategies. Although we still have much to do in these areas, progress has been made on each of these fronts over the past year.

Enhancing Clinical Surveillance and Response

The U.S. Government is working to enhance the Nation's ability to detect and respond early and effectively to a pandemic, particularly through partnerships with State and local governments.

To better detect first cases of pandemic influenza in a community, the U.S. Government has provided resources to State and local health departments to increase the number of sentinel providers, to improve laboratory detection at public health laboratories, to support an influenza coordinator in each jurisdiction, and to educate clinicians to increase testing for and detection of influenza infection. The Sentinel Provider Network includes approximately 2,300 healthcare providers nationwide who report the number of weekly outpatient visits for influenza-like illness and submit specimens to State public health laboratories for influenza virus testing. This information helps identify emerging influenza strains and monitor disease patterns.

Since 2003, the Federal Government had designated $5 million per year for the States bordering Canada and Mexico to create and maintain an Early Warning Infectious Disease Surveillance System. This system is a unique collaboration of State, Federal, and international partners who work together to provide rapid and effective laboratory confirmation of urgent infectious disease case reports in the border regions of the United States, Canada, and Mexico. More recently, the border surveillance system has expanded to include, among other activities, 11 border pandemic influenza tabletop exercises, which included testing response by local personnel to the arrival of inbound flights with ill passengers.

In partnership with the Council of State and Territorial Epidemiologists (CSTE), the Federal Government operates the National Notifiable Disease Surveillance System. Through this system, public health practitioners at local, State, and national levels provide weekly information about specific diseases occurring in the 50 States, 5 territories, New York City, and the District of Columbia. In January 2007, the CSTE adopted an interim position statement that added "novel influenza A virus infections" to its list of reportable diseases. This action will help activate timely and appropriate health responses to human infections that might have pandemic potential and meets WHO's International Health Regulations 2005 revision that member states report human infections with new human influenza viruses.

The U.S. Laboratory Response Network (LRN), which includes State public health laboratories, has the capacity to perform tests using the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) technique. All 50 States are prepared to conduct initial testing of suspectedhuman infection with H5N1 within 24 hours of receipt, using RT-PCR primers and probes developed and validated at the CDC. Reagents and protocols for testing for H5 influenza have been distributed to 99 LRN laboratories throughout the country.

The U.S. Government is also working to create a test that would, within 30 minutes, detect and differentiate seasonal influenza from highly pathogenic avian influenza H5N1. In November 2006, the Federal Government awarded contracts to four companies to develop new diagnostic tests that doctors and field epidemiologists could eventually use to quickly and accurately test patients for avian-origin H5N1 and other emerging influenza viruses, as well as more common influenza viruses.

The Federal Government has been working to ensure that both Emergency Medical Services (EMS) and 9-1-1 public safety answering points are well integrated into the Nation's pandemic influenza planning and response, as both are essential to the Nation's health and safety in the event of a pandemic. To accomplish this integration new guidelines and protocols for both EMS and 9-1-1 have been developed. Representatives from Federal agencies and national EMS, 9-1-1, and public health organizations jointly developed these new guidelines. Taken together, the two documents provide general guidance, considerations, and ideas that can enhance the optimal delivery of emergency care and 9-1-1 services during an influenza pandemic.

Expanding Vaccine Supply

If our containment efforts fail, a well-matched pandemic vaccine will be our most effective countermeasure during an influenza pandemic. However, the current global capacity to produce a vaccine to respond to an influenza pandemic is insufficient to meet global needs. Developing improved vaccines and novel vaccine technologies and enhancing vaccine production is a top priority. The U.S. Government is providing direct financial support to WHO to expand the development and manufacturing infrastructure for influenza vaccine in six key developing countries, which will give them the capability to manufacture safe and effective influenza vaccines for seasonal influenza, and for their own, and possibly regional, needs in the event of a pandemic.

It is the goal of the Federal Government to be able to vaccinate every American as rapidly as possible during a pandemic. To help accomplish this, the Federal Government is investing in the expansion of both egg- and cell-based vaccine manufacturing capacity, the advanced development of new cell-based vaccines, antigen-sparing technologies, and the establishment and maintenance of pre-pandemic vaccine stockpiles.

Licensed influenza vaccines are currently produced in special chicken eggs, in a technique that has changed little in over 50 years. In contrast, cell-based vaccine manufacturing, a technology that is used to produce other modern vaccines, holds the promise of a reliable, flexible, and scalable method of producing influenza vaccines. To help achieve this goal, the U.S. Government awarded over $1 billion in May 2006 to major influenza vaccine manufacturers to enable them, over the next 5 years, to produce at least 300 million courses of egg- and cell-based pandemic vaccine within 6 months of the emergence of a pandemic virus. This year, the U.S. Government will request proposals from commercial manufacturers for the advanced development of other technologies such as recombinant DNA vaccines that may be made more rapidly at the time of a pandemic. Not only will such vaccines further diversify our vaccine arsenal, these vaccine technologies have the potential to be manufactured faster than traditional vaccines.

In April 2007, the Federal Government approved the first vaccine for humans against the H5N1 avian-origin influenza virus. We currently have enough of this pre-pandemic H5N1 vaccine for approximately 6 million people, with plans to stockpile enough pre-pandemic vaccine for 20 million people. The approval and availability of this vaccine will enhance national readiness and the Nation's ability to protect those at increased risk of exposure. This vaccine could be used if the current H5N1 avian virus were to develop the capability for efficient, sustained spread among humans, resulting in the spread of the disease across the globe. Should the H5N1 virus lead to a pandemic, this vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced.

We are also investing heavily in the evaluation of adjuvants, which could allow us to greatly increase the number of people vaccinated with a limited supply of vaccine material. An adjuvant is a substance that may be added to a vaccine to increase the body's immune response to the vaccine's active ingredient, called antigen. Adjuvants are one of the most promising technologies, given that they could dramatically extend the reach of a limited supply of the pre-pandemic vaccine and expand the production of a well-matched pandemic vaccine when it becomes available. Contracts totaling $132.5 million were awarded in January 2007 to three vaccine makers for the advanced development of H5N1 influenza vaccines for humans using antigen-sparing techniques. Initial clinical studies from two of the vaccine manufacturers have shown that the addition of their adjuvants to H5N1 vaccines may increase the vaccine's efficacy 10- to 20-fold and may provide cross protection against variants of virus subtypes. Additional clinical studies are planned in 2007 for the H5N1 vaccine products with each of the three new adjuvants. If these results are confirmed, then these adjuvants offer hope that we will be able to stretch our pre-pandemic vaccine supplies and, in effect, increase our pandemic vaccine manufacturing capacity 10- to 20-fold.

At the beginning of a pandemic, the scarcity of vaccine will require the limited supply to be prioritized for distribution and administration. The Federal Government has begun a process to revise previous interim guidance for Federal, State, local, tribal, and territorial planners on groups to target for earlier access to pandemic vaccines. The U.S. Government has sought input from influenza experts, State and local public health officials, homeland security experts, ethicists, private sector stakeholders, and the public in developing this guidance.

Stockpiling Antiviral Medications

Antiviral medications are an important element of pandemic influenza preparedness. Our current national goal is to have 81 million courses of antiviral drugs in Federal and State stockpiles by 2008, of which 50 million regimens will be purchased and managed in Federal stockpiles and 31 million in State stockpiles. As of June 2007, the Strategic National Stockpile contains more than 35 million regimens of antiviral drugs with an additional 2 million regimens on order. Thus far, States have stockpiled over 13 million regimens of antiviral drugs. At this time all State and Federal stockpiles of antiviral medications should be reserved for treatment of symptomatic patients. As stockpiles of antiviral drugs increase, the strategies for use may be expanded to include prophylaxis. Additional guidance on prophylaxis strategies is being developed.

The Government's antiviral strategy includes not only stockpiling existing antiviral drugs, but also developing new antiviral medications to further broaden our capabilities to treat and prevent influenza. In January 2007, the Federal Government awarded a 4-year contract of over $100 million for advanced development of a new influenza antiviral drug that can be given by injection to rapidly treat persons with severe influenza.

Limiting the Spread and Impact of a Pandemic:Community Mitigation

There is no question that the United States and the world stand to benefit from the unprecedented investments in influenza vaccine production, but the reality is that it will be years before we have enough capacity to quickly produce enough pandemic vaccine for the entire population. Even then, the time required to produce a vaccine may exceed the duration of the first wave of a pandemic. This means that we must have a plan to deal with a pandemic that does not rely upon the immediate availability of a vaccine.

In February 2007, the U.S. Government released groundbreaking Federal guidance for non-pharmaceutical interventions for mitigating the impact of a pandemic. This community mitigation strategy is important because the best protection against pandemic influenza, a matched pandemic vaccine, is not likely to be available at the outset of a pandemic.

The impact of a poorly mitigated 1918-like pandemic today would be staggering. In the United States alone, we could face 90 million ill persons and nearly two million deaths. Recent scientific modeling and historical reviews of the 1918 pandemic suggest that non-pharmaceutical interventions could be very effective at slowing the spread of disease and mitigating the outbreak, but only if they are implemented early and maintained consistently across communities affected by a pandemic. We estimate that these interventions could dramatically reduce the number of people who become infected, potentially preventing illness and death in millions of Americans. Therefore, community mitigation measures will serve as a first line of defense to help delay or mitigate the spread of influenza.

These interventions include:

• Staying home if one is ill;
• Staying home if someone in one's household is ill;
• Dismissing students from school, closing childcare facilities, and keeping children home; and
• Reducing close contacts in the community and at work (i.e., social distancing).

These interventions are strengthened by the combining of these non-pharmaceutical interventions with antiviral medications and the layering of other infection control measures to reduce disease transmission, such as hand hygiene (frequent hand washing), respiratory etiquette (covering coughs and sneezes), and the use of facemasks.

The Community Mitigation Guidance also introduces a Pandemic Severity Index (PSI) for assessing the health threat posed by a pandemic virus. The index will allow us to tailor community mitigation interventions and balance the need to protect the public's health while minimizing societal and economic disruptions. The community mitigationstrategy was designed with input from many Federal agencies, State and local public health officials, researchers and mathematical modelers, healthcare and influenza experts, private sector entities, faith-based and community organizations, labor unions, educational stakeholders, and the public. The development from inception to adoption of a Federal policy on community mitigation within 9 months of the release of the National Plan underscores the level of commitment and coordination among government agencies with responsibility for emergency response.

Expanding Medical Capacity to Care for large Numbers of Ill Patients

A severe influenza pandemic would place a tremendous burden on the U.S. healthcare system. Estimates based on extrapolation of a severe 1918-like pandemic project that 45 million Americans would seek medical care with 10 million of those requiring hospitalization. The projected demand for inpatient and intensive care unit beds and mechanical ventilation services would overwhelm the Nation's healthcare system. Pre-pandemic planning by healthcare facilities is essential to prepare for the surge in medical care associated with a pandemic.

Coordinated community-wide and regional planning is needed for an optimal medical care response to a pandemic. An essential part of community and regional planning is the development and implementation of electronic systems that exchange information among hospitals and public health agencies to provide the needed situational awareness to manage patients, medical supplies, and staff during an influenza pandemic. The Federal Government has produced tools to assist in planning for improvements in hospital capacity during a pandemic. The Community Planning Guide for Providing Mass Medical Care with Scarce Resources offers specific recommendations for providing the highest possible standard of care where resources are limited. This guide addresses ethical and legal issues and offers recommendations across the spectrum of care, including pre-hospital, hospital, alternative care sites, and palliative care. Implementing these recommendations will help prevent degradation of care if large numbers of patients are seeking care in healthcare facilities.

Pre-hospital care and emergency response is a critical component of medical surge planning. EMS responders are a respected, well-trained, mobile healthcare workforce that exists in every community in the country and can be quickly dispatched when the public calls 9-1-1 for assistance. Because the Nation will rely on this workforce during an influenza pandemic, the Federal Government has developed new guidelines and protocols to enhance the delivery of EMS and 9-1-1 services during an influenza pandemic.

The Federal Government has incorporated both funding and guidance to ensure that public health and healthcare delivery partners throughout the country work together to strengthen public health and health system preparedness. Awardees of Federal Pandemic Influenza funding were required to hold exercises in the areas critical to expanding mass casualty care capability and health system preparedness, including:use of the Emergency System for Advanced Registration of Volunteer Health Professionals (ESAR-VHP), mass-fatality plans, communications systems, triage and admission plans, alternate care sites, and healthcare facility-level infection control. These activities support both pandemic and all-hazards preparedness.

As part of the joint effort to strengthen capacity within the healthcare and medical communities, funding has been directed to the purchase and storage of pharmaceutical caches, personal protective equipment, ventilators, and other critical medical materiel. In addition to these stockpiles, the Department of Veterans Affairs has more than 150 emergency pharmaceutical and medical caches around the Nation.

By reducing disease transmission and decreasing the number of Americans becoming ill, and therefore the number requiring hospitalization, community mitigation measures offer an additional strategy to help narrow the gap between existing acute care capacity in the United States and the surge demand for medical care. The community mitigation measures, as well as infection control practices such as hand hygiene and respiratory etiquette, can help lessen the strain on healthcare systems by focusing on the goal of reducing disease transmission.

Risk Communication

Effective risk and crisis communications will help guide the public, the news media, healthcare providers, and other groups to respond appropriately in outbreak situations and to adhere to public health measures. The website www.pandemicflu.gov, available in English, Spanish, Chinese, and Vietnamese, provides one-stop access to all Federal avian and pandemic influenza information. More than 1,700 websites around the world link to the PandemicFlu. Gov homepage.

In early 2007, the U.S. Government sponsored tabletop exercises with key media leaders and senior government officials in Atlanta, Chicago, Los Angeles, Miami, New York, and Washington, DC. These exercises facilitated effective two-way communication between the media and senior government officials about the challenges of delivering timely, accurate information to the public during a pandemic. In addition, the U.S. Government has delivered 10 Crisis and Emergency-Risk Communications courses to State and local officials, presenting and applying proven tools and approaches to the communication of crisis information.

In February 2007, the Federal Government launched a series of television and radio public service announcements (PSAs) to raise awareness of pandemic influenza and to educate members of the public about the steps they can take now to prepare. The PSAs, released under the brand "Know What to do About Pandemic Flu," were distributed to 300 television and 1,000 radio stations across the country. Basic collateral materials were developed to support the PSA campaign and have been posted on PandemicFlu.gov. As of May 21, 2007, the PSAs have been aired more than 20,000 times. Overseas, the U.S. Government has reached out to the estimated 4 to 5 million private U.S. citizens abroad through a variety of methods to provide information on individual pandemic preparedness measures. The Department of State, through its website (www.travel.state.gov), American community newsletters, warden messages, and town hall meetings, has conducted an aggressive outreach campaign to private U.S. citizens traveling and residing abroad.

In the event of a pandemic, the Federal Government will communicate to the public through both traditional and new media channels and will work with partners including the business community, faith-based and civic organizations, and healthcare providers to reach the general public with critical information on how to protect themselves and their loved ones.